FLIPI24: A Modern Prognostic Model and Clinical Trial Enrichment Tool for Newly Diagnosed Follicular Lymphoma.
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Maurer Matthew J, Prochazka Vit K, El-Galaly Tarec Christoffer, Flowers Christopher R, Villa Diego, Bachy Emmanuel, Cahn Elliot J, Fournier Marguerite, Larson Melissa C, Dietrich Caroline E, Jakobsen Lasse Hjort, Ghesquières Hervé, Kridel Robert, Gandhi Maher K, Cheah Chan Y, Hawkes Eliza A, Seymour John F, Freeman Ciara L, Clausen Michael R, Wahlin Björn E, Friedberg Jonathan W, Casulo Carla, Habermann Thomas M, Wang Yucai, Nastoupil Loretta J, de Nully Brown Peter, Belada David, Janíková Andrea, Mocikova Heidi, Fürst Tomáš, Feugier Pierre, Tilly Hervé, Haioun Corinne, Davies Andrew J, Cartron Guillaume, Burack Richard, Chihara Dai, Martin Peter, Cohen Jonathon B, Lossos Izidore S, Kahl Brad S, Sehn Laurie H, Smedby Karin E, Salles Gilles, Trneny Marek, Link Brian K, Morschhauser Franck, Cerhan James R
Аннотация
METHODS: The FLIPI24 model was developed and internally validated to predict 24-month event rates using individual data from 4,485 patients treated with 1L immunochemotherapy from 10 observational cohorts of FL. Overall and cause-specific survival was further evaluated in FLIPI24 risk groups. External validation in the 1L immunochemotherapy setting was performed using the prospective observational Lymphoma Epidemiology of Outcomes (LEO) cohort (N = 565) and three randomized phase III trials (N = 3,192); extension to all patients with FL (any 1L therapy) was performed in the LEO cohort (N = 1,445) and its Molecular Epidemiology Resource subcohort (N = 1,074).
RESULTS: The FLIPI24 model uses age and four blood-based variables (hemoglobin, lactate dehydrogenase, beta-2 microglobulin, and WBC count). FLIPI24 showed consistent performance across validation and extension data sets, which was superior to existing prognostic tools. Across the four external immunochemotherapy validation data sets, patients with high-risk FLIPI24 (23%-32% of patients) had significantly higher 24-month event rates (22%-35%) and inferior 5-year overall survival (77%-83%) compared with patients with low-risk FLIPI24 (29%-31% of patients, 24-month event rates: 10%-12%; 5-year OS: 96%-97%). Results were consistent when evaluating lymphoma-related death and when extended to all patients with FL.
CONCLUSION: The FLIPI24 model robustly stratifies, at diagnosis, patients with FL at increased risk of lymphoma-related death versus patients with very low lymphoma-related mortality during the first decade after diagnosis. FLIPI24 can be used to enrich future clinical trial designs in newly diagnosed FL.