Fiche publication
Date publication
janvier 2026
Journal
Leukemia
Auteurs
Membres identifiés du Cancéropôle Est :
Dr GUERCI-BRESLER Agnès
Tous les auteurs :
Burchert A, Nicolini FE, le Coutre P, Saussele S, Hochhaus A, Tuere E, Metzelder SK, Pauck K, Garn H, Raifer H, Huber M, Gattermann N, Crysandt M, Schafhausen P, Bormann M, Radsak MP, Guerci-Bresler A, Illmer T, Goebeler ME, Herhaus P, Teichmann LL, Franke GN, Lang F, Krause SW, Möhle R, Klausmann M, Stegelmann F, Lutz C, Etienne G, Stoltefuß A, Göthert JR, Ernst T, Abu-Samra M, Höffkes HG, Neubauer A, Wang Y, Weiland P, Otto C, Kiessler L, Weber T, Kroning L, Nist A, Stiewe T, Hehlmann R, Aminossadati B, Wittenberg M, Winterstein K, Oellerich T, Lechner M, Pfirrmann M, Schade-Brittinger C, Klemm P, Michel C
Lien Pubmed
Résumé
Treatment-free remission (TFR) after discontinuation of ABL tyrosine kinase inhibitors (TKIs) is an important therapeutic goal in chronic myeloid leukemia (CML). Interferon-α (IFN) has been suggested to promote durable TFR. The phase 3 ENDURE trial (NCT03117816; EUDRA-CT 2016-001030-94) prospectively tested this hypothesis in patients with stable deep molecular remission after TKI therapy. A total of 203 patients were randomised 1:1 to receive ropeginterferon alfa-2b (ropeg-IFN; 100 µg subcutaneously every two weeks for 15 months, n = 95) or observation alone (n = 108) after TKI discontinuation. The primary endpoint was molecular relapse-free survival (MRFS), defined as time to loss of major molecular response (MMR) or death. At a median follow-up of 36 months, 25-month MRFS was 56% (95% confidence interval (CI), 45-66) with ropeg-IFN and 59% (95% CI, 49-68) with observation (hazard ratio (HR), 1.02; 95% CI, 0.68-1.55; P = 0.91). Among 83 patients with molecular data after TKI restart, 79 (95%) regained at least MMR, 78 within 12 months (median 3 months, interquartile range: 2-4 months). Ropeg-IFN was well tolerated (median administered dose of 92 µg, range 3-104), and no new safety signals were observed. Ropeg-IFN maintenance did not improve the probability of sustained TFR after TKI discontinuation.
Référence
Leukemia. 2026 01 12;:
