Bio


Dr. Riaz is dedicated to advancing breast cancer treatment through an innovative clinical trial program that focuses on cutting-edge therapeutics and biomarkers.

Dr. Riaz is studying circulating tumor (ct)DNA-minimal residual disease (MRD) as a pivotal biomarker for early-stage breast cancer. She aims to enhance its use in surveillance and early detection while guiding personalized treatment strategies through novel clinical trials. Furthermore, she is committed to improving immunotherapy efficacy by modifying the tumor microenvironment. Her research involves developing early-phase trials that integrate novel therapeutic approaches, combining immunotherapy and radiotherapy. As a Clinical Assistant Professor at Stanford University School of Medicine, Dr. Riaz is also committed to improving the accessibility of cutting edge therapies to all patients. She is leading a collaborative effort with multiple institutions to develop databases that track patient outcomes and inform treatment practices.

Dr. Riaz’s overarching goal is to expand early-phase clinical trials and foster academic-industry partnerships to advance the field of breast oncology and improve patient care.

Clinical Focus


  • Breast Oncology
  • Medical Oncology

Academic Appointments


Boards, Advisory Committees, Professional Organizations


  • Panel Member, National Comprehensive Cancer Network--Hematopoietic Growth Factors Panel (2020 - Present)

Professional Education


  • Board Certification: American Board of Internal Medicine, Medical Oncology (2019)
  • Board Certification: American Board of Internal Medicine, Internal Medicine (2015)
  • Fellowship: Yale Cancer Center (2019) CT
  • Chief Residency, Georgetown University Medical Center, DC (2016)
  • Residency: Georgetown University Medical Center (2016) DC
  • Medical Education: University of South Florida Morsani College of Medicine (2012) FL

Clinical Trials


  • Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects Recruiting

    This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A\*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A\*02 positive and HER2/neu positive subjects.

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  • A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) Not Recruiting

    The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.

    Stanford is currently not accepting patients for this trial. For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.

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  • A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors Not Recruiting

    The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.

    Stanford is currently not accepting patients for this trial.

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  • An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic Not Recruiting

    This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dose combination formulation for subcutaneous injection (PH FDC SC) administered at home by a home health nursing provider for patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer who have completed concurrent chemotherapy with pertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV) and are currently receiving or will be receiving maintenance therapy with P+H IV, PH FDC SC, or trastuzumab SC in the clinic. The main objective is to enable continuity of care during the COVID-19 pandemic. This study will enroll approximately 200 patients in the United States. Participants with early or metastatic HER2+ breast cancer will be enrolled in this study. Participants with metastatic HER2+ breast cancer will receive treatment every 3 weeks and continue treatment unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity, participant withdrawal of consent, or per physician's recommendation. Participants with early HER2+ breast cancer will receive PH FDC SC to complete 1 year (up to 18 cycles) of dual blockade, including the P+H IV, PH FDC SC, or trastuzumab SC they received prior to enrolling in this study, unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity, participant withdrawal of consent, or per physician's recommendation. A remote cardiac surveillance substudy will be optional for patients enrolled at select sites. The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer a risk for this patient population.

    Stanford is currently not accepting patients for this trial. For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.

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  • Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy Not Recruiting

    The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

    Stanford is currently not accepting patients for this trial. For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.

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  • Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] Not Recruiting

    This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: * Cannot be removed by an operation * Has spread to other parts of the body

    Stanford is currently not accepting patients for this trial. For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.

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All Publications


  • Impact of timing and breastfeeding on postpartum breast cancer diagnostic patterns and outcomes. Breast cancer research and treatment Klebaner, D., Park, N., Stone, K., Riaz, F., Crowe, S., Telli, M., Marquez, C., Horst, K. 2025

    Abstract

    Postpartum breast cancers (PPBC) have a worse prognosis than other breast cancers, but the impact of timing postpartum (PP) and concurrent breastfeeding (BF) on diagnostic patterns and outcomes remains unclear.We analyzed 161 PPBC patients diagnosed from 2002 to 2014, hypothesizing that diagnosis < 2 years PP (vs 2-5 years) and concurrent BF (vs not BF) at diagnosis would be associated with delayed diagnosis. We compared 2-year PP patients (N = 60) and 2-5 year PP patients (N = 101), and subsequently, patients who were (n = 36) and were not (n = 24) BF at diagnosis among the 2-year PP group with respect to clinicopathologic characteristics, breastfeeding details, diagnostic patterns, and disease outcomes. Differences were evaluated using chi-square and Mann-Whitney tests. Kaplan-Meier analysis assessed overall survival (OS) and distant disease-free survival (DDFS).Median follow-up was 54 months. Patients in the 2-year PP group were more likely to be BF at diagnosis (60% vs 7%, p < 0.001), and have their symptoms attributed to lactational change (37 vs 9%, p < 0.001). They were also diagnosed at a higher stage (43 vs 24% Stage III/IV, p = 0.01), had worse 5-year OS (79% vs 97%, p < 0.001), and DDFS (74% vs 93%, p = 0.003) compared to 2-5 year PP patients. Among 2-year PP patients, patients BF at diagnosis were more likely to be diagnosed with mastitis preceding diagnosis (31% vs 4%, p = 0.03), more often had their symptoms attributed to lactational change (58% vs 4%), trended toward higher stage at diagnosis (53 vs 29% Stage III/IV, p = 0.1), had significantly worse 5-year DDFS (62% vs 91%, p = 0.032), and trended toward worse OS (74% vs 86%, p = 0.08) compared to those not BF.Our findings suggest that early PPBC and BF at diagnosis are associated with diagnostic delay and higher stage at diagnosis, which may have implications for prognosis.

    View details for DOI 10.1007/s10549-025-07796-2

    View details for PubMedID 40739382

  • Impact of timing of diagnosis and breastfeeding on postpartum breast cancer outcomes. Klebaner, D., Park, N., Marquez, C., Stone, K., Crowe, S., Riaz, F., Telli, M. L., Horst, K. C. LIPPINCOTT WILLIAMS & WILKINS. 2025: e12537
  • New Treatment Approaches for Triple-Negative Breast Cancer. American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting Riaz, F., Gruber, J. J., Telli, M. L. 2025; 45 (3): e481154

    Abstract

    Triple-negative breast cancer (TNBC) was first described as a distinct disease entity 20 years ago. Since that time, there has been tremendous effort invested in understanding the clinical features and biology of this breast cancer subtype and developing novel therapeutics specifically targeted for this group of tumors. This review will focus on therapeutic advances in the treatment of metastatic TNBC, outlining successes that contributed to expanded treatment options for advanced TNBC at present and highlight areas of ongoing investigation with potential to further advance treatment paradigms for this aggressive breast cancer subtype. Since 2018, five new therapies have been introduced into clinical practice for the treatment of advanced TNBC. Poly(ADP-ribose) polymerase inhibitors represent the only success for genomically targeted therapy, and this is an option only for a small subgroup of patients with TNBC and a germline BRCA1 or BRCA2 pathogenic variant. Pembrolizumab is currently the only PD-1 checkpoint inhibitor approved in the United States in combination with chemotherapy in the first-line setting and is an option for roughly 40% of patients with PD-L1 positive tumors. Antibody-drug conjugates have been an important advance in the treatment of advanced TNBC, although these drugs do not represent a TNBC-specific advance as both sacituzumab govitecan and trastuzumab deruxtecan have activity in breast tumors beyond TNBC. Thus, despite significant strides over the past decade, significant unmet clinical need persists, and novel therapeutics remain a pressing need for the treatment of advanced TNBC.

    View details for DOI 10.1200/EDBK-25-481154

    View details for PubMedID 40460322

  • Association of driving distance to clinic with treatment route and dosing for metastatic breast cancer Riaz, F., Luo, I., Satoyoshi, M., Dalal, N., John, E. M., Schapira, L., Caswell-Jin, J., Kurian, A. W. LIPPINCOTT WILLIAMS & WILKINS. 2025: e13077
  • Cost and Cost-Effectiveness of Treating Human Epidermal Growth Factor Receptor 2-Low Metastatic Breast Cancer. Journal of clinical oncology : official journal of the American Society of Clinical Oncology Dickerson, J. C., Moen, M. T., Nielsen, P., Riaz, F., Tran, E., Caswell-Jin, J. L., Suen, W., Goldhaber-Fiebert, J. D., Alarid-Escudero, F. 2025: JCO2401960

    Abstract

    Creating value-aligned treatment pathways in breast cancer requires understanding the cost and cost-effectiveness of new therapies. To address uncertainty in the optimal treatment sequence, we developed a decision model to assess the cost-effectiveness of various treatment sequences for patients with human epidermal growth factor receptor 2 (HER2)-low metastatic breast cancer who are eligible for trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG) under current US Food and Drug Administration labeling.We derived disease progression and therapy data from the Destiny-Breast04 trial and sourced cost and quality-of-life data from the published literature. Our simulation modeled 57-year-old women with HER2-low, endocrine refractory, and triple-negative metastatic breast cancer eligible for third-line treatment. We evaluated four sequences: chemotherapy (chemo) → chemo, T-DXd → chemo, chemo → T-DXd, and T-DXd → SG. Outcomes included quality-adjusted life years (QALYs), total lifetime costs (2020 US dollars [USD], 3% annual discount), and incremental cost-effectiveness ratios. Sequences that cost <$150,000 USD to gain an additional QALY were considered cost effective.Chemo → chemo has the lowest cost at $176,000 (USD) per patient and yields 0.82 QALYs. T-DXd → chemo costs $282,000 (USD) and yields 1.08 QALYs, with an incremental cost-effectiveness ratio of $408,000 (USD) per QALY gained. T-DXd → SG costs $304,000 (USD) and yields 1.09 QALYs, with an incremental cost-effectiveness ratio of $2,200,000 (USD) per QALY gained. Drug cost drives the cost differences between each strategy. For T-DXd → chemo to be cost effective at the $150,000 (USD) per QALY threshold, we estimate that a 41% price reduction for T-DXd is needed.At its current price, T-DXd is not cost effective for HER2-low metastatic breast cancer. Price reductions can make this drug cost effective. Optimal value-based sequencing in this patient population uses a single antibody-drug conjugate rather than back-to-back conjugates.

    View details for DOI 10.1200/JCO-24-01960

    View details for PubMedID 40397834

  • Patient-Centered Research Through Artificial Intelligence to Identify Priorities in Cancer Care. JAMA oncology Kim, J., Chen, M. L., Rezaei, S. J., Ramirez-Posada, M., Caswell-Jin, J. L., Kurian, A. W., Riaz, F., Sarin, K. Y., Tang, J. Y., Asch, S. M., Linos, E. 2025

    Abstract

    Patient-centered research is essential for bridging the gap between research and patient care, yet patient perspectives are often inadequately represented in health research.To leverage artificial intelligence (AI) and natural language processing (NLP) to analyze a large dataset of patient messages, defining patient concerns and generating relevant research topics, and to quantify the quality of these AI-generated topics.This case series was conducted using an automated framework involving a 2-staged unsupervised NLP topic model and AI-generated research topic suggestions. The study was based on deidentified patient portal message data from individuals with breast or skin cancer at Stanford Health Care and 22 affiliated centers over July 2013 to April 2024.A widely used large language model (ChatGPT-4o [OpenAI]; April 2024) was used and guided through multiple prompt-engineering strategies to perform multilevel tasks, including knowledge interpretation and summarization (eg, interpreting and summarizing the NLP-defined topics), knowledge generation (eg, generating research ideas corresponding to patients' issues), self-reflection and correction (eg, ensuring and revising the research ideas after searching for scientific articles), and self-reassurance (eg, confirming and finalizing the research ideas).Three breast oncologists (J.L.C., A.W.K., F.R) and 3 dermatologists (K.Y.S, J.Y.T., E.L.) evaluated the meaningfulness and novelty of the AI-generated research topics using a 5-point Likert scale (1 representing exceptional to 5 representing poor). Mean (SD) scores for meaningfulness and novelty were computed for each topic.A total of 614 464 patient messages were analyzed from 25 549 individuals, 10 665 with breast cancer (98.6% female) and 14 884 had skin cancer (49.0% female). The overall mean (SD) scores for meaningfulness and novelty were 3.00 (0.50) and 3.29 (0.74), respectively, for breast cancer topics and 2.67 (0.45) and 3.09 (0.68), respectively, for skin cancer topics. One-third of the AI-suggested research topics were highly meaningful and novel when both scores were lower than the average (5 of 15 for breast cancer and 6 of 15 for skin cancer). Notably, two-thirds of the AI-suggested topics were novel (10 of 15 for breast cancer and 11 of 15 for skin cancer).This case series demonstrates that AI/NLP-driven analysis of large volumes of patient messages can generate quality research topics in cancer care that reflect patient perspectives, providing valuable guidance for future patient-centered health research endeavors.

    View details for DOI 10.1001/jamaoncol.2025.0694

    View details for PubMedID 40272833

  • Inpatient Immunotherapy Outcomes Study: A Multicenter Retrospective Analysis. JCO oncology practice Riaz, F., Vaughn, J. L., Zhu, H., Dickerson, J. C., Sayegh, H. E., Brongiel, S., Baldwin, E., Kier, M. W., Zaemes, J., Hearn, C., Abdelghany, O., Cohen, R. B., Parikh, R. B., Reuss, J. E., Prsic, E., Doroshow, D. B. 2025: OP2400788

    Abstract

    Immune checkpoint inhibitors (ICIs) have revolutionized the care of patients with cancer, but use among hospitalized patients is controversial as a result of questionable benefit and high costs. To evaluate the role of ICIs in the inpatient (IP) setting, we conducted the Inpatient Immunotherapy Outcomes Study (IIOS) to describe characteristics and outcomes of patients who received IP ICIs.IIOS is a retrospective study of patients treated with ICIs during hospitalization between 2012 and 2021 at five academic institutions. Data collection was performed using each institution's electronic medical record. We estimated overall survival (OS) from the first administration of ICI using the Kaplan-Meier method and used adjusted Cox proportional hazards models to explore associations between clinicodemographic variables and OS.Two hundred fifteen patients received IP ICIs (median age 60 years; 55% White; 14% Black; 13% Hispanic). Thoracic and head and neck (24%), GI (21%), and hematologic (19%) malignancies were most common. Most of the patients were ICI-naïve (75%), had stage IV solid malignancies (75%) at the time of IP ICI initiation, and had no radiographic response to ICI therapy (88%). Median OS from the first IP ICI dose was 1.55 months (95% CI, 1.08 to 1.81) for all patients and 1.28 months (95% CI, 0.95 to 1.80) for patients with advanced solid malignancies. Multivariable Cox proportional hazards model analysis found no clinicodemographic variables associated with improved OS after IP ICI administration.IIOS is the largest multi-institutional effort to describe outcomes after IP ICI administration. Clinical outcomes are poor after IP ICI use and IP ICIs should be used with caution.

    View details for DOI 10.1200/OP-24-00788

    View details for PubMedID 39937997

  • New strategies for the management of triple-negative breast cancer. Current opinion in obstetrics & gynecology Riaz, F. 2024; 36 (1): 40-44

    Abstract

    This review highlights important changes in our understanding of triple-negative breast cancer. It highlights important novel approaches in treatment and reviews predicts potential challenges facing the treatment of triple-negative breast cancer.There is a clear shift away from chemotherapy-centric approaches to the treatment of breast cancer, and instead, a move towards incorporating immune checkpoint inhibitors, antibody-drug conjugates, and other targeted therapies. There is a focus on understanding biomarkers and leveraging novel targets in drug development.It is now standard of care to use neoadjuvant combination immunotherapy-chemotherapy in patients with Stage 1 and 2 breast cancers. Chemo-immunotherapy combinations when appropriate biomarkers are present (PD-L1) are standard first-line therapy in metastatic triple-negative breast cancer. Antibody-drug conjugates are now a mainstay in the treatment of this disease. These findings have shifted the treatment paradigm of the treatment of triple-negative breast cancer.

    View details for DOI 10.1097/GCO.0000000000000927

    View details for PubMedID 38170551

  • Pharmacovigilance Analysis of HeartFailure Associated With Anti-HER2 Monotherapies and Combination Regimens for Cancer. JACC. CardioOncology Waliany, S., Caswell-Jin, J., Riaz, F., Myall, N., Zhu, H., Witteles, R. M., Neal, J. W. 2023; 5 (1): 85-98

    Abstract

    Background: Trastuzumab improves outcomes in patients with HER2-overexpressing malignancies but is associated with decreases in left ventricular ejection fraction. Heart failure (HF) risks from other anti-HER2 therapies are less clear.Objectives: Using World Health Organization pharmacovigilance data, the authors compared HF odds across anti-HER2 regimens.Methods: In VigiBase, 41,976 patients had adverse drug reactions (ADRs) with anti-HER2 monoclonal antibodies (trastuzumab, n=16,900; pertuzumab, n=1,856), antibody-drug conjugates (trastuzumab emtansine [T-DM1], n=3,983; trastuzumab deruxtecan, n=947), and tyrosine kinase inhibitors (afatinib, n=10,424; lapatinib, n=5,704; neratinib, n=1,507; tucatinib, n=655); additionally, 36,052 patients had ADRs with anti-HER2-based combination regimens. Most patients had breast cancer (monotherapies, n=17,281; combinations, n=24,095). Outcomes included comparison of HF odds with each monotherapy relative to trastuzumab, within each therapeutic class, and among combination regimens.Results: Of 16,900 patients with trastuzumab-associated ADRs, 2,034 (12.04%) had HF reports (median time to onset 5.67months; IQR: 2.85-9.32months) compared with 1% to 2% with antibody-drug conjugates. Trastuzumab had higher odds of HF reporting relative to other anti-HER2 therapies collectively in the overall cohort (reporting OR [ROR]: 17.37; 99% CI: 14.30-21.10) and breast cancer subgroup (ROR: 17.10; 99% CI: 13.12-22.27). Pertuzumab/T-DM1 had 3.4 times higher odds of HF reporting than T-DM1 monotherapy; tucatinib/trastuzumab/capecitabine had similar odds as tucatinib. Among metastatic breast cancer regimens, HF odds were highest with trastuzumab/pertuzumab/docetaxel (ROR: 1.42; 99% CI: 1.17-1.72) and lowest with lapatinib/capecitabine (ROR: 0.09; 99% CI: 0.04-0.23).Conclusions: Trastuzumab and pertuzumab/T-DM1 had higher odds of HF reporting than other anti-HER2 therapies. These data provide large-scale, real-world insight into which HER2-targeted regimens would benefit from left ventricular ejection fraction monitoring.

    View details for DOI 10.1016/j.jaccao.2022.09.007

    View details for PubMedID 36875913

  • The Inpatient Immunotherapy Outcomes study: A multicenter retrospective study of patients treated with immune checkpoint inhibitors in the inpatient setting Riaz, F., Zhu, H., Cheng, W., Brongiel, S., Baldwin, E., Kier, M., Zaemes, J., Hearn, C., Abdelghany, O., Parikh, R., Reuss, J. E., Prsic, E., Doroshow, D. LIPPINCOTT WILLIAMS & WILKINS. 2022: 300
  • Preliminary analysis of an expanded access study of the fixed-dose combination of pertuzumab (P) and trastuzumab (H) for subcutaneous injection (PH FDC SC) for at-home administration (admin) in patients (pts) with HER2-positive (HER2+) breast cancer (BC) during the COVID-19 pandemic. Dang, C. T., Tolaney, S. M., Riaz, F., Tan, A. R., Tkaczuk, K. R., Yu, A., Liu, J., Fung, A. M., Yang, A., Day, B., Rugo, H. S. LIPPINCOTT WILLIAMS & WILKINS. 2022
  • NCCN Guidelines Insights: Hematopoietic Growth Factors, Version 1.2022. Journal of the National Comprehensive Cancer Network : JNCCN Griffiths, E. A., Roy, V., Alwan, L., Bachiashvili, K., Baird, J., Cool, R., Dinner, S., Geyer, M., Glaspy, J., Gojo, I., Hicks, A., Kallam, A., Kidwai, W. Z., Kloth, D. D., Kraut, E. H., Landsburg, D., Lyman, G. H., Mahajan, A., Miller, R., Nachar, V., Patel, S., Patel, S., Perez, L. E., Poust, A., Riaz, F., Rosovsky, R., Rugo, H. S., Simon, S., Vasu, S., Wadleigh, M., Westbrook, K., Westervelt, P., Berardi, R. A., Pluchino, L. 2022; 20 (5): 436-442

    Abstract

    The NCCN Guidelines for Hematopoietic Growth Factors provide recommendations for the appropriate use of growth factors in the clinical management of febrile neutropenia (FN), chemotherapy-induced thrombocytopenia (CIT), and chemotherapy-induced anemia (CIA). Management and prevention of these sequelae are an integral part of supportive care for many patients undergoing cancer treatment. The purpose of these guidelines is to operationalize the evaluation, prevention, and treatment of FN, CIT, and CIA in adult patients with nonmyeloid malignancies and to enable the patient and clinician to assess management options for FN, CIT, and CIA in the context of an individual patient's condition. These NCCN Guidelines Insights provide a summary of the important recent updates to the NCCN Guidelines for Hematopoietic Growth Factors, with particular emphasis on the incorporation of a newly developed section on CIT.

    View details for DOI 10.6004/jnccn.2022.0026

    View details for PubMedID 35545171

  • Uptake and Survival Outcomes Following Immune Checkpoint Inhibitor Therapy Among Trial-Ineligible Patients With Advanced Solid Cancers. JAMA oncology Parikh, R. B., Min, E. J., Wileyto, E. P., Riaz, F., Gross, C. P., Cohen, R. B., Hubbard, R. A., Long, Q., Mamtani, R. 2021

    Abstract

    Importance: Immune checkpoint inhibitors (ICIs) are part of standard of care for patients with many advanced solid tumors. Patients with poor performance status or organ dysfunction are traditionally ineligible to partake in pivotal randomized clinical trials of ICIs.Objective: To assess ICI use and survival outcomes among patients with advanced cancers who are traditionally trial ineligible based on poor performance status or organ dysfunction.Design, Setting, and Participants: This retrospective cohort study was conducted in 280 predominantly community oncology practices in the US and included 34 131 patients (9318 [27.3%] trial ineligible) who initiated first-line systemic therapy from January 2014 through December 2019 for newly diagnosed metastatic or recurrent nontargetable non-small cell lung, urothelial cell, renal cell, or hepatocellular carcinoma. Data analysis was performed from December 1, 2019, to June 1, 2021.Exposures: Trial ineligibility (Eastern Cooperative Oncology Group performance status ≥2 or the presence of kidney or liver dysfunction); first-line systemic therapy.Main Outcomes and Measures: The association between trial ineligibility and ICI monotherapy uptake was assessed using inverse probability-weighted (IPW) logistic regressions. The comparative survival outcomes following ICI and non-ICI therapy among trial-ineligible patients were assessed using treatment IPW survival analyses. Because we observed nonproportional hazards, we reported 12-month and 36-month restricted mean survival times (RMSTs) and time-varying hazard ratios (HRs) of less than 6 months and 6 months or greater.Results: Among the overall cohort (n=34 131), the median (IQR) age was 70 (62-77) years; 23 586 (69%) were White individuals, and 14 478 (42%) were women. Over the study period, the proportion of patients receiving ICI monotherapy increased from 0% to 30.2% among trial-ineligible patients and 0.1% to 19.4% among trial-eligible patients. Trial ineligibility was associated with increased ICI monotherapy use (IPW-adjusted odds ratio compared with non-ICI therapy, 1.8; 95% CI, 1.7-1.9). Among trial-ineligible patients, there were no overall survival differences between ICI monotherapy, ICI combination therapy, and non-ICI therapy at 12 months (RMST, 7.8 vs 7.7 vs 8.1 months) or 36 months (RMST, 15.0 vs 13.9 vs 14.4 months). Compared with non-ICI therapy, ICI monotherapy showed evidence of early harm (IPW-adjusted HR within 6 months, 1.2; 95% CI, 1.1-1.2) but late benefit (adjusted HR among patients who survived 6 months, 0.8; 95% CI, 0.7-0.8).Conclusions and Relevance: In this cohort study, compared with trial-eligible patients, trial-ineligible patients with advanced cancers preferentially received first-line ICI therapy. A survival difference was not detected between ICI and non-ICI therapies among trial-ineligible patients. Positive results for ICI in phase 3 trials may not translate to this vulnerable population.

    View details for DOI 10.1001/jamaoncol.2021.4971

    View details for PubMedID 34734979

  • Uptake and effectiveness of checkpoint inhibitor therapy among trial-ineligible patients with advanced solid malignancies. Parikh, R., Min, E., Wileyto, E., Riaz, F., Gross, C., Cohen, R. B., Hubbard, R. A., Long, Q., Mamtani, R. LIPPINCOTT WILLIAMS & WILKINS. 2021
  • Adoption of Immune Checkpoint Inhibitors and Patterns of Care at the End of Life. JCO oncology practice Riaz, F., Gan, G., Li, F., Davidoff, A. J., Adelson, K. B., Presley, C. J., Adamson, B. J., Shaw, P., Parikh, R. B., Mamtani, R., Gross, C. P. 2020: OP2000010

    Abstract

    PURPOSE: As immune checkpoint inhibitors (ICIs) have transformed the care of patients with cancer, it is unclear whether treatment at the end of life (EOL) has changed. Because aggressive therapy at the EOL is associated with increased costs and patient distress, we explored the association between the Food and Drug Administration (FDA) approvals of ICIs and treatment patterns at the EOL.METHODS: We conducted a retrospective, observational study using patient-level data from a nationwide electronic health record-derived database. Patients had advanced melanoma, non-small-cell lung cancer (NSCLC; cancer types with an ICI indication), or microsatellite stable (MSS) colon cancer (a cancer type without an ICI indication) and died between 2013 and 2017. We calculated annual proportions of decedents who received systemic cancer therapy in the final 30 days of life, using logistic regression to model the association between the post-ICI FDA approval time and use of systemic therapy at the EOL, adjusting for patient characteristics. We assessed the use of chemotherapy or targeted/biologic therapies at the EOL, before and after FDA approval of ICIs using Pearson chi-square test.RESULTS: There was an increase in use of EOL systemic cancer therapy in the post-ICI approval period for both melanoma (33.9% to 43.2%; P < .001) and NSCLC (37.4% to 40.3%; P < .001), with no significant change in use of systemic therapy in MSS colon cancer. After FDA approval of ICIs, patients with NSCLC and melanoma had a decrease in the use of chemotherapy, with a concomitant increase in use of ICIs at the EOL.CONCLUSION: The adoption of ICIs was associated with a substantive increase in the use of systemic therapy at the EOL in melanoma and a smaller yet significant increase in NSCLC.

    View details for DOI 10.1200/OP.20.00010

    View details for PubMedID 32678688

  • Uptake of first-line immune checkpoint inhibitors among medically frail patients with advanced solid malignancies. Parikh, R., Cohen, R. B., Min, E., Wileyto, E., Riaz, F., Gross, C., Long, Q., Mamtani, R. LIPPINCOTT WILLIAMS & WILKINS. 2020
  • The adoption of immune checkpoint inhibitors and patterns of care at the end of life. Riaz, F., Gan, G., Li, F., Davidoff, A. J., Adelson, K. B., Presley, C. J., Adamson, B. S., Shaw, P., Parikh, R., Mamtani, R., Gross, C. AMER SOC CLINICAL ONCOLOGY. 2020
  • Disparities in broad-based genomic sequencing for patients with advanced non-small cell lung cancer JOURNAL OF GERIATRIC ONCOLOGY Riaz, F., Presley, C. J., Chiang, A. C., Longtine, J. A., Soulos, P. R., Adelson, K. B., Herbst, R. S., Nussbaum, N. C., Sorg, R. A., Abernethy, A. P., Agarwala, V., Gross, C. P. 2019; 10 (4): 669–72