Meeting trial eligibility in Follicular lymphoma patients is associated with overall survival but not progression-free survival.

Abstract

Clinical trial eligibility criteria are necessary for safety and target population homogeneity; however, increasingly restrictive organ function eligibility rarely precludes standard therapies and impedes clinical application of trial results. This multicenter, retrospective study applied safety-related eligibility criteria from 4 landmark phase 3 trials (GALLIUM, RELEVANCE, StiL NHL1, BRIGHT) to 528 treatment-naive patients with follicular lymphoma receiving standard immunochemotherapy. In total, 55% of included patients were ineligible for at least 1 study, and 12% were ineligible for all 4 studies. Ineligible patients were more likely to be older than 60 years of age and have poorer performance status than eligible patients (P < .05). There was no difference between response rate or progression-free survival among eligible vs ineligible patients. Patients ineligible for all trials had inferior 5-year overall survival than patients eligible for at least 1 study (69% vs 92%; P < .001). More than half of deaths were due to causes other than lymphoma. Current trials select populations with favorable overall survival despite similar disease-based outcomes. Patients suitable for standard chemoimmunotherapy should not be routinely excluded based on age, performance status, or organ function from frontline randomized trials with progression-free survival primary endpoints. There is a substantial need to broaden trial eligibility to include all patients fit for standard treatment to correctly benchmark new therapies.