Sumit Shah

All Publications

• Association of Tumor-informed Circulating Tumor DNA Detectability Before and After Radical Cystectomy with Disease-free Survival in Patients with Bladder Cancer. European urology oncology Sfakianos, J. P., Basu, A., Laliotis, G., Cumarasamy, S., Rich, J. M., Kommalapati, A., Glover, M., Mahmood, T., Tillu, N., Hoimes, C. J., Selig, G., Kollipara, R., Stewart, T. F., Rivero-Hinojosa, S., Dutta, P., Calhoun, M., Sharma, S., Malhotra, M., ElNaggar, A. C., Liu, M. C., Ferguson, J. E., Diniz, M., Mehrazin, R., Wiklund, P., Tan, A., Shah, S., Galsky, M. D. 2024

  Abstract

  Despite curative-intent radical cystectomy (RC), patients with muscle-invasive bladder cancer (MIBC) are at high risk of recurrence. Biomarkers are urgently needed to refine prognostication and selection of appropriate perioperative systemic therapies. Our aim was to evaluate the prognostic and predictive value of tumor-informed circulating tumor DNA (ctDNA) results in a multicenter cohort of patients with bladder cancer who underwent RC.We performed a retrospective analysis of real-world data for a commercial ctDNA test (Signatera; Natera, Austin, TX, USA) performed in 167 patients (852 plasma samples) before RC and during molecular residual disease (MRD; adjuvant decision) and surveillance windows. We assessed the correlation between recurrence and ctDNA status before and after RC using Cox regression analysis.During study-defined postoperative MRD and surveillance windows, detectable ctDNA was associated with shorter disease-free survival (DFS) when compared to undetectable ctDNA (MRD: hazard ratio 6.93; p < 0.001; surveillance: hazard ratio 23.02; p < 0.001). Of note, patients with undetectable ctDNA did not appear to benefit from adjuvant therapy (p = 0.34). Detectable ctDNA in the pre-RC (p = 0.045), MRD (p = 0.002), and surveillance (p < 0.001) windows was the only risk factor independently associated with shorter DFS. Limitations include the retrospective and nonrandomized nature of the study.ctDNA testing in patients with bladder cancer undergoing RC was prognostic and potentially predictive. Identification of patients at high risk of recurrence may aid in patient counseling and decision-making.We found that outcomes for patients with muscle-invasive bladder cancer are strongly linked to detection of tumor DNA in blood samples. The results show the value of tumor-informed testing for tumor DNA in blood for decisions on the best treatment for each individual patient.

  View details for DOI 10.1016/j.euo.2024.07.001

  View details for PubMedID 39013741

• The Will to Go On. Journal of clinical oncology : official journal of the American Society of Clinical Oncology Shah, S. 2022: JCO2201188

  View details for DOI 10.1200/JCO.22.01188

  View details for PubMedID 36099556

• Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study. Lancet (London, England) Kuderer, N. M., Choueiri, T. K., Shah, D. P., Shyr, Y. n., Rubinstein, S. M., Rivera, D. R., Shete, S. n., Hsu, C. Y., Desai, A. n., de Lima Lopes, G. n., Grivas, P. n., Painter, C. A., Peters, S. n., Thompson, M. A., Bakouny, Z. n., Batist, G. n., Bekaii-Saab, T. n., Bilen, M. A., Bouganim, N. n., Larroya, M. B., Castellano, D. n., Del Prete, S. A., Doroshow, D. B., Egan, P. C., Elkrief, A. n., Farmakiotis, D. n., Flora, D. n., Galsky, M. D., Glover, M. J., Griffiths, E. A., Gulati, A. P., Gupta, S. n., Hafez, N. n., Halfdanarson, T. R., Hawley, J. E., Hsu, E. n., Kasi, A. n., Khaki, A. R., Lemmon, C. A., Lewis, C. n., Logan, B. n., Masters, T. n., McKay, R. R., Mesa, R. A., Morgans, A. K., Mulcahy, M. F., Panagiotou, O. A., Peddi, P. n., Pennell, N. A., Reynolds, K. n., Rosen, L. R., Rosovsky, R. n., Salazar, M. n., Schmidt, A. n., Shah, S. A., Shaya, J. A., Steinharter, J. n., Stockerl-Goldstein, K. E., Subbiah, S. n., Vinh, D. C., Wehbe, F. H., Weissmann, L. B., Wu, J. T., Wulff-Burchfield, E. n., Xie, Z. n., Yeh, A. n., Yu, P. P., Zhou, A. Y., Zubiri, L. n., Mishra, S. n., Lyman, G. H., Rini, B. I., Warner, J. L. 2020

  Abstract

  Data on patients with COVID-19 who have cancer are lacking. Here we characterise the outcomes of a cohort of patients with cancer and COVID-19 and identify potential prognostic factors for mortality and severe illness.In this cohort study, we collected de-identified data on patients with active or previous malignancy, aged 18 years and older, with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection from the USA, Canada, and Spain from the COVID-19 and Cancer Consortium (CCC19) database for whom baseline data were added between March 17 and April 16, 2020. We collected data on baseline clinical conditions, medications, cancer diagnosis and treatment, and COVID-19 disease course. The primary endpoint was all-cause mortality within 30 days of diagnosis of COVID-19. We assessed the association between the outcome and potential prognostic variables using logistic regression analyses, partially adjusted for age, sex, smoking status, and obesity. This study is registered with ClinicalTrials.gov, NCT04354701, and is ongoing.Of 1035 records entered into the CCC19 database during the study period, 928 patients met inclusion criteria for our analysis. Median age was 66 years (IQR 57-76), 279 (30%) were aged 75 years or older, and 468 (50%) patients were male. The most prevalent malignancies were breast (191 [21%]) and prostate (152 [16%]). 366 (39%) patients were on active anticancer treatment, and 396 (43%) had active (measurable) cancer. At analysis (May 7, 2020), 121 (13%) patients had died. In logistic regression analysis, independent factors associated with increased 30-day mortality, after partial adjustment, were: increased age (per 10 years; partially adjusted odds ratio 1·84, 95% CI 1·53-2·21), male sex (1·63, 1·07-2·48), smoking status (former smoker vs never smoked: 1·60, 1·03-2·47), number of comorbidities (two vs none: 4·50, 1·33-15·28), Eastern Cooperative Oncology Group performance status of 2 or higher (status of 2 vs 0 or 1: 3·89, 2·11-7·18), active cancer (progressing vs remission: 5·20, 2·77-9·77), and receipt of azithromycin plus hydroxychloroquine (vs treatment with neither: 2·93, 1·79-4·79; confounding by indication cannot be excluded). Compared with residence in the US-Northeast, residence in Canada (0·24, 0·07-0·84) or the US-Midwest (0·50, 0·28-0·90) were associated with decreased 30-day all-cause mortality. Race and ethnicity, obesity status, cancer type, type of anticancer therapy, and recent surgery were not associated with mortality.Among patients with cancer and COVID-19, 30-day all-cause mortality was high and associated with general risk factors and risk factors unique to patients with cancer. Longer follow-up is needed to better understand the effect of COVID-19 on outcomes in patients with cancer, including the ability to continue specific cancer treatments.American Cancer Society, National Institutes of Health, and Hope Foundation for Cancer Research.

  View details for DOI 10.1016/S0140-6736(20)31187-9

  View details for PubMedID 32473681

• First-in-Human, First-in-Class Phase I Trial of the Anti-CD47 Antibody Hu5F9-G4 in Patients With Advanced Cancers. Journal of clinical oncology : official journal of the American Society of Clinical Oncology Sikic, B. I., Lakhani, N., Patnaik, A., Shah, S. A., Chandana, S. R., Rasco, D., Colevas, A. D., O'Rourke, T., Narayanan, S., Papadopoulos, K., Fisher, G. A., Villalobos, V., Prohaska, S. S., Howard, M., Beeram, M., Chao, M. P., Agoram, B., Chen, J. Y., Huang, J., Axt, M., Liu, J., Volkmer, J., Majeti, R., Weissman, I. L., Takimoto, C. H., Supan, D., Wakelee, H. A., Aoki, R., Pegram, M. D., Padda, S. K. 2019: JCO1802018

  Abstract

  PURPOSE: To evaluate the safety, pharmacokinetics, and pharmacodynamics of Hu5F9-G4 (5F9), a humanized IgG4 antibody that targets CD47 to enable phagocytosis.PATIENTS AND METHODS: Adult patients with solid tumors were treated in four cohorts: part A, to determine a priming dose; part B, to determine a weekly maintenance dose; part C, to study a loading dose in week 2; and a tumor biopsy cohort.RESULTS: Sixty-two patients were treated: 11 in part A, 14 in B, 22 in C, and 15 in the biopsy cohort. Part A used doses that ranged from 0.1 to 3 mg/kg. On the basis of tolerability and receptor occupancy studies that showed 100% CD47 saturation on RBCs, 1 mg/kg was selected as the priming dose. In subsequent groups, patients were treated with maintenance doses that ranged from 3 to 45 mg/kg, and most toxicities were mild to moderate. These included transient anemia (57% of patients), hemagglutination on peripheral blood smear (36%), fatigue (64%), headaches (50%), fever (45%), chills (45%), hyperbilirubinemia (34%), lymphopenia (34%), infusion-related reactions (34%), and arthralgias (18%). No maximum tolerated dose was reached with maintenance doses up to 45 mg/kg. At doses of 10 mg/kg or more, the CD47 antigen sink was saturated by 5F9, and a 5F9 half-life of approximately 13 days was observed. Strong antibody staining of tumor tissue was observed in a patient at 30 mg/kg. Two patients with ovarian/fallopian tube cancers had partial remissions for 5.2 and 9.2 months.CONCLUSION: 5F9 is well tolerated using a priming dose at 1 mg/kg on day 1 followed by maintenance doses of up to 45 mg/kg weekly.

  View details for PubMedID 30811285

• Consolidative Radiotherapy in Metastatic Urothelial Cancer. Clinical genitourinary cancer Shah, S., Zhang, C. A., Hancock, S., Fan, A., Skinner, E., Srinivas, S. 2017

  Abstract

  We report outcomes of a retrospective, single-institution experience with consolidative radiation after chemotherapy in metastatic urothelial cancer (MUC).From our single-institution database of 2597 patients with urothelial carcinoma treated since 1997, we identified 22 patients with MUC who underwent consolidative radiotherapy after a partial response to chemotherapy with the intent of rendering them disease-free. All patients had undergone primary surgical therapy with either cystectomy or nephroureterectomy. Progression-free survival (PFS) was defined as time from completion of radiation therapy to relapse or last follow-up. Overall survival (OS) was defined as time from start of chemotherapy to death or last follow-up.In the selected group of patients with MUC, the median age was 67 years; 59% had received previous cisplatin-based chemotherapy. The most common sites radiated were the regional lymph nodes (64%). Other radiated sites included the lung, adrenal glands, and omental metastases. Median survival from diagnosis to cystectomy was 48 months. Median PFS was 13 months and median OS was 29 months. Eight patients (36%) were alive and disease-free 6 years after radiation therapy. Patients who were rendered disease-free were those with nodal metastases and delivery of radiation to a single site of metastasis.In this highly selective cohort of patients with MUC treated with consolidative radiation after chemotherapy, 36% were rendered disease-free. This suggests that radiation is feasible and might contribute to long-term disease control. Further prospective studies are needed to better characterize the benefit of combined modality treatment.

  View details for DOI 10.1016/j.clgc.2017.04.007

  View details for PubMedID 28465049

• Real-world implementation of an EHR-integrated, SMS text remote patient monitoring platform at an academic cancer center Shah, S., Kadurugamuwa, G., Tisch, A., Lu, M., Modarresi, S., Johnston, C., Colbert, J. LIPPINCOTT WILLIAMS & WILKINS. 2024

  View details for Web of Science ID 001275557403426

• Efficacy of erdafitinib in FGFR2/3-altered metastatic urothelial cancer including patients with CDK2NA/B or MTAP loss: Analysis of UNITE study. Jiang, C. Y., Jindal, T., Epstein, I. B., Nguyen, C. B., Nizam, A., Bakaloudi, D., Taylor, A. K., Milowsky, M. I., Shah, S., Hoimes, C. J., Bilen, M., Zakharia, Y., Emamekhoo, H., Grivas, P., Gupta, S., Bellmunt, J., Alva, A., Koshkin, V. S., Alhalabi, O., Campbell, M. T. LIPPINCOTT WILLIAMS & WILKINS. 2024

  View details for Web of Science ID 001275557404531

• Coaches Activating, Reaching, and Engaging Patients to Engage in Advance Care Planning: A Randomized Clinical Trial. JAMA oncology Rodriguez, G. M., Parikh, D. A., Kapphahn, K., Gupta, D. M., Fan, A. C., Shah, S., Srinivas, S., Teuteberg, W., Seevaratnam, B., Asuncion, K., Chien, J., Moore, K., Ruiz, S. M., Patel, M. I. 2024

  Abstract

  Importance: Advance care planning (ACP) remains low among patients with advanced cancer. Multilevel interventions compared with clinician-level interventions may be more effective in improving ACP.Objective: To evaluate whether a multilevel intervention could improve clinician-documented ACP compared with a clinician-level intervention alone.Design, Setting, and Participants: This randomized clinical trial, performed from September 12, 2019, through May 12, 2021, included adults with advanced genitourinary cancers at an academic, tertiary hospital. Data analysis was performed by intention to treat from May 1 to August 10, 2023.Intervention: Participants were randomized 1:1 to a 6-month patient-level lay health worker structured ACP education along with a clinician-level intervention composed of 3-hour ACP training and integration of a structured electronic health record documentation template (intervention group) or to the clinician-level intervention alone (control group).Main Outcome and Measures: The primary outcome was ACP documentation in the electronic health record by the oncology clinician within 12 months after randomization. Secondary, exploratory outcomes included shared decision-making, palliative care use, hospice use, emergency department visits, and hospitalizations within 12 months after randomization.Results: Among 402 participants enrolled in the study, median age was 71 years (range, 21-102 years); 361 (89.8%) identified as male. More intervention group participants had oncology clinician-documented ACP than control group participants (82 [37.8%] vs 40 [21.6%]; odds ratio [OR], 2.29; 95% CI, 1.44-3.64). At 12-month follow-up, more intervention than control group participants had palliative care (72 [33.2%] vs 25 [13.5%]; OR, 3.18; 95% CI, 1.91-5.28) and hospice use (49 [22.6%] vs 19 [10.3%]; OR, 2.54; 95% CI, 1.44-4.51). There were no differences in the proportion of participants between groups with an emergency department visit (65 [30.0%] vs 61 [33.0%]; OR, 0.87; 95% CI, 0.57-1.33) or hospitalization (89 [41.0%] vs 85 [46.0%]; OR, 0.82; 95% CI, 0.55-1.22). Intervention group participants had fewer hospitalizations than control group participants (mean [SD] number of hospitalizations per year, 0.87 [1.60] vs 1.04 [1.77]) and a lower risk of hospitalization (incidence rate ratio, 0.80; 95% CI, 0.65-0.98).Conclusions and Relevance: In this randomized clinical trial, a multilevel intervention improved oncology clinician-documented ACP compared with a clinician-level intervention alone for patients with genitourinary cancer. The intervention is one approach to effectively increase ACP among patients with cancer.Trial Registration: ClinicalTrials.gov Identifier: NCT03856463.

  View details for DOI 10.1001/jamaoncol.2024.1242

  View details for PubMedID 38780960

• Same-day post-therapy imaging with a new generation whole-body digital SPECT/CT in assessing treatment response to [177Lu]Lu-PSMA-617 in metastatic castration-resistant prostate cancer. European journal of nuclear medicine and molecular imaging Song, H., Leonio, M. I., Ferri, V., Duan, H., Aparici, C. M., Davidzon, G., Franc, B. L., Moradi, F., Shah, J., Bergstrom, C. P., Fan, A. C., Shah, S., Khaki, A. R., Srinivas, S., Iagaru, A. 2024

  Abstract

  PURPOSE: Lutetium-177 [177Lu]Lu-PSMA-617 radioligand therapy (RLT) represents a significant advancement for metastatic castration-resistant prostate cancer (mCRPC), demonstrating improvements in radiographic progression free survival (rPFS) and overall survival (OS) with a low rate of associated side effects. Currently, most post-therapy SPECT/CT is conducted at 24h after infusion. This study examines the clinical utility of a next-generation multi-detector Cadmium-Zinc-Telluride (CZT) SPECT/CT system (StarGuide) in same-day post-infusion assessment and early treatment response to [177Lu]Lu-PSMA-617.METHODS: In this retrospective study, 68 men with progressive mCRPC treated with [177Lu]Lu-PSMA-617 at our center from June 2022 to June 2023 were evaluated. Digital whole-body SPECT/CT imaging was performed after [177Lu]Lu-PSMA-617infusion (mean±SD: 1.8±0.6h, range 1.1-4.9h). Quantitative analysis of [177Lu]Lu-PSMA-617 positive lesions was performed in patients who underwent at least 2 post-therapy SPECT/CT, using liver parenchyma uptake as reference. Metrics including [177Lu]Lu-PSMA-617 positive total tumor volume (Lu-TTV), SUVmax and SUVmean were calculated. These quantitative metrics on post-infusion SPECT/CT images after cycles 1, 2 and 3 were correlated with overall survival (OS), prostate specific antigen-progression free survival (PSA-PFS) as defined by prostate cancer working group 3 (PCWG3), and PSA decrease over 50% (PSA50) response rates.RESULTS: 56 patients (means age 76.2±8.1 years, range: 60-93) who underwent at least 2 post-therapy SPECT/CT were included in the image analysis. The whole-body SPECT/CT scans (~12min per scan) were well tolerated, with 221 same-day scans performed (89%). At a median of 10-months follow-up, 33 (58.9%) patients achieved PSA50 after [177Lu]Lu-PSMA-617 treatment and median PSA-PFS was 5.0 months (range: 1.0-15 months) while median OS was not reached. Quantitative analysis of SPECT/CT images showed that 37 patients (66%) had>30% reduction in Lu-TTV, associated with significantly improved overall survival (median not reached vs. 6 months, P=0.008) and PSA-PFS (median 6 months vs. 1 months, P<0.001). However, changes in SUVmax or SUVmean did not correlate with PSA-PFS or OS.CONCLUSION: We successfully implemented same-day post-therapy SPECT/CT after [177Lu]Lu-PSMA-617 infusions. Quantitation of 1-2h post-therapy SPECT/CT images is a promising method for assessing treatment response. However, the approach is currently limited by its suboptimal detection of small tumor lesions and the necessity of incorporating a third-cycle SPECT/CT to mitigate the effects of any potential treatment-related flare-up. Further investigation in a larger patient cohort and prospective validation is essential to confirm these findings and to explore the role of SPECT/CT as a potential adjunct to PSMA PET/CT in managing mCRPC.

  View details for DOI 10.1007/s00259-024-06718-6

  View details for PubMedID 38635050

• Lay healthcare worker financial toxicity intervention: a pilot financial toxicity screening and referral program. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer Parikh, D. A., Rodriguez, G. M., Ragavan, M., Kerr, E., Asuncion, M. K., Hansen, J., Srinivas, S., Fan, A. C., Shah, S., Patel, M. I. 2024; 32 (3): 161

  Abstract

  Financial toxicity is a source of significant distress for patients with urologic cancers, yet few studies have addressed financial burden in this patient population.We developed a financial toxicity screening program using a lay health worker (LHW) and social worker (SW) to assess and mitigate financial toxicity in a single academic medical clinic. As part of a quality improvement project, the LHW screened all newly diagnosed patients with advanced stages of prostate, kidney, or urothelial cancer for financial burden using three COST tool questions and referred patients who had significant financial burden to an SW who provided personalized recommendations. The primary outcome was feasibility defined as 80% of patients with financial burden completing the SW consult. Secondary outcomes were patient satisfaction, change in COST Tool responses, and qualitative assessment of financial resources utilized.The LHW screened a total of 185 patients for financial toxicity; 82% (n = 152) were male, 65% (n = 120) White, and 75% (n = 139) reported annual household income >$100,000 US Dollars; 60% (n = 114) had prostate cancer. A total of 18 (9.7%) participants screened positive for significant financial burden and were referred to the SW for consultation. All participants (100%) completed and reported satisfaction with the SW consultation and had 0.83 mean lower scores on the COST Tool post-intervention assessment compared to pre-intervention (95% confidence interval [0.26, 1.41]).This multidisciplinary financial toxicity intervention using an LHW and SW was feasible, acceptable, and associated with reduced financial burden among patients with advanced stages of urologic cancers. Future work should evaluate the effect of this intervention among cancer patients in diverse settings.

  View details for DOI 10.1007/s00520-024-08357-x

  View details for PubMedID 38366165

  View details for PubMedCentralID 6494243

• COVID-19 severity and cardiovascular outcomes in SARS-CoV-2-infected patients with cancer and cardiovascular disease. Translational oncology Moey, M. Y., Hennessy, C., French, B., Warner, J. L., Tucker, M. D., Hausrath, D. J., Shah, D. P., DeCara, J. M., Bakouny, Z., Labaki, C., Choueiri, T. K., Dent, S., Akhter, N., Ismail-Khan, R., Tachiki, L., Slosky, D., Polonsky, T. S., Awosika, J. A., Crago, A., Wise-Draper, T., Balanchivadze, N., Hwang, C., Fecher, L. A., Gomez, C. G., Hayes-Lattin, B., Glover, M. J., Shah, S. A., Gopalakrishnan, D., Griffiths, E. A., Kwon, D. H., Koshkin, V. S., Mahmood, S., Bashir, B., Nonato, T., Razavi, P., McKay, R. R., Nagaraj, G., Oligino, E., Puc, M., Tregubenko, P., Wulff-Burchfield, E. M., Xie, Z., Halfdanarson, T. R., Farmakiotis, D., Klein, E. J., Robilotti, E. V., Riely, G. J., Durand, J. B., Hayek, S. S., Kondapalli, L., Berg, S., O'Connor, T. E., Bilen, M. A., Castellano, C., Accordino, M. K., Sibel, B., Weissmann, L. B., Jani, C., Flora, D. B., Rudski, L., Dutra, M. S., Nathaniel, B., Ruíz-García, E., Vilar-Compte, D., Gupta, S., Morgans, A., Nohria, A. 2023; 34: 101709

  Abstract

  Data regarding outcomes among patients with cancer and co-morbid cardiovascular disease (CVD)/cardiovascular risk factors (CVRF) after SARS-CoV-2 infection are limited.To compare Coronavirus disease 2019 (COVID-19) related complications among cancer patients with and without co-morbid CVD/CVRF.Retrospective cohort study of patients with cancer and laboratory-confirmed SARS-CoV-2, reported to the COVID-19 and Cancer Consortium (CCC19) registry from 03/17/2020 to 12/31/2021. CVD/CVRF was defined as established CVD or no established CVD, male ≥ 55 or female ≥ 60 years, and one additional CVRF. The primary endpoint was an ordinal COVID-19 severity outcome including need for hospitalization, supplemental oxygen, intensive care unit (ICU), mechanical ventilation, ICU or mechanical ventilation plus vasopressors, and death. Secondary endpoints included incident adverse CV events. Ordinal logistic regression models estimated associations of CVD/CVRF with COVID-19 severity. Effect modification by recent cancer therapy was evaluated.Among 10,876 SARS-CoV-2 infected patients with cancer (median age 65 [IQR 54-74] years, 53% female, 52% White), 6253 patients (57%) had co-morbid CVD/CVRF. Co-morbid CVD/CVRF was associated with higher COVID-19 severity (adjusted OR: 1.25 [95% CI 1.11-1.40]). Adverse CV events were significantly higher in patients with CVD/CVRF (all p<0.001). CVD/CVRF was associated with worse COVID-19 severity in patients who had not received recent cancer therapy, but not in those undergoing active cancer therapy (OR 1.51 [95% CI 1.31-1.74] vs. OR 1.04 [95% CI 0.90-1.20], pinteraction <0.001).Co-morbid CVD/CVRF is associated with higher COVID-19 severity among patients with cancer, particularly those not receiving active cancer therapy. While infrequent, COVID-19 related CV complications were higher in patients with comorbid CVD/CVRF. (COVID-19 and Cancer Consortium Registry [CCC19]; NCT04354701).

  View details for DOI 10.1016/j.tranon.2023.101709

  View details for PubMedID 37302348

  View details for PubMedCentralID PMC10235676

• Renal cell carcinoma with metastasis to the pancreas: Genomic signatures and clinical outcomes Glover, M., Chiang, R. S., Hoerner, C. R., Khan, O. A., Kao, C., Shah, S., Srinivas, S., Fan, A. C., Khaki, A. LIPPINCOTT WILLIAMS & WILKINS. 2023

  View details for Web of Science ID 001053772002374

• Independent biomarkers predictive of outcomes with enfortumab vedotin (EV) in patients (pts) with advanced urothelial carcinoma (aUC): Analysis of the UNITE study. Jindal, T., Zhang, L., Jiang, C., Kilari, D., Alhalabi, O., Nizam, A., Basu, A., Bilen, M., Zakharia, Y., Milowsky, M. I., Shah, S., Hoimes, C. J., Davis, N. B., Gupta, S., Emamekhoo, H., Grivas, P., Bellmunt, J., Campbell, M. T., Alva, A., Koshkin, V. S. LIPPINCOTT WILLIAMS & WILKINS. 2023

  View details for Web of Science ID 001053772001061

• Association of tumor-informed minimal residual disease (MRD) with clinical outcomes for muscle invasive bladder cancer (MIBC): A multicenter retrospective real-world analysis Kommalapati, A., Laliotis, G., Glover, M., Selig, G., Kollipara, R., Mahmood, T., Shah, S., Hoimes, C. J., Stewart, T. F., Sharma, S., Malhotra, M., Pajak, N., Calhoun, M., ElNaggar, A., Liu, M. C., Basu, A., Galsky, M. D., Tan, A. LIPPINCOTT WILLIAMS & WILKINS. 2023

  View details for Web of Science ID 001053772000606

• Impact of COVID-19 in patients on active melanoma therapy and with history of melanoma. BMC cancer Johnson, D. B., Atkins, M. B., Hennessy, C., Wise-Draper, T., Heilman, H., Awosika, J., Bakouny, Z., Labaki, C., Saliby, R. M., Hwang, C., Singh, S. R., Balanchivadze, N., Friese, C. R., Fecher, L. A., Yoon, J. J., Hayes-Lattin, B., Bilen, M. A., Castellano, C. A., Lyman, G. H., Tachiki, L., Shah, S. A., Glover, M. J., Flora, D. B., Wulff-Burchfield, E., Kasi, A., Abbasi, S. H., Farmakiotis, D., Viera, K., Klein, E. J., Weissman, L. B., Jani, C., Puc, M., Fahey, C. C., Reuben, D. Y., Mishra, S., Beeghly-Fadiel, A., French, B., Warner, J. L., COVID-19 and Cancer Consortium, Reid, S. A., Brown, A. J., Cheng, A., Croessmann, S., Davis, E. J., Enriquez, K. T., Gillaspie, E. A., Hausrath, D., Li, X., Slosky, D. A., Solorzano, C. C., Tucker, M. D., Vega-Luna, K., Wang, L. L., Wise-Draper, T. M., Ahmad, S. A., Grover, P., Gulati, S., Kharofa, J., Latif, T., Marcum, M., Sohal, D. P., Zamulko, O., Choueiri, T. K., Connors, J. M., Demetri, G. D., Duma, N., Freeman, D. A., Giordano, A., Morgans, A. K., Nohria, A., Saliby, R., Schmidt, A. L., Van Allen, E. M., Xu, W., Zon, R. L., Gadgeel, S. M., Tejwani, S., Boldt, A., Cohen, A. M., McWeeney, S., Nemecek, E. R., Williamson, S. P., Ravindranathan, D., Graber, J. J., Grivas, P., Hawley, J. E., Loggers, E. T., Lynch, R. C., Nakasone, E. S., Schweizer, M. T., Vinayak, S., Wagner, M. J., Yeh, A., Cabebe, E. C., Glover, M. J., Jha, A., Khaki, A. R., Schapira, L., Wu, J. T., Kloecker, G., Logan, B. B., Mandapakala, C., Rock, C. D., Arvanitis, P., Egan, P. C., Khan, H., Olszewski, A. J., Vieira, K., Weissmann, L. B., Bhatt, P. S., Mariano, M. G., Thomson, C. C., Carducci, T. M., Goldsmith, K. J., Van Loon, S., Alexander, M., Matar, S., Mushtaq, S., Stockerl-Goldstein, K. E., Butt, O., Fiala, M. A., Henderson, J. P., Monahan, R. S., Zhou, A. Y., Lammers, P. E., Revankar, S. G., Del Prete, S. A., Bar, M. H., Gulati, A. P., Lo, K. M., Rose, S. J., Stratton, J., Weinstein, P. L., Gupta, S., Pennell, N. A., Ahluwalia, M. S., Dawsey, S. J., Lemmon, C. A., Nizam, A., Sharifi, N., Hoppenot, C., Li, A., Halabi, S., Dzimitrowicz, H., Zhang, T., Goyal, S., Huynh-Le, M., Yu, P. P., Clement, J. M., Daher, A., Dailey, M. E., Elias, R., Jayaraj, A., Hsu, E., Menendez, A. G., Serrano, O. K., Accordino, M. K., Bhutani, D., Hershman, D., Ingham, M. A., Schwartz, G. K., Bernicker, E. H., Deeken, J. F., Shafer, D., Ruiz-Garcia, E., Ramirez, A., Vilar-Compte, D., Lewis, M. A., Rhodes, T. D., Gill, D. M., Low, C. A., Mashru, S. H., Mansoor, A., Lewis, G. C., Smith, S. J., Zaren, H. A., Nagaraj, G., Akhtari, M., Castillo, D. R., Lau, E., Reeves, M. E., Berg, S., Knox, N., O'Connor, T. E., Durbin, E. B., Kulkarni, A. A., Nelson, H. H., Sachs, Z., Rosovsky, R. P., Reynolds, K. L., Bardia, A., Boland, G., Gainor, J. F., Zubiri, L., Halfdanarson, T. R., Bekaii-Saab, T. S., Desai, A., Riaz, I. B., Shah, S., Smith, K. E., Williams, C., Bouganim, N., Elkrief, A., Panasci, J., Vinh, D. C., Riely, G. J., Belenkaya, R., Philip, J., Faller, B., McKay, R. R., Ajmera, A., Brouha, S. S., Choi, S., Hsiao, A., Kligerman, S., Nonato, T. K., Blau, E. G., Jhawar, S. R., Addison, D., Chen, J. L., Gatti-Mays, M. E., Karivedu, V., Karivedu, V., Palmer, J. D., Stover, D. G., Wall, S., Williams, N. O., Joshi, M., Polimera, H. V., Pomerantz, L. D., Rovito, M. A., Griffiths, E. A., Advani, P. G., Puzanov, I., Jabbour, S. K., Misdary, C. F., Shah, M. R., Batist, G., Cook, E., Dutra, M. S., Ferrario, C., Miller, W. H., Bashir, B., McNair, C., Mahmood, S. Z., Mico, V., Rivera, A. V., Edwin, N. C., Smits, M., Doroshow, D. B., Galsky, M. D., Wotman, M., Fazio, A., Fu, J. C., Huber, K. E., Sueyoshi, M. H., Koshkin, V. S., Borno, H. T., Kwon, D. H., Small, E. J., Zhang, S., Rubinstein, S. M., Wood, W. A., Andermann, T. M., Jensen, C., Bowles, D. W., Geiger, C. L., Feldman, L. E., Hoskins, K. F., Gantt, G. J., Liu, L. C., Khan, M., Nguyen, R. H., Pasquinelli, M., Schwartz, C., Venepalli, N. K., Mavromatis, B. H., Bijjula, R. R., Zaman, Q. U., Aboulafiam, D. M., Schroeder, B. A., Topaloglu, U., Alimohamed, S. I., Moore, J. K., Peddi, P., Rosen, L. R., McCollough, B. B., Hafez, N., Herbst, R., LoRusso, P., Lustberg, M. B., Masters, T., Stratton, C. 2023; 23 (1): 265

  Abstract

  INTRODUCTION: COVID-19 particularly impacted patients with co-morbid conditions, including cancer. Patients with melanoma have not been specifically studied in large numbers. Here, we sought to identify factors that associated with COVID-19 severity among patients with melanoma, particularly assessing outcomes of patients on active targeted or immune therapy.METHODS: Using the COVID-19 and Cancer Consortium (CCC19) registry, we identified 307 patients with melanoma diagnosed with COVID-19. We used multivariable models to assess demographic, cancer-related, and treatment-related factors associated with COVID-19 severity on a 6-level ordinal severity scale. We assessed whether treatment was associated with increased cardiac or pulmonary dysfunction among hospitalized patients and assessed mortality among patients with a history of melanoma compared with other cancer survivors.RESULTS: Of 307 patients, 52 received immunotherapy (17%), and 32 targeted therapy (10%) in the previous 3months. Using multivariable analyses, these treatments were not associated with COVID-19 severity (immunotherapy OR 0.51, 95% CI 0.19 - 1.39; targeted therapy OR 1.89, 95% CI 0.64 - 5.55). Among hospitalized patients, no signals of increased cardiac or pulmonary organ dysfunction, as measured by troponin, brain natriuretic peptide, and oxygenation were noted. Patients with a history of melanoma had similar 90-day mortality compared with other cancer survivors (OR 1.21, 95% CI 0.62 - 2.35).CONCLUSIONS: Melanoma therapies did not appear to be associated with increased severity of COVID-19 or worsening organ dysfunction. Patients with history of melanoma had similar 90-day survival following COVID-19 compared with other cancer survivors.

  View details for DOI 10.1186/s12885-023-10708-6

  View details for PubMedID 36949413

• Phase 2 open label study of durvalumab with neoadjuvant chemotherapy in variant histology bladder cancer. Khaki, A., Fan, A. C., Shah, S., Parikh, D., Chien, J., Moore, K., Ruiz, S., Haas, D., Fakhoury, L., Del Toro, N., Baker, P., O'Brien, A., Srinivas, S. LIPPINCOTT WILLIAMS & WILKINS. 2023

  View details for Web of Science ID 001098050200553

• Biomarkers of response to enfortumab vedotin (EV) in patients (pts) with advanced urothelial carcinoma (aUC): Analysis of the UNITE study. Jindal, T., Kilari, D., Alhalabi, O., Nizam, A., Khaki, A., Basu, A., Barata, P. C., Bilen, M., Shah, S., Zakharia, Y., Milowsky, M. I., Bellmunt, J., Emamekhoo, H., Davis, N. B., Grivas, P., Gupta, S., Hoimes, C. J., Campbell, M. T., Alva, A., Koshkin, V. S. LIPPINCOTT WILLIAMS & WILKINS. 2023

  View details for Web of Science ID 001098050200479

• Enfortumab vedotin (EV) outcomes with and without immediate prior immune checkpoint inhibitor (ICI) in patients (pts) with advanced urothelial carcinoma (aUC). Koshkin, V. S., Henderson, N., Kilari, D., Jindal, T., Alhalabi, O., Freeman, D., Basu, A., Barata, P. C., Bilen, M., Zakharia, Y., Emamekhoo, H., Shah, S., Milowsky, M. I., Davis, N. B., Gupta, S., Hoimes, C. J., Grivas, P., Bellmunt, J., Campbell, M. T., Alva, A. LIPPINCOTT WILLIAMS & WILKINS. 2023

  View details for Web of Science ID 001098050200543

• In Patients with Advanced Urothelial Carcinoma, Immune Checkpoint Inhibition Prior to Enfortumab Vedotin Is Associated with High-grade Skin Toxicity. European urology Molina, G. E., Schwartz, B., Srinivas, S., Shah, S., Zaba, L. C. 2023

  View details for DOI 10.1016/j.eururo.2022.12.009

  View details for PubMedID 36623949

• Associations of Renal Cell Carcinoma Subtype with Patient Demographics, Comorbidities, and Neighborhood Socioeconomic Status in the California Population. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology Lichtensztajn, D. Y., Hofer, B. M., Leppert, J. T., Brooks, J. D., Chung, B. I., Shah, S. A., DeRouen, M. C., Cheng, I. 2022

  Abstract

  Renal cell carcinoma (RCC) subtypes differ in molecular characteristics and prognosis. We investigated the associations of RCC subtype with patient demographics, comorbidity, and neighborhood socioeconomic status (nSES).Using linked California Cancer Registry and Office of Statewide Health Planning and Development data, we identified history of hypertension, diabetes, and kidney disease prior to RCC diagnosis in Asian/Pacific Islander, non-Latino Black, Latino, and non-Latino White adults diagnosed with their first pathologically-confirmed RCC from 2005 through 2015. We used multinomial multivariable logistic regression to model the association of demographics, comorbidity, and nSES with clear cell, papillary, and chromophobe RCC subtype.Of the 40,016 RCC cases included, 62.6% were clear cell, 10.9% papillary, and 5.9% chromophobe. The distribution of subtypes differed strikingly by race and ethnicity, ranging from 40.4% clear cell and 30.4% papillary in non-Latino Black adults to 70.7% clear cell and 4.5% papillary in Latino adults. In multivariable analysis, non-Latino Black individuals had a higher likelihood of presenting with papillary (odds ratio (OR) 3.99, 95% confidence interval 3.61-4.42) and chromophobe (OR 1.81, 1.54-2.13) vs clear cell subtype compared to non-Latino White individuals. Both hypertension (OR 1.19, 1.10-1.29) and kidney disease (OR 2.38, 2.04-2.77 end stage disease; OR 1.52, 1.33-1.72 non end-stage disease) were associated with papillary subtype. Diabetes was inversely associated with both papillary (OR 0.63, 0.58-0.69) and chromophobe (OR 0.61, 0.54-0.70) subtypes.RCC subtype is independently associated with patient demographics, and comorbidity.Targeted RCC treatments or RCC prevention efforts may have differential impact across population subgroups.

  View details for DOI 10.1158/1055-9965.EPI-22-0784

  View details for PubMedID 36480301

• Use of Machine Learning and Lay Care Coaches to Increase Advance Care Planning Conversations for Patients With Metastatic Cancer. JCO oncology practice Gensheimer, M. F., Gupta, D., Patel, M. I., Fardeen, T., Hildebrand, R., Teuteberg, W., Seevaratnam, B., Asuncion, M. K., Alves, N., Rogers, B., Hansen, J., DeNofrio, J., Shah, N. H., Parikh, D., Neal, J., Fan, A. C., Moore, K., Ruiz, S., Li, C., Khaki, A. R., Pagtama, J., Chien, J., Brown, T., Tisch, A. H., Das, M., Srinivas, S., Roy, M., Wakelee, H., Myall, N. J., Huang, J., Shah, S., Lee, H., Ramchandran, K. 2022: OP2200128

  Abstract

  Patients with metastatic cancer benefit from advance care planning (ACP) conversations. We aimed to improve ACP using a computer model to select high-risk patients, with shorter predicted survival, for conversations with providers and lay care coaches. Outcomes included ACP documentation frequency and end-of-life quality measures.In this study of a quality improvement initiative, providers in four medical oncology clinics received Serious Illness Care Program training. Two clinics (thoracic/genitourinary) participated in an intervention, and two (cutaneous/sarcoma) served as controls. ACP conversations were documented in a centralized form in the electronic medical record. In the intervention, providers and care coaches received weekly e-mails highlighting upcoming clinic patients with < 2 year computer-predicted survival and no prior prognosis documentation. Care coaches contacted these patients for an ACP conversation (excluding prognosis). Providers were asked to discuss and document prognosis.In the four clinics, 4,968 clinic visits by 1,251 patients met inclusion criteria (metastatic cancer with no prognosis previously documented). In their first visit, 28% of patients were high-risk (< 2 year predicted survival). Preintervention, 3% of both intervention and control clinic patients had ACP documentation during a visit. By intervention end (February 2021), 35% of intervention clinic patients had ACP documentation compared with 3% of control clinic patients. Providers' prognosis documentation rate also increased in intervention clinics after the intervention (2%-27% in intervention clinics, P < .0001; 0%-1% in control clinics). End-of-life care intensity was similar in intervention versus control clinics, but patients with ≥ 1 provider ACP edit met fewer high-intensity care measures (P = .04).Combining a computer prognosis model with care coaches increased ACP documentation.

  View details for DOI 10.1200/OP.22.00128

  View details for PubMedID 36395436

• Interplay of Immunosuppression and Immunotherapy Among Patients With Cancer and COVID-19. JAMA oncology Bakouny, Z., Labaki, C., Grover, P., Awosika, J., Gulati, S., Hsu, C. Y., Alimohamed, S. I., Bashir, B., Berg, S., Bilen, M. A., Bowles, D., Castellano, C., Desai, A., Elkrief, A., Eton, O. E., Fecher, L. A., Flora, D., Galsky, M. D., Gatti-Mays, M. E., Gesenhues, A., Glover, M. J., Gopalakrishnan, D., Gupta, S., Halfdanarson, T. R., Hayes-Lattin, B., Hendawi, M., Hsu, E., Hwang, C., Jandarov, R., Jani, C., Johnson, D. B., Joshi, M., Khan, H., Khan, S. A., Knox, N., Koshkin, V. S., Kulkarni, A. A., Kwon, D. H., Matar, S., McKay, R. R., Mishra, S., Moria, F. A., Nizam, A., Nock, N. L., Nonato, T. K., Panasci, J., Pomerantz, L., Portuguese, A. J., Provenzano, D., Puc, M., Rao, Y. J., Rhodes, T. D., Riely, G. J., Ripp, J. J., Rivera, A. V., Ruiz-Garcia, E., Schmidt, A. L., Schoenfeld, A. J., Schwartz, G. K., Shah, S. A., Shaya, J., Subbiah, S., Tachiki, L. M., Tucker, M. D., Valdez-Reyes, M., Weissmann, L. B., Wotman, M. T., Wulff-Burchfield, E. M., Xie, Z., Yang, Y. J., Thompson, M. A., Shah, D. P., Warner, J. L., Shyr, Y., Choueiri, T. K., Wise-Draper, T. M. 2022

  Abstract

  Cytokine storm due to COVID-19 can cause high morbidity and mortality and may be more common in patients with cancer treated with immunotherapy (IO) due to immune system activation.To determine the association of baseline immunosuppression and/or IO-based therapies with COVID-19 severity and cytokine storm in patients with cancer.This registry-based retrospective cohort study included 12 046 patients reported to the COVID-19 and Cancer Consortium (CCC19) registry from March 2020 to May 2022. The CCC19 registry is a centralized international multi-institutional registry of patients with COVID-19 with a current or past diagnosis of cancer. Records analyzed included patients with active or previous cancer who had a laboratory-confirmed infection with SARS-CoV-2 by polymerase chain reaction and/or serologic findings.Immunosuppression due to therapy; systemic anticancer therapy (IO or non-IO).The primary outcome was a 5-level ordinal scale of COVID-19 severity: no complications; hospitalized without requiring oxygen; hospitalized and required oxygen; intensive care unit admission and/or mechanical ventilation; death. The secondary outcome was the occurrence of cytokine storm.The median age of the entire cohort was 65 years (interquartile range [IQR], 54-74) years and 6359 patients were female (52.8%) and 6598 (54.8%) were non-Hispanic White. A total of 599 (5.0%) patients received IO, whereas 4327 (35.9%) received non-IO systemic anticancer therapies, and 7120 (59.1%) did not receive any antineoplastic regimen within 3 months prior to COVID-19 diagnosis. Although no difference in COVID-19 severity and cytokine storm was found in the IO group compared with the untreated group in the total cohort (adjusted odds ratio [aOR], 0.80; 95% CI, 0.56-1.13, and aOR, 0.89; 95% CI, 0.41-1.93, respectively), patients with baseline immunosuppression treated with IO (vs untreated) had worse COVID-19 severity and cytokine storm (aOR, 3.33; 95% CI, 1.38-8.01, and aOR, 4.41; 95% CI, 1.71-11.38, respectively). Patients with immunosuppression receiving non-IO therapies (vs untreated) also had worse COVID-19 severity (aOR, 1.79; 95% CI, 1.36-2.35) and cytokine storm (aOR, 2.32; 95% CI, 1.42-3.79).This cohort study found that in patients with cancer and COVID-19, administration of systemic anticancer therapies, especially IO, in the context of baseline immunosuppression was associated with severe clinical outcomes and the development of cytokine storm.ClinicalTrials.gov Identifier: NCT04354701.

  View details for DOI 10.1001/jamaoncol.2022.5357

  View details for PubMedID 36326731

• Characterization of remote second-opinion oncology patients and associated changes in management. Shah, A. P., Shi, S., Shah, S. LIPPINCOTT WILLIAMS & WILKINS. 2022: E18563

  View details for Web of Science ID 000863680303717

• Post-acute sequelae of SARS-CoV-2 infection in patients with cancer. Warner, J., Pinato, D., Mishra, S., Saliby, R., Hwang, C., Gulati, S., Mckay, R. R., Labaki, C., Griffiths, E. A., Jani, C., Yu, P., Portuguese, A., Puc, M., Egan, P., Shah, S., Kasi, A., Berg, S. A., Flora, D., Accordino, M., Shah, D. P., Covid 19 Cancer Consortium LIPPINCOTT WILLIAMS & WILKINS. 2022: E18746

  View details for Web of Science ID 000863680303883

• COVID-19 in patients with gynecologic cancer: A preliminary report from the COVID-19 and Cancer Consortium (CCC19). Beeghly-Fadiel, A., Prescott, L. S., Ruiz-Garcia, E., Hwang, C., Heilman, H., Mckay, R. R., Saliby, R., Lau, S., Nagaraj, G., Puc, M., Zsiros, E., Shah, S., Jani, C., Cosin, J., Nakasone, E., O'Cearbhaill, R., Crispens, M. A., Brown, A. J., Covid-19 Cancer Consortium LIPPINCOTT WILLIAMS & WILKINS. 2022

  View details for Web of Science ID 000863680301560

• Patients recently treated for B-lymphoid malignancies show increased risk of severe COVID-19: a CCC19 registry analysis. Blood cancer discovery Rubinstein, S. M., Bhutani, D., Lynch, R. C., Hsu, C., Shyr, Y., Advani, S., Mesa, R. A., Mishra, S., Mundt, D. P., Shah, D. P., Sica, R. A., Stockerl-Goldstein, K. E., Stratton, C., Weiss, M., Beeghly-Fadiel, A., Accordino, M., Assouline, S. E., Awosika, J., Bakouny, Z., Bashir, B., Berg, S., Bilen, M. A., Castellano, C. A., Cogan, J. C., Kc, D., Friese, C. R., Gupta, S., Hausrath, D., Hwang, C., Johnson, N. A., Joshi, M., Kasi, A., Klein, E. J., Koshkin, V. S., Kuderer, N. M., Kwon, D. H., Labaki, C., Latif, T., Lau, E., Li, X., Lyman, G. H., McKay, R. R., Nagaraj, G., Nizam, A., Nonato, T. K., Olszewski, A. J., Polimera, H. V., Portuguese, A. J., Puc, M. M., Razavi, P., Rosovski, R., Schmidt, A., Shah, S. A., Shastri, A., Su, C., Torka, P., Wise-Draper, T. M., Zubiri, L., Warner, J. L., Thompson, M. A. 2022

  Abstract

  Patients with B-lymphoid malignancies have been consistently identified as a population at high risk of severe COVID-19. Whether this is exclusively due to cancer-related deficits in humoral and cellular immunity, or whether risk of severe COVID-19 is increased by anti-cancer therapy, is uncertain. Using data derived from the COVID-19 and Cancer Consortium (CCC19), we show that patients treated for B-lymphoid malignancies have an increased risk of severe COVID-19 compared to control populations of patients with non-B-lymphoid hematologic malignancies. Among patients with B-lymphoid malignancies, those who received anti-cancer therapy within 12 months of COVID-19 diagnosis experienced increased COVID-19 severity compared to patients with B-lymphoid malignancies off therapy, after adjustment for cancer status and several other prognostic factors. Our findings suggest that patients recently treated for a B-lymphoid malignancy are at uniquely high risk for severe COVID-19.

  View details for DOI 10.1158/2643-3230.BCD-22-0013

  View details for PubMedID 35262738

• Coinfections in Patients With Cancer and COVID-19: A COVID-19 and Cancer Consortium (CCC19) Study. Open forum infectious diseases Satyanarayana, G., Enriquez, K. T., Sun, T., Klein, E. J., Abidi, M., Advani, S. M., Awosika, J., Bakouny, Z., Bashir, B., Berg, S., Bernardes, M., Egan, P. C., Elkrief, A., Feldman, L. E., Friese, C. R., Goel, S., Gomez, C. G., Grant, K. L., Griffiths, E. A., Gulati, S., Gupta, S., Hwang, C., Jain, J., Jani, C., Kaltsas, A., Kasi, A., Khan, H., Knox, N., Koshkin, V. S., Kwon, D. H., Labaki, C., Lyman, G. H., McKay, R. R., McNair, C., Nagaraj, G., Nakasone, E. S., Nguyen, R., Nonato, T. K., Olszewski, A. J., Panagiotou, O. A., Puc, M., Razavi, P., Robilotti, E. V., Santos-Dutra, M., Schmidt, A. L., Shah, D. P., Shah, S. A., Vieira, K., Weissmann, L. B., Wise-Draper, T. M., Wu, U., Wu, J. T., Choueiri, T. K., Mishra, S., Warner, J. L., French, B., Farmakiotis, D. 2022; 9 (3): ofac037

  Abstract

  Background: The frequency of coinfections and their association with outcomes have not been adequately studied among patients with cancer and coronavirus disease 2019 (COVID-19), a high-risk group for coinfection.Methods: We included adult (≥18 years) patients with active or prior hematologic or invasive solid malignancies and laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection, using data from the COVID-19 and Cancer Consortium (CCC19, NCT04354701). We captured coinfections within ±2 weeks from diagnosis of COVID-19, identified factors cross-sectionally associated with risk of coinfection, and quantified the association of coinfections with 30-day mortality.Results: Among 8765 patients (hospitalized or not; median age, 65 years; 47.4% male), 16.6% developed coinfections: 12.1% bacterial, 2.1% viral, 0.9% fungal. An additional 6.4% only had clinical diagnosis of a coinfection. The adjusted risk of any coinfection was positively associated with age >50 years, male sex, cardiovascular, pulmonary, and renal comorbidities, diabetes, hematologic malignancy, multiple malignancies, Eastern Cooperative Oncology Group Performance Status, progressing cancer, recent cytotoxic chemotherapy, and baseline corticosteroids; the adjusted risk of superinfection was positively associated with tocilizumab administration. Among hospitalized patients, high neutrophil count and C-reactive protein were positively associated with bacterial coinfection risk, and high or low neutrophil count with fungal coinfection risk. Adjusted mortality rates were significantly higher among patients with bacterial (odds ratio [OR], 1.61; 95% CI, 1.33-1.95) and fungal (OR, 2.20; 95% CI, 1.28-3.76) coinfections.Conclusions: Viral and fungal coinfections are infrequent among patients with cancer and COVID-19, with the latter associated with very high mortality rates. Clinical and laboratory parameters can be used to guide early empiric antimicrobial therapy, which may improve clinical outcomes.

  View details for DOI 10.1093/ofid/ofac037

  View details for PubMedID 35198648

• Association of renal cell carcinoma (RCC) metastatic to pancreas with a distinct molecular profile and immune cell population. Chiang, R. S., Ashok, A., Mauer, E., Barrett, A., Hoerner, C. R., Khan, O. A., Kao, C., Shah, S., Srinivas, S., Fan, A. C., Khaki, A. LIPPINCOTT WILLIAMS & WILKINS. 2022

  View details for DOI 10.1200/JCO.2022.40.6_suppl.366

  View details for Web of Science ID 000771008900370

• Assessment of Regional Variability in COVID-19 Outcomes Among Patients With Cancer in the United States. JAMA network open Hawley, J. E., Sun, T., Chism, D. D., Duma, N., Fu, J. C., Gatson, N. T., Mishra, S., Nguyen, R. H., Reid, S. A., Serrano, O. K., Singh, S. R., Venepalli, N. K., Bakouny, Z., Bashir, B., Bilen, M. A., Caimi, P. F., Choueiri, T. K., Dawsey, S. J., Fecher, L. A., Flora, D. B., Friese, C. R., Glover, M. J., Gonzalez, C. J., Goyal, S., Halfdanarson, T. R., Hershman, D. L., Khan, H., Labaki, C., Lewis, M. A., McKay, R. R., Messing, I., Pennell, N. A., Puc, M., Ravindranathan, D., Rhodes, T. D., Rivera, A. V., Roller, J., Schwartz, G. K., Shah, S. A., Shaya, J. A., Streckfuss, M., Thompson, M. A., Wulff-Burchfield, E. M., Xie, Z., Yu, P. P., Warner, J. L., Shah, D. P., French, B., Hwang, C., COVID-19 and Cancer Consortium (CCC19), Halmos, B., Verma, A. K., Gartrell, B. A., Goel, S., Ohri, N., Sica, R. A., Thakkar, A., Stockerl-Goldstein, K. E., Butt, O., Campian, J. L., Fiala, M. A., Henderson, J. P., Monahan, R., Zhou, A. Y., Thompson, M. A., Bohachek, P., Mundt, D., Streckfuss, M., Tadesse, E., Lammers, P. E., Panagiotou, O. A., Egan, P. C., Farmakiotis, D., Khan, H., Olszewski, A. J., Loaiza-Bonilla, A., Del Prete, S. A., Bar, M. H., Gulati, A. P., Steve Lo, K. M., Rose, S. J., Stratton, J., Weinstein, P. L., Caimi, P. F., Barnholtz-Sloan, J. S., Garcia, J. A., Nakayama, J. M., Gupta, S., Pennell, N. A., Ahluwalia, M. S., Dawsey, S. J., Lemmon, C. A., Nizam, A., Hoppenot, C., Li, A., Choueiri, T. K., Bakouny, Z., Bouchard, G., Busser, F. J., Connors, J. M., Curran, C. R., Demetri, G. D., Giordano, A., Kelleher, K., Nohria, A., Schmidt, A., Shaw, G., Van Allen, E., Vitale, P., Xu, V., Zon, R. L., Zhang, T., Halabi, S., Leighton, J. C., Lyman, G. H., Graber, J. J., Grivas, P., Khaki, A. R., Loggers, E. T., Lynch, R. C., Nakasone, E. S., Schweizer, M. T., Tachiki, L., Vinayak, S., Wagner, M. J., Yeh, A., Gatson, N. T., Goyal, S., Huynh-Le, M., Rosenstein, L. J., Yu, P. P., Clement, J. M., Daher, A., Dailey, M., Elias, R., Jayaraj, A., Hsu, E., Menendez, A. G., Rathmann, J., Serrano, O., Hwang, C., Gadgeel, S. M., Singh, S. R., Hawley, J. E., Hershman, D., Accordino, M. K., Bhutani, D., Schwartz, G. K., Reuben, D. Y., Alexander, M., Mushtaq, S., Bernicker, E. H., Deeken, J., Shafer, D., Lewis, M. A., Rhodes, T. D., Gill, D. M., Low, C. A., Mashru, S. H., Mansoor, A., Zaren, H. A., Smith, S. J., Nagaraj, G., Akhtari, M., Lau, E., Reeves, M. E., Berg, S., Elms, D., Morgans, A. K., Wehbe, F. H., Altman, J., Gurley, M., Mulcahy, M. F., Durbin, E. B., Kulkarni, A. A., Nelson, H. H., Sachs, Z., Shah, S., Rosovsky, R. P., Reynolds, K., Bardia, A., Boland, G., Gainor, J., Zubiri, L., Halfdanarson, T. R., Bekaii-Saab, T., Desai, A., Xie, Z., Mesa, R. A., Bonnen, M., Mahadevan, D., Ramirez, A. G., Salazar, M., Shah, D. P., Shah, P. K., Faller, B., McKay, R. R., Ajmera, A., Brouha, S. S., Cabal, A., Hsiao, A., Kligerman, S., Shaya, J. A., Weissmann, L. B., Jani, C., Thomson, C. C., Knoble, J., Glace, M. G., Rink, C., Stauffer, K., Zacks, R., Blau, S., Joshi, M., Menon, H., Rovito, M. A., Griffiths, E. A., Elshoury, A., Jabbour, S. K., Misdary, C. F., Shah, M. R., Bashir, B., McNair, C., Mahmood, S. Z., Mico, V., Rivera, A. V., Flora, D. B., Logan, B. B., Kloecker, G., Mandapakala, C., Shah, S. A., Cabebe, E. C., Glover, M. J., Jha, A., Schapira, L., Wu, J. T., Subbiah, S., Lopes, G. d., Revankar, S. G., Stover, D. G., Addison, D., Chen, J. L., Gatti-Mays, M. E., Jhawar, S. R., Karivedu, V., Lustberg, M. B., Palmer, J. D., Wall, S., Williams, N., Wulff-Burchfield, E., Kasi, A., Edwin, N., Smits, M., Chism, D. D., Owenby, S., Doroshow, D. B., Galsky, M. D., Wotman, M., Zhu, H., Fu, J. C., Fazio, A., Sueyoshi, M. H., Huber, K. E., Riess, J., Patel, K. G., Rubinstein, S. M., Wood, W. A., Jensen, C., Kumar, V., Wise-Draper, T. M., Ahmad, S. A., Grover, P., Gulati, S., Kharofa, J., Latif, T., Marcum, M., Park, C., Shaikh, H. G., Bowles, D. W., Geiger, C. L., Markham, M., Bishnoi, R., Russ, A. D., Shah, C., Acoba, J. D., Rho, Y. S., Feldman, L. E., Hoskins, K. F., Gantt, G. J., Liu, L. C., Khan, M., Nguyen, R. H., Pasquinelli, M., Schwartz, C., Venepalli, N. K., Vikas, P., Friese, C. R., Fecher, L. A., Mavromatis, B. H., Bijjula, R. R., Zaman, Q. U., Warner, J. L., Cheng, A., Davis, E. J., Duda, S. N., Enriquez, K. T., French, B., Gillaspie, E. A., Hennessy, C., Hausrath, D., Hsu, C., Johnson, D. B., Li, X., Mishra, S., Reid, S. A., Rini, B. I., Slosky, D. A., Shyr, Y., Solorzano, C. C., Sun, T., Tucker, M. D., Vega-Luna, K., Wang, L. L., Kennecke, H. F., Aboulafia, D. M., Schroeder, B. A., Puc, M., Carducci, T. M., Goldsmith, K. J., Van Loon, S., Topaloglu, U., Alimohamed, S. I., Rice, R. L., Cabalona, W. D., Pilar, C., Peddi, P., Rosen, L. R., McCollough, B. B., Bilen, M. A., Ravindranathan, D., Hafez, N., Herbst, R., LoRusso, P., Masters, T., Stratton, C. 1800; 5 (1): e2142046

  Abstract

  Importance: The COVID-19 pandemic has had a distinct spatiotemporal pattern in the United States. Patients with cancer are at higher risk of severe complications from COVID-19, but it is not well known whether COVID-19 outcomes in this patient population were associated with geography.Objective: To quantify spatiotemporal variation in COVID-19 outcomes among patients with cancer.Design, Setting, and Participants: This registry-based retrospective cohort study included patients with a historical diagnosis of invasive malignant neoplasm and laboratory-confirmed SARS-CoV-2 infection between March and November 2020. Data were collected from cancer care delivery centers in the United States.Exposures: Patient residence was categorized into 9 US census divisions. Cancer center characteristics included academic or community classification, rural-urban continuum code (RUCC), and social vulnerability index.Main Outcomes and Measures: The primary outcome was 30-day all-cause mortality. The secondary composite outcome consisted of receipt of mechanical ventilation, intensive care unit admission, and all-cause death. Multilevel mixed-effects models estimated associations of center-level and census division-level exposures with outcomes after adjustment for patient-level risk factors and quantified variation in adjusted outcomes across centers, census divisions, and calendar time.Results: Data for 4749 patients (median [IQR] age, 66 [56-76] years; 2439 [51.4%] female individuals, 1079 [22.7%] non-Hispanic Black individuals, and 690 [14.5%] Hispanic individuals) were reported from 83 centers in the Northeast (1564 patients [32.9%]), Midwest (1638 [34.5%]), South (894 [18.8%]), and West (653 [13.8%]). After adjustment for patient characteristics, including month of COVID-19 diagnosis, estimated 30-day mortality rates ranged from 5.2% to 26.6% across centers. Patients from centers located in metropolitan areas with population less than 250 000 (RUCC 3) had lower odds of 30-day mortality compared with patients from centers in metropolitan areas with population at least 1 million (RUCC 1) (adjusted odds ratio [aOR], 0.31; 95% CI, 0.11-0.84). The type of center was not significantly associated with primary or secondary outcomes. There were no statistically significant differences in outcome rates across the 9 census divisions, but adjusted mortality rates significantly improved over time (eg, September to November vs March to May: aOR, 0.32; 95% CI, 0.17-0.58).Conclusions and Relevance: In this registry-based cohort study, significant differences in COVID-19 outcomes across US census divisions were not observed. However, substantial heterogeneity in COVID-19 outcomes across cancer care delivery centers was found. Attention to implementing standardized guidelines for the care of patients with cancer and COVID-19 could improve outcomes for these vulnerable patients.

  View details for DOI 10.1001/jamanetworkopen.2021.42046

  View details for PubMedID 34982158

• Efficacy of enfortumab vedotin in advanced urothelial cancer: Analysis from the Urothelial Cancer Network to Investigate Therapeutic Experiences (UNITE) study. Cancer Koshkin, V. S., Henderson, N., James, M., Natesan, D., Freeman, D., Nizam, A., Su, C. T., Khaki, A. R., Osterman, C. K., Glover, M. J., Chiang, R., Makrakis, D., Talukder, R., Lemke, E., Olsen, T. A., Jain, J., Jang, A., Ali, A., Jindal, T., Chou, J., Friedlander, T. W., Hoimes, C., Basu, A., Zakharia, Y., Barata, P. C., Bilen, M. A., Emamekhoo, H., Davis, N. B., Shah, S. A., Milowsky, M. I., Gupta, S., Campbell, M. T., Grivas, P., Sonpavde, G. P., Kilari, D., Alva, A. S. 2021

  Abstract

  BACKGROUND: Enfortumab vedotin (EV) is a novel antibody-drug conjugate approved for advanced urothelial cancer (aUC) refractory to prior therapy. In the Urothelial Cancer Network to Investigate Therapeutic Experiences (UNITE) study, the authors looked at the experience with EV in patient subsets of interest for which activity had not been well defined in clinical trials.METHODS: UNITE was a retrospective study of patients with aUC treated with recently approved agents. This initial analysis focused on patients treated with EV. Patient data were abstracted from chart reviews by investigators at each site. The observed response rate (ORR) was investigator-assessed for patients with at least 1 post-baseline scan or clear evidence of clinical progression. ORRs were compared across subsets of interest for patients treated with EV monotherapy.RESULTS: The initial UNITE analysis included 304 patients from 16 institutions; 260 of these patients were treated with EV monotherapy and included in the analyses. In the monotherapy cohort, the ORR was 52%, and it was >40% in all reported subsets of interest, including patients with comorbidities previously excluded from clinical trials (baseline renal impairment, diabetes, and neuropathy) and patients with fibroblast growth factor receptor 3 (FGFR3) alterations. Progression-free survival and overall survival were 6.8 and 14.4 months, respectively. Patients with a pure urothelial histology had a higher ORR than patients with a variant histology component (58% vs 42%; P = .06).CONCLUSIONS: In a large retrospective cohort, responses to EV monotherapy were consistent with data previously reported in clinical trials and were also observed in various patient subsets, including patients with variant histology, patients with FGFR3 alterations, and patients previously excluded from clinical trials with an estimated glomerular filtration rate < 30 mL/min and significant comorbidities.LAY SUMMARY: Enfortumab vedotin, approved by the Food and Drug Administration in 2019, is an important new drug for the treatment of patients with advanced bladder cancer. This study looks at the effectiveness of enfortumab vedotin as it has been used at multiple centers since approval, and focuses on important patient populations previously excluded from clinical trials. These populations include patients with decreased kidney function, diabetes, and important mutations. Enfortumab vedotin is effective for treating these patients. Previously reported clinical trial data have been replicated in this real-world setting, and support the use of this drug in broader patient populations.

  View details for DOI 10.1002/cncr.34057

  View details for PubMedID 34882781

• Use of a computer model and care coaches to increase advance care planning conversations for patients with metastatic cancer Gupta, D., Fardeen, T., Teuteberg, W., Seevaratnam, B., Asuncion, M., Alves, N., Rogers, B., Neal, J. W., Fan, A. C., Parikh, D., Patel, M. I., Shah, S., Srinivas, S., Huang, J. E., Reddy, S. A., Ganjoo, K. N., Bui, N., Hansen, J., Gensheimer, M. F., Ramchandran, K. LIPPINCOTT WILLIAMS & WILKINS. 2021

  View details for DOI 10.1200/JCO.2020.39.28_suppl.8

  View details for Web of Science ID 000707130200008

• Implementation of a cloud-based electronic patient-reported outcome (ePRO) platform in patients with advanced cancer. Journal of patient-reported outcomes Generalova, O., Roy, M., Hall, E., Shah, S. A., Cunanan, K., Fardeen, T., Velazquez, B., Chu, G., Bruzzone, B., Cabot, A., Fisher, G. A., Srinivas, S., Fan, A. C., Haraldsdottir, S., Wakelee, H. A., Neal, J. W., Padda, S. K., Johnson, T., Heestand, G. M., Hsieh, R. W., Ramchandran, K. 2021; 5 (1): 91

  Abstract

  BACKGROUND: Patient reported outcomes (PROs) have been associated with improved symptom management and quality of life in patients with cancer. However, the implementation of PROs in an academic clinical practice has not been thoroughly described. Here we report on the execution, feasibility and healthcare utilization outcomes of an electronic PRO (ePRO) application for cancer patients at an academic medical center.METHODS: We conducted a randomized trial comparing an experimental ePRO arm to standard of care in patients with advanced cancer in the thoracic, gastrointestinal, and genitourinary oncology groups at Stanford Cancer Center from March 2018 to November 2019. We describe the pre-implementation, implementation, and post-implementation phases of the ePRO arm, technological barriers, electronic health record (EHR) integration, clinician burden, and patient data privacy and security. Feasibility was pre-specified to be at least 70% completion of all questionnaires. Acceptability was based on patient and clinician feedback. Ambulatory healthcare utilization was assessed by reviewing numbers of phone messages, electronic portal messages, and referrals for supportive care.RESULTS: Of 617 ePRO questionnaires sent to 72 patients, 445 (72%) were completed. Most clinicians (87.5%) and patients (93%) felt neutral or positive about the ePRO tool's ease of use. Exposure to ePRO did not cause a measurable change in ambulatory healthcare utilization, with a median of less than two phone messages and supportive care referrals, and 5-6 portal messages.CONCLUSIONS: Web-based ePRO tools for patients with advanced cancer are feasible and acceptable without increasing clinical burden. Key lessons include the importance of pilot testing, engagement of stakeholders at all levels, and the need for customization by disease group. Future directions for this work include completion of EHR integration, expansion to other centers, and development of integrated workflows for routine clinical practice.

  View details for DOI 10.1186/s41687-021-00358-2

  View details for PubMedID 34524558

• Patterns in cancer management changes for patients with COVID-19 in northern California. Glover, M., Wu, J., Kwon, D. H., Zhang, S., Henry, S., Wood, D., Rubin, D., Borno, H., Small, E., Schapira, L., Koshkin, V. S., Shah, S. LIPPINCOTT WILLIAMS & WILKINS. 2021

  View details for DOI 10.1200/JCO.2021.39.15_suppl.1535

  View details for Web of Science ID 000708120600235

• Reply to R. Kebudi et al. JCO oncology practice Tsu-Yu Wu, J., Kwon, D. H., Glover, M., Henry, S., Wood, D., Rubin, D., Koshkin, V., Schapira, L., Shah, S. A. 2021: OP2100105

  View details for DOI 10.1200/OP.21.00105

  View details for PubMedID 33881937

• PSMA- and GRPR-targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer. Journal of nuclear medicine : official publication, Society of Nuclear Medicine Baratto, L., Song, H., Duan, H., Hatami, N., Bagshaw, H., Buyyounouski, M., Hancock, S., Shah, S. A., Srinivas, S., Swift, P., Moradi, F., Davidzon, G. A., Iagaru, A. 2021

  Abstract

  Rationale: Novel radiopharmaceuticals for positron emission tomography (PET) are evaluated for the diagnosis of biochemically recurrent prostate cancer (BCR PC). Here, we compare the gastrin releasing peptide receptors (GRPR) - targeting 68Ga-RM2 with the prostate specific membrane antigen (PSMA) - targeting 68Ga-PSMA11 and 18F-DCFPyL. Methods: Fifty patients had both 68Ga-RM2 PET/MRI and 68Ga-PSMA11 PET/CT (n = 23) or 18F-DCFPyL PET/CT (n = 27) at an interval ranging from 1 to 60 days (mean±SD: 15.8±17.7). Maximum standardized uptake values (SUVmax) were collected for all lesions. Results: RM2 PET was positive in 35 and negative in 15 of the 50 patients. PSMA PET was positive in 37 and negative in 13 of the 50 patients. Both scans detected 70 lesions in 32 patients. Forty-three lesions in 18 patients were identified only on one scan: 68Ga-RM2 detected 7 more lesions in 4 patients, while PSMA detected 36 more lesions in 13 patients. Conclusion: 68Ga-RM2 remains a valuable radiopharmaceutical even when compared with the more widely used 68Ga-PSMA11/18F-DCFPyL in the evaluation of BCR PC. Larger studies are needed to verify that identifying patients for whom these two classes of radiopharmaceuticals are complementary may ultimately allow for personalized medicine.

  View details for DOI 10.2967/jnumed.120.259630

  View details for PubMedID 33674398

• Myocarditis Surveillance with High-Sensitivity Troponin I During Cancer Treatment with Immune Checkpoint Inhibitors. JACC. CardioOncology Waliany, S., Neal, J. W., Reddy, S., Wakelee, H., Shah, S. A., Srinivas, S., Padda, S. K., Fan, A. C., Colevas, A. D., Wu, S. M., Witteles, R. M., Zhu, H. 2021; 3 (1): 137–39

  View details for DOI 10.1016/j.jaccao.2021.01.004

  View details for PubMedID 33796869

• Racial and socioeconomic disparities in retroperitoneal lymph node dissection and survival in nonseminomatous germ cell tumor: A population-based study. Urologic oncology Bhambhvani, H. P., Greenberg, D. R., Kasman, A. M., DeRouen, M. C., Cheng, I., Eisenberg, M. L., Shah, S. A. 2021

  Abstract

  BACKGROUND: Though testicular cancer is the most common cancer in young men, there is a paucity of epidemiologic studies examining sociodemographic disparities in adjuvant therapy and outcomes. We examined the associations of sociodemographic factors with retroperitoneal lymph node dissection (RPLND) and survival among patients with nonseminomatous germ cell tumors (NSGCTs).METHODS: Within the Surveillance Epidemiology and End Results database (2005-2015), we identified 8,573 patients with nonseminomatous germ cell tumors. Multivariable logistic regression and Fine-Gray competing-risks regression models were constructed to examine the association of sociodemographic factors (neighborhood SES (nSES), race, and insurance) with, respectively, adjuvant RPLND within 1 year of diagnosis and cancer-specific mortality.RESULTS: Patients in the lowest nSES quintile (OR 0.59, 95% CI = 0.40-0.88, P = 0.01) and Black patients (OR 0.41, 95% CI = 0.15-1.00, P= 0.058) with stage II disease were less likely to receive RPLND compared to those in the highest quintile and White patients, respectively. Stage III patients with Medicaid (OR 0.64, 95% CI = 0.46-0.89, P= 0.009) or without insurance (OR 0.46, 95% CI = 0.27-0.76, P= 0.003) were less likely to receive RPLND compared to patients with private insurance. Lowest quintile nSES patients of all disease stages and Black patients with stage I disease (HR = 2.64, 95% CI = 1.12-6.20, P = 0.026) or stage II disease (HR=4.93, 95% CI = 1.48-16.44, P = 0.009) had higher risks of cancer-specific mortality compared to highest quintile nSES and White patients, respectively.CONCLUSIONS: This national study found multilevel, stage-specific sociodemographic disparities in receipt of RPLND and survival.

  View details for DOI 10.1016/j.urolonc.2020.12.016

  View details for PubMedID 33423934

• Remote Oncology Care: Review of Current Technology and Future Directions CUREUS McGregor, B. A., Vidal, G. A., Shah, S. A., Mitchell, J. D., Hendifar, A. E. 2020; 12 (8)

  View details for DOI 10.7759/cureus.10156

  View details for Web of Science ID 000564098300009

• Remote Oncology Care: Review of Current Technology and Future Directions. Cureus McGregor, B. A., Vidal, G. A., Shah, S. A., Mitchell, J. D., Hendifar, A. E. 2020; 12 (8): e10156

  Abstract

  Cancer patients frequently develop tumor and treatment-related complications, leading to diminished quality of life, shortened survival, and overutilization of emergency department and hospital services. Outpatient oncology treatment has potential to leave cancer patients unmonitored for long periods while at risk of clinical deterioration which has been exaggerated during the COVID19 pandemic. Visits to cancer clinics and hospitals risk exposing immunocompromised patients to infectious complications. Remote patient reported outcomes monitoring systems have been developed for use in cancer treatment, showing benefits in economic and survival outcomes. While advanced devices such as pulmonary artery pressure monitors and implantable loop recorders have proven benefits in cardiovascular care, similar options do not exist for oncology. Here we review the current literature around remote patient monitoring in cancer care and propose the use of reliable devices for capturing and reporting patient symptoms and physiology.

  View details for DOI 10.7759/cureus.10156

  View details for PubMedID 33014652

  View details for PubMedCentralID PMC7526951

• Utilization of COVID-19 treatments and clinical outcomes among patients with cancer: A COVID-19 and Cancer Consortium (CCC19) cohort study. Cancer discovery Rivera, D. R., Peters, S., Panagiotou, O. A., Shah, D. P., Kuderer, N. M., Hsu, C., Rubinstein, S. M., Lee, B. J., Choueiri, T. K., de Lima Lopes, G., Grivas, P., Painter, C. A., Rini, B. I., Thompson, M. A., Arcobello, J., Bakouny, Z., Doroshow, D. B., Egan, P. C., Farmakiotis, D., Fecher, L. A., Friese, C. R., Galsky, M. D., Goel, S., Gupta, S., Halfdanarson, T. R., Halmos, B., Hawley, J. E., Khaki, A. R., Lemmon, C. A., Mishra, S., Olszewski, A. J., Pennell, N. A., Puc, M. M., Revankar, S. G., Schapira, L., Schmidt, A., Schwartz, G. K., Shah, S. A., Wu, J. T., Xie, Z., Yeh, A. C., Zhu, H., Shyr, Y., Lyman, G. H., Warner, J. L. 2020

  Abstract

  Among 2,186 US adults with invasive cancer and laboratory-confirmed SARS-CoV-2 infection, we examined the association of COVID-19 treatments with 30-day all-cause mortality, and factors associated with treatment. Logistic regression with multiple adjustments (e.g., comorbidities, cancer status, baseline COVID-19 severity) was performed. Hydroxychloroquine with any other drug was associated with increased mortality versus treatment with any COVID-19 treatment other than hydroxychloroquine or untreated controls; this association was not present with hydroxychloroquine alone. Remdesivir had numerically reduced mortality versus untreated controls that did not reach statistical significance. Baseline COVID-19 severity was strongly associated with receipt of any treatment. Black patients were approximately half as likely to receive remdesivir as white patients. While observational studies can be limited by potential unmeasured confounding, our findings add to the emerging understanding of patterns of care for patients with cancer and COVID-19 and support evaluation of emerging treatments through prospective controlled trials inclusive of this population.

  View details for DOI 10.1158/2159-8290.CD-20-0941

  View details for PubMedID 32699031

• 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

• Clinical impact of COVID-19 on patients with cancer: Data from the COVID-19 and Cancer Consortium (CCC19) Rubinstein, S., Grivas, P., Choueiri, T. K., Kuderer, N., Shah, D., Rivera, D. R., Gupta, S., Bilen, M., Halfdanarson, T., Doroshow, D., Wehbe, F., Shah, S., Shyr, Y., Lopes, G., Painter, C., Lyman, G. H., Thompson, M. A., Peters, S., Rini, B. I. LIPPINCOTT WILLIAMS & WILKINS. 2020

  View details for DOI 10.1200/JCO.2020.38.18_suppl.LBA110

  View details for Web of Science ID 000572436700004

• Association of renal cell carcinoma subtypes with race/ethnicity and comorbid medical conditions Lichtensztajn, D. Y., Hofer, B. M., Leppert, J. T., Brooks, J. D., Chung, B., Shah, S. A., DeRouen, M. C., Gomez, S. L., Cheng, I. AMER ASSOC CANCER RESEARCH. 2020

  View details for DOI 10.1158/1538-7755.DISP19-PR16

  View details for Web of Science ID 000580647800537

• Testicular cancer in Hispanics: Incidence of subtypes over time according to neighborhood sociodemographic factors in California DeRouen, M. C., McKinley, M., Shah, S. A., Borno, H. T., Aoki, R., Lichtensztajn, D. Y., Leppert, J. T., Brooks, J. D., Chung, B., Gomez, S. L., Cheng, I. AMER ASSOC CANCER RESEARCH. 2020

  View details for DOI 10.1158/1538-7755.DISP19-C053

  View details for Web of Science ID 000580647800288

• Testicular cancer in Hispanics: incidence of subtypes over time according to neighborhood sociodemographic factors in California. Cancer causes & control : CCC DeRouen, M. C., McKinley, M., Shah, S. A., Borno, H. T., Aoki, R., Lichtensztajn, D. Y., Leppert, J. T., Brooks, J. D., Chung, B. I., Gomez, S. L., Cheng, I. 2020

  Abstract

  PURPOSE: Hispanic men in the USA experience the second-highest incidence rate of testicular germ cell tumors (TGCTs), behind non-Hispanic (NH) White men, and have experienced steep increases in TGCT in recent decades. It is unknown whether increases in incidence differ according to neighborhood sociodemographic factors.METHODS: We conducted a population-based study of n=3759 Hispanic and n=8469 NH White men (n=12,228 total) diagnosed with TGCT in California during the three most recent pericensal periods. We calculated incidence rates according to neighborhood socioeconomic status (nSES) and among Hispanics, according to ethnic enclave. We calculated incidence rate ratios to compare rates across nSES and ethnic enclave and to examine changes in rates over pericensal time periods according to these neighborhood factors for major histologic types (i.e., seminoma and nonseminoma).RESULTS: Hispanic men residing in high SES, compared to low SES, neighborhoods had greater incidence of seminoma and nonseminoma testicular cancer across pericensal periods, as did Hispanic men in low enclave (less ethnic), compared to high enclave, neighborhoods. Between the periods 1998-2002 and 2008-2012, Hispanic men residing in low SES neighborhoods experienced a 39% increased incidence of seminoma, while those residing in low and middle SES neighborhoods experienced 87% and 48% increased incidence of nonseminoma, respectively.CONCLUSION: While TGCT incidence has increased among all Hispanic men, incidence increases appear to be driven disproportionately by those residing in lower SES and lower enclave neighborhoods, particularly for nonseminoma.

  View details for DOI 10.1007/s10552-020-01311-2

  View details for PubMedID 32440828

• Safety and efficacy of immune checkpoint inhibitors in advanced urological cancers with pre-existing autoimmune disorders: a retrospective international multicenter study. Journal for immunotherapy of cancer Martinez Chanza, N., Xie, W., Issa, M., Dzimitrowicz, H., Tripathi, A., Beuselinck, B., Lam, E., Zakharia, Y., Mckay, R., Shah, S., Mortazavi, A., R Harrison, M., Sideris, S., Kaymakcalan, M. D., Abou Alaiwi, S., Nassar, A. H., Nuzzo, P. V., Hamid, A., K Choueiri, T., C Harshman, L. 2020; 8 (1)

  Abstract

  BACKGROUND: There is limited experience regarding the safety and efficacy of checkpoint inhibitors (CPI) in patients with autoimmune disorders (AD) and advanced urological cancers as they are generally excluded from clinical trials due to risk of exacerbations.METHODS: This multicenter retrospective cohort analysis of patients with advanced renal cell cancer (RCC) and urothelial cancer (UC) with pre-existing AD treated with CPI catalogued the incidence of AD exacerbations, new immune-related adverse events (irAEs) and clinical outcomes. Competing risk models estimated cumulative incidences of exacerbations and new irAEs at 3 and 6 months.RESULTS: Of 106 patients with AD (58 RCC, 48 UC) from 10 centers, 35 (33%) had grade 1/2 clinically active AD of whom 10 (9%) required corticosteroids or immunomodulators at baseline. Exacerbations of pre-existing AD occurred in 38 (36%) patients with 17 (45%) requiring corticosteroids and 6 (16%) discontinuing CPI. New onset irAEs occurred in 40 (38%) patients with 22 (55%) requiring corticosteroids and 8 (20%) discontinuing CPI. Grade 3/4 events occurred in 6 (16%) of exacerbations and 13 (33%) of new irAEs. No treatment-related deaths occurred. Median follow-up was 15 months. For RCC, objective response rate (ORR) was 31% (95% CI 20% to 45%), median time to treatment failure (TTF) was 7 months (95% CI 4 to 10) and 12-month overall survival (OS) was 78% (95% CI 63% to 87%). For UC, ORR was 40% (95% CI 26% to 55%), median TTF was 5.0 months (95% CI 2.3 to 9.0) and 12-month OS was 63% (95% CI 47% to 76%).CONCLUSIONS: Patients with RCC and UC with well-controlled AD can benefit from CPI with manageable toxicities that are consistent with what is expected of a non-AD population. Prospective study is warranted to comprehensively evaluate the benefits and safety of CPI in patients with AD.

  View details for DOI 10.1136/jitc-2020-000538

  View details for PubMedID 32217762

• DEVELOPING THE ADVANCED PRACTICE ROLE IN INFUSION TREATMENT AREA Shah, D., Kuriakose, C., Healy, D., Shah, S. ONCOLOGY NURSING SOC. 2020

  View details for Web of Science ID 000569150400015

• Changes in Cancer Management due to COVID-19 Illness in Patients with Cancer in Northern California. JCO oncology practice Wu, J. T., Kwon, D. H., Glover, M. J., Henry, S. n., Wood, D. n., Rubin, D. L., Koshkin, V. S., Schapira, L. n., Shah, S. A. 2020: OP2000790

  Abstract

  The response to the COVID-19 pandemic has affected the management of patients with cancer. In this pooled retrospective analysis, we describe changes in management patterns for patients with cancer diagnosed with COVID-19 in two academic institutions in the San Francisco Bay Area.Adult and pediatric patients diagnosed with COVID-19 with a current or historical diagnosis of malignancy were identified from the electronic medical record at the University of California, San Francisco, and Stanford University. The proportion of patients undergoing active cancer management whose care was affected was quantified and analyzed for significant differences with regard to management type, treatment intent, and the time of COVID-19 diagnosis. The duration and characteristics of such changes were compared across subgroups.A total of 131 patients were included, of whom 55 were undergoing active cancer management. Of these, 35 of 55 (64%) had significant changes in management that consisted primarily of delays. An additional three patients not undergoing active cancer management experienced a delay in management after being diagnosed with COVID-19. The decision to change management was correlated with the time of COVID-19 diagnosis, with more delays identified in patients treated with palliative intent earlier in the course of the pandemic (March/April 2020) compared with later (May/June 2020) (OR, 4.2; 95% CI, 1.03 to 17.3; P = .0497). This difference was not seen among patients treated with curative intent during the same timeframe.We found significant changes in the management of cancer patients with COVID-19 treated with curative and palliative intent that evolved over time. Future studies are needed to determine the impact of changes in management and treatment on cancer outcomes for patients with cancer and COVID-19.

  View details for DOI 10.1200/OP.20.00790

  View details for PubMedID 33332170

• Feasibility and design of a cloud-based digital platform in patients with advanced cancer. Roy, M., Hall, E., Velazquez, B., Shah, S., Fardeen, T., Cunanan, K., San Pedro-Salcedo, M., Wakelee, H. A., Neal, J. W., Padda, S., Das, M., Fan, A. C., Srinivas, S., Fisher, G. A., Haraldsdottir, S., Johnson, T., Chu, G., McMillan, A., Ramchandran, K. AMER SOC CLINICAL ONCOLOGY. 2019

  View details for DOI 10.1200/JCO.2019.37.27_suppl.211

  View details for Web of Science ID 000518223100208

• Retrospective analysis of the safety and efficacy of immune checkpoint inhibitors (CPI) among patients (pts) with pre-existing autoimmune disorders (AD) and renal cell carcinoma (RCC) or urothelial carcinoma (UC). Chanza, N., Xie, W., Issa, M., Dzimitrowicz, H., Tripathi, A., Beuselinck, B., Lam, E., Zakharia, Y., Mckay, R. R., Shah, S., Mortazavi, A., Harrison, M., Choueiri, T. K., Harshman, L. AMER SOC CLINICAL ONCOLOGY. 2019

  View details for Web of Science ID 000487345805393

• Cabozantinib in advanced non-clear-cell renal cell carcinoma: a multicentre, retrospective, cohort study LANCET ONCOLOGY Changa, N., Xie, W., Bilen, M., Dzimitrowicz, H., Burkart, J., Geynisman, D. M., Balakrishnan, A., Bowman, I., Jain, R., Stadler, W., Zakharia, Y., Narayan, V., Beuselinck, B., McKay, R. R., Tripathi, A., Pachynski, R., Hahn, A. W., Hsu, J., Shah, S. A., Lam, E. T., Rose, T. L., Mega, A. E., Vogelzang, N., Harrison, M. R., Mortazavi, A., Plimack, E. R., Vaishampayan, U., Hammers, H., George, S., Haas, N., Agarwal, N., Pal, S. K., Srinivas, S., Carneiro, B. A., Heng, D. C., Bosse, D., Choueiri, T. K., Harshman, L. C. 2019; 20 (4): 581–90

  View details for DOI 10.1016/S1470-2045(18)30907-0

  View details for Web of Science ID 000463009600039

• Undertreatment of High-Risk Localized Prostate Cancer in the California Latino Population. Journal of the National Comprehensive Cancer Network : JNCCN Lichtensztajn, D. Y., Leppert, J. T., Brooks, J. D., Shah, S. A., Sieh, W., Chung, B. I., Gomez, S. L., Cheng, I. 2018; 16 (11): 1353–60

  Abstract

  Background: The NCCN Clinical Practice Guidelines in Oncology recommend definitive therapy for all men with high-risk localized prostate cancer (PCa) who have a life expectancy >5 years or who are symptomatic. However, the application of these guidelines may vary among ethnic groups. We compared receipt of guideline-concordant treatment between Latino and non-Latino white men in California. Methods: California Cancer Registry data were used to identify 2,421 Latino and 8,636 non-Latino white men diagnosed with high-risk localized PCa from 2010 through 2014. The association of clinical and sociodemographic factors with definitive treatment was examined using logistic regression, overall and by ethnicity. Results: Latinos were less likely than non-Latino whites to receive definitive treatment before (odds ratio [OR], 0.79; 95% CI, 0.71-0.88) and after adjusting for age and tumor characteristics (OR, 0.84; 95% CI, 0.75-0.95). Additional adjustment for sociodemographic factors eliminated the disparity. However, the association with treatment differed by ethnicity for several factors. Latino men with no health insurance were considerably less likely to receive definitive treatment relative to insured Latino men (OR, 0.34; 95% CI, 0.23-0.49), an association that was more pronounced than among non-Latino whites (OR, 0.63; 95% CI, 0.47-0.83). Intermediate-versus high-grade disease was associated with lower odds of definitive treatment in Latinos (OR, 0.75; 95% CI, 0.59-0.97) but not non-Latino whites. Younger age and care at NCI-designated Cancer Centers were significantly associated with receipt of definitive treatment in non-Latino whites but not in Latinos. Conclusions: California Latino men diagnosed with localized high-risk PCa are at increased risk for undertreatment. The observed treatment disparity is largely explained by sociodemographic factors, suggesting it may be ameliorated through targeted outreach, such as that aimed at younger and underinsured Latino men.

  View details for PubMedID 30442735

• Undertreatment of High-Risk Localized Prostate Cancer in the California Latino Population JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK Lichtensztajn, D. Y., Leppert, J. T., Brooks, J. D., Shah, S. A., Sieh, W., Chung, B., Gomez, S. L., Cheng, I. 2018; 16 (11): 1353-1360

  View details for DOI 10.6004/jnccn.2018.7060

  View details for Web of Science ID 000450238000006

• The CD47 Macrophage Checkpoint as a New Immunotherapy Target Sikic, B. I., Padda, S. K., Shah, S. A., Colevas, D., Narayanan, S., Fisher, G. A., Supan, D., Wakelee, H. A., Aoki, R., Pegram, M. D., Villalobos, V. M., Liu, J., Takimoto, C., Chao, M. P., Volkmer, J. P., Majeti, R., Weissman, I. L. ELSEVIER SCIENCE INC. 2017: S108–S109

  View details for Web of Science ID 000413055800089

• Prognostic factors for pancreatic metastases in renal cell cancer. Chung, A., Li, S., Shah, S., Fan, A. C., Srinivas, S. AMER SOC CLINICAL ONCOLOGY. 2016

  View details for DOI 10.1200/JCO.2016.34.15_suppl.e16106

  View details for Web of Science ID 000404711500073

• In situ vaccination against mycosis fungoides by intratumoral injection of a TLR9 agonist combined with radiation: a phase 1/2 study BLOOD Kim, Y. H., Gratzinger, D., Harrison, C., Brody, J. D., Czerwinski, D. K., Ai, W. Z., Morales, A., Abdulla, F., Xing, L., Navi, D., Tibshirani, R. J., Advani, R. H., Lingala, B., Shah, S., Hoppe, R. T., Levy, R. 2012; 119 (2): 355-363

  Abstract

  We have developed and previously reported on a therapeutic vaccination strategy for indolent B-cell lymphoma that combines local radiation to enhance tumor immunogenicity with the injection into the tumor of a TLR9 agonist. As a result, antitumor CD8(+) T cells are induced, and systemic tumor regression was documented. Because the vaccination occurs in situ, there is no need to manufacture a vaccine product. We have now explored this strategy in a second disease: mycosis fungoides (MF). We treated 15 patients. Clinical responses were assessed at the distant, untreated sites as a measure of systemic antitumor activity. Five clinically meaningful responses were observed. The procedure was well tolerated and adverse effects consisted mostly of mild and transient injection site or flu-like symptoms. The immunized sites showed a significant reduction of CD25(+), Foxp3(+) T cells that could be either MF cells or tissue regulatory T cells and a similar reduction in S100(+), CD1a(+) dendritic cells. There was a trend toward greater reduction of CD25(+) T cells and skin dendritic cells in clinical responders versus nonresponders. Our in situ vaccination strategy is feasible also in MF and the clinical responses that occurred in a subset of patients warrant further study with modifications to augment these therapeutic effects. This study is registered at www.clinicaltrials.gov as NCT00226993.

  View details for DOI 10.1182/blood-2011-05-355222

  View details for PubMedID 22045986