ASCO 2019: Expanding Traditional Clinical Trial Eligibility in NSCLC
Posted: Monday, June 3, 2019
Almost twice as many patients with advanced non–small cell lung cancer (NSCLC) would be eligible for consideration as clinical trial participants if traditional eligibility criteria were expanded, based on the findings of a retrospective analysis presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract LBA108). The traditional criteria a patient must meet are no brain metastases, no other malignancies, and creatinine clearance greater than 60 mL/minute. Expanded criteria, from ASCO and Friends of Cancer Research, would allow participation by patients with brain metastases, other malignancies, and a creatinine clearance greater than 30 mL/minute.
“Restrictive trial eligibility criteria limit data generalizability and patient opportunity to participate,” noted R. Donald Harvey, PharmD, Director of the Phase I Clinical Trials Unit at Winship Cancer Institute of Emory University in Atlanta, and colleagues. The team undertook the retrospective, observational analysis using de-identified data from the ASCO CancerLinQ™ database. A cohort of adult patients with advanced NSCLC with two or more physician visits and one or more doses of systemic treatment (received after their advanced disease diagnosis) between 2011 and 2018 was created.
Of the 10,500 patients identified, 47.7% (n = 5,005) would have been excluded from clinical trials by traditional criteria. However, only 1.5% (n = 154) would have been excluded by the expanded criteria. Included patients under the expanded criteria were older (67.5 vs. 66.1 years; P < .001), more likely to be female (44% vs. 40%) and never-smokers (16% vs. 13%), and more likely to have nonsquamous histology (47% vs. 45%) and stage IV disease (60% vs. 55%).
“Narrower criteria should only be used based on compelling scientific rationale for exclusion,” concluded Dr. Harvey and colleagues.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.
