1. Long-term outcome of imatinib 400 mg compared to imatinib 600 mg or imatinib 400 mg daily in combination with cytarabine or pegylated interferon alpha 2a for chronic myeloid leukaemia: results from the French SPIRIT phase III randomised trial
- Author
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Francois, Guilhot, Françoise, Rigal-Huguet, Joëlle, Guilhot, Agnès-Paule, Guerci-Bresler, Frédéric, Maloisel, Delphine, Rea, Valérie, Coiteux, Martine, Gardembas, Christian, Berthou, Anne, Vekhoff, Eric, Jourdan, Marc, Berger, Loïc, Fouillard, Magda, Alexis, Laurence, Legros, Philippe, Rousselot, Alain, Delmer, Pascal, Lenain, Martine, Escoffre Barbe, Emmanuel, Gyan, Claude-Eric, Bulabois, Viviane, Dubruille, Bertrand, Joly, Bertrand, Pollet, Pascale, Cony-Makhoul, Hyacinthe, Johnson-Ansah, Melanie, Mercier, Denis, Caillot, Aude, Charbonnier, Jean-Jacques, Kiladjian, Jacques, Chapiro, Amélie, Penot, Véronique, Dorvaux, Iona, Vaida, Alberto, Santagostino, Lydia, Roy, Hacene, Zerazhi, Eric, Deconinck, Herve, Maisonneuve, Isabelle, Plantier, Delphine, Lebon, Yazid, Arkam, Nathalie, Cambier, Kamel, Ghomari, Jean-Michel, Miclea, Sylvie, Glaisner, Jean-Michel, Cayuela, Jean-Claude, Chomel, Marc, Muller, Ludovic, Lhermitte, Marc, Delord, Claude, Preudhomme, Gabriel, Etienne, François-Xavier, Mahon, and Franck-Emmanuel, Nicolini
- Subjects
Adult ,Aged, 80 and over ,Male ,Dose-Response Relationship, Drug ,Cytarabine ,Interferon-alpha ,Middle Aged ,Prognosis ,Recombinant Proteins ,Polyethylene Glycols ,Survival Rate ,Young Adult ,Leukemia, Myelogenous, Chronic, BCR-ABL Positive ,Antineoplastic Combined Chemotherapy Protocols ,Imatinib Mesylate ,Humans ,Female ,Prospective Studies ,Aged ,Follow-Up Studies - Abstract
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.
- Published
- 2020