Journal of the National Cancer Institute · 2025
Meeting trial eligibility in Follicular lymphoma patients is associated with overall survival but not progression-free survival.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Wong Kimberly S Q, Martynchyk Arina, Krisnadi Zoe, Swain Fiona, Zargari Ahmad, Cassidy Luke, Mills Georgia, Lim Kenneth, Gervasi Jeremy, Smallbone Portia, Wang Jenny, Slifirski Olivia, Loh Zoe, Cheah Chan, Keane Colm, Gregory Gareth, Lasica Masa, Chong Geoffrey, Barraclough Allison, Cochrane Tara, Lee Denise, Hawkes Eliza
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.