Guilhot F, Rigal-Huguet F, Guilhot J, Guerci-Bresler AP, Maloisel F, Rea D, Coiteux V, Gardembas M, Berthou C, Vekhoff A, Jourdan E, Berger M, Fouillard L, Alexis M, Legros L, Rousselot P, Delmer A, Lenain P, Escoffre Barbe M, Gyan E, Bulabois CE, Dubruille V, Joly B, Pollet B, Cony-Makhoul P, Johnson-Ansah H, Mercier M, Caillot D, Charbonnier A, Kiladjian JJ, Chapiro J, Penot A, Dorvaux V, Vaida I, Santagostino A, Roy L, Zerazhi H, Deconinck E, Maisonneuve H, Plantier I, Lebon D, Arkam Y, Cambier N, Ghomari K, Miclea JM, Glaisner S, Cayuela JM, Chomel JC, Muller M, Lhermitte L, Delord M, Preudhomme C, Etienne G, Mahon FX, and Nicolini FE
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., (© 2021. The Author(s), under exclusive licence to Springer Nature Limited part of Springer Nature.)