Broadening clinical trial inclusion criteria doubles number of eligible NSCLC patients
medwireNews: Using expanded criteria for clinical trial inclusion could lead to nearly twice as many patients with advanced non-small-cell lung cancer (NSCLC) being eligible for participation compared with traditional criteria, participants at the 2019 ASCO Annual Meeting in Chicago, Illinois, USA, heard.
In a retrospective study based on real-world data, R Donald Harvey (Winship Cancer Institute of Emory University, Atlanta, Georgia, USA) and colleagues analyzed the effect of using broadened trial criteria in which – unlike traditional criteria – patients with previous or concurrent cancers, brain metastases, or limited kidney function (creatinine clearance ≥30 mL/min) would all be eligible for clinical trial enrollment.
Using electronic health record data from 10,500 patients with advanced NSCLC from the ASCO’s CancerLinQ Discovery database, the researchers found that 5005 (47.7%) individuals would be excluded from trial participation under traditional criteria, compared with just 154 (1.5%) under the broadened criteria – translating to an increase in the trial population from 5495 (52.3% of patients in the database) to 10,346 (98.5%) patients.
The majority of this increase was seen in the group of patients aged 75 years and older, with the proportion of such patients jumping from 16.1% of the population under traditional criteria to 22.2% under the broadened criteria, and the median age significantly increasing from 66.1 to 67.5 years.
Using the broadened criteria also increased the proportion of women (44 vs 40%), those with stage IV disease (60 vs 55%) and nonsquamous histology (47 vs 45%), and never-smokers (16 vs 13%).
The broadened criteria are therefore “likely to result in trial participants more reflective of [the] broader patient population, improving trial generalizability,” Harvey told the audience.
He urged all clinical trial sponsors to adapt the broadened criteria, stressing that “narrower criteria to exclude patients should only be used based on compelling scientific rationale.”
Commenting on the findings, ASCO expert David Graham (Levine Cancer Institute, Charlotte, North Carolina, USA) said in a press release: “This study makes the case for universal adoption of broader clinical trial eligibility criteria […] so that more lung cancer patients and others have the opportunity to safely participate in potentially lifesaving research.”
By Catherine Booth
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