• Carlo Gambacorti-Passerini, Tim H Brümmendorf, Dong-Wook Kim, Anna G Turkina, Tamas Masszi, Sarit Assouline, Simon Durrant, Hagop M Kantarjian, H Jean Khoury, Andrey Zaritskey, Zhi-Xiang Shen, Jie Jin, Edo Vellenga, Ricardo Pasquini, Vikram Mathews, Francisco Cervantes, Nadine Besson, Kathleen Turnbull, Eric Leip, Virginia Kelly, and Jorge E Cortes.
• University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy.
• Am. J. Hematol. 2014 Jul 1; 89 (7): 732-42.

AbstractBosutinib is an orally active, dual Src/Abl tyrosine kinase inhibitor for treatment of chronic myeloid leukemia (CML) following resistance/intolerance to prior therapy. Here, we report the data from the 2-year follow-up of a phase 1/2 open-label study evaluating the efficacy and safety of bosutinib as second-line therapy in 288 patients with chronic phase CML resistant (n = 200) or intolerant (n = 88) to imatinib. The cumulative response rates to bosutinib were as follows: 85% achieved/maintained complete hematologic response, 59% achieved/maintained major cytogenetic response (including 48% with complete cytogenetic response), and 35% achieved major molecular response. Responses were durable, with 2-year estimates of retaining response >70%. Two-year probabilities of progression-free survival and overall survival were 81% and 91%, respectively. The most common toxicities were primarily gastrointestinal adverse events (diarrhea [84%], nausea [45%], vomiting [37%]), which were primarily mild to moderate, typically transient, and first occurred early during treatment. Thrombocytopenia was the most common grade 3/4 hematologic laboratory abnormality (24%). Outcomes were generally similar among imatinib-resistant and imatinib-intolerant patients and did not differ with age. The longer-term results of the present analysis confirm that bosutinib is an effective and tolerable second-line therapy for patients with imatinib-resistant or imatinib-intolerant chronic phase CML. ClinicalTrials.gov Identifier: NCT00261846.© 2014 The Authors American Journal of Hematology Published by Wiley Periodicals, Inc.

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