The DOI matches its Crossref record; 34 of the 34 references it cites were found in a registry or an index.
Tolerability-Adapted Imatinib 800 mg/d Versus 400 mg/d Versus 400 mg/d Plus Interferon-α in Newly Diagnosed Chronic Myeloid Leukemia
Abstract
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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CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
the CONSORT Group, Schulz, K. F., Altman, D. G., & Moher, D. (2010) · BMC Medicine · doi:10.1186/1741-7015-8-18 · Cited by 13,371
CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials
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Five-Year Follow-up of Patients Receiving Imatinib for Chronic Myeloid Leukemia
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Self-citationA Multiple Testing Procedure for Clinical Trials
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Self-citationDasatinib versus Imatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia
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Self-citationMahon, F.-X., Réa, D., Guilhot, J., Guilhot, F., Huguet, F., Nicolini, F., Legros, L., Charbonnier, A., Guerci, A., Varet, B., et al. (2010) · The Lancet Oncology · doi:10.1016/s1470-2045(10)70233-3 · Cited by 1,550
IFNα activates dormant haematopoietic stem cells in vivo
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Cited by
Steegmann, J. L., Baccarani, M., Breccia, M., Casado, L. F., García-Gutiérrez, V, Hochhaus, A., Kim, D.-W., Kim, T. D., Khoury, H. J., Le Coutre, P., et al. (2016) · Leukemia · doi:10.1038/leu.2016.104 · Cited by 482
Self-citationCortes, J. E., Kim, D.-W., Kantarjian, H. M., Brümmendorf, T. H., Dyagil, I., Griskevicius, L., Malhotra, H., Powell, C., Gogat, K., Countouriotis, A. M., et al. (2012) · Journal of Clinical Oncology · doi:10.1200/jco.2011.38.7522 · Cited by 466
for the SAKK and the German CML Study Group, Hehlmann, R., Lauseker, M., Saußele, S., Pfirrmann, M., Krause, S., Kolb, H. J., Neubauer, A., Hossfeld, D. K., Nerl, C., et al. (2017) · Leukemia · doi:10.1038/leu.2017.253 · Cited by 341
Self-citationImmunological off-target effects of imatinib
Zitvogel, L., Rusakiewicz, S., Routy, B., Ayyoub, M., & Kroemer, G. (2016) · Nature Reviews Clinical Oncology · doi:10.1038/nrclinonc.2016.41 · Cited by 142
Cortes, J. E., Sasaki, K., Kim, D.-W., Hughes, T. P., Etienne, G., Mauro, M. J., Hochhaus, A., Lang, F., Heinrich, M. C., Breccia, M., et al. (2024) · Leukemia · doi:10.1038/s41375-024-02278-8 · Cited by 56
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Metadata
- Authors
- Hehlmann, R., Lauseker, M., Jung-Munkwitz, S., Leitner, A., Müller, M. C., Pletsch, N., Proetel, U., Haferlach, C., Schlegelberger, B., Balleisen, L., Hänel, M., Pfirrmann, M., Krause, S. W., Nerl, C., Pralle, H., Gratwohl, A., Hossfeld, D. K., Hasford, J., Hochhaus, A., & Saußele, S.
- Venue
- Journal of Clinical Oncology
- Published
- 2011-04-20
- Volume
- 29
- Issue
- 12
- Pages
- 1634-1642
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2057827171
- Cited by
- 323
- References
- 34
- FWCI
- 28.11
- Type
- journal article
- Language
- en
- Open access
- closed
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- Hehlmann, R., Lauseker, M., Jung-Munkwitz, S., Leitner, A., Müller, M. C., Pletsch, N., Proetel, U., Haferlach, C., Schlegelberger, B., Balleisen, L., Hänel, M., Pfirrmann, M., Krause, S. W., Nerl, C., Pralle, H., Gratwohl, A., Hossfeld, D. K., Hasford, J., Hochhaus, A., & Saußele, S. (2011). Tolerability-Adapted Imatinib 800 mg/d Versus 400 mg/d Versus 400 mg/d Plus Interferon-α in Newly Diagnosed Chronic Myeloid Leukemia. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2010.32.0598
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