Evaluating Real-World Characteristics of Patients With Advanced Urothelial Carcinoma Eligible for Avelumab Maintenance Therapy: A Multicountry Retrospective Medical Chart Review.

Introduction: Urothelial carcinoma (UC) is a malignancy of the urothelium that encompasses the renal pelvis, bladder, and urethra. Current treatment guidelines for advanced (ie, locally advanced or metastatic) UC recommend using avelumab maintenance therapy in patients with nonprogressive disease following first-line platinum-based chemotherapy. This study aimed to assess the representativeness of the patient population in the JAVELIN Bladder 100 (JB-100) trial, which examined the efficacy and safety of avelumab first-line maintenance, vs. real-world patients with advanced UC that had not progressed with first-line platinum-based chemotherapy treated between 2015 and 2018 by reviewing demographic and clinical characteristics.
Patients and Methods: A medical chart review (MCR) study collected demographics and treatment characteristics for patients with advanced UC in the United States, the United Kingdom, and France. Data were analyzed descriptively for review with data collected from patients enrolled in JB-100.
Results: Clinical characteristics were consistent between JB-100 and the MCR. Most patients were male, received 4 to 6 cycles of platinum-based chemotherapy, and had an Eastern Cooperative Oncology Group performance status of 0 or 1. All patients in the MCR had either stable disease or a response with platinum-based chemotherapy (∼75% achieved a complete or partial response). Fewer than half (42.5%) of all patients in the MCR received subsequent therapy.
Conclusion: Patient demographics, clinical characteristics, and treatment patterns from a MCR of patients with advanced UC that had not progressed following first-line platinum-based chemotherapy appeared similar to data from patients enrolled in JB-100. Future studies should examine whether real-world outcomes are consistent with findings from JB-100.
Gov Identifier: NCT02603432.
Competing Interests: Disclosure JB has served in consulting or advisory roles for Astellas Pharma, AstraZeneca/MedImmune, Bristol Myers Squibb, Genentech, Novartis, Pfizer, Pierre Fabre, and the healthcare business of Merck KGaA, Darmstadt, Germany; has received travel and accommodation expenses from Ipsen, Merck & Co, Kenilworth, NJ, and Pfizer; has stock and other ownership interests in Rainier Therapeutics; has received honoraria from UpToDate; has received institutional research funding from Millennium, Pfizer, Sanofi, and the healthcare business of Merck KGaA, Darmstadt, Germany; and is an Editorial Board Member of this journal, but was not involved in the peer-review process nor had access to any information regarding its peer review. JC is an employee of Pfizer and holds stock in Bayer, Bristol Myers Squibb, and Pfizer. MP-K is an employee of Pfizer. JCC is an employee and a stockholder of Pfizer. NC is an employee of, has stock and other ownership interests in, and reports honoraria from Pfizer. EE, AH, and SDC are full-time employees of RTI Health Solutions, an independent nonprofit research organization, which was a paid consultant to Pfizer and the healthcare business of Merck KGaA, Darmstadt, Germany in connection with the research for and development of this manuscript. Their compensation is unconnected to the studies on which they work. MK is an employee of the healthcare business of Merck KGaA, Darmstadt, Germany. MA was an employee of RTI Health Solutions, which was a paid consultant to Pfizer and the healthcare business of Merck KGaA, Darmstadt, Germany in connection with the research for and development of this manuscript, when this study was conducted.
(Copyright © 2023. Published by Elsevier Inc.)