Ronac Mamtani
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View article: Considerations for emulations of randomized controlled trials using real-world data: learnings from an emulation of MONALEESA-2
Considerations for emulations of randomized controlled trials using real-world data: learnings from an emulation of MONALEESA-2 Open
Aim: The eligibility criteria of randomized controlled trials can exclude groups of patients indicated for the therapy post-approval and the trial population may not be generalizable to routine care. We attempted to emulate the MONALEESA-2…
View article: Cost-effectiveness of enfortumab vedotin plus pembrolizumab as a first-line treatment of locally advanced or metastatic urothelial carcinoma in the United States
Cost-effectiveness of enfortumab vedotin plus pembrolizumab as a first-line treatment of locally advanced or metastatic urothelial carcinoma in the United States Open
EV+Pem is cost-effective compared to platinum-based regimens for the treatment of previously untreated la/mUC from a US third party payer perspective at a willingness-to-pay threshold of $200,000/QALY.
View article: MON-730 Mitigating The Effects of Weight Bias in Clinical Practice: Enhancing Communication and Documentation Skills Among Medical Trainees
MON-730 Mitigating The Effects of Weight Bias in Clinical Practice: Enhancing Communication and Documentation Skills Among Medical Trainees Open
Disclosure: R. Mamtani: None. D. LaMarra: None. C. Maskart: None. Background: Weight bias is common in healthcare and can negatively impact patient-provider interactions, quality of care, and patient outcomes. In clinical practice, weight …
View article: SUN-825 Designing a Weight Bias Curriculum: A Qualitative Analysis of Standardized Patient Experiences
SUN-825 Designing a Weight Bias Curriculum: A Qualitative Analysis of Standardized Patient Experiences Open
Disclosure: R. Mamtani: None. C. Maskart: None. D. LaMarra: None. S. Cardillo: None. Background: Weight bias in healthcare negatively impacts patient experiences and outcomes. Standardized patients (SPs) who have personally experienced or …
View article: Association Between Early on-Treatment Weight Loss With Enfortumab Vedotin Plus Pembrolizumab and Survival in Advanced Urothelial Carcinoma
Association Between Early on-Treatment Weight Loss With Enfortumab Vedotin Plus Pembrolizumab and Survival in Advanced Urothelial Carcinoma Open
Early weight loss ≥5% occurred in one fifth of patients receiving 1L EV+P treatment and was associated with inferior overall survival.
View article: Assessment of synergistic vs. independent drug activity for enfortumab vedotin and pembrolizumab in untreated advanced urothelial carcinoma
Assessment of synergistic vs. independent drug activity for enfortumab vedotin and pembrolizumab in untreated advanced urothelial carcinoma Open
Among cisplatin-ineligible patients with untreated aUC, the observed clinical efficacy of combination EV+P is supported by a model of independent drug action. These findings suggest that distinct patient subgroups respond to EV and/or pemb…
View article: Prescribing Changes After Accelerated vs Regular Approval of Oncology Therapies
Prescribing Changes After Accelerated vs Regular Approval of Oncology Therapies Open
This cross-sectional study analyzes prescribing practices for oncologic drugs following US Food and Drug Administration accelerated approval or regular approval.
View article: Survival Trends in Urothelial Cancer Before and After ICIs and Antibody Drug Conjugates
Survival Trends in Urothelial Cancer Before and After ICIs and Antibody Drug Conjugates Open
This cohort study compares population-level temporal trends in survival before and after using immune checkpoint inhibitors and antibody-drug conjugates among patients with metastatic urothelial cancer.
View article: Survival Disparities by Sex, Race, and Age in the Era of Contemporary Advanced Urothelial Carcinoma Therapy: A Real-World Analysis
Survival Disparities by Sex, Race, and Age in the Era of Contemporary Advanced Urothelial Carcinoma Therapy: A Real-World Analysis Open
A total of 5142 patients with aUC were identified. 1419 were (28%) female and 575 (11%) were > 65 y. Of those with recorded race (n = 3492), 1% were API, 5% Black, 14% categorized as "other," and 80% White. There was no difference in PFS (…
View article: Second-Line Treatment Strategies for Right-Sided, RAS/RAF Wild-Type Colorectal Cancer
Second-Line Treatment Strategies for Right-Sided, RAS/RAF Wild-Type Colorectal Cancer Open
This comparative effectiveness study investigates anti–vascular endothelial growth factor vs anti–epidermal growth factor receptor therapy in second-line treatment among patients with RAS/RAF wild-type, right-sided cancer.
View article: Specificity of Food and Drug Administration postmarketing requirements and associations with timely submissions and regulatory decisions for oncology accelerated approvals, 2011–2023: a cross-sectional analysis
Specificity of Food and Drug Administration postmarketing requirements and associations with timely submissions and regulatory decisions for oncology accelerated approvals, 2011–2023: a cross-sectional analysis Open
Objectives To assess the specificity of postmarketing requirement (PMR) statements and associations between PMR statement specificity and PMR study characteristics, timeliness and regulatory decisions. Methods and analysis This was a cross…
View article: Evolving racial/ethnic disparities in AML survival in the novel therapy era
Evolving racial/ethnic disparities in AML survival in the novel therapy era Open
Little is known about the impact of recent advances in acute myeloid leukemia (AML) treatment on racial/ethnic disparities in survival outcomes. We performed a retrospective cohort study of patients with newly diagnosed AML using data from…
View article: Evolving treatment patterns and outcomes among patients with metastatic urothelial carcinoma post-avelumab maintenance approval: insights from The US Oncology Network
Evolving treatment patterns and outcomes among patients with metastatic urothelial carcinoma post-avelumab maintenance approval: insights from The US Oncology Network Open
Background: The addition of immune checkpoint inhibitors (ICIs) and antibody–drug conjugates into the metastatic urothelial cancer (mUC) treatment landscape has advanced therapeutic strategies beyond platinum-based chemotherapy (PBT). We e…
View article: Evaluating generalizability of oncology trial results to real-world patients using machine learning-based trial emulations
Evaluating generalizability of oncology trial results to real-world patients using machine learning-based trial emulations Open
View article: Supplementary Figure S4 from Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma
Supplementary Figure S4 from Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma Open
Supplementary Figure 4. Kaplan-Meier estimates of survival by dual TMB and PD-L1 CPS cutoffs for pembrolizumab plus chemotherapy versus chemotherapy. A, PFS. B, OS.
View article: Supplementary Figure S1 from Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma
Supplementary Figure S1 from Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma Open
Supplementary Figure 1. OncoPrint showing biomarker distribution and most frequently mutated genes.
View article: Supplementary Table S1 from Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma
Supplementary Table S1 from Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma Open
Supplementary Table 1. Representativeness of study participants.
View article: Supplementary Figure S3 from Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma
Supplementary Figure S3 from Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma Open
Supplementary Figure 3. Kaplan-Meier estimates of survival by dual TMB and PD-L1 CPS cutoffs for pembrolizumab monotherapy versus chemotherapy. A, PFS. B, OS.
View article: Supplementary Figure S2 from Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma
Supplementary Figure S2 from Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma Open
Supplementary Figure 2. Joint effect of TMB and PD-L1 CPS on ORR by treatment arm
View article: Data from Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma
Data from Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma Open
Purpose:The three-arm, phase III KEYNOTE-361 study did not meet its dual primary endpoints of progression-free survival (PFS) or overall survival (OS) with first-line pembrolizumab plus chemotherapy versus chemotherapy in advanced urotheli…
View article: Supplementary Table S2 from Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma
Supplementary Table S2 from Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma Open
Supplementary Table 2. Baseline characteristics for the evaluable TMB population
View article: Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma
Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma Open
Purpose: The three-arm, phase III KEYNOTE-361 study did not meet its dual primary endpoints of progression-free survival (PFS) or overall survival (OS) with first-line pembrolizumab plus chemotherapy versus chemotherapy in advanced urothel…
View article: Meta-Analysis of Age, Sex, and Race Disparities in the Era of Contemporary Urothelial Carcinoma Treatment
Meta-Analysis of Age, Sex, and Race Disparities in the Era of Contemporary Urothelial Carcinoma Treatment Open
Background: Urothelial carcinoma (UC) is one of the most common cancers diagnosed worldwide. However, minority populations, such as female, elder, and Black patients, may have disparate outcomes and are commonly neglected in randomized pro…
View article: Mediators of racial and ethnic inequities in clinical trial participation among patients with cancer, 2011-2023
Mediators of racial and ethnic inequities in clinical trial participation among patients with cancer, 2011-2023 Open
Background Although racially and ethnically minoritized populations are less likely to participate in cancer trials, it is unknown whether social determinants of health (SDOH) explain these inequities. Here we identify SDOH factors that co…
View article: Real-world uptake and effectiveness of triplet versus doublet chemotherapy with bevacizumab in patients with metastatic colorectal cancer in the United States
Real-world uptake and effectiveness of triplet versus doublet chemotherapy with bevacizumab in patients with metastatic colorectal cancer in the United States Open
Introduction: Triplet chemotherapy + bevacizumab (TripletBev) demonstrated an overall survival (OS) benefit for patients with newly diagnosed metastatic colorectal cancer in randomized trials. We aimed to evaluate the uptake and estimate t…
View article: Classification and Regression Trees to Predict for Survival for Patients With Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab
Classification and Regression Trees to Predict for Survival for Patients With Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab Open
PURPOSE Systemic therapy with atezolizumab and bevacizumab can extend life for patients with advanced hepatocellular carcinoma (HCC). However, there is substantial variability in response to therapy and overall survival. Although current p…
View article: Low- vs High-Dose 5-FU in Triplet Chemotherapy Plus Bevacizumab for Patients With Colorectal Cancer
Low- vs High-Dose 5-FU in Triplet Chemotherapy Plus Bevacizumab for Patients With Colorectal Cancer Open
This cohort study examines the association of low-dose vs high-dose 5-fluorouracil with overall survival when used in triplet chemotherapy plus bevacizumab in patients from the metastatic colorectal cancer (CRC).
View article: Bladder Cancer, Version 3.2024
Bladder Cancer, Version 3.2024 Open
Bladder cancer, the sixth most common cancer in the United States, is most commonly of the urothelial carcinoma histologic subtype. The clinical spectrum of bladder cancer is divided into 3 categories that differ in prognosis, management, …
View article: Comparing survival in trial‐ versus routine‐care advanced urothelial cancer patients on immune checkpoint blockade
Comparing survival in trial‐ versus routine‐care advanced urothelial cancer patients on immune checkpoint blockade Open
Purpose Although recent trials involving first‐line immune checkpoint inhibitors have expanded treatment options for patients with advanced urothelial carcinoma (aUC) who are ineligible for standard cisplatin‐based chemotherapy, there exis…
View article: Cost-effectiveness of nivolumab versus surveillance for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence: a US payer perspective
Cost-effectiveness of nivolumab versus surveillance for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence: a US payer perspective Open
Nivolumab is estimated to be a life-extending and cost-effective option for adjuvant treatment of MIUC for patients who are at high risk of recurrence after undergoing radical resection in the United States. Using a threshold of $150,000/Q…