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Patterns and prognostic indicators of response to CML treatment in a multi-country medical record review study

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Abstract

We conducted a review of patient medical records to assess treatment response patterns and prognostic indicators of response among chronic myeloid leukemia (CML) patients in the United States, the United Kingdom, Germany, and Japan. All 1,063 patients selected met the following inclusion criteria: aged 18 or older and in chronic phase at the time of diagnosis, Philadelphia chromosome and/or BCR-ABL positive, received first-line treatment with imatinib, and not enrolled in a randomized clinical trial during the period of retrospective review. Multivariable logistic regression models were used to evaluate prognostic indicators of complete hematological response (CHR), complete cytogenetic response (CCyR), and complete or major molecular response (C/MMR). Among patients treated with first-line imatinib, CHR at three months, CCyR at 12 months, and C/MMR at 18 months were observed in 53, 53.1, and 57.8 % of patients, respectively. Among patients treated with second-line dasatinib or nilotinib, CHR was achieved at three months in 49 and 42 %, CCyR at 12 months in 32 and 23 %, and MMR at 18 months in 30.5 and 26.1 % of patients, respectively. Prognostic indicators of first-line response included age, race, and Sokal score. For second-line treatment, duration of first-line hematological response and choice of drug used were also significant.

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Acknowledgments

The study was funded in full by Pfizer, Inc. All authors had complete access to the data that support this manuscript, and the authors confirm that the paper is an accurate representation of the study results. Dr. Trask was an employee of Pfizer, Inc. at the time that this study was conducted. He is now an employee of sanofi-aventis. Dr. Iyer is an employee of Pfizer, Inc. Drs. Trask and Iyer and were involved in the conception, organization, funding, and execution of the research project; the review and critique of the statistical analyses; the writing and reviewing the manuscript; and the final approval for the submission of the manuscript and its content. Ms. Mitra and Drs. Candrilli and Kaye are employees of RTI Health Solutions, who were paid consultants to Pfizer in connection with the development of the research project and this manuscript. Ms Mitra led the organization and execution of the research project and the development of the study design, conducted all statistical analyses, reviewed and critiqued the manuscript, and provided final approval for the submission of the manuscript and its content. Drs. Candrilli and Kaye were involved in the conception and development of the study design, the review and critique of the statistical analyses, the review and critique of the manuscript, and the final approval for the submission of the manuscript and its content. The authors also wish to acknowledge the critical contributions of Valerie Derrien to this study. An employee of A+A Healthcare Research, Ms. Derrien led and executed all medical record data collection activities required for this study. The publication of this study’s results is not contingent on the sponsor’s approval or censorship of the manuscript.

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Authors and Affiliations

  1. Pfizer Inc., 235, E.42nd Street, New York, NY, 10017, USA

    Peter C. Trask & Shrividya Iyer

  2. RTI Health Solutions, 200 Park Office Drive, Research Triangle Park, NC, 27709, USA

    Debanjali Mitra, Sean D. Candrilli & James A. Kaye

Authors
  1. Peter C. Trask
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  2. Debanjali Mitra
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  3. Shrividya Iyer
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  4. Sean D. Candrilli
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  5. James A. Kaye
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Correspondence to Debanjali Mitra.

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Trask, P.C., Mitra, D., Iyer, S. et al. Patterns and prognostic indicators of response to CML treatment in a multi-country medical record review study. Int J Hematol 95, 535–544 (2012). https://doi.org/10.1007/s12185-012-1043-8

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  • DOI: https://doi.org/10.1007/s12185-012-1043-8

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