Jay Shah

All Publications

• The effect of cisplatin-based neoadjuvant chemotherapy on the renal function of patients undergoing radical cystectomy. Canadian Urological Association journal = Journal de l'Association des urologues du Canada Ho, M. D., Black, A. J., Zargar, H., Fairey, A. S., Mertens, L. S., Dinney, C. P., Mir, M. C., Krabbe, L. M., Cookson, M. S., Jacobsen, N. E., Montgomery, J. S., Yu, E. Y., Xylinas, E., Kassouf, W., Dall'Era, M. A., Vasdev, N., Sridhar, S. S., McGrath, J. S., Aning, J., Holzbeierlein, J. M., Thorpe, A. C., Shariat, S. F., Wright, J. L., Morgan, T. M., Bivalacqua, T. J., North, S., Barocas, D. A., Lotan, Y., Grivas, P., Stephenson, A. J., Shah, J. B., van Rhijn, B. W., Daneshmand, S., Spiess, P. E., Black, P. C. 2023; 17 (10): 301-309

  Abstract

  Cisplatin-based neoadjuvant chemotherapy (NAC) is the standard of care for patients with muscle-invasive bladder cancer (MIBC) undergoing radical cystectomy (RC). Cisplatin, however, can induce renal toxicity. Furthermore, RC is an independent risk factor for renal injury, with decreases in estimated glomerular filtration rate (eGFR) of up to 6 mL/min/1.73 m2 reported at one year postoperatively. Our objective was to evaluate the effect of cisplatin-based NAC and RC on the renal function of patients undergoing both.We analyzed a multicenter database of patients with MIBC, all of whom received cisplatin-based NAC prior to RC. eGFR values were collected at time points T1 (before NAC), T2 (after NAC but before RC), and T3 (one year post-RC). eGFR and proportion of patients with eGFR <60 ml/min/1.73m2 (chronic kidney disease [CKD] stage ≥3) were compared between these time points. As all patients in this dataset had received NAC, we identified a retrospective cohort of patients from one institution who had undergone RC during the same time period without NAC for context.We identified 234 patients with available renal function data. From T1 to T3, there was a mean decline in eGFR of 17% (13 mL/min/1.73 m2) in the NAC cohort and an increase in proportion of patients with stage ≥3 CKD from 27% to 50%. The parallel cohort of patients who did not receive NAC was comprised of 236 patients. The mean baseline eGFR in this cohort was lower than in the NAC cohort (66 vs. 75 mL/min/1.73 m2). The mean eGFR decline in this non-NAC cohort from T1 to T3 was 6% (4 mL/min/1.73 m2), and the proportion of those with stage ≥3 CKD increased from 37% to 51%.Administration of NAC prior to RC was associated with a 17% decline in eGFR and a nearly doubled incidence of stage ≥3 CKD at one year after RC. Patients who underwent RC without NAC had a higher rate of stage ≥3 CKD at baseline but appeared to have less renal function loss at one year.

  View details for DOI 10.5489/cuaj.8570

  View details for PubMedID 37851909

  View details for PubMedCentralID PMC10581722

• A Leak in the System: Addressing the Environmental Impact of Urologic Care. European urology Kornberg, Z., Wu, J., Wilmot, H., Duffina, T., Shah, J. B. 2023

  Abstract

  As urologists we have an opportunity to reduce the carbon footprint of the procedures we perform. We highlight some areas of interest in urology and potential initiatives to reduce the energy and waste footprint of urology care. Urologists can and should make an impact on the growing climate crisis.

  View details for DOI 10.1016/j.eururo.2023.04.035

  View details for PubMedID 37225526

• Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept study. Patient safety in surgery Kang, H. S., Khoraki, J., Gie, J., Duval, D., Haynes, S., Siev, M., Shah, J., Kim, F., Mangino, M., Procter, L., Autorino, R., Weprin, S. 2023; 17 (1): 10

  Abstract

  BACKGROUND: Retained surgical sharps (RSS) is a "never event" that is preventable but may still occur despite of correct count and negative X-ray. This study assesses the feasibility of a novel device ("Melzi Sharps Finder" or MSF) in effective detection of RSS.METHODS: The first study consisted of determination of the presence of RSS or identification of RSS in an ex-vivo model (a container with hay in a laparoscopic trainer box). The second study consisted of determining presence of RSS in an in-vivo model (laparoscopy in live adult Yorkshire pigs) with 3 groups: C-arm, C-arm with MSF and MSF. The third study used similar apparatus though with laparotomy and included 2 groups: manual search and MSF.RESULTS: In the first study, the MSF group had a higher rate of identification of a needle and decreased time to locate a needle versus control (98.1% vs. 22.0%, p<0.001; 1.64min±1.12vs. 3.34min±1.28, p<0.001). It also had increased accuracy of determining the presence of a needle and decreased time to reach this decision (100% vs. 58.8%, p<0.001; 1.69min±1.43 vs. 4.89min±0.63, p<0.001). In-the second study, the accuracy of determining the presence of a needle and time to reach this decision were comparable in each group (88.9% vs. 100% vs. 84.5%, p<0.49; 2.2min±2.2 vs. 2.7min±2.1vs. 2.8min±1.7, p=0.68). In the third study, MSF group had higher accuracy in determining the presence of a needle and decreased time to reach this decision than the control (97.0% vs. 46.7%, p<0.001; 2.0min±1.5 vs. 3.9min±1.4; p<0.001). Multivariable analysis showed that MSF use was independently associated with an accurate determination of the presence of a needle (OR 12.1, p<0.001).CONCLUSIONS: The use of MSF in this study's RSS models facilitated the determination of presence and localization of RSS as shown by the increased rate of identification of a needle, decreased time to identification and higher accuracy in determining the presence of a needle. This device may be used in conjunction with radiography as it gives live visual and auditory feedback for users during the search for RSS.

  View details for DOI 10.1186/s13037-023-00359-8

  View details for PubMedID 37101230

• Association Between Antibiotic Prophylaxis Before Cystectomy or Stent Removal and Infection Complications: A Systematic Review. European urology focus Antonelli, L., Sebro, K., Lahmar, A., Black, P. C., Ghodoussipour, S., Hamilton-Reeves, J. M., Shah, J., Bente Thoft, J., Lerner, S. P., Llorente, C., Lucca, I., Preston, M. A., Psutka, S. P., Sfakianos, J. P., Vahr Lauridsen, S., Williams, S. B., Catto, J., Djaladat, H., Kassouf, W., Loftus, K., Daneshmand, S., Fankhauser, C. D. 2023

  Abstract

  Patients undergoing radical cystectomy frequently suffer from infectious complications, including urinary tract infections (UTIs) and surgical site infections (SSIs) leading to emergency department visits, hospital readmission, and added cost.To summarize the literature regarding perioperative antibiotic prophylaxis, ureteric stent usage, and prevalence of infectious complications after cystectomy.A systematic review of PubMed/Medline, EMBASE, Cochrane Library, and reference lists was conducted.We identified 20 reports including a total of 55 306 patients. The median rates of any infection, UTIs, SSIs, and bacteremia were 40%, 20%, 11%, and 6%, respectively. Perioperative antibiotic prophylaxis differed substantially between reports. Perioperative antibiotics were used only during surgery in one study but were continued over several days after surgery in all other studies. Empirical use of antibiotics for 1-3 d after surgery was described in 12 studies, 3-10 d in two studies, and >10 d in four studies. Time to stent removal ranged from 4 to 25 d after cystectomy. Prophylactic antibiotics were used before stent removal in nine of 20 studies; two of these studies used targeted antibiotics based on urine cultures from the ureteric stents, and the other seven studies used a single shot or 2 d of empirical antibiotics. Studies with any prophylactic antibiotic before stent removal found a lower median percentage of positive blood cultures after stent removal than studies without prophylactic antibiotics before stent removal (2% vs 9%).We confirmed a high proportion of infectious complications after cystectomy, and a heterogeneous pattern of choice and duration of antibiotics during and after surgery or stent removal. These findings highlight a need for further studies and support quality prospective trials.In this review, we observed wide variability in the use of antibiotics before or after surgical removal of the bladder.

  View details for DOI 10.1016/j.euf.2023.01.012

  View details for PubMedID 36710211

• Multicenter evaluation of neoadjuvant and induction gemcitabine-carboplatin versus gemcitabine-cisplatin followed by radical cystectomy for muscle-invasive bladder cancer. World journal of urology Einerhand, S. M., Black, A. J., Zargar, H., Fairey, A. S., Dinney, C. P., Mir, M. C., Krabbe, L. M., Cookson, M. S., Jacobson, N. E., Montgomery, J. S., Vasdev, N., Yu, E. Y., Xylinas, E., Kassouf, W., Dall'Era, M. A., Sridhar, S. S., McGrath, J. S., Aning, J., Shariat, S. F., Wright, J. L., Thorpe, A. C., Morgan, T. M., Holzbeierlein, J. M., Bivalacqua, T. J., North, S., Barocas, D. A., Lotan, Y., Grivas, P., Garcia, J. A., Stephenson, A. J., Shah, J. B., Daneshmand, S., Zargar-Shoshtari, K., Spiess, P. E., van Rhijn, B. W., Black, P. C., Mertens, L. S. 2022

  Abstract

  Cisplatin-based chemotherapy followed by radical cystectomy (RC) is recommended in patients with muscle-invasive bladder cancer (MIBC). However, up to 50% of patients are cisplatin ineligible. The aim of this study was to compare clinical outcomes after ≥ 3 cycles of preoperative gemcitabine-carboplatin (gem-carbo) versus gemcitabine-cisplatin (gem-cis).We identified 1865 patients treated at 19 centers between 2000 and 2013. Patients were included if they had received ≥ 3 cycles of neoadjuvant (cT2-4aN0M0) or induction (cTanyN + M0) gem-carbo or gem-cis followed by RC.We included 747 patients treated with gem-carbo (n = 147) or gem-cis (n = 600). Patients treated with gem-carbo had a higher Charlson Comorbidity Index (p = 0.016) and more clinically node-positive disease (32% versus 20%; p = 0.013). The complete pathological response (pCR; ypT0N0) rate did not significantly differ between gem-carbo and gem-cis (20.7% versus 22.1%; p = 0.73). Chemotherapeutic regimen was not significantly associated with pCR (OR 0.99 [95%CI 0.61-1.59]; p = 0.96), overall survival (OS) (HR 1.20 [95%CI 0.85-1.67]; p = 0.31), or cancer-specific survival (CSS) (HR 1.35 [95%CI 0.93-1.96]; p = 0.11). Median OS of patients treated with gem-carbo and gem-cis was 28.6 months (95%CI 18.1-39.1) and 45.1 months (95%CI 32.7-57.6) (p = 0.18), respectively. Median CSS of patients treated with gem-carbo and gem-cis was 28.8 months (95%CI 9.8-47.8) and 71.0 months (95%CI median not reached) (p = 0.02), respectively. Subanalyses of the neoadjuvant and induction setting did not show significant survival differences.Our results show that a subset of cisplatin-ineligible patients with MIBC achieve pCR on gem-carbo and that survival outcomes seem comparable to gem-cis provided patients are able to receive ≥ 3 cycles and undergo RC.

  View details for DOI 10.1007/s00345-022-04160-7

  View details for PubMedID 36169695

• Postoperative opioid-free ureteroscopy discharge: A quality initiative pilot protocol. Current urology Kasman, A. M., Schmidt, B., Spradling, K., Chow, C., Hunt, R., Wu, M., Sockol, A., Liao, J., Leppert, J. T., Shah, J., Conti, S. L. 2021; 15 (3): 176-180

  Abstract

  Background: Opioids are commonly prescribed after ureteroscopy. With an increasing adoption of ureteroscopy for management of urolithiasis, this subset of patients is at high risk for opioid dependence. We sought to pilot an opioid-free discharge protocol for patients undergoing ureteroscopy for urolithiasis.Materials and methods: A prospective cohort study was performed of all patients undergoing ureteroscopy for urolithiasis and compared them to a historical control group. An opioid-free discharge protocol was initiated targeting all areas of surgical care from June 20th, 2019 to September 20th, 2019 as part of an institutional quality improvement initiative. Demographic and surgical data were collected as were morphine equivalent doses (MEDs) prescribed at discharge, postoperative measures including phone calls, clinic visits, and emergency room visits for pain.Results: Between October 1st, 2017 and February 1st, 2018, a total of 54 patients who underwent ureteroscopy were identified and comprised the historical control cohort while 54 prospective patients met the inclusion criteria since institution of the quality improvement initiative. There were no statistically significant differences in baseline patient demographics or surgical characteristics between the 2 patient groups. Total 37% of the intervention group had a preexisting opioid prescription versus 42.6% of the control group with no difference in preoperative MED (p = 0.55). The intervention group had a mean MED of 12.03 at discharge versus 110.5 in the control cohort (p ≤ 0.001). At discharge 3.7% of the intervention group received an opioid prescription versus 88.9% of the control group (p < 0.001). Overall, there was no difference in postoperative pain related phone calls (p = 1.0) or emergency room visits (p = 1.0).Conclusions: An opioid-free discharge protocol can dramatically reduce opioid prescription at discharge following ureteroscopy for urinary calculi without affecting postoperative measures such as phone calls, clinic visits, or subsequent prescriptions.

  View details for DOI 10.1097/CU9.0000000000000025

  View details for PubMedID 34552459

• Identifying the Optimal Number of Neoadjuvant Chemotherapy Cycles in Patients with Muscle-Invasive Bladder Cancer. The Journal of urology D'Andrea, D., Black, P. C., Zargar, H., Dinney, C. P., Soria, F., Cookson, M. S., Montgomery, J. S., Kassouf, W., Dall'Era, M. A., Sridhar, S. S., McGrath, J. S., Wright, J. L., Thorpe, A. C., Holzbeierlein, J. M., Carrion, D. M., Di Trapani, E., Bivalacqua, T. J., North, S., Barocas, D. A., Lotan, Y., Grivas, P., Stephenson, A. J., van Rhijn, B. W., Daneshmand, S., Spiess, P. E., Shariat, S. F., Zargar-Shoshtar, K., Mertens, L. S., Fairey, A. S., Mir, M. C., Krabbe, L., Jacobsen, N., Vasdev, N., Yu, E. Y., Xylinas, E., Pradere, B., Pichler, R., Campain, N. J., Seah, J., Ercole, C. E., Horenblas, S., Aning, J., Morgan, T. M., Shah, J. B., Moschini, M. 2021: 101097JU0000000000002190

  Abstract

  PURPOSE: To investigate the pathologic response rates and survival associated with 3 versus 4 cycles of cisplatin-based NAC in patients with cT2-4N0M0 MIBC.MATERIAL AND METHODS: In this cohort study we analyzed clinical data of 828 patients treated with NAC and RC between 2000 and 2020. A total of 384 and 444 patients were treated with 3 and 4 cycles of NAC, respectively. Pathologic objective response (pOR; ypT0-Ta-Tis-T1 N0), pathologic complete response (pCR; ypT0 N0), cancer-specific survival (CSS) and overall survival (OS) were investigated.RESULTS: pOR and pCR were achieved in 378 (45%; 95%CI 42, 49) and 207 (25%; 95%CI 22, 28) patients, respectively. Patients treated with 4 cycles of NAC had higher pOR (49% vs 42%, p=0.03) and pCR (28% vs 21%, p=0.02) rates compared to those treated with 3 cycles. This effect was confirmed on multivariable logistic regression analysis (pOR OR 1.46 p=0.008, pCR OR 1.57,p=0.007). On multivariable Cox regression analysis, 4 cycles of NAC were significantly associated with OS (HR 0.68; 95%CI 0.49, 0.94; p=0.02) but not with CSS (HR 0.72; 95%CI 0.50, 1.04; p=0.08).CONCLUSIONS: 4 cycles of NAC achieved better pathologic response and survival compared to 3 cycles. These findings may aid clinicians in counselling patients and serve as a benchmark for prospective trials. Prospective validation of these findings and assessment of cumulative toxicity derived from an increased number of cycles are needed.

  View details for DOI 10.1097/JU.0000000000002190

  View details for PubMedID 34445891

• Association of age with response to preoperative chemotherapy in patients with muscle-invasive bladder cancer. World journal of urology D'Andrea, D., Black, P. C., Zargar, H., Zargar-Shoshtari, K., Soria, F., Fairey, A. S., Mertens, L. S., Dinney, C. P., Mir, M. C., Krabbe, L., Cookson, M. S., Jacobsen, N., Montgomery, J. S., Vasdev, N., Yu, E. Y., Xylinas, E., Campain, N. J., Kassouf, W., Dall'Era, M. A., Seah, J., Ercole, C. E., Horenblas, S., Sridhar, S. S., McGrath, J. S., Aning, J., Wright, J. L., Thorpe, A. C., Morgan, T. M., Holzbeierlein, J. M., Bivalacqua, T. J., North, S., Barocas, D. A., Lotan, Y., Grivas, P., Stephenson, A. J., Shah, J. B., van Rhijn, B. W., Daneshmand, S., Spiess, P. E., Shariat, S. F. 2021

  Abstract

  PURPOSE: To assess the association of patient age with response to preoperative chemotherapy in patients with muscle-invasive bladder cancer (MIBC).MATERIALS AND METHODS: We analyzed data from 1105 patients with MIBC. Patients age was evaluated as continuous variable and stratified in quartiles. Pathologic objective response (pOR; ypT0-Ta-Tis-T1N0) and pathologic complete response (pCR; ypT0N0), as well survival outcomes were assessed. We used data of 395 patients from The Cancer Genome Atlas (TCGA) to investigate the prevalence of TCGA molecular subtypes and DNA damage repair (DDR) gene alterations according to patient age.RESULTS: pOR was achieved in 40% of patients. There was no difference in distribution of pOR or pCR between age quartiles. On univariable logistic regression analysis, patient age was not associated with pOR or pCR when evaluated as continuous variables or stratified in quartiles (all p>0.3). Median follow-up was 18months (IQR 6-37). On Cox regression and competing risk regression analyses, age was not associated with survival outcomes (all p>0.05). In the TCGA cohort, patient with age≤60years has 7% less DDR gene mutations (p=0.59). We found higher age distribution in patients with luminal (p<0.001) and luminal infiltrated (p=0.002) compared to those with luminal papillary subtype.CONCLUSIONS: While younger patients may have less mutational tumor burden, our analysis failed to show an association of age with response to preoperative chemotherapy or survival outcomes. Therefore, the use of preoperative chemotherapy should be considered regardless of patient age.

  View details for DOI 10.1007/s00345-021-03793-4

  View details for PubMedID 34370078

• Utilizing time-driven activity-based costing to determine open radical cystectomy and ileal conduit surgical episode cost drivers. Urologic oncology Kukreja, J. B., Seif, M. A., Mery, M. W., Incalcaterra, J. R., Kamat, A. M., Dinney, C. P., Shah, J. B., Feeley, T. W., Navai, N. 2020

  Abstract

  OBJECTIVES: Patients undergoing radical cystectomy represent a particularly resource-intensive patient population. Time-driven activity based costing (TDABC) assigns time to events and then costs are based on the people involved in providing care for specific events. To determine the major cost drivers of radical cystectomy care we used a TDABC analysis for the cystectomy care pathway.SUBJECTS AND METHODS: We retrospectively reviewed a random sample of 100 patients out of 717 eligible patients undergoing open radical cystectomy and ileal conduit for bladder cancer at our institution between 2012 and 2015. We defined the cycle of care as beginning at the preoperative clinic visit and ending with the 90-day postoperative clinic visit. TDABC was carried out with construction of detailed process maps. Capacity cost rates were calculated and the care cycle was divided into 3 phases: surgical, inpatient, and readmissions. Costs were normalized to the lowest cost driver within the cohort.RESULTS: The mean length of stay was 6.9 days. Total inpatient care was the main driver of cost for radical cystectomy making up 32% of the total costs. Inpatient costs were mainly driven by inpatient staff care (76%). Readmissions were responsible for 29% of costs. Surgery was 31% of the costs, with the majority derived from operating room staff costs (65%).CONCLUSION: The major driver of cost in a radical cystectomy pathway is the inpatient stay, closely followed by operating room costs. Surgical costs, inpatient care and readmissions all remain significant sources of expense for cystectomy and efforts to reduce cystectomy costs should be focused in these areas.

  View details for DOI 10.1016/j.urolonc.2020.11.030

  View details for PubMedID 33308972

• Neoadjuvant chemotherapy plus radical cystectomy versus radical cystectomy alone in clinical T2 bladder cancer without hydronephrosis. BJU international Soria, F., Black, P. C., Fairey, A. S., Cookson, M. S., Yu, E. Y., Kassouf, W., Dall'Era, M. A., Sridhar, S. S., McGrath, J. S., Wright, J. L., Thorpe, A. C., Morgan, T. M., Daneshmand, S., Holzbeierlein, J. M., Bivalacqua, T. J., North, S., Barocas, D. A., Lotan, Y., Grivas, P., Stephenson, A. J., Shah, J. B., van Rhijn, B. W., Spiess, P. E., Shariat, S. F., Gontero, P. 2020

  Abstract

  OBJECTIVES: To assess the efficacy of neoadjuvant chemotherapy (NAC) before radical cystectomy (RC) in a retrospective multicenter patient cohort of patients with cT2N0M0 BCa without preoperative hydronephrosis.MATERIALS AND METHODS: This was a propensity-based analysis of 619 patients. Of these, 316 were treated with NAC followed by RC and 303 with upfront RC. After multiple imputations, inverse probability of treatment weighting (IPTW) was used to account for potential selection bias. Multivariable logistic regression analysis was performed to evaluate the impact of NAC on pathologic complete response and downstaging at RC, while IPTW-adjusted Kaplan-Meier curves and Cox regression models were built to evaluate the impact of NAC on overall survival (OS).RESULTS: After IPTW-adjusted analysis, standardized differences between groups were less than 15%. A complete response (pT0N0) at final pathology was achieved in 94 (30%) patients receiving NAC and 9 (3%) patients undergoing upfront RC. Downstaging to non-muscle invasive disease (

  View details for DOI 10.1111/bju.15289

  View details for PubMedID 33152179

• Critical Appraisal of Quality Improvement Publications in the Urological Literature UROLOGY PRACTICE Greenberg, D. R., Sohlberg, E. M., Shkolyar, E., Shah, J. B. 2020; 7 (5): 413–17

  View details for DOI 10.1097/UPJ.0000000000000119

  View details for Web of Science ID 000569064700023

• Critical Appraisal of Quality Improvement Publications in the Urological Literature. Urology practice Greenberg, D. R., Sohlberg, E. M., Shkolyar, E., Shah, J. B. 2020; 7 (5): 413-418

  Abstract

  Quality improvement efforts enable rapid improvement in health care by measuring, analyzing and controlling the delivery of patient care. However, publications on quality improvement initiatives often vary in quality, decreasing their impact and restricting adoption by other institutions. We aim to compare the number, quality and trends of quality improvement publications in the urological literature.PubMed®/MEDLINE® and EMBASE® were used to identify relevant quality improvement publications in the urological literature since 1999. Critical appraisal of each publication was performed using the Quality Improvement Minimum Quality Criteria Set.Inclusion criteria were met by 34 publications. Mean Quality Improvement Minimum Quality Criteria Set score ± SD was 10.8 ± 2.2 out of 16. Of the publications 44.1% (15) scored 10/16 or lower reflecting low quality. Only 8.8% (3) used the Standards for Quality Improvement Reporting Excellence. The majority of quality improvement publications consist of process rather than outcome or structural measures. The number of publications per year increased dramatically in 2015. However, average Quality Improvement Minimum Quality Criteria Set score before and after this time showed no change (p=0.88). Overall, 70.6% (24) of publications failed to report the quality improvement intervention's penetration/reach and 64.7% failed to report on a patient health related outcome.Critical appraisal of quality improvement publications in the urological literature indicates that the number of quality improvement publications is increasing over time. However, the reporting quality of quality improvement publications has stagnated. Adherence to reporting guidelines, quality standards and inclusion of all domains of the Quality Improvement Minimum Quality Criteria Set will potentially improve the quality of quality improvement publications and facilitate adoption of best practices in the field of urology.

  View details for DOI 10.1097/UPJ.0000000000000119

  View details for PubMedID 37296544

• NEOADJUVANT CHEMOTHERAPY PLUS RADICAL CYSTECTOMY VERSUS RADICAL CYSTECTOMY IN CT2 BLADDER CANCER: A MULTICENTER STUDY Giordano, A., Black, P., Fairey, A., Cookson, M., Yu, E., Kassouf, W., Dall'Era, M., Sridhar, S., McGrath, J., Wright, J., Thorpe, A., Morgan, T., Daneshmand, S., Holzbeierlein, J., Bivalacqua, T., North, S., Barocas, D., Lotan, Y., Grivas, P., Stephenson, A., Shah, J., Van Rhijn, B., Spiess, P., Shariat, S., Soria, F., Gontero, P. INT INST ANTICANCER RESEARCH. 2020: 4636–37

  View details for Web of Science ID 000554889000090

• The Impact of Early Exposure to Urology: Evaluation of an Introductory Preclinical Course UROLOGY PRACTICE Greenberg, D. R., Conti, S. L., Shah, J. B. 2020; 7 (4): 322–27

  View details for DOI 10.1097/UPJ.0000000000000090

  View details for Web of Science ID 000542493300024

• Reply by Authors. Urology practice Greenberg, D. R., Conti, S. L., Shah, J. B. 2020; 7 (4): 328

  View details for DOI 10.1097/UPJ.0000000000000090.02

  View details for PubMedID 37317431

• The Impact of Early Exposure to Urology: Evaluation of an Introductory Preclinical Course. Urology practice Greenberg, D. R., Conti, S. L., Shah, J. B. 2020; 7 (4): 322-328

  Abstract

  Early exposure in medical school can increase student interest in urology. The majority of medical students graduate without completing a clinical rotation in this field. The primary objectives of our study were to increase exposure to urology and to facilitate interactions between preclinical students and department faculty.A 7-week urology curriculum consisting of a weekly 1-hour class was introduced into the M.D. curriculum. Lectures were taught by faculty, fellows and resident physicians, and focused on the professional trajectory of the speaker, a career in urology, information on urological subspecialties and teaching points relevant to each topic. Pre/post surveys were administered to evaluate the effectiveness of the course.A total of 16 students enrolled in the course. Before this course the majority of students had less than 1 hour of teaching focused on urological topics. Informal exposure to urology was similar between preclinical students and graduating fourth year medical students (p >0.05). Post-course surveys showed that students had increased exposure to urology, greater opportunity to interact with residents, fellows and faculty, and overall they were satisfied with their course experience. Students who attended 4 or more courses reported they understood what a career in urology entails and had acquired the necessary information to decide whether to enroll in a clinical rotation in urology.This course increased exposure to urology among preclinical students and is a feasible addition to a standard medical school curriculum. Future studies will follow these students longitudinally and determine if this course increases student enrollment in urological clinical rotations and increases urology residency applications.

  View details for DOI 10.1097/UPJ.0000000000000090

  View details for PubMedID 37317454

• Clinical -Bladder cancer Impact of sex on response to neoadjuvant chemotherapy in patients with bladder cancer UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS D'Andrea, D., Black, P. C., Zargar, H., Zargar-Shoshtari, K., Zehetmayer, S., Fairey, A. S., Mertens, L. S., Dinney, C. P., Mir, M. C., Krabbe, L., Cookson, M. S., Jacobsen, N., Montgomery, J. S., Vasdev, N., Yu, E. Y., Xylinas, E., Campain, N. J., Kassouf, W., Dall'Era, M. A., Seah, J., Ercole, C. E., Horenblas, S., Sridhar, S. S., McGrath, J. S., Aning, J., Wright, J. L., Thorpe, A. C., Morgan, T. M., Holzbeierlein, J. M., Bivalacqua, T. J., North, S., Barocas, D. A., Lotan, Y., Grivas, P., Stephenson, A. J., Shah, J. B., van Rhijn, B. W., Daneshmand, S., Spiess, P. E., Shariat, S. F. 2020; 38 (7)

  View details for Web of Science ID 000542437900015

• Development of robust artificial neural networks for prediction of 5-year survival in bladder cancer. Urologic oncology Bhambhvani, H. P., Zamora, A., Shkolyar, E., Prado, K., Greenberg, D. R., Kasman, A. M., Liao, J., Shah, S., Srinivas, S., Skinner, E. C., Shah, J. B. 2020

  Abstract

  PURPOSE: When exploring survival outcomes for patients with bladder cancer, most studies rely on conventional statistical methods such as proportional hazards models. Given the successful application of machine learning to handle big data in many disciplines outside of medicine, we sought to determine if machine learning could be used to improve our ability to predict survival in bladder cancer patients. We compare the performance of artificial neural networks (ANN), a type of machine learning algorithm, with that of multivariable Cox proportional hazards (CPH) models in the prediction of 5-year disease-specific survival (DSS) and overall survival (OS) in patients with bladder cancer.SUBJECTS AND METHODS: The National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) 18 program database was queried to identify adult patients with bladder cancer diagnosed between 1995 and 2010, yielding 161,227 patients who met our inclusion criteria. ANNs were trained and tested on an 80/20 split of the dataset. Multivariable CPH models were developed in parallel. Variables used for prediction included age, sex, race, grade, SEER stage, tumor size, lymph node involvement, degree of extension, and surgery received. The primary outcomes were 5-year DSS and 5-year OS. Receiver operating characteristic curve analysis was conducted, and ANN models were tested for calibration.RESULTS: The area under the curve for the ANN models was 0.81 for the OS model and 0.80 for the DSS model. Area under the curve for the CPH models was 0.70 for OS and 0.81 for DSS. The ANN OS model achieved a calibration slope of 1.03 and a calibration intercept of -0.04, while the ANN DSS model achieved a calibration slope of 0.99 and a calibration intercept of -0.04.CONCLUSIONS: Machine learning algorithms can improve our ability to predict bladder cancer prognosis. Compared to CPH models, ANNs predicted OS more accurately and DSS with similar accuracy. Given the inherent limitations of administrative datasets, machine learning may allow for optimal interpretation of the complex data they contain.

  View details for DOI 10.1016/j.urolonc.2020.05.009

  View details for PubMedID 32593506

• POST-OPERATIVE OPIOID FREE URETEROSCOPY: A PROTOCOL PILOT STUDY Kasman, A., Schmidt, B., Spradling, K., Chow, C., Wu, M., Hunt, R., Sockol, A., Smith, H., Shah, J., Conti, S. LIPPINCOTT WILLIAMS & WILKINS. 2020: E162

  View details for Web of Science ID 000527010301291

• Radical cystectomy in women: Impact of the robot-assisted versus open approach on surgical outcomes. Urologic oncology Narayan, V. M., Seif, M. A., Lim, A. H., Li, R., Matulay, J. T., Kukreja, J. B., Qiao, W., Hwang, H., Shah, J. B., Pisters, L., Kamat, A. M., Dinney, C., Navai, N. 2020

  Abstract

  OBJECTIVES: To perform a comparison of complications following open versus robot-assisted radical cystectomy (RC) among women who undergo the procedure. Studies comparing robotic to open RC have been mixed without a clear delineation of which patients benefit the most from one modality vs. the other, leading to continued debate.PATIENTS AND METHODS: This was a retrospective study of women who underwent either open or robotic RC at the MD Anderson Cancer Center from 1/2014 to 6/2018. Co-morbidities, pathologic data, and complications were assessed with descriptive statistics, along with uni- and multivariable logistic regression.RESULTS: 122 women underwent either open (n = 76) or robotic (n = 46) RC. Open RC was associated with greater intraoperative blood loss (median EBL 775 ml vs. 300 ml, P < 0.001). In both uni- and multivariable analyses, open RC was associated with a greater odds of intraoperative transfusion compared to robotic RC (odds ratio 6.49, 95% CI 2.85-14.78, P < 0.001). Women undergoing open RC were also at greater odds of receiving 4 or more units of packed red blood cells (odds ratio 5.46 (1.75-17.02), P = 0.003). Robotic RC conferred a higher median lymph node yield (27 vs. 20 nodes, P, <0.001) and operative times (median 513 min vs. 391.5 min, P < 0.001). There were no differences in margin positivity, length of stay, or readmission rates at 30 and 90 days.CONCLUSIONS: Robotic RC was associated with a significantly lower risk of transfusion and EBL, and a higher median lymph node yield and operative time. Unique anatomic considerations may in part be responsible for these findings.

  View details for DOI 10.1016/j.urolonc.2019.12.005

  View details for PubMedID 31953001

• Bupivacaine local anesthetic to decrease opioid requirements after radical cystectomy: Does formulation matter? Urologic oncology Schmidt, B. n., Bhambhvani, H. P., Greenberg, D. R., Prado, K. n., Shafer, S. n., Thong, A. n., Gill, H. n., Skinner, E. n., Shah, J. B. 2020

  Abstract

  Reduction of opioids is an important goal in the care of patients undergoing radical cystectomy (RC). Liposomal bupivacaine (LB) has been shown to be a safe and effective pain reliever in the immediate postoperative period and has been reported to reduce postoperative opioid requirements. Since the liposomal formulation is predicated on slow systemic absorption, the amount of bupivacaine administered is notably higher than that typically used with standard bupivacaine (SB) formulations. In addition, LB is costly, not universally available, and studies comparing this formulation to SB are lacking. We sought to determine if there is a difference in postoperative opioid requirements in patients who receive LB vs. high dose SB at the time of RC.In May 2019 we transitioned to administration of high-volume SB injected intraoperatively at the time of RC. This prospective cohort was compared to a historical cohort of patients who received injection of LB at the time of surgery. Primary endpoints included postsurgical opioid use measured in morphine equivalent dose (MED) and patient-reported Numeric Rating Scale (NRS) pain scores and length of stay. All patients were managed using principles of enhanced recovery after surgery (ERAS).From May 2019 through August 2019, 28 patients underwent RC and met eligibility criteria to receive SB at the time of surgery. They were compared to a historical cohort of 34 patients who received LB between November 2017 and July 2018. There was no difference in MED exposure either in the postanesthesia care unit (SB 9.0 ± 8.9 MED vs. LB 6.5 ± 9.4 MED, P= 0.29) or during the remainder of the hospital stay (SB 36.8 ± 56.9 MED vs. LB 42.1 ± 102.5 MED, P= 0.81), no difference in NRS pain scores on postoperative day 1 (SB 2.6 ± 1.6 vs. LB 2.1 ± 1.7, P= 0.23), day 2 (SB 2.4 ± 1.8 vs. LB 1.9 ± 1.6, P= 0.19), or day 3 (SB 1.9 ± 1.8 vs. LB 1.7 ± 1.7, P= 0.69) and no difference in length of stay (SB 5.0 ± 1.7 days, LB 4.9 ± 3.3 days, P= 0.93). Subgroup analysis of open RC and robotic-assisted RC showed no significant difference in MED or pain scores between LB and SB patients.Among patients undergoing RC under ERAS protocol there was no significant difference in postoperative opioid consumption, NRS pain scores, or length of stay among patients receiving SB compared to LB.

  View details for DOI 10.1016/j.urolonc.2020.11.008

  View details for PubMedID 33303378

• Implementation of a Reduced Opioid Utilization Protocol for Radical Cystectomy BLADDER CANCER Greenberg, D. R., Kee, J. R., Stevenson, K., Van Zyl, E., Dugala, A., Prado, K., Gill, H. S., Skinner, E. C., Shah, J. B. 2020; 6 (1): 33–42

  View details for DOI 10.3233/BLC-190243

  View details for Web of Science ID 000523301600004

• Impact of sex on response to neoadjuvant chemotherapy in patients with bladder cancer. Urologic oncology D'Andrea, D. n., Black, P. C., Zargar, H. n., Zargar-Shoshtari, K. n., Zehetmayer, S. n., Fairey, A. S., Mertens, L. S., Dinney, C. P., Mir, M. C., Krabbe, L. M., Cookson, M. S., Jacobsen, N. E., Montgomery, J. S., Vasdev, N. n., Yu, E. Y., Xylinas, E. n., Campain, N. J., Kassouf, W. n., Dall'Era, M. A., Seah, J. A., Ercole, C. E., Horenblas, S. n., Sridhar, S. S., McGrath, J. S., Aning, J. n., Wright, J. L., Thorpe, A. C., Morgan, T. M., Holzbeierlein, J. M., Bivalacqua, T. J., North, S. n., Barocas, D. A., Lotan, Y. n., Grivas, P. n., Stephenson, A. J., Shah, J. B., van Rhijn, B. W., Daneshmand, S. n., Spiess, P. E., Shariat, S. F. 2020

  Abstract

  To assess the effect of patient's sex on response to neoadjuvant chemotherapy (NAC) in patients with clinically nonmetastatic muscle-invasive bladder cancer (MIBC).Complete pathologic response, defined as ypT0N0 at radical cystectomy, and downstaging were evaluated using sex-adjusted univariable and multivariable logistic regression modeling. We used interaction terms to account for age of menopause and smoking status. The association of sex with overall survival and cancer-specific survival was evaluated using Cox regression analyses.A total of 1,031 patients were included in the analysis, 227 (22%) of whom were female. Female patients had a higher rate of extravesical disease extension (P = 0.01). After the administration of NAC, ypT stage was equally distributed between sexes (P = 0.39). On multivariable logistic regression analyses, there was no difference between the sexes or age of menopause with regards to ypT0N0 rates or downstaging (all P > 0.5). On Cox regression analyses, sex was associated with neither overall survival (hazard ratio 1.04, 95% confidence interval 0.75-1.45, P = 0.81) nor cancer-specific survival (hazard ratio 1.06, 95% confidence interval 0.71-1.58, P = 0.77).Our study generates the hypothesis that NAC equalizes the preoperative disparity in pathologic stage between males and females suggesting a possible differential response between sexes. This might be the explanation underlying the comparable survival outcomes between sexes despite females presenting with more advanced tumor stage.

  View details for DOI 10.1016/j.urolonc.2020.01.010

  View details for PubMedID 32057595

• The prognostic value of the neutrophil-to-lymphocyte ratio in patients with muscle-invasive bladder cancer treated with neoadjuvant chemotherapy and radical cystectomy. Urologic oncology Black, A. J., Zargar, H., Zargar-Shoshtari, K., Fairey, A. S., Mertens, L. S., Dinney, C. P., Mir, M. C., Krabbe, L., Cookson, M. S., Jacobsen, N., Griffin, J., Montgomery, J. S., Vasdev, N., Yu, E. Y., Xylinas, E., Campain, N. J., Kassouf, W., Dall'Era, M. A., Seah, J., Ercole, C. E., Horenblas, S., McGrath, J. S., Aning, J., Shariat, S. F., Wright, J. L., Thorpe, A. C., Morgan, T. M., Holzbeierlein, J. M., Bivalacqua, T. J., North, S., Barocas, D. A., Lotan, Y., Grivas, P., Stephenson, A. J., Shah, J. B., van Rhijn, B. W., Spiess, P. E., Daneshmand, S., Sridhar, S. S., Black, P. C. 2019

  Abstract

  INTRODUCTION: The neutrophil-to-lymphocyte ratio (NLR) is an attractive marker because it is derived from routine bloodwork. NLR has shown promise as a prognostic factor in muscle invasive bladder cancer (MIBC) but its value in patients receiving neoadjuvant chemotherapy (NAC) before radical cystectomy (RC) is not yet established. Since NLR is related to an oncogenic environment and poor antitumor host response, we hypothesized that a high NLR would be associated with a poor response to NAC and would remain a poor prognostic indicator in patients receiving NAC.METHODS: A retrospective analysis was performed on patients with nonmetastatic MIBC (cT2-4aN0M0) who received NAC prior to RC between 2000 and 2013 at 1 of 19 centers across Europe and North America. The pre-NAC NLR was used to split patients into a low (NLR ≤ 3) and high (NLR > 3) group. Demographic and clinical parameters were compared between the groups using Student's t test, chi-squared, or Fisher's exact test. Putative risk factors for disease-specific and overall survival were analyzed using Cox regression, while predictors of response to NAC (defined as absence of MIBC in RC specimen) were investigated using logistic regression.RESULTS: Data were available for 340 patients (199 NLR ≤ 3, 141 NLR > 3). Other than age and rate of lymphovascular invasion, demographic and pretreatment characteristics did not differ significantly. More patients in the NLR > 3 group had residual MIBC after NAC than the NLR ≤ 3 group (70.8% vs. 58.3%, P = 0.049). NLR was the only significant predictor of response (odds ratio: 0.36, P = 0.003) in logistic regression. NLR was a significant risk factor for both disease-specific (hazard ratio (HR): 2.4, P = 0.006) and overall survival (HR:1.8, P = 0.02).CONCLUSION: NLR > 3 was associated with a decreased response to NAC and shorter disease-specific and overall survival. This suggests that NLR is a simple tool that can aid in MIBC risk stratification in clinical practice.

  View details for DOI 10.1016/j.urolonc.2019.09.023

  View details for PubMedID 31676278

• IMPLEMENTATION OF A REDUCED OPIOID UTILIZATION PROTOCOL FOR RADICAL CYSTECTOMY Greenberg, D., Kee, J., Stevenson, K., Van Zyl, E., Dugala, A., Prado, K., Gill, H., Skinner, E., Shah, J. LIPPINCOTT WILLIAMS & WILKINS. 2019: E1196–E1197

  View details for Web of Science ID 000473345204010

• ICUD-SIU International Consultation on Bladder Cancer 2017: management of non-muscle invasive bladder cancer WORLD JOURNAL OF UROLOGY Monteiro, L. L., Witjes, J., Agarwal, P. K., Anderson, C. B., Bivalacqua, T. J., Bochner, B. H., Boormans, J. L., Chang, S. S., Dominguez-Escrig, J. L., McKiernan, J. M., Dinney, C., Godoy, G., Kulkarni, G. S., Mariappan, P., O'Donnell, M. A., Rentsch, C. A., Shah, J. B., Solsona, E., Svatek, R. S., van der Heijden, A. G., van Valenberg, F. P., Kassouf, W. 2019; 37 (1): 51–60

  Abstract

  To provide a summary of the Third International Consultation on Bladder Cancer recommendations for the management of non-muscle invasive bladder cancer (NMIBC).A detailed review of the literature was performed focusing on original articles for the management of NMIBC. An international committee assessed and graded the articles based on the Oxford Centre for Evidence-based Medicine system. The entire spectrum of NMIBC was covered such as prognostic factors of recurrence and progression, risk stratification, staging, management of positive urine cytology with negative white light cystoscopy, indications of bladder and prostatic urethral biopsies, management of Ta low grade (LG) and high risk tumors (Ta high grade [HG], T1, carcinoma in situ [CIS]), impact of BCG strain and host on outcomes, management of complications of intravesical therapy, role of alternative therapies, indications for early cystectomy, surveillance strategies, and new treatments. The working group provides several recommendations on the management of NMIBC.Recommendations were summarized with regard to staging; management of primary and recurrent LG Ta and high risk disease, positive urine cytology with negative white light cystoscopy and prostatic urethral involvement; indications for timely cystectomy; and surveillance strategies.NMIBC remains a common and challenging malignancy to manage. Accurate staging, grading, and risk stratification are critical determinants of the management and outcomes of these patients. Current tools for risk stratification are limited but informative, and should be used in clinical practice when determining diagnosis, surveillance, and treatment of NMIBC.

  View details for PubMedID 30109483

• Reducing opioid utilization after urologic oncology surgery. Stevenson, K., Kee, J., Van Zyl, E., Dugala, A., Shah, J. AMER SOC CLINICAL ONCOLOGY. 2018

  View details for DOI 10.1200/JCO.2018.36.30_suppl.269

  View details for Web of Science ID 000464875300263

• Neurocognitive deficits in older patients with cancer. Journal of geriatric oncology Edwards, B. J., Zhang, X., Sun, M., Holmes, H. M., Ketonen, L., Guha, N., Khalil, P., Song, J., Kesler, S., Shah, J. B., Tripathy, D., Valero, V., Champlin, R. E. 2018; 9 (5): 482-487

  Abstract

  To assess cognitive function in older adults undergoing cancer care.This is a cross-sectional study, in the University of Texas MD Anderson Cancer Center, in older adults undergoing cancer care. Comprehensive geriatric assessments were conducted prior to surgery, chemotherapy or allogeneic stem cell transplantation, at the Program for Healthy Aging from January 1, 2013 through March 31, 2015. Cognitive assessment was conducted through personal and family interview, and the Montreal cognitive assessment (MoCA). Functional, physical, nutritional, social support, comorbidity assessment and medication review were conducted.Patients with mild cognitive impairment (MCI) or dementia were compared to patients who were cognitively intact.One hundred and ninety-two patients underwent geriatric assessment, mean (±SD) age was 78 ± 7 years, 121 (63%) had some degree of neurocognitive deficit, with 64 patients (33%) presenting with major neurocognitive deficit (dementia), and 57 cases (30%), minor neurocognitive deficit (MCI). Early stage dementia was evident in 50% of cases, moderate stage in 32%, and severe stage in 18%. The prevalence of dementia and MCI were higher than in the general population studies (70-79 years). Associated factors for neurocognitive deficits as compared to older patients with cancer with normal cognition, included a higher comorbidity index (p = 0.04), stroke (p = 0.03), metastatic disease (p = 0.04), and warfarin use (p = 0.03).Neurocognitive deficits (MCI and dementia) are more common in older adults with cancer. Factors associated with neurocognitive deficits include high comorbidity, stroke, warfarin use and metastatic cancer. Identification and management of these conditions is of great relevance in the course of cancer therapy.

  View details for DOI 10.1016/j.jgo.2018.02.010

  View details for PubMedID 29530493

• Absence of Tumor on Repeat Transurethral Resection of Bladder Tumor Does Not Predict Final Pathologic T0 Stage in Bladder Cancer Treated with Radical Cystectomy. European urology focus Kukreja, J. B., Porten, S., Golla, V., Ho, P. L., Noguera-Gonzalez, G., Navai, N., Kamat, A. M., Dinney, C. P., Shah, J. B. 2018; 4 (5): 720-724

  Abstract

  For patients with bladder cancer (BC) receiving neoadjuvant chemotherapy (NAC), complete pathologic absence of tumor (pT0) at radical cystectomy (RC) is associated with better survival. It is unclear if pT0 status can be attributed to the absence of residual disease (cT0) on transurethral resection of bladder tumor (TURBT) or to the effects of NAC.To determine how often cT0 is associated with pT0 and identify preoperative and postoperative factors associated with survival.Between 1995 and 2011, 157 out of 1897 RC patients were identified as stage cT0 after at least two TURBT procedures at a single center.RC with or without NAC.Initial TURBT pathology and clinical staging were reviewed. The primary endpoint was pathologic stage at RC. Cox proportional hazards ratios identified factors associated with residual disease at RC, overall survival (OS), recurrence-free survival (RFS), and disease-specific survival (DSS).Of the cT0 patients, 49.7% (n=78) underwent NAC. pT0 was found in 35.7% (n=56). Residual tumor was found at RC in 63.7% (n=101), of whom 24.8% (n=39) had advanced disease (≥pT3 or node-positive disease). Positive lymph nodes at RC were found in 12.7% (n=20) of the patients. There was no significant difference in achieving pT0 status between patients with and without NAC. The presence of advanced BC was most predictive of OS. NAC was associated with longer OS and RFS. During median follow-up of 6.3 yr, the 5-yr RFS was 81% for those with non-advanced disease and 46% for advanced BC (p<0.001). The 5-yr OS rate was 77% for non-advanced BC and 46% for invasive BC (p<0.001). Limitations include the retrospective design.Complete TURBT does not predict pT0 at RC. A notable fraction of patients with cT0 bladders have locally advanced and/or lymph node-positive disease. These findings may be of value when counseling patients on bladder preservation strategies for muscle-invasive BC.Among patients thought to have had the entire tumor in their bladder removed via cystoscopy, a majority have persistent tumors when their bladders were removed. In a sizable proportion, these persistent tumors were even more invasive than initially thought.

  View details for DOI 10.1016/j.euf.2016.12.005

  View details for PubMedID 28753837

• Determining the optimal time for radical cystectomy after neoadjuvant chemotherapy BJU INTERNATIONAL Mmeje, C. O., Benson, C. R., Nogueras-Gonzalez, G. M., Jayaratna, I. S., Gao, J., Siefker-Radtke, A. O., Kamat, A. M., Dinney, C. P., Navai, N., Shah, J. B. 2018; 122 (1): 89–98

  Abstract

  To determine whether the recovery window (RW) between neoadjuvant chemotherapy (NAC) and radical cystectomy (RC) affects 90-day postoperative morbidity and incidence of lymph node metastasis.We reviewed patients treated with NAC and RC from 1995 to 2013 for ≤cT4 N0 M0 bladder cancer. The association of the RW with 90-day perioperative morbidity and lymph node metastasis was determined. Generalised linear models were used to determine predictors of each endpoint. Patients were stratified into four RWs by 21-day intervals (18-42; 43-63; 64-84; and ≥85 days) from last day of NAC to RC.We evaluated 306 patients with RW information during the study period. The median (range) RW was 46 (18-199) days. There was no difference in overall morbidity, re-admission, or major complication rates amongst the four RWs. In the multivariable analysis extravesical disease was an independent predictor of overall morbidity (odds ratio [OR] 1.95, 95% confidence interval [CI] 1.16-3.26; P = 0.011). Age (OR 1.05, 95% CI: 1.02-1.09; P = 0.004), and surgical duration ≥7 h (OR 2.87, 95% CI: 1.52-5.42; P = 0.001) were independent predictors of major complications. Only surgical duration ≥7 h was a predictor of re-admission (OR 2.24; 95% CI: 1.26-3.98; P = 0.006). A RW of ≥85 days had the highest incidence of node-positive disease (pN+; 40%). In a separate multivariable model that included clinical predictors for pN+, a RW of ≥85 days was an independent predictor of nodal metastasis (OR 2.92, 95% CI: 1.20-7.09; P = 0.018).Patients treated with NAC for bladder cancer can undergo RC between 18 and 84 days (2.5-12 weeks) after NAC with no difference in the risk of perioperative morbidity. Delaying surgery beyond 12 weeks was associated with a significant risk of lymph node metastasis.

  View details for PubMedID 29569824

• Neoadjuvant Dose Dense MVAC versus Gemcitabine and Cisplatin in Patients with cT3-4aN0M0 Bladder Cancer Treated with Radical Cystectomy JOURNAL OF UROLOGY Zargar, H., Shah, J. B., van Rhijn, B. W., Daneshmand, S., Bivalacqua, T. J., Spiess, P. E., Black, P. C., Kassouf, W. 2018; 199 (6): 1453–59

  Abstract

  Level I evidence supports the usefulness of neoadjuvant cisplatin based chemotherapy for muscle invasive bladder cancer. Since dose dense MVAC (methotrexate, vinblastine, doxorubicin and cisplatin) has mostly replaced traditional MVAC, we compared pathological response and survival rates in patients with locally advanced bladder cancer who received neoadjuvant chemotherapy with dose dense MVAC vs gemcitabine and cisplatin.We retrospectively reviewed the records of patients with urothelial cancer who received neoadjuvant chemotherapy and underwent cystectomy at a total of 20 contributing institutions from 2000 to 2015. Patients with cT3-4aN0M0 disease were selected for this analysis. The rates of ypT0N0 and ypT1N0 or less were compared between the gemcitabine and cisplatin, and dose dense MVAC regimens. Two multivariable Cox proportional hazards regression models of overall mortality were generated using preoperative and postoperative data.Of the patients who underwent neoadjuvant chemotherapy and radical cystectomy during the study period 319 met our inclusion criteria. A significantly lower rate of ypT0N0 was observed in the gemcitabine and cisplatin arm than in the dose dense MVAC arm (14.6% vs 28.0%, p = 0.005). The rate of ypT1N0 or less was 30.1% for gemcitabine and cisplatin compared to 41.0% for dose dense MVAC (p = 0.07). The mean Kaplan-Meier estimates of overall survival in the gemcitabine and cisplatin, and dose dense MVAC groups were 4.2 and 7.0 years, respectively (p = 0.001). On multivariable cox regression analysis based on preoperative data patients who received gemcitabine and cisplatin were at higher risk for death than patients who received dose dense MVAC (HR 2.07, 95% CI 1.25-3.42, p = 0.003). Lymph node invasion (HR 1.97, 95% CI 1.15-3.36, p = 0.01) and hydronephrosis (HR 2.18, 95% CI 1.43-3.30, p <0.001) were also associated with higher risk of death.In our retrospective cohort of patients with locally advanced bladder cancer dose dense MVAC was associated with higher complete pathological response and improved survival rates compared to gemcitabine and cisplatin. A clinical trial is warranted to validate these hypothesis generating results to test the superiority of neoadjuvant dose dense MVAC in patients with locally advanced bladder cancer.

  View details for PubMedID 29329894

• Patient-Reported Outcomes Are Associated With Enhanced Recovery Status in Patients With Bladder Cancer Undergoing Radical Cystectomy Kukreja, J., Shi, Q., Chang, C. M., Seif, M. A., Sterling, B. M., Chen, T., Creel, K. M., Kamat, A. M., Dinney, C. P., Navai, N., Shah, J. B., Wang, X. SAGE PUBLICATIONS INC. 2018: 242–50

  Abstract

  Bladder cancer is a disease of the elderly that is associated with high morbidity in those treated with radical cystectomy. In this observational study of patients with bladder cancer undergoing radical cystectomy, we analyzed and compared patient-reported outcomes from those treated with Enhanced Recovery After Surgery (ERAS) methods versus those who received traditional perioperative care.We enrolled patients who underwent radical cystectomy at a high-volume tertiary care referral center from November 2013 to December 2016, when the ERAS concept was being introduced into postoperative care at our institution. Patients reported symptom outcomes using the MD Anderson Symptom Inventory preoperatively and on postoperative days 1 to 5. Mann-Whitney U tests were used to compare symptom burden between the ERAS and traditional-care groups. General linear mixed-effects models were used for longitudinal data; linear regression models were used for multivariable analysis.Patients (N = 383) reported dry mouth, disturbed sleep, drowsiness, fatigue, pain, and lack of appetite as the most severe symptoms. Compared with the traditional-care group, the ERAS group had significantly less pain (est. = -0.98, P = .005), drowsiness (est. = -0.91, P = .009), dry mouth (est. = -1.21, P = .002), disturbed sleep (est. = -0.97, P = .01), and interference with functioning (est. = -0.70, P = .022) (adjusted for age, sex, surgical technique, and neoadjuvant chemotherapy status).These results suggest that ERAS practice significantly reduced immediate postoperative symptom burden in bladder cancer patients recovering from radical cystectomy, supporting the use of patient-reported symptom burden as an outcome measure in perioperative care.

  View details for PubMedID 29557251

• Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study JOURNAL OF UROLOGY Daneshmand, S., Patel, S., Lotan, Y., Pohar, K., Trabulsi, E., Woods, M., Downs, T., Huang, W., Jones, J., O'Donnell, M., Bivalacqua, T., DeCastro, J., Steinberg, G., Kamat, A., Resnick, M., Konety, B., Schoenberg, M., Jones, J., Flexible Blue Light Study Grp 2018; 199 (5): 1158–86

  Abstract

  We compared blue light flexible cystoscopy with white light flexible cystoscopy for the detection of bladder cancer during surveillance.Patients at high risk for recurrence received hexaminolevulinate intravesically before white light flexible cystoscopy and randomization to blue light flexible cystoscopy. All suspicious lesions were documented. Patients with suspicious lesions were referred to the operating room for repeat white and blue light cystoscopy. All suspected lesions were biopsied or resected and specimens were examined by an independent pathology consensus panel. The primary study end point was the proportion of patients with histologically confirmed malignancy detected only with blue light flexible cystoscopy. Additional end points were the false-positive rate, carcinoma in situ detection and additional tumors detected only with blue light cystoscopy.Following surveillance 103 of the 304 patients were referred, including 63 with confirmed malignancy, of whom 26 had carcinoma in situ. In 13 of the 63 patients (20.6%, 95% CI 11.5-32.7) recurrence was seen only with blue light flexible cystoscopy (p <0.0001). Five of these cases were confirmed as carcinoma in situ. Operating room examination confirmed carcinoma in situ in 26 of 63 patients (41%), which was detected only with blue light cystoscopy in 9 of the 26 (34.6%, 95% CI 17.2-55.7, p <0.0001). Blue light cystoscopy identified additional malignant lesions in 29 of the 63 patients (46%). The false-positive rate was 9.1% for white and blue light cystoscopy. None of the 12 adverse events during surveillance were serious.Office based blue light flexible cystoscopy significantly improves the detection of patients with recurrent bladder cancer and it is safe when used for surveillance. Blue light cystoscopy in the operating room significantly improves the detection of carcinoma in situ and detects lesions that are missed with white light cystoscopy.

  View details for PubMedID 29203268

• Fractures frequently occur in older cancer patients: the MD Anderson Cancer Center experience. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer Edwards, B. J., Sun, M., Zhang, X., Holmes, H. M., Song, J., Khalil, P., Karuturi, M., Shah, J. B., Dinney, C. P., Gagel, R. F., Valero, V., Champlin, R. E., Tripathy, D., Murphy, W. A. 2018; 26 (5): 1561-1568

  Abstract

  A growing number of cancer patients are older adults aged 65 years and older. Patients with cancer are at increased risk for developing osteoporosis, falls, and fractures. We sought to identify the incidence of fractures in older adults who underwent cancer care between January 2013 and December 2015.A comprehensive geriatric assessment was performed, and bone densitometry was measured at baseline, with a 2-year follow-up.In this study, among 304 patients with gastrointestinal, urologic, breast, lung, and gynecologic cancers we evaluated, and who completed the bone density testing (n = 199), 80% had osteoporosis or low bone mass (osteopenia). There was a higher prevalence of osteoporosis in cancer patients (40 vs. 16%, p = 0.05) than in population studies. Vitamin D insufficiency (< 30 ng/ml) was identified in 49% of tested cases (n = 245). Risk factors for low bone mass or osteoporosis were advanced age (p = 0.05), malnutrition (p = 0.04), and frailty (p = 0.01). Over the following 2 years (median follow-up 18 months), there was an incidence of fractures of 110 per 1000 person-years, or 2.8 times higher than reported in individuals without cancer. Risk factors for fractures included advanced age (70-79 vs. 60-69 years, p = 0.05) and frailty (p = 0.03).Most older cancer patients studied have osteoporosis or low bone mass, resulting in an almost 3-fold increase in fracture risk as compared to epidemiologic studies. Bone health issues are commonly seen in older cancer patients, we recommend universal bone density testing. The initiation of antiresorptive treatment when findings are of osteopenia or osteoporosis will reduce the risk of fractures.

  View details for DOI 10.1007/s00520-017-3962-7

  View details for PubMedID 29197959

• Malnutrition in older patients with cancer: Appraisal of the Mini Nutritional Assessment, weight loss, and body mass index. Journal of geriatric oncology Zhang, X., Sun, M., McKoy, J. M., Bhulani, N. N., Valero, V., Barcenas, C. H., Popat, U. R., Sri, M. K., Shah, J. B., Dinney, C. P., Hedberg, A. M., Champlin, R., Tripathy, D., Holmes, H. M., Stroehlein, J. R., Edwards, B. J. 2018; 9 (1): 81-83

  View details for DOI 10.1016/j.jgo.2017.07.012

  View details for PubMedID 28844850

• Association of Distance to Treatment Facility With Survival and Quality Outcomes After Radical Cystectomy: A Multi-Institutional Study CLINICAL GENITOURINARY CANCER Haddad, A. Q., Hutchinson, R., Wood, E. L., Miranda, G., Gershman, B., Messer, J., Svatek, R., Black, P. C., Boorjian, S. A., Shah, J., Daneshmand, S., Lotan, Y. 2017; 15 (6): 689-+

  View details for DOI 10.1016/j.clgc.2017.05.006

  View details for Web of Science ID 000417112200040

• Association of Distance to Treatment Facility With Survival and Quality Outcomes After Radical Cystectomy: A Multi-Institutional Study. Clinical genitourinary cancer Haddad, A. Q., Hutchinson, R., Wood, E. L., Miranda, G., Gershman, B., Messer, J., Svatek, R., Black, P. C., Boorjian, S. A., Shah, J., Daneshmand, S., Lotan, Y. 2017; 15 (6): 689-695.e2

  Abstract

  We sought to determine the effect of the travel distance on mortality and quality outcomes after radical cystectomy in a large multi-institutional cohort.A total of 3957 patients who had undergone radical cystectomy for urothelial carcinoma at 6 North American tertiary care institutions were included. The association of travel distance with quality-of-care endpoints, 90-day mortality, and long-term survival were evaluated.The median patient age was 69 years (interquartile range, 61-76 years), and most patients were men (80%). Most patients had clinical stage T2 (45.2%) and T1 (24.7%) tumors. The median distance to the treatment facility was 102.9 miles (interquartile range, 24-271 miles). Patients residing in the first quartile of travel distance to treatment facility (< 24 miles) had lower usage of neoadjuvant chemotherapy compared with patients in the fourth distance quartile (adjusted odds ratio, 1.58; 95% confidence interval, 1.22-2.05; P = .001). Patients in the first distance quartile were also less likely to experience a delay in time to cystectomy (> 3 months) compared with patients with a greater travel distance (adjusted odds ratio, 0.673; 95% confidence interval, 0.532-0.851). Distance to the treatment facility was not associated with 90-day mortality or cancer-specific or all-cause mortality on multivariate analysis.Despite the potential health care disparities for bladder cancer patients residing distant to a regional surgical oncology facility, the study results suggest that the travel distance is not a barrier to appropriate oncologic care at regional tertiary care centers.

  View details for DOI 10.1016/j.clgc.2017.05.006

  View details for PubMedID 28558988

• Dose dense MVAC prior to radical cystectomy: a real-world experience. World journal of urology Zargar, H., Shah, J. B., van de Putte, E. E., Potvin, K. R., Zargar-Shoshtari, K., van Rhijn, B. W., Daneshmand, S., Holzbeierlein, J. M., Spiess, P. E., Winquist, E., Horenblas, S., Dinney, C., Black, P. C., Kassouf, W. 2017; 35 (11): 1729-1736

  Abstract

  Our primary endpoint was to assess pathological response rate (pT0N0 and ≤pT1N0) for patients with BCa treated with the accelerated or dose dense MVAC (ddMVAC) chemotherapy followed by radical cystectomy (RC) in this real-word multi-institutional cohort.We retrospectively reviewed records of patients with urothelial cancer who underwent ddMVAC and RC at seven contributing institutions from 2000 to 2015. Patients with cT2-4a, M0 BCa were included. Presence of cT3-4 disease, hydronephrosis, lymphovascular invasion and/or existence of sarcomatoid, or micropapillary features on the initial transurethral resection of bladder tumor specimen was defined as high-risk disease. Logistic regression models for prediction of pT0N0 and ≤pT1N0 were generated for the entire cohort as well as for the cN0 subgroup. The multivariable Cox proportional hazards regression model for survival using post RC data was used to assess hazard ratios (HRs) for the variables of interest.A total of 345 patients received ddMVAC chemotherapy during the study period; 85% had high-risk features. The median number of chemotherapy cycles was 4 (IQR 4-4); >90% of patients completed all scheduled cycles. The observed rates of pT0N0 and ≤pT1N0 were 30.4 and 49.3%, respectively, among cN0 patients. On the multivariable regression model, the presence of more than one clinical high-risk element was associated with 70% [OR 0.30 95% CI (0.10-0.86); p = 0.02] reduction in the odds of achieving partial pathological response.A complete response (pT0N0) was observed in one-third of patients after neoadjuvant ddMVAC therapy, and a partial response (≤pT1N0) was observed in nearly half of the cases in this real-world experience with this regimen. To our knowledge, this represents the largest experience outside clinical trial settings.

  View details for DOI 10.1007/s00345-017-2065-x

  View details for PubMedID 28625005

• Risk of hospitalisation after primary treatment for prostate cancer. BJU international Williams, S. B., Duan, Z., Chamie, K., Hoffman, K. E., Smith, B. D., Hu, J. C., Shah, J. B., Davis, J. W., Giordano, S. H. 2017; 120 (1): 48-55

  Abstract

  To compare the risk of hospitalisation and associated costs in patients after treatment for prostate cancer.We identified 29 571 patients aged 66-75 years without significant comorbidity from the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database who were diagnosed with localised prostate cancer between 2004 and 2009. We compared the rates of all-cause and treatment-related hospitalisation that occurred within 365 days of the initiation of definitive therapy. We used multivariable logistic regression analysis to identify determinants associated with hospitalisation.Men who underwent radical prostatectomy (RP) rather than radiotherapy (RT) had lower odds of being hospitalised for any cause after therapy [odds ratio (OR) 0.80, 95% confidence interval (CI): 0.74-0.87]. Patients who underwent RP rather than RT had higher odds of being hospitalised for treatment-related complications (OR 1.15, 95% CI: 1.03-1.29). However, men who underwent external beam RT (EBRT)/intensity modulated RT (IMRT) (OR 0.84, 95% CI: 0.72-0.99) had a 16% lower odds of hospitalisation from treatment-related complications than patients undergoing RP. Using propensity score-weighted analyses there was no significant difference in the odds of hospitalisation from treatment-related complications for men who underwent RP vs RT (OR 1.06, 95% CI: 0.92-1.21). Patients hospitalised for treatment-related complications after RT were costlier than patients who underwent RP (Mean $18 381 vs $13 203, P < 0.001).With the exception of men who underwent EBRT/IMRT, there was no statistically significant difference in the odds of hospitalisation from treatment-related complications. Costs from hospitalisation after treatment were significantly higher for men undergoing RT than RP. Our findings are relevant in the context of penalties linked to hospital readmissions and bundled payment models.

  View details for DOI 10.1111/bju.13647

  View details for PubMedID 27561186

  View details for PubMedCentralID PMC6089382

• Advances in surgical management of muscle invasive bladder cancer. Indian journal of urology : IJU : journal of the Urological Society of India Kukreja, J. B., Shah, J. B. 2017; 33 (2): 106-110

  Abstract

  Bladder cancer remains a disease of the elderly with relatively few advances that have improved survival over the last 20 years. Radical cystectomy (RC) has long remained the principal treatment for muscle-invasive bladder cancer (MIBC).A literature search of PubMed was performed. The content was reviewed for continuity with the topic of surgical advances in MIBC. Articles and society guidelines were included in this review.Despite the associated morbidity, even in the elderly, RC is still a reasonable option. Modifications during RC may have a positive or negative impact on survival and quality of life. The extent of pelvic lymph node dissection is one such factor which may positively impact survival outcomes. In addition, preservation of pelvic organs, robotic surgery and the adoption of enhanced recovery after surgery principles continues to improve the postoperative recovery and quality of life in RC patients.There are some ongoing studies in many of these areas, but overall the new advances in MIBC may improve patient quality and quantity of life. The advances in surgical treatment of MIBC are important and the focus of the review here.

  View details for DOI 10.4103/0970-1591.203416

  View details for PubMedID 28469297

  View details for PubMedCentralID PMC5396397

• Clinical risk stratification in patients with surgically resectable micropapillary bladder cancer. BJU international Fernández, M. I., Williams, S. B., Willis, D. L., Slack, R. S., Dickstein, R. J., Parikh, S., Chiong, E., Siefker-Radtke, A. O., Guo, C. C., Czerniak, B. A., McConkey, D. J., Shah, J. B., Pisters, L. L., Grossman, H. B., Dinney, C. P., Kamat, A. M. 2017; 119 (5): 684-691

  Abstract

  To analyse survival in patients with clinically localised, surgically resectable micropapillary bladder cancer (MPBC) undergoing radical cystectomy (RC) with and without neoadjuvant chemotherapy (NAC) and develop risk strata based on outcome data.A review of our database identified 103 patients with surgically resectable (≤cT4acN0 cM0) MPBC who underwent RC. Survival estimates were calculated using Kaplan-Meier method and compared using log-rank tests. Classification and regression tree (CART) analysis was performed to identify risk groups for survival.For the entire cohort, estimated 5-year overall survival and disease-specific survival (DSS) rates were 52% and 58%, respectively. CART analysis identified three risk subgroups: low-risk: cT1, no hydronephrosis; high-risk: ≥cT2, no hydronephrosis; and highest-risk: cTany with tumour-associated hydronephrosis. The 5-year DSS for the low-, high-, and highest-risk groups were 92%, 51%, and 17%, respectively (P < 0.001). Patients down-staged at RC

  View details for DOI 10.1111/bju.13689

  View details for PubMedID 27753185

• Papillary Recurrence of Bladder Cancer at First Evaluation after Induction Bacillus Calmette-Guerin Therapy: Implication for Clinical Trial Design EUROPEAN UROLOGY Mmeje, C. O., Guo, C. C., Shah, J. B., Navai, N., Grossman, H. B., Dinney, C. P., Kamat, A. M. 2016; 70 (5): 778-785

  Abstract

  Recurrence with papillary tumor(s) by 3-mo after induction bacillus Calmette-Guérin (BCG) is historically believed to be a poor prognostic indicator in patients with high-risk non-muscle invasive bladder cancer. However, the impact of a clinical Ta (cTa) papillary recurrence at 3 mo after BCG is often debated.To evaluate the prognostic implications of cTa papillary recurrence found 3 mo after induction BCG therapy and to evaluate its significance in clinical trial design.We reviewed our database of 917 patients who underwent transurethral resection and induction of BCG from 1995 to 2012. Clinical characteristics were compared between 3-mo recurrence stages.Transurethral resection of bladder tumor and intravesical therapy.Chi-square analysis and Student t test were used to compare clinical characteristics between 3-mo recurrence stages. Kaplan-Meier method was used to determine bladder-preservation time, progression-free survival, and disease-specific survival.We identified 84 patients who met the study criteria (66 patients with cTa and 18 patients with clinical T1 [cT1]). The median follow-up for the entire cohort was 74 mo. Of the patients with cTa recurrence, 60 continued with bladder-sparing therapy. Patients with a high-grade cTa recurrence who continued bladder-sparing therapy had a 17% incidence of disease progression and a 62% incidence of recurrence within 1 yr. No patients with low-grade cTa recurrence (n=13) developed disease progression or underwent radical cystectomy. Patients with an initial cTa at diagnosis had a higher 5-yr bladder preservation rate than those with an initial cT1 diagnosis (84% vs 61%; p=0.041). Patients with high-grade cTa recurrence and those with cT1 recurrence had similar outcomes with respect to death rates over the entire follow-up period (11% and 15%, respectively), as well as 5-yr progression-free survival (77% vs 83%). Limitations include using a single institution and a retrospective review.Patients with low-grade cTa papillary recurrence 3 mo after induction of BCG can safely continue with bladder-sparing therapy. Patients with high-grade cTa papillary recurrence at that time have risks of recurrence and progression similar to those of patients with cT1 recurrence. These are important factors to consider during clinical trial design.Low-grade clinical Ta papillary recurrence following induction of bacillus Calmette-Guérin therapy can be safely managed conservatively, although a high-grade clinical Ta recurrence should be treated similar to a clinical T1 recurrence due to its comparable progression rates.

  View details for DOI 10.1016/j.eururo.2016.02.031

  View details for Web of Science ID 000385515600020

  View details for PubMedID 26922408

  View details for PubMedCentralID PMC5115993

• Phase 1b Trial to Evaluate Tissue Response to a Second Dose of Intravesical Recombinant Adenoviral Interferon α2b Formulated in Syn3 for Failures of Bacillus Calmette-Guerin (BCG) Therapy in Nonmuscle Invasive Bladder Cancer. Annals of surgical oncology Navai, N., Benedict, W. F., Zhang, G., Abraham, A., Ainslie, N., Shah, J. B., Grossman, H. B., Kamat, A. M., Dinney, C. P. 2016; 23 (12): 4110-4114

  Abstract

  A phase 1b trial was conducted to evaluate the duration of interferon-alpha (IFNα) production after intravesical administration of recombinant adenovirus-mediated interferon α2b (Ad-IFN) formulated with the excipient Syn3. The primary aim was to determine whether a second instillation 3 days after initial treatment produced prolonged urinary IFN production.The study enrolled seven patients who experienced recurrent non-muscle invasive bladder cancer after bacillus Calmette-Guerin therapy. Each treatment consisted of intravesical instillation of SCH721015 (Syn3) and Ad-IFN at a concentration of 3 × 1011 particles/mL to a total volume of 75 mL given on days 1 and 4. The patients were followed for 12 weeks, during which the magnitude and duration of gene transfer were determined by urine INFα levels. Drug efficacy was determined by cystoscopy and biopsy, and patients who had no recurrence at 12 weeks were eligible for a second course of treatment.Seven patients were treated with an initial course (instillation on days 1 and 4). Two of the patients had a complete response at 12 weeks and received a second course of treatment. One patient remained without evidence of recurrence after a second course (total 24 weeks). One patient experienced a non-treatment-associated adverse event. Despite a transient rise in IFNα levels, sustained production was not demonstrated.Previously, Ad-IFNα intravesical therapy has shown promising drug efficacy. A prior phase 1 trial with a single instillation compared similarly with the current study, suggesting that a second instillation is not necessary to achieve sufficient urinary IFNα levels.

  View details for DOI 10.1245/s10434-016-5300-6

  View details for PubMedID 27387678

  View details for PubMedCentralID PMC5459317

• The Future of Enhanced Recovery for Radical Cystectomy: Current Evidence, Barriers to Adoption, and the Next Steps. Urology Danna, B. J., Wood, E. L., Baack Kukreja, J. E., Shah, J. B. 2016; 96: 62-68

  Abstract

  Radical cystectomy (RC) is a complex procedure that can involve long postoperative hospital stays and complicated, burdensome recoveries. Enhanced recovery after surgery is a broad term encompassing an overall approach to perioperative management of postsurgical patients and is becoming more widely accepted for cystectomy patients. This review examines the current evidence for using enhanced recovery protocols for RC as well as current rates of adoption of enhanced recovery among urologists performing RC. We also discuss the next steps for overcoming barriers to the widespread implementation of enhanced recovery for RC.

  View details for DOI 10.1016/j.urology.2016.04.038

  View details for PubMedID 27164287

• Assessing Symptom Burden in Bladder Cancer: An Overview of Bladder Cancer Specific Health-Related Quality of Life Instruments. Bladder cancer (Amsterdam, Netherlands) Danna, B. J., Metcalfe, M. J., Wood, E. L., Shah, J. B. 2016; 2 (3): 329-340

  Abstract

  Background: A key component to monitoring and investigating patient QOL is through patient reported health related quality of life (HRQOL) outcome measures. Many instruments have been used to assess HRQOL in bladder cancer and each instrument varies in its development, validation, the context of its usage in the literature and its applicability to certain disease states. Objective: In this review, we sought to summarize how clinicians and researchers should most appropriately utilize the available HRQOL instruments for bladder cancer. Methods: We performed a comprehensive literature search of each instrument used in bladder cancer, paying particular attention to the outcomes assessed. We used these outcomes to group the available instruments into categories best reflecting their optimal usage by stage of disease. Results: We found 5 instruments specific to bladder cancer, of which 3 are validated. Only one of the instruments (the EORTC-QLQ-NMIBC24) was involved in a randomized, prospective validation study. The most heavily used instruments are the EORTC-QLQ-BLM30 for muscle-invasive disease and the FACT-Bl which is used across all disease states. Of the 5 available instruments, 4 are automatically administered with general instruments, while the BCI lacks modularity, and requires co-administration with a generalized instrument. Conclusion: There are multiple strong instruments for use in gauging HRQOL in bladder cancer patients. We have divided these instruments into three categories which optimize their usage: instruments for use following NMIBC treatments (EORTC-QLQ-NMIBC24), instruments for use following radical cystectomy (FACT-Bl-Cys and EORTC-QLQ-BLM30) and more inclusive instruments not limited by treatment modality (BCI and FACT-Bl).

  View details for DOI 10.3233/BLC-160057

  View details for PubMedID 27500200

  View details for PubMedCentralID PMC4969686

• Disease reclassification risk with stringent criteria and frequent monitoring in men with favourable-risk prostate cancer undergoing active surveillance. BJU international Davis, J. W., Ward, J. F., Pettaway, C. A., Wang, X., Kuban, D., Frank, S. J., Lee, A. K., Pisters, L. L., Matin, S. F., Shah, J. B., Karam, J. A., Chapin, B. F., Papadopoulos, J. N., Achim, M., Hoffman, K. E., Pugh, T. J., Choi, S., Troncoso, P., Logothetis, C. J., Kim, J. 2016; 118 (1): 68-76

  Abstract

  To determine the frequency of disease reclassification and to identify clinicopathological variables associated with it in patients with favourable-risk prostate cancer undergoing active surveillance (AS).We assessed 191 men, selected by what may be the most stringent criteria used in AS studies yet conducted, who were enrolled in a prospective cohort AS trial. Clinicopathological characteristics were analysed in a multivariate Cox proportional hazards regression model. Key features were an extended biopsy with a single core positive for Gleason score (GS) 3 + 3 (<3 mm) or 3 + 4 (<2 mm) and a prostate-specific antigen (PSA) level <4 ng/mL (adjusted for prostate volume). Biopsies were repeated every 1-2 years and clinical evaluations every 6 months. Disease was reclassified when PSA level increased by 30% from baseline, or when biopsy tumour length increased beyond the enrolment criteria, more than one positive core was detected or any grade increased to a dominant 4 pattern or any 5 pattern.Disease was reclassified in 32 patients (16.8%) including upgrading to GS 4 + 3 in five patients (2.6%). The median (interquartile range) follow-up time among survivors was 3 (1.9-4.6) years. Overall, 13 of the 32 (40.6%) had incremental increases in GS. Tumour length (hazard ratio 2.95, 95% confidence interval [CI] 1.34-6.46; P = 0.007) and older age (hazard ratio 1.05, 95% CI 1.00-1.09; P = 0.05) were identified as significant and marginally significant predictors of disease reclassification, respectively. Disease remained stable in 83.2% of patients.The need persists for improvements in risk stratification and predictive indicators of cancer progression.

  View details for DOI 10.1111/bju.13193

  View details for PubMedID 26059275

  View details for PubMedCentralID PMC4808616

• Clinical and therapeutic factors associated with adverse pathological outcomes in clinically node-negative patients treated with neoadjuvant cisplatin-based chemotherapy and radical cystectomy. World journal of urology Zargar-Shoshtari, K., Zargar, H., Dinney, C. P., Ercole, C. E., Sharma, P., Kovac, E., Grivas, P. D., Stephenson, A. J., Shah, J. B., Black, P. C., Spiess, P. E. 2016; 34 (5): 695-701

  Abstract

  Several disease characteristics have been identified as potential predictors for pathological node involvement (pN+) following radical cystectomy (RC). However, these have not been assessed in patients treated with neoadjuvant chemotherapy (NAC). We endeavored to assess factors predicting adverse pathology in clinically node-negative patients treated with NAC and RC.Patients from four North American institutions with cT2-4aN0M0 UC who received three or four cycles of NAC followed by RC were selected. Logistic regression was used to predict pN+,

  View details for DOI 10.1007/s00345-015-1667-4

  View details for PubMedID 26286880

• Collaborating to Move Research Forward: Proceedings of the 10th Annual Bladder Cancer Think Tank. Bladder cancer (Amsterdam, Netherlands) Kamat, A. M., Agarwal, P., Bivalacqua, T., Chisolm, S., Daneshmand, S., Doroshow, J. H., Efstathiou, J. A., Galsky, M., Iyer, G., Kassouf, W., Shah, J., Taylor, J., Williams, S. B., Quale, D. Z., Rosenberg, J. E. 2016; 2 (2): 203-213

  Abstract

  The 10th Annual Bladder Cancer Think Tank was hosted by the Bladder Cancer Advocacy Network and brought together a multidisciplinary group of clinicians, researchers, representatives and Industry to advance bladder cancer research efforts. Think Tank expert panels, group discussions, and networking opportunities helped generate ideas and strengthen collaborations between researchers and physicians across disciplines and between institutions. Interactive panel discussions addressed a variety of timely issues: 1) data sharing, privacy and social media; 2) improving patient navigation through therapy; 3) promising developments in immunotherapy; 4) and moving bladder cancer research from bench to bedside. Lastly, early career researchers presented their bladder cancer studies and had opportunities to network with leading experts.

  View details for DOI 10.3233/BLC-169007

  View details for PubMedID 27376139

  View details for PubMedCentralID PMC4927866

• Final Pathological Stage after Neoadjuvant Chemotherapy and Radical Cystectomy for Bladder Cancer-Does pT0 Predict Better Survival than pTa/Tis/T1? The Journal of urology Zargar, H., Zargar-Shoshtari, K., Lotan, Y., Shah, J. B., van Rhijn, B. W., Daneshmand, S., Spiess, P. E., Black, P. 2016; 195 (4 Pt 1): 886-93

  Abstract

  We assessed survival dependent on pathological response after neoadjuvant chemotherapy in a large multicenter patient cohort, with a particular focus on the difference between the absence of residual cancer (pT0) and the presence of only nonmuscle invasive residual cancer (pTa, pTis, pT1).We retrospectively reviewed records of patients with urothelial cancer who received neoadjuvant chemotherapy and underwent radical cystectomy at 19 contributing institutions from 2000 to 2013. Patients with cT2-4aN0M0 and eventual pN0 disease were selected for this analysis. Estimated overall survival was compared between patients with pT0 and pTa/Tis/T1 disease. A multivariable Cox proportional hazards regression model for overall survival was generated to evaluate hazard ratios for variables of interest.Of 1,543 patients treated with neoadjuvant chemotherapy and radical cystectomy during the study period 257 had pT0N0 and 207 had pTa/Tis/T1N0 disease. The Kaplan-Meier mean estimates of overall survival for pT0 and pTa/Tis/T1 cases were 186.7 months (95% CI 145.9-227.6, median 241.1) and 138 months (95% CI 118.2-157.8, median 187.4), respectively (p=0.58). In the Cox proportional hazards regression model for overall survival pTa/Tis/T1N0 status (HR 0.36, 95% CI 0.23-0.67) and pT0N0 status (HR 0.28, 95% CI 0.17-0.47) compared to pT2N0 pathology, positive surgical margin (HR 1.75, 95% CI 1.07-2.86), and receiving a methotrexate, vinblastine, doxorubicin and cisplatin regimen compared to an "other" regimen (HR 0.45, 95% CI 0.27-0.76) were predictors of overall survival.pTa/Tis/T1N0 and pT0N0 stage on the final cystectomy specimen are strong predictors of survival in patients treated with neoadjuvant chemotherapy and radical cystectomy. We did not discern a statistically significant difference in overall survival when comparing these 2 end points.

  View details for DOI 10.1016/j.juro.2015.10.133

  View details for PubMedID 26521718

• Association between Perioperative Blood Transfusions and Clinical Outcomes in Patients Undergoing Bladder Cancer Surgery: A Systematic Review and Meta-Analysis Study. Journal of blood transfusion Cata, J. P., Lasala, J., Pratt, G., Feng, L., Shah, J. B. 2016; 2016: 9876394-?

  Abstract

  Background. Perioperative blood transfusions are associated with poor survival in patients with solid tumors including bladder cancer. Objective. To investigate the impact of perioperative blood transfusions on oncological outcomes after radical cystectomy. Design. Systematic review and meta-analysis. Setting and Participants. Adult patients who underwent radical cystectomy for bladder cancer. Intervention. Packed red blood cells transfusion during or after radical cystectomy for bladder cancer. Outcome Measurements and Statistical Analysis. Recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS). We calculated the pooled hazard ratio (HR) estimates and 95% confidence intervals by random and fixed effects models. Results and Limitation. Eight, seven, and five studies were included in the OS, CSS, and RFS analysis, respectively. Blood transfusions were associated with 27%, 29%, and 12% reduction in OS, CSS, and RFS, respectively. A sensitivity analysis supported the association. This study has several limitations; however the main problem is that it included only retrospective studies. Conclusions. Perioperative BT may be associated with reduced RFS, CSS, and OS in patients undergoing RC for BC. A randomized controlled study is needed to determine the causality between the administration of blood transfusions and bladder cancer recurrence.

  View details for DOI 10.1155/2016/9876394

  View details for PubMedID 26942040

  View details for PubMedCentralID PMC4752988

• A Multi-Institutional Analysis of Outcomes of Patients with Clinically Node Positive Urothelial Bladder Cancer Treated with Induction Chemotherapy and Radical Cystectomy. The Journal of urology Zargar-Shoshtari, K., Zargar, H., Lotan, Y., Shah, J. B., van Rhijn, B. W., Daneshmand, S., Spiess, P. E., Black, P. C. 2016; 195 (1): 53-9

  Abstract

  Selected patients with bladder cancer with pelvic lymphadenopathy (cN1-3) are treated with induction chemotherapy followed by radical cystectomy. However, the data on clinical outcomes in these patients are limited. In this study we assess pathological and survival outcomes in patients with cN1-3 disease treated with induction chemotherapy and radical cystectomy.Data were collected on patients from 19 North American and European centers with cT1-4aN1-N3 urothelial carcinoma who received chemotherapy followed by radical cystectomy between 2000 and 2013. The primary end points were pathological complete (pT0N0) and partial (pT1N0 or less) response rates, with overall survival as a secondary end point. Logistic regression and Cox proportional hazard ratios were used for multivariate analysis of factors predicting these outcomes.The total of 304 patients had clinical evidence of lymph node involvement (cN1-N3). Methotrexate/vinblastine/doxorubicin/cisplatin was used in 128 (42%), gemcitabine/cisplatin in 132 (43%) and other regimens in 44 (15%) patients. The pN0 rate was 48% (cN1-56%, cN2-39%, cN3-39%, p=0.03). The complete and partial pathological response rates for the entire cohort were 14.5% and 27%, respectively. The estimated median overall survival time for the cohort was 22 months (IQR 8.0, 54). On Cox regression analysis overall survival was associated with pN0, negative surgical margins, removal of 15 or more pelvic nodes and cisplatin therapy.Complete pathological nodal response can be achieved in a proportion of patients with cN1-3 disease receiving induction chemotherapy. The best survival outcomes are observed in male patients on cisplatin regimens with subsequent negative radical cystectomy margins and complete nodal response (pN0) with excision of 15 or more pelvic nodes.

  View details for DOI 10.1016/j.juro.2015.07.085

  View details for PubMedID 26205531

• Is Exam under Anesthesia Still Necessary for the Staging of Bladder Cancer in the Era of Modern Imaging? Bladder cancer (Amsterdam, Netherlands) Rozanski, A. T., Benson, C. R., McCoy, J. A., Green, C., Grossman, H. B., Svatek, R. S., Shah, J. B. 2015; 1 (1): 91-96

  Abstract

  The ability to accurately determine tumor stage in bladder cancer is critical because it impacts the management paradigm and overall prognosis. There is often discrepancy between clinical and pathologic staging. Historically, exam under anesthesia (EUA) has been recommended to assist in the staging of bladder cancer.In this era of modern imaging technology, we sought to determine if EUA still contributes meaningfully to the local staging of bladder cancer.We retrospectively reviewed the charts of 1898 patients from 1994-2013 in our radical cystectomy database at MD Anderson Cancer Center. There were 414 patients that had complete information including EUA and whose surgery was performed by one of two surgeons and included in the final analysis. Univariate and multiple logistic regression models were generated to determine the ability of EUA, imaging, and other patient characteristics to predict pathological fat extension at the time of cystectomy.38% of patients had≥pT3 disease at the time of cystectomy. 30.9% of patients had findings on EUA suggestive of T3 disease and 28.7% had radiologic findings suggestive of T3 disease. In a model including age, BMI, ethnicity, year of operation, and neoadjuvant chemotherapy among other factors, the only factors predictive of pT3 disease were EUA and imaging (p = 0.002). The combination of EUA and imaging improved the accuracy of clinical staging compared to either modality alone.Despite modern advances in imaging, EUA contributes meaningfully to accurate determination of local bladder cancer stage.

  View details for DOI 10.3233/BLC-150006

  View details for PubMedID 30561436

  View details for PubMedCentralID PMC6218177

• Multicenter assessment of neoadjuvant chemotherapy for muscle-invasive bladder cancer. European urology Zargar, H., Espiritu, P. N., Fairey, A. S., Mertens, L. S., Dinney, C. P., Mir, M. C., Krabbe, L. M., Cookson, M. S., Jacobsen, N. E., Gandhi, N. M., Griffin, J., Montgomery, J. S., Vasdev, N., Yu, E. Y., Youssef, D., Xylinas, E., Campain, N. J., Kassouf, W., Dall'Era, M. A., Seah, J. A., Ercole, C. E., Horenblas, S., Sridhar, S. S., McGrath, J. S., Aning, J., Shariat, S. F., Wright, J. L., Thorpe, A. C., Morgan, T. M., Holzbeierlein, J. M., Bivalacqua, T. J., North, S., Barocas, D. A., Lotan, Y., Garcia, J. A., Stephenson, A. J., Shah, J. B., van Rhijn, B. W., Daneshmand, S., Spiess, P. E., Black, P. C. 2015; 67 (2): 241-9

  Abstract

  The efficacy of neoadjuvant chemotherapy (NAC) for muscle-invasive bladder cancer (BCa) was established primarily with methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC), with complete response rates (pT0) as high as 38%. However, because of the comparable efficacy with better tolerability of gemcitabine and cisplatin (GC) in patients with metastatic disease, GC has become the most commonly used regimen in the neoadjuvant setting.We aimed to assess real-world pathologic response rates to NAC with different regimens in a large, multicenter cohort.Data were collected retrospectively at 19 centers on patients with clinical cT2-4aN0M0 urothelial carcinoma of the bladder who received at least three cycles of NAC, followed by radical cystectomy (RC), between 2000 and 2013.NAC and RC.The primary outcome was pathologic stage at cystectomy. Univariable and multivariable analyses were used to determine factors predictive of pT0N0 and ≤pT1N0 stages.Data were collected on 935 patients who met inclusion criteria. GC was used in the majority of the patients (n=602; 64.4%), followed by MVAC (n=183; 19.6%) and other regimens (n=144; 15.4%). The rates of pT0N0 and ≤pT1N0 pathologic response were 22.7% and 40.8%, respectively. The rate of pT0N0 disease for patients receiving GC was 23.9%, compared with 24.5% for MVAC (p=0.2). There was no difference between MVAC and GC in pT0N0 on multivariable analysis (odds ratio: 0.89 [95% confidence interval, 0.61-1.34]; p=0.6).Response rates to NAC were lower than those reported in prospective randomized trials, and we did not discern a difference between MVAC and GC. Without any evidence from randomized prospective trials, the best NAC regimen for invasive BCa remains to be determined.There was no apparent difference in the response rates to the two most common presurgical chemotherapy regimens for patients with bladder cancer.

  View details for DOI 10.1016/j.eururo.2014.09.007

  View details for PubMedID 25257030

  View details for PubMedCentralID PMC4840190

• Intravesical tumor involvement of the trigone is associated with nodal metastasis in patients undergoing radical cystectomy. Urology Svatek, R. S., Clinton, T. N., Wilson, C. A., Kamat, A. M., Grossman, H. B., Dinney, C. P., Shah, J. B. 2014; 84 (5): 1147-51

  Abstract

  To evaluate the influence of intravesical tumor location on nodal metastasis and mortality after cystectomy. The microvascular anatomy of the urinary bladder is variable in distinct regions of the bladder and thus tumor location may influence the tumors' ability to access lymphatic and vascular structures.An observational cohort study was conducted of all patients undergoing radical cystectomy at a single institution between January 2000 and July 2008. Tumor location was classified into the following 6 locations: lateral wall, posterior wall, anterior wall, trigone, dome, and bladder neck. The association between tumor location with nodal metastasis and cancer-specific mortality was assessed.A total of 545 patients were identified in this cohort. Location of tumor at the bladder trigone was associated with an increased likelihood of nodal metastasis on univariate (odds ratio, 1.63; 95% confidence interval [CI], 1.01-2.62) and multivariate (odds ratio, 1.83; 95% CI 1.11-2.99) analysis. In addition, trigone location was associated with a decreased cancer-specific survival on univariate (hazard ratio, 1.49; 95% CI, 1.03-2.16) and multivariate (hazard ratio, 1.68; 95% CI, 1.11-2.55) analysis.Patients with bladder tumor in the trigone have a greater risk of lymph node metastasis at cystectomy and decreased cancer-specific survival. Tumor location may be a useful prognostic factor in risk stratification of patients with invasive bladder cancer.

  View details for DOI 10.1016/j.urology.2014.05.011

  View details for PubMedID 25174656

• Physician variation in management of low-risk prostate cancer: a population-based cohort study. JAMA internal medicine Hoffman, K. E., Niu, J., Shen, Y., Jiang, J., Davis, J. W., Kim, J., Kuban, D. A., Perkins, G. H., Shah, J. B., Smith, G. L., Volk, R. J., Buchholz, T. A., Giordano, S. H., Smith, B. D. 2014; 174 (9): 1450-9

  Abstract

  Up-front treatment of older men with low-risk prostate cancer can cause morbidity without clear survival benefit; however, most such patients receive treatment instead of observation. The impact of physicians on the management approach is uncertain.To determine the impact of physicians on the management of low-risk prostate cancer with up-front treatment vs observation.Retrospective cohort of men 66 years and older with low-risk prostate cancer diagnosed from 2006 through 2009. Patient and tumor characteristics were obtained from the Surveillance, Epidemiology, and End Results cancer registries. The diagnosing urologist, consulting radiation oncologist, cancer-directed therapy, and comorbid medical conditions were determined from linked Medicare claims. Physician characteristics were obtained from the American Medical Association Physician Masterfile. Mixed-effects models were used to evaluate management variation and factors associated with observation.No cancer-directed therapy within 12 months of diagnosis (observation).A total of 2145 urologists diagnosed low-risk prostate cancer in 12,068 men, of whom 80.1% received treatment and 19.9% were observed. The case-adjusted rate of observation varied widely across urologists, ranging from 4.5% to 64.2% of patients. The diagnosing urologist accounted for 16.1% of the variation in up-front treatment vs observation, whereas patient and tumor characteristics accounted for 7.9% of this variation. After adjustment for patient and tumor characteristics, urologists who treat non-low-risk prostate cancer (adjusted odds ratio [aOR], 0.71 [95% CI, 0.55-0.92]; P = .01) and graduated in earlier decades (P = .004) were less likely to manage low-risk disease with observation. Treated patients were more likely to undergo prostatectomy (aOR, 1.71 [95% CI, 1.45-2.01]; P < .001), cryotherapy (aOR, 28.2 [95% CI, 19.5-40.9]; P < .001), brachytherapy (aOR, 3.41 [95% CI, 2.96-3.93]; P < .001), or external-beam radiotherapy (aOR, 1.31 [95% CI, 1.08-1.58]; P = .005) if their urologist billed for that treatment. Case-adjusted rates of observation also varied across consulting radiation oncologists, ranging from 2.2% to 46.8% of patients.Rates of management of low-risk prostate cancer with observation varied widely across urologists and radiation oncologists. Patients whose diagnosis was made by urologists who treated prostate cancer were more likely to receive up-front treatment and, when treated, more likely to receive a treatment that their urologist performed. Public reporting of physicians' cancer management profiles would enable informed selection of physicians to diagnose and manage prostate cancer.

  View details for DOI 10.1001/jamainternmed.2014.3021

  View details for PubMedID 25023650

  View details for PubMedCentralID PMC4372187

• Multi-institutional quality care initiative (QCI) to improve the care of patients with invasive bladder cancer (BlCa). Bochner, B. H., Feifer, A., Sperling, D., Mashni, J. W., Bajorin, D. F., Shah, J., Kamat, A. M., Steinberg, G. D., Stadler, W., Grubb, R. L., Kibel, A. S., Schoenberg, M., Black, P. C., Zlotta, A., Kassouf, W., Lerner, S. P., Lotan, Y., Collaborators BCAN Quality Care AMER SOC CLINICAL ONCOLOGY. 2014

  View details for DOI 10.1200/jco.2014.32.4_suppl.298

  View details for Web of Science ID 000335318100299

• Hiding in Plain View: Genetic Profiling Reveals Decades Old Cross Contamination of Bladder Cancer Cell Line KU7 with HeLa JOURNAL OF UROLOGY Jaeger, W., Horiguchi, Y., Shah, J., Hayashi, T., Awrey, S., Gust, K. M., Hadaschik, B. A., Matsui, Y., Anderson, S., Bell, R. H., Ettinger, S., So, A. I., Gleave, M. E., Lee, I., Dinney, C. P., Tachibana, M., McConkey, D. J., Black, P. C. 2013; 190 (4): 1404-1409

  Abstract

  KU7 is a popular urothelial carcinoma cell line that was isolated from the bladder of a patient at Keio University in 1980. It has subsequently been widely used in laboratories around the world. We describe how routine cell line authentication revealed that KU7 was cross contaminated almost 30 years ago with HeLa, a cervical carcinoma cell line.Presumed KU7 clones dating from 1984 to 1999 were provided by M.D. Anderson Cancer Center, Vancouver Prostate Centre, Kyoto University, Tokyo Medical University and Keio University. HeLa was obtained from ATCC. Genomic DNA was isolated and short tandem repeat analysis was performed at the M.D. Anderson Cancer Center Characterized Cell Line Core Facility, Johns Hopkins University Fragment Analysis Facility and RIKEN BioResource Center, Ibaraki, Japan. Comparative genomic hybridization was performed on a platform (Agilent Technologies, Santa Clara, California) at Vancouver Prostate Centre.The short tandem repeat profile of all KU7 clones was an exact match with that of HeLa. Comparative genomic hybridization of all samples revealed an abundance of shared chromosomal aberrations. Slight differences in some genomic areas were explained by genomic drift in different KU7 clones separated by many years.Our analysis identified that cross contamination of KU7 with HeLa occurred before 1984 at the source institution. All KU7 clones in the urological literature should be considered HeLa and experimental results should be viewed in this light. Our results emphasize the need to authenticate cell lines in oncological research.

  View details for DOI 10.1016/j.juro.2013.03.009

  View details for Web of Science ID 000325091700102

  View details for PubMedID 23500642

  View details for PubMedCentralID PMC3805942

• Neoadjuvant chemotherapy in small cell urothelial cancer improves pathologic downstaging and long-term outcomes: results from a retrospective study at the MD Anderson Cancer Center. European urology Lynch, S. P., Shen, Y., Kamat, A., Grossman, H. B., Shah, J. B., Millikan, R. E., Dinney, C. P., Siefker-Radtke, A. 2013; 64 (2): 307-13

  Abstract

  Small cell urothelial carcinoma (SCUC) is a rare, aggressive malignancy with a propensity for early microscopic metastases. Data suggest that neoadjuvant chemotherapy may lead to improved survival compared with initial surgery.To determine the influence of neoadjuvant chemotherapy on survival of SCUC patients in a large single-institution cohort.Between 1985 and 2010, 172 patients were treated for SCUC at MD Anderson Cancer Center (MDACC). Clinical, pathologic, and surgical data were collected and analyzed.Overall survival (OS) and disease-specific survival (DSS) were calculated using the Kaplan-Meier method. Multivariable Cox proportional hazards models were used to evaluate the effects of neoadjuvant chemotherapy on survival.Of 125 patients with resectable disease (≤ cT4aN0M0), 95 were surgical candidates. Forty-eight received neoadjuvant chemotherapy, and 47 underwent initial surgery. Neoadjuvant treatment was associated with improved OS and DSS compared with initial cystectomy (median OS: 159.5 mo vs 18.3 mo, p<0.001; 5-yr DSS: 79% vs 20%, p<0.001). Neoadjuvant chemotherapy resulted in pathologic downstaging to ≤ pT1N0 in 62% of tumors compared with only 9% treated with initial surgery (odds ratio: 44.55; 95% confidence interval, 10.39-191). Eight patients with clinically node-positive disease had surgical consolidation with cystectomy and extended lymph node dissection after clinical complete response to chemotherapy. Median OS and DSS in this group of patients were 23.3 mo and 21.8 mo, respectively, with 5-yr OS and DSS of 38%.Neoadjuvant chemotherapy is associated with a high rate of pathologic downstaging and correlates with significantly higher survival compared with historical expectations. Although limited by a small sample size and retrospective analysis, in the context of a rare disease, this experience suggests neoadjuvant chemotherapy as a standard approach in treating SCUC.

  View details for DOI 10.1016/j.eururo.2012.04.020

  View details for PubMedID 22564397

  View details for PubMedCentralID PMC3815632

• Strategies for optimizing bacillus Calmette-Guérin. The Urologic clinics of North America Shah, J. B., Kamat, A. M. 2013; 40 (2): 211-8

  Abstract

  For treating patients with superficial bladder cancer and a moderate-to-high risk of tumor recurrence or progression, intravesical BCG has been the key development of the last generation. However, BCG has also brought with it a novel set of challenges. An understanding of when, to whom, and how BCG should be given is critical if optimal outcomes are to be achieved. This article the authors reviews the role that BCG has played in the management of bladder cancer over the last several decades and discusses specific approaches to optimize BCG. It focuses on selection and technical strategies.

  View details for DOI 10.1016/j.ucl.2013.01.012

  View details for PubMedID 23540779

• Demographic analysis of randomized controlled trials in bladder cancer BJU INTERNATIONAL Bachir, B. G., Shariat, S. F., Zlotta, A., Svatek, R., Black, P. C., Shah, J. B., Kassouf, W., Bladder Canc Think Tank Bladder, Canadian Bladder Canc Network 2013; 111 (3): 419-426

  Abstract

  WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Results from well designed randomized controlled trials usually provide the strongest evidence possible in favour of one medical intervention over another. For this reason, it is of paramount importance to conduct such trials in bladder cancer, where randomized trials are lacking, in particular to answer questions that have so far confounded us or to investigate the efficacy of new diagnostic tools or interventions. This study provides a demographic analysis of randomized controlled trials published in bladder cancer between the years of 1995 and 2010, with only 238 articles identified. Less than one-third of these reported a statistical power calculation, and only 8% were double-blinded. With many publications inaccurately labelled as randomized trials, we reveal the scarcity of trials performed over the given time period, even compared with other cancers with similar incidence, and highlight the need for more well designed trials to be conducted.To demographically examine randomized controlled trials (RCTs) that have been conducted in bladder cancer over a predefined time period.Various techniques have been described to detect RCTs using different databases. We searched the MEDLINE database by crossing the heading 'Urinary bladder neoplasms' with the MeSHs 'Clinical trial$.mp. OR clinical trial.pt. OR random:.mp. OR tu.xs.' between 1995 and 2010. For the RCTs identified, analysis was performed on each RCT, placing particular emphasis on modality of intervention, cohort size, principal author, region, journal type, disease status, histology, blinding, number of centres involved, performance of a statistical power calculation, accrual status and trial support.Of 5002 RCT bladder cancer papers retrieved over the given period, only 238 represented actual RCTs after manual appraisal. More than half of the RCTs investigated medical and surgical therapies (54.2%), and only half had a sample size of >100 patients. A small percentage of studies were double-blinded (8.0%), and there was an almost equal distribution of multicentre vs single centre trials (54.6% vs 45.4%). More studies were conducted in Europe (61.3%) than the rest of the world combined, with urologists principally the lead investigators in the majority (72.3%). Most studies were conducted on patients with urothelial carcinoma (97.1%), with less than one-third reporting a statistical power calculation (31.5%).Only 238 RCTs were published for bladder cancer between 1995 and 2010. RCTs are under-utilized in bladder cancer. More trials need to be designed with larger sample sizes in order to optimize diagnostic and treatment strategies for patients with bladder cancer.

  View details for DOI 10.1111/j.1464-410X.2012.11401.x

  View details for Web of Science ID 000315395200027

  View details for PubMedID 22928764

• Robot-assisted extended pelvic lymph node dissection (PLND) at the time of radical prostatectomy (RP): a video-based illustration of technique, results, and unmet patient selection needs. BJU international Davis, J. W., Shah, J. B., Achim, M. 2011; 108 (6 Pt 2): 993-8

  Abstract

  • To describe the differences in technique and results between standard vs extended template pelvic lymph node dissection (PLND) at the time of radical prostatectomy (RP) using a robot-assisted (RA) technique.• Using extended templates illustrated for the open surgical technique, a RA technique was developed to solve obstacles related to surgical exposure, identification of key landmarks, proper sequencing of operative steps, and prevention of complicationsshown in the accompanying video. • From May 2006 to October 2007, 261 patients underwent a standard PLND, and from November 2007 to November 2010, 670 underwent an extended PLND (E-PLND) by one surgeon.• The lymph node (LN) yield increased from a median(interquartile range) of 8 (5-11) to 16 (11-21) with the extended technique (P < 0.001). • The ratio of positive LNs increased from 7% to 18%. Among E-PLND cases by risk group, positive LNs were found in 39%, 9%, and 3% of high-, intermediate-, and low-risk cases, and the later two groups strongly associated with upgrading and/or upstaging. • Extensive clipping appears necessary to avoid postoperative lymphoceles, and peritoneal fenestration for the extraperitoneal technique. • The median operative duration for E-PLND was 42 min, roughly double that of a standard PLND.• E-PLND is feasible with a RA technique, and increases the LN yield and positive LN ratio;the latter especially in high-risk disease. • The procedure takes twice as long and requires several updates in technique shown in the video.

  View details for DOI 10.1111/j.1464-410X.2011.10454.x

  View details for PubMedID 21917102

• New strategies in muscle-invasive bladder cancer: on the road to personalized medicine. Clinical cancer research : an official journal of the American Association for Cancer Research Shah, J. B., McConkey, D. J., Dinney, C. P. 2011; 17 (9): 2608-12

  Abstract

  Bladder cancer remains one of the most deadly and expensive diseases affecting modern society. The options currently available to patients with muscle-invasive bladder cancer have remained essentially unchanged for the last generation. As the roles for surgery and chemotherapy in the management of this lethal disease have become better defined, so too have the limitations of these two treatment modalities. Despite the lack of groundbreaking clinical advances over the past two decades, recent years have witnessed a notable increase in the amount of promising preclinical and early translational research that will greatly improve our understanding of the molecular underpinnings of bladder cancer. If this momentum in bladder cancer research continues to build, it is likely that in the next 5 to 10 years we will be able to achieve our goal of bringing bladder cancer treatment into the age of personalized medicine.

  View details for DOI 10.1158/1078-0432.CCR-10-2770

  View details for PubMedID 21415213

• Friend or foe? Role of peroxisome proliferator-activated receptor-gamma in human bladder cancer. Urologic oncology Inamoto, T., Shah, J. B., Kamat, A. M. 2009; 27 (6): 585-91

  Abstract

  The peroxisome proliferator-activated receptor (PPAR) family is an important group of transcription factors that regulates immune surveillance, cell proliferation, fatty acid regulation, and angiogenesis--functions which have all been implicated in the pathogenesis of bladder cancer. One particular subtype, PPARgamma, is expressed at higher levels in bladder cancer specimens than in benign urothelium, and is an attractive molecular target for the development of novel treatment strategies for bladder cancer. In this review, we summarize the data available regarding relevance of PPARgamma in bladder cancer and discuss the potential value of PPAR-targeted treatment of bladder cancer.

  View details for DOI 10.1016/j.urolonc.2008.11.002

  View details for PubMedID 19162510

• Prostate biopsy patterns in the CaPSURE database: evolution with time and impact on outcome after prostatectomy. The Journal of urology Shah, J. B., McKiernan, J. M., Elkin, E. P., Carroll, P. R., Meng, M. V. 2008; 179 (1): 136-40

  Abstract

  Significant variability exists in the urological community regarding the number of cores that should be taken during prostate biopsy. Using CaPSURE we determined trends in prostate biopsy patterns during the last decade and assessed whether changes in biopsy number have had an impact on outcomes after radical prostatectomy.In CaPSURE between 1995 and 2004 we identified 6,450 men with newly diagnosed prostate cancer who underwent biopsy with 6 cores or greater. The number of cores removed, number of cores positive for cancer and percent of cores containing cancer were analyzed by year of diagnosis. For 1,757 men who underwent radical prostatectomy these variables were entered into Cox proportional hazards models controlling for preoperative prostate specific antigen, biopsy Gleason sum and clinical stage to predict recurrence-free survival.The mean number of removed cores increased from 6.9 in 1995 to 10.2 in 2004 (p <0.0001). The mean number of positive cores remained unchanged from 2.9 in 1995 to 3.2 in 2004 (p = 0.40). The percent of positive cores decreased from 42.6% in 1995 to 32.1% in 2004 (p <0.0001). The number and percent of positive cores were associated with recurrence-free survival after radical prostatectomy throughout the study period (each p <0.001).The percent of positive cores is an independent predictor of disease recurrence after radical prostatectomy. The total number of tissue cores sampled increased during the last decade, thereby driving down the mean percent of positive cores from 42.6% to 32.1%. The trend toward an increasing number of removed cores may have contributed indirectly to improved outcomes after radical prostatectomy in the last decade.

  View details for DOI 10.1016/j.juro.2007.08.126

  View details for PubMedID 17997437

• Water under the bridge: 5-year outcomes after percutaneous ablation of obstructing parapelvic renal cysts. Journal of endourology Shah, J. B., Whitman, C., Lee, M., Gupta, M. 2007; 21 (10): 1167-70

  Abstract

  There have been no large case series reporting on the success of percutaneous transparenchymal endocystolysis for obstructing parapelvic renal cysts. We report the largest series to date with 5-year outcomes.Percutaneous endocystolysis was performed in eight patients with obstructing parapelvic cysts between September 1998 and May 2002. The patients ranged in age from 52 to 79 years. Each patient underwent preoperative CT and retrograde pyelography. Postoperative follow-up, ranging from 60 to 103 months (mean 83.9 months), has included both symptomatic and radiologic assessment.There were no intraoperative or postoperative complications. The mean operative time was 55 minutes (range 34-135 minutes). The mean decrease in the hematocrit was 2.7% (range 0.2-4.9%), with no patient requiring blood transfusion. The mean hospital stay was 1.3 days (range 1-2 days). Two patients have persistent small fluid-filled cysts but no clinical or radiographic evidence of obstruction. The six remaining patients have no evidence of symptomatic or radiographic recurrence.Percutaneous endocystolysis is an effective minimally invasive treatment option for obstructing parapelvic cysts and is associated with excellent 5-year outcomes.

  View details for DOI 10.1089/end.2007.9914

  View details for PubMedID 17949318

• Changes in prognostic significance and predictive accuracy of Gleason grading system throughout PSA era: Impact of grade migration in prostate cancer UROLOGY Mitchell, R. E., Shah, J. B., Desai, M., Mansukhani, M. M., Olsson, C. A., Benson, M. C., McKiernan, J. M. 2007; 70 (4): 706-710

  Abstract

  To describe the changes in the Gleason grading system over time and evaluate how a shift in Gleason grading has affected the overall predictive accuracy of the system in predicting biochemical disease-free survival after radical prostatectomy.The Columbia University Urologic Oncology Database was reviewed, and 1515 patients who met the inclusion criteria were identified who had undergone radical prostatectomy from 1988 to 2004. The patients were divided into two time cohorts (1988 to 1997 and 1998 to 2004). To determine whether a shift in the Gleason sum distribution has occurred, a chi-square test was performed. Survival curves and log-rank tests were used to compare the biochemical disease-free survival between cohorts stratified by the Gleason sum. To estimate the predictive ability of the Gleason system over time, concordance indexes were calculated.A shift toward greater Gleason sums over time was confirmed using the chi-square test (P <0.001). A significant difference was observed in biochemical disease-free survival between the two time cohorts for those with Gleason sum 6 cancer (P <0.01). The concordance indexes corresponding to Gleason sum alone for each time cohort were 0.71 and 0.87, demonstrating that the Gleason sum's predictive ability improved significantly over time. After adjusting for other variables, the Gleason sum continued to demonstrate a significantly improved predictive ability in the more recent time cohort.We found a trend toward the assignment of increasing Gleason sums over time in our data set. This shift in Gleason sum distribution between the two time cohorts has resulted in a significant improvement in the predictive ability of the Gleason system.

  View details for DOI 10.1016/j.urology.2007.06.1084

  View details for Web of Science ID 000251145400019

  View details for PubMedID 17707892

• New treatments for superficial bladder cancer. Current oncology reports Shah, J. B., Badalato, G. M., McKiernan, J. M. 2006; 8 (3): 201-5

  Abstract

  The successful treatment of bladder cancer remains a challenge for urologists and oncologists. Substantial changes have been made in the therapeutic options for the management of superficial bladder cancer in the past 5 years. We review the preclinical and clinical developments over the past year in bladder cancer therapeutics. A growing trend involves the use of multimodality treatments for all bladder cancers. For superficial disease, intravesical instillation of chemotherapeutic agents after transurethral resection is quickly becoming the standard of care. Novel therapeutic modalities under investigation include DNA vaccines, magnetically targeted carriers, bioadhesive microspheres, and antisense oligodeoxynucleotides. Treatment goals for superficial bladder cancer are complete removal of the initial tumor, prevention of disease recurrence, and inhibition of progression to invasive disease. The myriad novel therapeutic modalities under exploration suggest that these goals may be achievable within our lifetime.

  View details for PubMedID 16618384

• Preoperative serum prostate specific antigen remains a significant prognostic variable in predicting biochemical failure after radical prostatectomy JOURNAL OF UROLOGY Mitchell, R. E., Desai, M., Shah, J. B., Olsson, C. A., Benson, M. C., McKiernan, J. M. 2006; 175 (5): 1663-1667

  Abstract

  Multiple investigators have argued that PSA may no longer be an accurate marker of prostate cancer biology. We determined whether the impact of PSA in predicting biochemical failure after radical prostatectomy has changed since the beginning of the PSA era.A total of 1,246 patients were identified from the Columbia University Comprehensive Urological Oncology Database who underwent radical prostatectomy by 1 of 3 surgeons between 1988 and 2003. Cox proportional hazards models were fit to the data to estimate the impact of PSA (logPSA) in predicting BCF (PSA 0.2 ng/ml or greater). To determine if the predictive impact of PSA changed over time, patients were classified based on year of surgery, and an interaction term between PSA and time was included. Finally concordance indexes were estimated to determine if the predictive ability of PSA has changed over time.In a Cox model including PSA, year of surgery and a year/PSA interaction term, the impact of PSA appears to change over time (p = 0.002). However, when correcting for the effects of stage and grade there was no significant change in the impact of PSA. In addition, concordance analysis indicated that the predictive ability of PSA has remained constant throughout the PSA era (0.65, 0.66 and 0.64 for each period, respectively).This study demonstrates that the predictive ability of PSA as a cancer outcomes biomarker has not changed significantly since the beginning of the PSA era. Despite suggestions to the contrary, PSA remains an important variable in predicting risk of BCF after RP.

  View details for DOI 10.1016/S0022-5347(05)01022-0

  View details for Web of Science ID 000236928400016

  View details for PubMedID 16600724

• Does year of radical prostatectomy independently predict outcome in prostate cancer? Urology Mitchell, R. E., Shah, J. B., Olsson, C. A., Benson, M. C., McKiernan, J. M. 2006; 67 (2): 368-72

  Abstract

  To examine how the biochemical outcomes after radical prostatectomy (RP) have changed in the prostate-specific antigen (PSA) era when controlling for the effects of other prognostic variables. Since the beginning of the PSA era, the presentation, treatment, and therapeutic outcomes of prostate cancer have evolved.We reviewed the Columbia University Comprehensive Urologic Oncology Database and identified 1319 patients who had undergone RP without adjuvant therapy, performed by three surgeons, between 1988 and 2003 (minimal follow-up of 12 months). Univariate Cox proportional hazards models were used to determine which variables affect the hazard of biochemical failure (BCF), defined as a PSA level of 0.2 ng/mL or greater on at least two occasions, after RP. Multivariate analysis, controlling for the effects of other prognostic variables, was used to determine the effect that the year of surgery had on hazard of BCF.Univariate analysis confirmed the importance of the year of surgery, preoperative PSA level, pathologic stage, Gleason sum, and surgical margin status in estimating the hazard of BCF (P <0.001). Age at surgery did not have a statistically significant effect. A multivariate Cox model showed that the year of surgery had a highly significant impact on the hazard of BCF even when controlling for PSA, stage, Gleason sum, and surgical margin status.Patients undergoing RP in more recent years are at significantly less risk of BCF compared with patients who underwent surgery earlier in the PSA era, even when controlling for the effects of other prognostic variables. The factors that account for this change in outcomes over time have yet to be identified.

  View details for DOI 10.1016/j.urology.2005.08.036

  View details for PubMedID 16461087

• Hypogonadism and metabolic syndrome: implications for testosterone therapy. The Journal of urology Makhsida, N., Shah, J., Yan, G., Fisch, H., Shabsigh, R. 2005; 174 (3): 827-34

  Abstract

  Metabolic syndrome, characterized by central obesity, insulin resistance, dyslipidemia and hypertension, is highly prevalent in the United States. When left untreated, it significantly increases the risk of diabetes mellitus and cardiovascular disease. It has been suggested that hypogonadism may be an additional component of metabolic syndrome. This has potential implications for the treatment of metabolic syndrome with testosterone. We reviewed the available literature on metabolic syndrome and hypogonadism with a particular focus on testosterone therapy.A comprehensive MEDLINE review of the world literature from 1988 to 2004 on hypogonadism, testosterone and metabolic syndrome was performed.Observational data suggest that metabolic syndrome is strongly associated with hypogonadism in men. Multiple interventional studies have shown that exogenous testosterone has a favorable impact on body mass, insulin secretion and sensitivity, lipid profile and blood pressure, which are the parameters most often disturbed in metabolic syndrome.Hypogonadism is likely a fundamental component of metabolic syndrome. Testosterone therapy may not only treat hypogonadism, but may also have tremendous potential to slow or halt the progression from metabolic syndrome to overt diabetes or cardiovascular disease via beneficial effects on insulin regulation, lipid profile and blood pressure. Furthermore, the use of testosterone to treat metabolic syndrome may also lead to the prevention of urological complications commonly associated with these chronic disease states, such as neurogenic bladder and erectile dysfunction. Physicians must be mindful to evaluate hypogonadism in all men diagnosed with metabolic syndrome as well as metabolic syndrome in all men diagnosed with hypogonadism. Future research in the form of randomized clinical trials should focus on further defining the role of testosterone for metabolic syndrome.

  View details for DOI 10.1097/01.ju.0000169490.78443.59

  View details for PubMedID 16093964

• PSA updated: Still relevant in the new millennium? EUROPEAN UROLOGY Shah, J. B., Reese, A. C., McKiernan, J. M., Benson, M. C. 2005; 47 (4): 427-432

  View details for DOI 10.1016/j.eururo.2004.12.020

  View details for Web of Science ID 000228121500001

  View details for PubMedID 15774237

• Novel therapeutics in the treatment of bladder cancer. Current opinion in urology Shah, J. B., McKiernan, J. M. 2004; 14 (5): 287-93

  Abstract

  The successful treatment of bladder cancer remains a challenge for urologists and oncologists. There have been substantial changes in the therapeutic options for the management of both superficial and muscle-invasive bladder cancer in the last 5 years. Here we review the preclinical and clinical developments over the last year in bladder cancer therapeutics.There is a growing trend toward the use of multimodal treatments for all bladder cancers. For superficial disease, intravesical instillation of chemotherapeutic agents after transurethral resection is quickly becoming the standard of care. Novel therapeutic modalities under investigation include DNA vaccines, magnetically targeted carriers, bio-adhesive microspheres and antisense oligodeoxynucleotides. For muscle-invasive bladder cancer, systemic perioperative chemotherapy is being used with increasing frequency and the latest preclinical research efforts are focused on the inhibition of angiogenesis and other processes predisposing to metastatic disease.Treatment goals for bladder cancer of any stage are complete removal of the initial tumor, prevention of disease recurrence and effective inhibition of progression to advanced disease with the ultimate aim of reducing mortality. The myriad novel therapeutic modalities currently being explored suggest that these goals may perhaps be achievable within our lifetime.

  View details for PubMedID 15300149

• A survey of US medical education in otolaryngology ARCHIVES OF OTOLARYNGOLOGY-HEAD & NECK SURGERY Haddad, J., Shah, J., Takoudes, T. G. 2003; 129 (11): 1166-1169

  Abstract

  With the increasing amount and complexity of medical information, medical schools are challenged with incorporating surgical subspecialty education, such as otolaryngology (OTO), into a time-limited curriculum.To understand the state of OTO education in US medical schools and to generate a discussion of the role of surgical subspecialty education in the medical school curriculum.Mail survey and follow-up letter and telephone survey conducted in 2000 to 2001.Academic faculty at each of the 125 US medical schools.Responses were obtained from all 122 OTO programs associated with the 125 US medical schools with Liaison Committee on Medical Education-accredited programs. One third (33.6%) of the schools have a required rotation in OTO in the clinical years, with others offering elective rotations; only 5.2% offered no exposure in the third year of medical school. Most schools offer some OTO in the first 2 years; 71.1% and 87.2% taught OTO in the first and second years, respectively, mostly in anatomy and physical diagnosis. In the fourth year, almost 68.9% of schools reported student participation in an OTO elective.Most medical schools in the United States offer some teaching and clinical exposure to OTO, with considerable variability in the type of experience.

  View details for DOI 10.1001/archotol.129.11.1166

  View details for Web of Science ID 000186611600003

  View details for PubMedID 14623745

• The role of free radicals in chronic rhinosinusitis. Archives of otolaryngology--head & neck surgery Friedman, A. D., Shah, J. B., Takoudes, T. G., Haddad, J. 2002; 128 (9): 1055-7

  Abstract

  To determine whether there is an increased amount of free radical-mediated damage in diseased vs healthy tissue from patients with chronic rhinosinusitis.Pathophysiologic study. Samples of heathly and diseased tissue were taken from each patient. Lipid peroxides (LPOs) are a by-product of free radical-mediated damage; LPO levels and LPO/protein ratios were determined for each patient.Consecutive series of 13 human subjects undergoing functional endoscopic sinus surgery to treat chronic rhinosinusitis.The mean LPO/protein ratio for healthy tissue was 3.52 x 10(-5), while that for the diseased tissue was 3.49 x 10(-5). There was no statistically significant difference in the LPO/protein ratio between healthy and diseased tissue (95% confidence interval, -3.00 x 10(-5) to 2.94 x 10(-5)).Free radical-induced damage, if present, was the same in infected and control tissues in this pilot investigation into the pathophysiologic characteristics of human chronic rhinosinusitis.

  View details for PubMedID 12220211