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Treatment-free remission in chronic myeloid leukemia patients treated front-line with nilotinib: 10-year followup of the GIMEMA CML 0307 study

Authors :
Gabriele Gugliotta
Fausto Castagnetti
Massimo Breccia
Luciano Levato
Tamara Intermesoli
Mariella D'Adda
Marzia Salvucci
Fabio Stagno
Giovanna Rege-Cambrin
Mario Tiribelli
Bruno Martino
Monica Bocchia
Michele Cedrone
Elena Trabacchi
Francesco Cavazzini
Ferdinando Porretto
Federica Sorà
Maria Pina Simula
Francesco Albano
Simona Soverini
Robin Foà
Fabrizio Pane
Michele Cavo
Giuseppe Saglio
Michele Baccarani
Gianantonio Rosti
Gugliotta G.
Castagnetti F.
Breccia M.
Levato L.
Intermesoli T.
D'Adda M.
Salvucci M.
Stagno F.
Rege-Cambrin G.
Tiribelli M.
Martino B.
Bocchia M.
Cedrone M.
Trabacchi E.
Cavazzini F.
Porretto F.
Sora F.
Simula M.P.
Albano F.
Soverini S.
Foa R.
Pane F.
Cavo M.
Saglio G.
Baccarani M.
Rosti G.
Source :
Haematologica. 107:2356-2364
Publication Year :
2022
Publisher :
Ferrata Storti Foundation (Haematologica), 2022.

Abstract

We report the final analysis, with a 10-year follow-up, of the phase II study GIMEMA CML 0307 (NCT 00481052), which enrolled 73 adult patients (median age 51 years; range, 18-83) with newly diagnosed chronic-phase chronic myeloid leukemia to investigate the efficacy and the toxicity of front-line treatment with nilotinib. The initial dose was 400 mg twice daily; the dose was reduced to 300 mg twice daily as soon as this dose was approved and registered. The 10-year overall survival and progression- free survival were 94.5%. At the last contact, 36 (49.3%) patients were continuing nilotinib (22 patients at 300 mg twice daily, 14 at lower doses), 18 (24.7%) patients were in treatment-free remission, 14 (19.2%) were receiving other tyrosinekinase inhibitors and four (5.5%) patients have died. The rates of major and deep molecular responses by 10 years were 96% and 83%, respectively. The median times to major and deep molecular response were 6 and 18 months, respectively. After a median duration of nilotinib treatment of 88 months, 24 (32.9%) patients discontinued nilotinib while in stable deep molecular response. In these patients, the 2-year estimated treatment-free survival was 72.6%. The overall treatment-free remission rate, calculated on all enrolled patients, was 24.7% (18/73 patients). Seventeen patients (23.3%), at a median age of 69 years, had at least one arterial obstructive event. In conclusion, the use of nilotinib front-line in chronic phase chronic myeloid leukemia can induce a stable treatment-free remission in a relevant number of patients, although cardiovascular toxicity remains of concern.

Details

ISSN :
15928721 and 03906078
Volume :
107
Database :
OpenAIRE
Journal :
Haematologica
Accession number :
edsair.doi.dedup.....f7295072001403d0046e288c3aa4ace7
Full Text :
https://doi.org/10.3324/haematol.2021.280175