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Published on: April 12, 2017
Assessment of eligibility criteria in renal cell carcinoma trials evaluating systemic therapy
Daniela V Castro1, Sweta R Prajapati1, Matthew I Feng1
1Department of Medical Oncology and Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Objectives:
To characterise 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.
Methods:
vPhase I-III trials assessing systemic therapies in patients with RCC starting between 30 June 2012 and 30 June 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 three groups: exclusion, conditional inclusion, and not reported. Descriptive statistics were used to determine the frequency of eligibility criteria. Fisher's exact test or chi-square test were used to calculate their associations with certain trial characteristics.
Results:
A total of 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%), combined 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 therapy, combined therapy and immunotherapy trials, respectively.
Conclusion:
A substantial proportion of RCC trials utilise restrictive eligibility criteria, excluding patients with fairly prevalent comorbidities. Implementing the ASCO-FCR recommendations will ensure resulting data are more inclusive and aligned with patient populations in the real-world.
Insights
Many renal cell carcinoma (RCC) trials exclude patients with common comorbidities like HIV or brain metastases. Adopting American Society of Clinical Oncology (ASCO)-Friends of Cancer Research (FCR) guidelines can make trial data more inclusive and reflective of real-world patient populations.
Area of Science:
- Oncology
- Clinical Trial Design
- Renal Cell Carcinoma Research
Background:
- Eligibility criteria in clinical trials significantly impact patient inclusion and generalizability of results.
- Renal cell carcinoma (RCC) trials often have specific inclusion/exclusion criteria that may limit participation.
- Recommendations from the American Society of Clinical Oncology (ASCO)-Friends of Cancer Research (FCR) initiative aim to standardize and broaden trial eligibility.
Purpose of the Study:
- To evaluate the restrictiveness of eligibility criteria in contemporary renal cell carcinoma (RCC) trials.
- To assess the frequency of exclusions based on specific comorbidities, including brain metastases, prior/concurrent malignancies, and infections (HIV, HBV, HCV).
- To compare trial restrictiveness against ASCO-FCR recommendations.
Main Methods:
- Systematic review of Phase I-III RCC trials assessing systemic therapies between June 2012 and June 2022.
- Identification and categorization of eligibility criteria related to brain metastases, prior/concurrent malignancies, HBV, HCV, and HIV.
- Stratification of criteria into exclusion, conditional inclusion, or not reported; statistical analysis of frequencies and associations.
Main Results:
- Of 112 analyzed trials, significant exclusion rates were observed: 74.1% for HIV, 53.6% for HBV/HCV, 33.0% for brain metastases, and 8.0% for prior/concurrent malignancies.
- Exclusion rates for HIV and HBV/HCV were particularly high in immunotherapy trials (94.4% and 77.8%, respectively).
- Brain metastases exclusion was common in targeted therapy (36.4%) and immunotherapy (22.2%) trials.
Conclusions:
- Contemporary RCC trials frequently employ restrictive eligibility criteria, excluding patients with prevalent comorbidities.
- These restrictive criteria limit the representation of real-world patient populations in clinical trial data.
- Adoption of ASCO-FCR recommendations is crucial for enhancing trial inclusivity and aligning outcomes with clinical practice.
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