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Multicenter Independent Assessment of Outcomes in Chronic Myeloid Leukemia Patients Treated With Imatinib
Open accessAbstract
BACKGROUND: Imatinib slows development of chronic myeloid leukemia (CML). However, available information on morbidity and mortality is largely based on sponsored trials, whereas independent long-term field studies are lacking. PATIENTS AND METHODS: Consecutive CML patients who started imatinib treatment before 2005 and who were in complete cytogenetic remission (CCyR) after 2 years (± 3 months) were eligible for enrollment in the independent multicenter Imatinib Long-Term (Side) Effects (ILTE) study. Incidence of the first serious and nonserious adverse events and loss of CCyR were estimated according to the Kaplan-Meier method and compared with the standard log-rank test. Attainment of negative Philadelphia chromosome hematopoiesis was assessed with cytogenetics and quantitative polymerase chain reaction. Cumulative incidence of death related or unrelated to CML progression was estimated, accounting for competing risks, according to the Kalbleisch-Prentice method. Standardized incidence ratios were calculated based on population rates specific for sex and age classes. Confidence intervals were calculated by the exact method based on the χ(2) distribution. All statistical tests were two-sided. RESULTS: A total of 832 patients who were treated for a median of 5.8 years were enrolled. There were 139 recorded serious adverse events, of which 19.4% were imatinib-related. A total of 830 nonserious adverse events were observed in 53% of patients; 560 (68%) were imatinib-related. The most frequent were muscle cramps, asthenia, edema, skin fragility, diarrhea, tendon, or ligament lesions. Nineteen patients (2.3%) discontinued imatinib because of drug-related toxic effects. Forty-five patients lost CCyR, at a rate of 1.4 per 100 person-years. Durable (>1 year) negative Philadelphia chromosome hematopoiesis was attained by 179 patients. Twenty deaths were observed, with a 4.8% mortality incidence rate (standardized incidence ratio = 0.7; 95% confidence interval = 0.40 to 1.10, P = .08), with only six (30%) associated with CML progression. CONCLUSIONS: In this study, CML-related deaths were uncommon in CML patients who were in CCyR 2 years after starting imatinib, and survival was not statistically significantly different from that of the general population.
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Self-citationFive-Year Follow-up of Patients Receiving Imatinib for Chronic Myeloid Leukemia
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Self-citationHematologic and Cytogenetic Responses to Imatinib Mesylate in Chronic Myelogenous Leukemia
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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-citationPeptides as a platform for targeted therapeutics for cancer: peptide–drug conjugates (PDCs)
Cooper, B. M., Iegre, J., O' Donovan, D. H., Ölwegård Halvarsson, M., & Spring, D. R. (2021) · Chemical Society Reviews · doi:10.1039/d0cs00556h · Cited by 414
Campiotti, L., Suter, M. B., Guasti, L., Piazza, R., Gambacorti-Passerini, C., Grandi, A. M., & Squizzato, A. (2017) · European Journal of Cancer · doi:10.1016/j.ejca.2017.02.028 · Cited by 96
Self-citationMagistroni, V., Mauri, M., D’Aliberti, D., Mezzatesta, C., Crespiatico, I., Nava, M., Fontana, D., Sharma, N., Parker, W., Schreiber, A., et al. (2019) · Haematologica · doi:10.3324/haematol.2017.179937 · Cited by 29
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Metadata
- Authors
- Gambacorti-Passerini, C., Antolini, L., Mahon, F.-X., Guilhot, F., Deininger, M., Fava, C., Nagler, A., Della Casa, C. M., Morra, E., Abruzzese, E., D’Emilio, A., Stagno, F., le Coutre, P., Hurtado-Monroy, R., Santini, V., Martino, B., Pane, F., Piccin, A., Giraldo, P., Assouline, S., Durosinmi, M. A., Leeksma, O., Pogliani, E. M., Puttini, M., Jang, E., Reiffers, J., Valsecchi, M. G., & Kim, D.-W.
- Venue
- JNCI: Journal of the National Cancer Institute
- Publisher
- Oxford University Press (OUP)
- Published
- 2011-03-21
- Volume
- 103
- Issue
- 7
- Pages
- 553-561
- ISSN
- 0027-8874 (ISSN-L)
- 1460-2105
- OpenAlex
- W2160811827
- Cited by
- 429
- References
- 22
- FWCI
- 18.86
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Gambacorti-Passerini, C., Antolini, L., Mahon, F.-X., Guilhot, F., Deininger, M., Fava, C., Nagler, A., Della Casa, C. M., Morra, E., Abruzzese, E., D’Emilio, A., Stagno, F., le Coutre, P., Hurtado-Monroy, R., Santini, V., Martino, B., Pane, F., Piccin, A., Giraldo, P., . . . Kim, D.-W. (2011). Multicenter Independent Assessment of Outcomes in Chronic Myeloid Leukemia Patients Treated With Imatinib. JNCI: Journal of the National Cancer Institute. https://doi.org/10.1093/jnci/djr060
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