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Type: Journal article
Title: Early molecular response and female sex strongly predict stable undetectable BCR-ABL1, the criteria for imatinib discontinuation in patients with CML
Author: Branford, S.
Yeung, D.
Ross, D.
Prime, J.
Field, C.
Altamura, H.
Yeoman, A.
Georgievski, J.
Jamison, B.
Phillis, S.
Sullivan, B.
Briggs, N.
Hertzberg, M.
Seymour, J.
Reynolds, J.
Hughes, T.
Citation: Blood, 2013; 121(19):3818-3824
Publisher: Amer Soc Hematology
Issue Date: 2013
ISSN: 0006-4971
Statement of
Susan Branford, David T. Yeung, David M. Ross, Jodi A. Prime, Chani R. Field, Haley K. Altamura, Alexandra L. Yeoman, Jasmina Georgievski, Bronte A. Jamison, Stuart Phillis, Brad Sullivan, Nancy E. Briggs, Mark Hertzberg, John F. Seymour, John Reynolds, and Timothy P. Hughes
Abstract: Recent studies have demonstrated that some patients with chronic myeloid leukemia (CML) can maintain remission after discontinuation of imatinib. A prerequisite is stable, undetectable BCR-ABL1. It is not known how many patients achieve this response or the factors associated with its achievement. We examined 423 de novo imatinib-treated patients to determine the cumulative incidence of achieving the discontinuation criteria as defined in the CML8 study (≥2 years of undetectable BCR-ABL1 [Stable MR(4.5)]), and predictive factors. After 8 years of imatinib, the cumulative incidence of Stable MR(4.5) was 36.5%. Therefore, 9% to 15% of first-line imatinib-treated patients would maintain remission after discontinuation. The BCR-ABL1 level at 3 months and factors at diagnosis were examined for association with Stable MR(4.5): Sokal risk, age, sex, and assigned imatinib dose. The only independent predictors were female sex (54.4% vs 27.2%; P = .018) and the 3-month BCR-ABL1 (P < .001). The highest cumulative incidence of Stable MR(4.5) after 8 years was 78.2% for patients with BCR-ABL1 ≤ 0.10%(IS) at 3 months (n = 38). Time to major molecular response (MMR) influenced the time to reach Stable MR(4.5) (P < .001), suggesting slower dynamics of response with a delayed MMR. The findings justify the focus on rapid reduction of BCR-ABL1 as a strategy to maximize potential suitability for imatinib discontinuation studies. The Iris trial was registered at as NCT00006343. The Tops trial was registered at as NCT00124748. The TIDEL I trial was registered at as ACTRN12607000614493. The TIDEL II trial was registered at as ACTRN12607000325404.
Keywords: Humans
Fusion Proteins, bcr-abl
Antineoplastic Agents
Withholding Treatment
Remission Induction
Cytogenetic Analysis
Sex Factors
Aged, 80 and over
Middle Aged
Clinical Trials as Topic
Multicenter Studies as Topic
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Biomarkers, Pharmacological
Imatinib Mesylate
Rights: © 2013 by The American Society of Hematology
DOI: 10.1182/blood-2012-10-462291
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