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Rotation of nilotinib and imatinib for first‐line treatment of chronic phase chronic myeloid leukemia
Author(s) -
Gugliotta Gabriele,
Castagnetti Fausto,
Breccia Massimo,
Gozzini Antonella,
Usala Emilio,
Carella Angelo M.,
RegeCambrin Giovanna,
Martino Bruno,
Abruzzese Elisabetta,
Albano Francesco,
Stagno Fabio,
Luciano Luigia,
D'Adda Mariella,
Bocchia Monica,
Cavazzini Francesco,
Tiribelli Mario,
Lunghi Monia,
Pia Falcone Antonietta,
Musolino Caterina,
Levato Luciano,
Venturi Claudia,
Soverini Simona,
Cavo Michele,
Alimena Giuliana,
Pane Fabrizio,
Martinelli Giovanni,
Saglio Giuseppe,
Rosti Gianantonio,
Baccarani Michele
Publication year - 2016
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.24362
Subject(s) - nilotinib , imatinib , medicine , myeloid leukemia , dasatinib , tyrosine kinase inhibitor , adverse effect , tyrosine kinase , oncology , imatinib mesylate , cancer , receptor
The introduction of second‐generation tyrosine‐kinase inhibitors (TKIs) has generated a lively debate on the choice of first‐line TKI in chronic phase, chronic myeloid leukemia (CML). Despite the TKIs have different efficacy and toxicity profiles, the planned use of two TKIs has never been investigated. We report on a phase 2 study that was designed to evaluate efficacy and safety of a treatment alternating nilotinib and imatinib, in newly diagnosed BCR‐ABL1 positive, chronic phase, CML patients. One hundred twenty‐three patients were enrolled. Median age was 56 years. The probabilities of achieving a complete cytogenetic response, a major molecular response, and a deep molecular response (MR 4.0) by 2 years were 93%, 87%, and 61%, respectively. The 5‐year overall survival and progression‐free survival were 89%. Response rates and survival are in the range of those reported with nilotinib alone. Moreover, we observed a relatively low rate of cardiovascular adverse events (5%). These data show that the different efficacy and toxicity profiles of TKIs could be favorably exploited by alternating their use. Am. J. Hematol. 91:617–622, 2016. © 2016 Wiley Periodicals, Inc.