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Author Notes:

Dr. Jorge Cortes, Professor of Medicine and Internist, Deputy Chair and Chief, CML and AML Sections, Department of Leukemia, Division of Cancer Medicine, 1515 Holcombe Blvd, University of Texas MD Anderson Cancer Center, Houston, TX 77030. E‐mail: jcortes@mdanderson.org

We wish to thank all of the participating patients and their families, as well as the global network of investigators, research nurses, study coordinators, and operations staff.

J.E.C.: consultancy, research funding (Novartis, Bristol‐Myers Squibb, Pfizer, Ariad, Teva); H.J.K.: honoraria and membership on Board of Directors or advisory committees (Novartis, Bristol‐Myers Squibb, Pfizer, Ariad, and Teva); H.M.K.: research funding (Pfizer); J.H.L.: honoraria, membership on Board of Directors or advisory committees and speaker's bureaus, research funding (Pfizer, Bristol‐Myers Squibb, Novartis, Ariad); D.‐W.K.: consultancy, honoraria, research funding and membership on Board of Directors or advisory committees (Bristol‐Myers Squibb, Novartis, Pfizer, ILYANG); P.S.: consultancy, honoraria (Pfizer, Bristol‐Myers Squibb, Novartis, Ariad); T.H.B.: consultancy, honoraria (Bristol‐Myers Squibb, Pfizer, Novartis, Ariad), research funding (Novartis), as well as patents and royalties (use of imatinib and hypusination inhibitors); C.G.P.: consultancy (Pfizer, Bristol‐Myers Squibb) and research funding (Pfizer).

E.L. and K.N. are Pfizer employees.

E.M. was an employee of Pfizer when the manuscript was initiated.

Subject:

Research Funding:

This study was sponsored by Pfizer Inc. Editorial and medical writing support was provided by Johna Van Stelten, PhD, and Simon J. Slater, PhD, of Complete Healthcare Communications, LLC, and was funded by Pfizer Inc.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Hematology
  • TYROSINE KINASE INHIBITORS
  • FOLLOW-UP
  • MOLECULAR RESPONSES
  • IN-VITRO
  • THERAPY
  • SAFETY
  • EFFICACY
  • TRIAL
  • INTOLERANCE
  • RESISTANCE

Long-term bosutinib for chronic phase chronic myeloid leukemia after failure of imatinib plus dasatinib and/or nilotinib

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Journal Title:

American Journal of Hematology

Volume:

Volume 91, Number 12

Publisher:

, Pages 1206-1214

Type of Work:

Article | Final Publisher PDF

Abstract:

Bosutinib is an Src/Abl tyrosine kinase inhibitor (TKI) indicated for adults with Ph+ chronic myeloid leukemia (CML) resistant/intolerant to prior TKIs. This long-term update of an ongoing phase 1/2 study evaluated the efficacy and safety of third-/fourth-line bosutinib in adults with chronic phase (CP) CML. Median durations of treatment and follow-up were 8.6 (range, 0.2–87.7) months and 32.7 (0.3–93.3) months, respectively. Cumulative confirmed complete hematologic response (cCHR) and major cytogenetic response (MCyR) rates were 74% (95% CI, 65–81%) and 40% (31–50%), respectively; Kaplan–Meier (K–M) probability of maintaining cCHR or MCyR at 4 years was 63% (95% CI, 50–73%) and 69% (52–81%). Cumulative incidence of on-treatment disease progression (PD)/death at 4 years was 24% (95% CI, 17–33%); K–M 4-year overall survival was 78% (68–85%). Baseline Ph+ cells ≤35 vs. ≥95% was prognostic of MCyR and CCyR by 3 and 6 months, increased baseline basophils was prognostic of PD/death, and no prior response to second-line TKI was prognostic of death. Common adverse events included diarrhea (83%), nausea (48%), vomiting (38%), and thrombocytopenia (39%). Bosutinib demonstrates durable efficacy and a toxicity profile similar to previous bosutinib studies in CP CML patients resistant/intolerant to multiple TKIs, representing an important treatment option for patients in this setting. This trial is registered at www.clinicaltrials.gov (NCT00261846). Am. J. Hematol. 91:1206–1214, 2016. © 2016 Wiley Periodicals, Inc.

Copyright information:

© 2016 Wiley Periodicals, Inc.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/).
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