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.
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Cytarabine
/ administration & dosage
Dose-Response Relationship, Drug
Female
Follow-Up Studies
Humans
Imatinib Mesylate
/ administration & dosage
Interferon-alpha
/ administration & dosage
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
/ drug therapy
Male
Middle Aged
Polyethylene Glycols
/ administration & dosage
Prognosis
Prospective Studies
Recombinant Proteins
/ administration & dosage
Survival Rate
Young Adult
Journal
Leukemia
ISSN: 1476-5551
Titre abrégé: Leukemia
Pays: England
ID NLM: 8704895
Informations de publication
Date de publication:
08 2021
08 2021
Historique:
received:
24
01
2020
accepted:
15
12
2020
revised:
20
11
2020
pubmed:
24
1
2021
medline:
1
9
2021
entrez:
23
1
2021
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 33483613
doi: 10.1038/s41375-020-01117-w
pii: 10.1038/s41375-020-01117-w
doi:
Substances chimiques
Interferon-alpha
0
Recombinant Proteins
0
Cytarabine
04079A1RDZ
Polyethylene Glycols
3WJQ0SDW1A
Imatinib Mesylate
8A1O1M485B
peginterferon alfa-2a
Q46947FE7K
Types de publication
Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2332-2345Investigateurs
Francois Guilhot
(F)
Francoise Rigal-Huguet
(F)
Joëlle Guilhot
(J)
Agnès-Paule Guerci-Bresler
(AP)
Delphine Rea
(D)
Valérie Coiteux
(V)
Martine Gardembas
(M)
Anne Vekhoff
(A)
Marc Berger
(M)
Laurence Legros
(L)
Philippe Rousselot
(P)
Pascal Lenain
(P)
Martine Escoffre Barbe
(M)
Viviane Dubruille
(V)
Pascale Cony-Makhoul
(P)
Hyacinthe Johnson-Ansah
(H)
Melanie Mercier
(M)
Charbonnier Aude
(C)
Lydia Roy
(L)
Nathalie Cambier
(N)
Jean-Michel Cayuela
(JM)
Jean-Claude Chomel
(JC)
Marc Delord
(M)
Claude Preudhomme
(C)
Gabriel Etienne
(G)
François-Xavier Mahon
(FX)
Franck-Emmanuel Nicolini
(FE)
Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer Nature Limited part of Springer Nature.
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