Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-α in newly diagnosed chronic myeloid leukemia
PURPOSE: Treatment of chronic-phase (CP) chronic myeloid leukemia (CML) with imatinib 400 mg/d can be unsatisfactory. Optimization of treatment is warranted. - PATIENTS AND METHODS: In all, 1,014 newly diagnosed CP-CML patients were randomly assigned to imatinib 800 mg/d (n = 338), imatinib 400 mg/d...
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| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
March 21, 2011
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| In: |
Journal of clinical oncology
Year: 2011, Volume: 29, Issue: 12, Pages: 1634-1642 |
| ISSN: | 1527-7755 |
| Online Access: |
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| Author Notes: | Rüdiger Hehlmann, Michael Lauseker, Susanne Jung-Munkwitz, Armin Leitner, Martin C. Müller, Nadine Pletsch, Ulrike Proetel, Claudia Haferlach, Brigitte Schlegelberger, Leopold Balleisen, Mathias Hänel, Markus Pfirrmann, Stefan W. Krause, Christoph Nerl, Hans Pralle, Alois Gratwohl, Dieter K. Hossfeld, Joerg Hasford, Andreas Hochhaus, and Susanne Saussele |
MARC
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| 245 | 1 | 0 | |a Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-α in newly diagnosed chronic myeloid leukemia |c Rüdiger Hehlmann, Michael Lauseker, Susanne Jung-Munkwitz, Armin Leitner, Martin C. Müller, Nadine Pletsch, Ulrike Proetel, Claudia Haferlach, Brigitte Schlegelberger, Leopold Balleisen, Mathias Hänel, Markus Pfirrmann, Stefan W. Krause, Christoph Nerl, Hans Pralle, Alois Gratwohl, Dieter K. Hossfeld, Joerg Hasford, Andreas Hochhaus, and Susanne Saussele |
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| 520 | |a PURPOSE: Treatment of chronic-phase (CP) chronic myeloid leukemia (CML) with imatinib 400 mg/d can be unsatisfactory. Optimization of treatment is warranted. - PATIENTS AND METHODS: In all, 1,014 newly diagnosed CP-CML patients were randomly assigned to imatinib 800 mg/d (n = 338), imatinib 400 mg/d (n = 325), or imatinib 400 mg/d plus interferon alfa (IFN-α; n = 351). Dose adaptation to avoid higher-grade toxicity was recommended. First primary end point was major molecular remission (MMR) at 12 months. - RESULTS: A higher rate of MMR at 12 months occurred with tolerability-adapted imatinib 800 mg/d than with imatinib 400 mg/d (59% [95% CI, 53% to 65%] v 44% [95% CI, 37% to 50%]; P < .001) or imatinib 400 mg/d plus IFN-α (59% v 46% [95% CI, 40% to 52%]; P = .002). Median dose in the 800-mg/d arm was 628 mg/d with a maximum dose of 737 mg/d during months 4 to 6 and a maintenance dose of 600 mg/d. All three treatment approaches were well tolerated with similar grade 3 and 4 adverse events. Independent of treatment approach, MMR at 12 months showed better progression-free survival (99% v 94%; P = .0023) and overall survival (99% v 93%; P = .0011) at 3 years when compared with > 1% on the international scale or no MMR but showed no difference in 0.1% to < 1% on the international scale, which closely correlates with complete cytogenetic remission. - CONCLUSION: Treatment of early-phase CML with imatinib can be optimized. Early high-dose therapy followed by rapid adaptation to good tolerability increases the rate of MMR at 12 months. Achievement of MMR by month 12 is directly associated with improved survival. | ||
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| 650 | 4 | |a Adult | |
| 650 | 4 | |a Aged | |
| 650 | 4 | |a Aged, 80 and over | |
| 650 | 4 | |a Antineoplastic Combined Chemotherapy Protocols | |
| 650 | 4 | |a Benzamides | |
| 650 | 4 | |a Chi-Square Distribution | |
| 650 | 4 | |a Disease-Free Survival | |
| 650 | 4 | |a Dose-Response Relationship, Drug | |
| 650 | 4 | |a Female | |
| 650 | 4 | |a Germany | |
| 650 | 4 | |a Humans | |
| 650 | 4 | |a Imatinib Mesylate | |
| 650 | 4 | |a Interferon-alpha | |
| 650 | 4 | |a Kaplan-Meier Estimate | |
| 650 | 4 | |a Leukemia, Myelogenous, Chronic, BCR-ABL Positive | |
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| 650 | 4 | |a Piperazines | |
| 650 | 4 | |a Protein Kinase Inhibitors | |
| 650 | 4 | |a Pyrimidines | |
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| 650 | 4 | |a Risk Assessment | |
| 650 | 4 | |a Risk Factors | |
| 650 | 4 | |a Survival Rate | |
| 650 | 4 | |a Time Factors | |
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