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Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion†

  1. Kimmo Porkka MD, PhD1,‡,*,
  2. H. Jean Khoury MD2,
  3. Ronald L. Paquette MD3,
  4. Yousif Matloub MD4,
  5. Ritwik Sinha PhD4,
  6. Jorge E. Cortes MD5

Article first published online: 18 NOV 2009

DOI: 10.1002/cncr.24734

Issue

Cancer

Cancer

Volume 116, Issue 2, pages 377–386, 15 January 2010

Additional Information

How to Cite

Porkka, K., Khoury, H. J., Paquette, R. L., Matloub, Y., Sinha, R. and Cortes, J. E. (2010), Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion. Cancer, 116: 377–386. doi: 10.1002/cncr.24734

Author Information

  1. 1

    Hematology Research Unit, Biomedicum Helsinki, Helsinki University Central Hospital, Helsinki, Finland

  2. 2

    Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia

  3. 3

    Department of Medicine, Division of Hematology/Oncology, Ronald Reagan UCLA Medical Center, Los Angeles, California

  4. 4

    Bristol-Myers Squibb, Wallingford, Connecticut

  5. 5

    Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas

  1. ‡

    Fax: (011) 358-9-471-71897

*Helsinki University Central Hospital, Biomedicum Helsinki, Hematology Research Unit, P.O. Box 700, FIN-00029 HUCH, Helsinki, Finland

  1. †

    David Dejardin (Bristol-Myers Squibb) provided assistance with statistical analysis.

Publication History

  1. Issue published online: 20 JAN 2010
  2. Article first published online: 18 NOV 2009
  3. Manuscript Accepted: 4 MAY 2009
  4. Manuscript Revised: 21 APR 2009
  5. Manuscript Received: 13 FEB 2009

Funded by

  • Funding for the clinical trial, statistical analysis, and medical writing assistance was provided by Bristol-Myers Squibb (BMS)

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Keywords:

  • Dasatinib;
  • chronic myeloid leukemia;
  • pleural effusion;
  • treatment outcome;
  • progression-free survival;
  • lymphocytosis

In patients with chronic myeloid leukemia in chronic phase, dasatinib 100 mg once daily significantly minimized the occurrence of pleural effusion. Dasatinib short-term and long-term efficacy was similar in patients with or without pleural effusion.

Abstract

BACKGROUND:

Dasatinib, a highly potent BCR-ABL inhibitor, is an effective treatment for patients with chronic myeloid leukemia in chronic phase (CML CP) after resistance, suboptimal response, or intolerance to prior imatinib. In a phase 3 dose optimization trial in patients with CML CP (CA180-034), the occurrence of pleural effusion was significantly minimized with dasatinib 100 mg once daily (QD) compared with other treatment arms (70 mg twice daily [twice daily], 140 mg QD, or 50 mg twice daily).

METHODS:

To investigate the occurrence and management of pleural effusion during dasatinib treatment, and efficacy in patients with or without pleural effusion, data from CA180-034 were analyzed.

RESULTS:

With 24-month minimum follow-up, 14% of patients treated with dasatinib 100 mg QD incurred pleural effusion (grade 3: 2%; grade 4: 0%) compared with 23% to 26% in other study arms. The pleural effusion rate showed only a minimal increment from 12 to 24 months. In the 100 mg QD study arm, median time to pleural effusion (any grade) was 315 days, and after pleural effusion, 52% of patients had a transient dose interruption, 35% had a dose reduction, 57% received a diuretic, and 26% received a corticosteroid. Three patients in the 100 mg QD study arm discontinued treatment after pleural effusion. Across all study arms, patients with or without pleural effusion demonstrated similar progression-free and overall survival, and cytogenetic response rates were higher in patients with a pleural effusion.

CONCLUSIONS:

Pleural effusion is minimized with dasatinib 100 mg QD dosing and its occurrence does not affect short- or long-term efficacy. Cancer 2010. © 2010 American Cancer Society.

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