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

Background Clinical trial eligibility criteria are necessary for safety and target population homogeneity; however, increasingly restrictive organ function eligibility rarely preclude standard therapies and impede clinical application of trial results. Methods This multicentre, retrospective study applied safety-related eligibility criteria from four landmark phase III trials (GALLIUM, RELEVANCE, StiL NHL1, BRIGHT) to 528 treatment-naïve follicular lymphoma (FL) patients receiving standard immunochemotherapy. Results 55% were ineligible for at least one study and 12% were ineligible for all four studies. Ineligible patients were more likely aged over 60 years with poorer performance status compared to eligible patients (p < .05 respectively). There was no difference between response rate or progression-free survival (PFS) of eligible vs ineligible patients. Patients ineligible for all trials had inferior 5-year overall survival (OS) compared to patients eligible for at least one study (69% vs 92%, p < .001). More than half of deaths were due to causes other than lymphoma. Conclusion In summary, current trials select populations with favourable OS despite similar disease-based outcomes. Patients suitable for standard chemoimmunotherapy should not be routinely excluded based on age, performance status and organ function from frontline randomised trials with PFS primary endpoints. There is a significant need to broaden trial eligibility to include all patients fit for standard treatment to correctly benchmark new therapies.