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Guilhot, Francois; Rigal-Huguet, Françoise; Guilhot, Joëlle; Guerci-Bresler, Agnès-Paule; Maloisel, Frédéric; Rea, Delphine; Coiteux, Valérie; Gardembas, Martine; Berthou, Christian; Vekhoff, Anne; Jourdan, Eric; Berger, Marc; Fouillard, Loïc; Alexis, Magda; Legros, Laurence; Rousselot, Philippe; Delmer, Alain; Lenain, Pascal; Escoffre Barbe, Martine; Gyan, Emmanuel; Bulabois, Claude-Eric; Dubruille, Viviane; Joly, Bertrand; Pollet, Bertrand; Cony-Makhoul, Pascale; Johnson-Ansah, Hyacinthe; Mercier, Melanie; Caillot, Denis; Charbonnier, Aude; Kiladjian, Jean-Jacques; Chapiro, Jacques; Penot, Amélie; Dorvaux, Véronique; Vaida, Iona; Santagostino, Alberto; Roy, Lydia; Zerazhi, Hacene; Deconinck, Eric; Maisonneuve, Herve; Plantier, Isabelle; Lebon, Delphine; Arkam, Yazid; Cambier, Nathalie; Ghomari, Kamel; Miclea, Jean-Michel; Glaisner, Sylvie; Cayuela, Jean-Michel; Chomel, Jean-Claude; Muller, Marc; Lhermitte, Ludovic; Delord, Marc; Preudhomme, Claude; Etienne, Gabriel; Mahon, François-Xavier; Nicolini, Franck-Emmanuel
Leukemia, 08/2021, Volume: 35, Issue: 8Journal Article
The STI571 prospective randomised trial (SPIRIT) French trial is a four-arm study comparing imatinib (IM) 400 mg versus IM 600 mg, IM 400 mg + cytarabine (AraC), and IM 400 mg + pegylated interferon alpha2a (PegIFN-α2a) for the front-line treatment of chronic-phase chronic myeloid leukaemia (CML). Long-term analyses included overall and progression-free survival, molecular responses to treatment, and severe adverse events. Starting in 2003, the trial included 787 evaluable patients. The median overall follow-up of the patients was 13.5 years (range 3 months to 16.7 years). Based on intention-to-treat analyses, at 15 years, overall and progression-free survival were similar across arms: 85%, 83%, 80%, and 82% and 84%, 87%, 79%, and 79% for the IM 400 mg (N = 223), IM 600 mg (N = 171), IM 400 mg + AraC (N = 172), and IM 400 mg + PegIFN-α2a (N = 221) arms, respectively. The rate of major molecular response at 12 months and deep molecular response (MR4) over time were significantly higher with the combination IM 400 mg + PegIFN-α2a than with IM 400 mg: p = 0.0001 and p = 0.0035, respectively. Progression to advanced phases and secondary malignancies were the most frequent causes of death. Toxicity was the main reason for stopping AraC or PegIFN-α2a treatment.
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