Evaluation of eligibility criteria in contemporary renal cell carcinoma based on ASCO-FCR recommendations.

Authors

null

Sweta R. Prajapati

City of Hope Comprehensive Cancer Center, Duarte, CA

Sweta R. Prajapati , Matthew I. Feng , Daniela V. Castro , Kyle O. Lee , Elyse H. Chan , Ishaan Sehgal , Jalen Patel , Anna O'Dell , Zeynep Busra Zengin , Xiaochen Li , Alex Chehrazi-Raffle , Nazli Dizman , Abhishek Tripathi , Adam Rock , Sandy Liu , Benjamin D. Mercier , Luis A Meza , Errol James Philip , Tanya B. Dorff , Sumanta Monty Pal

Organizations

City of Hope Comprehensive Cancer Center, Duarte, CA, Yale University School of Medicine, New Haven, CT, Department of Medical Oncology & Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, City of Hope Orange Country Lennar Foundation Cancer Center, Irvine, CA, University of California, San Francisco, San Francisco, CA

Research Funding

No funding received
None.

Background: A consensus statement from the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (FCR) collaboration highlights the importance of expanding eligibility criteria in cancer trials to more accurately reflect the real-world population (Kim et al., Clin Cancer Res 2021). We sought to characterize use of overly restrictive eligibility criteria in renal cell carcinoma (RCC) trials in the context of ASCO-FCR recommendations. Methods: Studies containing the MeSH terms “(metastatic OR advanced OR stage IV or unresectable) AND (kidney cancer OR renal cell carcinoma OR renal cell cancer)” from June 30, 2012 to June 30, 2022 were identified on the ClinicalTrials.gov platform. Our search query’s inclusion criteria identified international studies examining adult patients aged ≥ 18 in phase I-III trials. Exclusion criteria comprised pan-cancer studies, trials involving localized treatments, radiation therapy, and prognostic tools. Descriptive statistics were used to characterize the frequency of restrictive eligibility criteria across studies, while Fisher’s exact test or chi-square test were utilized to determine the association between treatment type and exclusion criteria. Results: The content of 423 RCC trials were analyzed, of which 112 (26.5%) had adequate data available. 48 (42.9%), 44 (39.3%) and 18 (16.1%) studies examined combination therapy, targeted therapy, and immunotherapy, respectively. The presence of HIV positivity, HBV/HCV positivity, brain metastases, and concurrent malignancies accounted for the most frequently cited exclusionary criteria, seen in 83/112 (74.1%), 60/112 (53.6%), 37/112 (33.0%), and 9/112 (8.0%) studies respectively. Differences in the use of HIV positivity (p<0.001) and HBV/HCV positivity (p<0.001) as eligibility criteria were observed across classes of therapy (see Table). Conclusions: A significant proportion of RCC studies utilize overly restrictive eligibility criteria as highlighted by the ASCO-FCR joint statement. Appropriate broadening of eligibility criteria to incorporate patient populations mirroring a real-world setting will provide more useful data going forward.

Brain Metastases (%)Concurrent Malignancies (%)HBV/HCV Positivity (%)HIV Positivity (%)
TreatmentChemotherapy (n=2)50.00.050.0100.0
Combination therapy (n=48)33.38.364.687.5
Immunotherapy (n=18)22.25.677.894.4
Targeted therapy (n=44)36.49.131.850.0
p-value0.650.390.000170.0000012

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Abstract Details

Meeting

2023 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral and Testicular Cancers

Track

Renal Cell Cancer,Adrenal Cancer,Penile Cancer,Testicular Cancer,Urethral Cancer

Sub Track

Cancer Disparities

Citation

J Clin Oncol 41, 2023 (suppl 6; abstr 612)

DOI

10.1200/JCO.2023.41.6_suppl.612

Abstract #

612

Poster Bd #

E2

Abstract Disclosures