Meeting trial eligibility in follicular lymphoma patients is associated with overall survival but not progression-free survival
Menée à partir de données de quatre essais de phase III portant au total sur 528 patients atteints d'un lymphome folliculaire et recevant une immunochimiothérapie standard, cette étude multicentrique met en évidence une association entre les critères d'éligibilité et la survie globale (et non la survie sans progression)
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.
Journal of the National Cancer Institute , résumé, 2025