Renal cell carcinoma (RCC) trials conducted in the past 10 years used exclusion criteria deemed potentially excessive by the Friends of Cancer Research (FCR) and American Society of Clinical Oncology (ASCO), according to findings presented at IKCS North America 2022.1
“In a joint statement,2 ASCO and Friends of Cancer Research underscored the need to broaden eligibility criteria in cancer trials in order to increase patient accrual, expand access to investigational treatments, and enhance the generalizability of study results,” explained study presenter Daniela V. Castro, of City of Hope Comprehensive Cancer Center in Duarte, California.
“While eligibility criteria intend to define a specific study population and prioritize patient safety, these criteria are often based on antiquated standards and may not be reflective of real-world practice,” she added.
With this in mind, Castro and colleagues assessed RCC trials of systemic therapies conducted in the last 10 years to quantify the use of exclusion criteria deemed potentially excessive by FCR and ASCO.1
The researchers used ClinicalTrials.gov to query studies with start dates from June 30, 2012, to June 30, 2022. Their analysis included international studies examining patients in phase 1-3 trials who were 18 years of age or older. Pan-cancer studies were excluded, as were trials involving localized treatments, imaging agents/prognostic tools, or insufficient study information.
There were 112 trials with sufficient data, including phase 1 (15.2%), phase 1/2 (12.5%), phase 2 (58.9%), and phase 3 trials (13.4%). The trials were designed to evaluate combination therapies (42.9%), targeted therapies (39.3%), immunotherapy (16.1%), and chemotherapy (1.8%).
The most frequently cited exclusion criteria across these trials were HIV positivity, hepatitis B/C positivity, brain metastases, and concurrent malignancies.
In 74.1% of trials, patients with a history of HIV or AIDS were excluded. In 7.1% of trials, HIV/AIDS patients could be included if they had CD4+ T-cell counts greater than 350 cells/μL or if they were receiving antiretroviral therapy and had a viral load of less than 400 copies/mL.
In 53.6% of trials, patients with known acute or chronic hepatitis B/C infection were excluded. In 27.7% of trials, patients who recovered from a prior infection and had no hepatitis B surface antigen or hepatitis C virus RNA could be included.
In 33.0% of trials, patients with symptomatic brain metastasis or a history of it were excluded. In 47.3% of trials, patients could be included if they had previously treated brain metastases, were stable, and had no evidence of new or enlarging brain metastases.
In 8.0% of trials, patients with any additional primary tumor or malignancy in the last 5 years were excluded. In 72.3% of trials, patients could be included if they had a history of another malignancy except adequately treated skin cancers, noninvasive bladder cancer, or other stage 1 or 2 cancers currently in complete remission.
“In conclusion, our study found that a significant proportion of contemporary metastatic RCC trials incorporate restrictive eligibility criteria,” Castro said. “Broadening eligibility criteria will ensure that resulting trial data will be more representative of real-world patient populations.”
Disclosures: The study authors did not provide disclosures.
- Castro DV, Chan EH, Feng MI, et al. Critical assessment of eligibility criteria in contemporary renal cell carcinoma (RCC) trials evaluating systemic therapy. Presented at IKCS North America 2022. November 4-5, 2022. Abstract 3.
- Kim ES, Uldrick TS, Schenkel C, et al. Continuing to broaden eligibility criteria to make clinical trials more representative and inclusive: ASCO-Friends of Cancer Research joint research statement. Clin Cancer Res. 2021;27(9):2394-2399. doi:10.1158/1078-0432.CCR-20-3852