Rotation of nilotinib and imatinib for first‐line treatment of chronic phase chronic myeloid leukemia |
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| Authors: | Gabriele Gugliotta Fausto Castagnetti Massimo Breccia Antonella Gozzini Emilio Usala Angelo M. Carella Giovanna Rege‐Cambrin Bruno Martino Elisabetta Abruzzese Francesco Albano Fabio Stagno Luigia Luciano Mariella D'Adda Monica Bocchia Francesco Cavazzini Mario Tiribelli Monia Lunghi Antonietta Pia Falcone Caterina Musolino Luciano Levato Claudia Venturi Simona Soverini Michele Cavo Giuliana Alimena Fabrizio Pane Giovanni Martinelli Giuseppe Saglio Gianantonio Rosti Michele Baccarani |
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| Affiliation: | 1. Institute of Hematology “L. and A. Seràgnoli”, Department of Experimental Diagnostic and Specialty Medicine, “S. Orsola‐Malpighi” Hospital, University of Bologna, Bologna, Italy;2. Chair of Hematology, “Sapienza” University, Rome, Italy;3. Chair of Hematology, “Careggi” Hospital, University of Florence, Florence, Italy;4. Hematology Unit, “A. Businco” Hospital, Cagliari, Italy;5. IRCCS AOU San Martino‐IST, Hematology and Bone Marrow Transplantation Unit, Genova, Italy;6. Chair of Hematology, Department of Clinical and Biological Sciences, “S. Luigi Gonzaga” University Hospital, University of Torino, Orbassano, (Torino), Italy;7. Hematology Unit, “Bianchi‐Melacrino‐Morelli” Hospital, Reggio Calabria, Italy;8. Hematology Unit, “S. Eugenio” Hospital, Rome, Italy;9. Chair of Hematology, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy;10. Chair of Hematology, “Ferrarotto” Hospital, University of Catania, Catania, Italy;11. Chair of Hematology, Department of Biochemistry and Medical Biotechnologies, “Federico II” University, Naples, Italy;12. Hematology Unit, “Spedali Civili” Hospital, Brescia, Italy;13. Chair of Hematology“S.Maria alle Scotte” Hospital, Siena, Italy, University of Siena;14. Chair of Hematology, “S. Anna” Hospital, University of Ferrara, Ferrara, Italy;15. Chair of Hematology, University of Udine, Udine, Italy;16. Chair of Hematology, “A. Avogadro” University of Eastern Piedmont, Novara, Italy;17. Hematology Unit, IRCCS “Ospedale Casa Sollievo della Sofferenza”, S.Giovanni Rotondo, Italy;18. Chair of Hematology, University of Messina, Messina, Italy;19. Hematology Unit, “Pugliese‐Ciaccio” Hospital, Catanzaro, Italy;20. Department of Hematology and Oncology “L. and A. Seràgnoli”, University of Bologna, Bologna, Italy |
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| Abstract: | 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. |
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