To characterize the restrictiveness of eligibility criteria in contemporary renal cell carcinoma (RCC) trials, using recommendations from the American Society of Clinical Oncology (ASCO)-Friends of Cancer Research (FCR) initiative.
Phase I-III trials assessing systemic therapies in patients with RCC starting between June 30, 2012 and June 30, 2022 were identified. Eligibility criteria regarding brain metastases, prior or concurrent malignancies, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, and human immunodeficiency virus (HIV) infection were identified and stratified into 3 groups: exclusion, conditional inclusion, and not reported. Descriptive statistics were used to determine the frequency of eligibility criteria. The Fischer's exact test or Chi-square test were performed to calculate their associations with certain trial characteristics.
423 RCC trials were initially identified of which 112 (26.5%) had sufficient accessible information. Exclusion of patients with HIV infection, HBV/HCV infection, brain metastases, and prior or concurrent malignancies were reported in 74.1%, 53.6%, 33.0%, and 8.0% of trials, respectively. In the context of HIV and HBV/HCV infection, patients were largely excluded from trials evaluating immunotherapy (94.4% and 77.8%, respectively). In addition, brain metastases were excluded in trials assessing targeted therapy (36.4%), combination therapy (33.3%), and immunotherapy (22.2%). Exclusion of patients with prior or concurrent malignancies was less frequently reported, accounting for 9.1%, 8.3%, and 5.6% targeted, combination and immunotherapy trials, respectively.
A substantial proportion of RCC trials utilize restrictive eligibility criteria, excluding patients with fairly prevalent comorbidities. Implementing the ASCO-FCR recommendations will ensure resulting data is more inclusive and aligned with patient populations in the real-world.
BJU international. 2023 Aug 07 [Epub ahead of print]
Daniela V Castro, Sweta R Prajapati, Matthew I Feng, Elyse H Chan, Kyle O Lee, Trishita Paul, Ishaan Sehgal, Jalen Patel, Xiaochen Li, Zeynep B Zengin, Hedyeh Ebrahimi, Ameish Govindarajan, Luis Meza, Benjamin D Mercier, Neal S Chawla, Nazli Dizman, Errol J Philip, JoAnn Hsu, Cristiane D Bergerot, Alex Chehrazi-Raffle, Adam Rock, Sandy Liu, Abhishek Tripathi, Tanya B Dorff, Sumanta K Pal
Department of Medical Oncology & Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA., University of California San Francisco (UCSF) School of Medicine, San Francisco, CA, USA., Centro de Câncer de Brasília (CETTRO), Instituto Unity de Ensino e Pesquisa, Brasília, Brazil., Department of Medical Oncology, City of Hope Orange County Lennar Foundation Cancer Center, Irvine, CA, USA.