Examining Exclusion Criteria in Advanced Prostate Cancer Clinical Trials: An Assessment of recommendations From the American Society Of Clinical Oncology and Friends of Cancer Research

Ebrahimi, Hedyeh; Castro, Daniela V.; Feng, Matthew; Prajapati, Sweta; Lee, Kyle O.; Chan, Elyse H.; Paul, Trishita; Sehgal, Ishaan; Patel, Jalen; Li, X.; Zengin, Zeynep Büşra; Meza, Luís; Mercier, Benjamin D.; Hsu, JoAnn; Govindarajan, Ameish; Chawla, Neal Shiv; Dizman, Nazlı; Bergerot, Cristiane Decat; Rock, Adam; Liu, Sandy; Tripathi, Abhishek; Dorff, Tanya B.; Pal, Sumanta K.; Chehrazi‐Raffle, Alex

doi:10.1016/j.clgc.2023.05.013

Cited by 1 publication

(1 citation statement)

References 31 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…To our knowledge, this study represents the first effort to characterise trends in eligibility criteria among RCC trials. However, a recent study evaluating ASCO-FCR eligibility criteria observed similar results in the setting of prostate cancer trials with the exclusion of a high proportion of patients with brain metastases, prior or concurrent malignancies, HIV infection, and HBV/HCV infection [29].…”

Section: Discussionmentioning

confidence: 77%

Assessment of eligibility criteria in renal cell carcinoma trials evaluating systemic therapy

Castro,

Prajapati,

Feng

et al. 2023

BJU International

Self Cite

View full text Add to dashboard Cite

ObjectivesTo 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.MethodsPhase 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.Results423 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.ConclusionA 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.

show abstract

Section: Discussionmentioning

confidence: 77%