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Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: Minimum 24‐month follow‐up
Authors: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  Jorge E. Cortes
Affiliation:1. University of Milano‐Bicocca, San Gerardo Hospital, Monza, Italy;2. Universit?tsklinikum Aachen, RWTH Aachen, Germany;3. Universit?tsklinikum Hamburg‐Eppendorf, Hamburg, Germany;4. Seoul St. Mary's Hospital, Seoul, South Korea;5. Hematology Research Center, Moscow, Russia;6. St. István and St. László Hospital, Budapest, Hungary;7. Jewish General Hospital, McGill University, Montreal, QC, Canada;8. Royal Brisbane Hospital, Herston, Queensland, Australia;9. University of Texas MD Anderson Cancer Center, Houston, Texas;10. Winship Cancer Institute of Emory University, Atlanta, Georgia;11. University of Pavlov and Almazov Federal Heart, Blood, and Endocrinology Centre, St, Petersburg, Russia;12. Ruijin Hospital, Shanghai, China;13. First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China;14. University of Groningen and University Medical Center Groningen, Groningen, Netherlands;15. Hospital das Clínicas da Universidade Federal do Paraná, Paraná, Brazil;16. Christian Medical College, Vellore, Tamil Nadu, India;17. Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain;18. Pfizer Global Research and Development, Paris, France;19. Pfizer, Cambridge, Massachusetts
Abstract:Bosutinib 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. Am. J. Hematol. 89:732–742, 2014. © 2014 The Authors American Journal of Hematology Published by Wiley Periodicals, Inc.
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