Conflict of interest: Dr Philippe Rousselot received research funding from Novartis and Bristol-Myers Squibb.
Version of Record online: 17 SEP 2012
Copyright © 2012 Wiley Periodicals, Inc.
American Journal of Hematology
Volume 88, Issue 1, pages 1–4, January 2013
How to Cite
Rousselot, P., Cony-Makhoul, P., Nicolini, F., Mahon, F. X., Berthou, C., Réa, D., Reiffers, J., Bornand, A., Saint-Jean, O., Guilhot, J., Guilhot, F. and on behalf of the French Intergroup For Chronic Myelogenous Leukemia (Fi-LMC) (2013), Long-term safety and efficacy of imatinib mesylate (Gleevec®) in elderly patients with chronic phase chronic myelogenous leukemia: Results of the AFR04 study. Am. J. Hematol., 88: 1–4. doi: 10.1002/ajh.23330
This study was presented in part at the 2007 Annual Meeting of the American Society of Hematology (Atlanta, December 2007).
- Issue online: 18 DEC 2012
- Version of Record online: 17 SEP 2012
- Accepted manuscript online: 3 SEP 2012 10:05AM EST
- Manuscript Received: 17 AUG 2012
- Manuscript Accepted: 17 AUG 2012
- CHU de Poitiers
Data from registries suggest that the median age of chronic myelogenous leukemia (CML) patients is 10–15 years older than that of clinical trials. We conducted a prospective phase II study to evaluate imatinib mesylate (IM, 400 mg daily) in newly diagnosed chronic phase CML (CP-CML) patients. Patients aged 70 years and over diagnosed with CP-CML within 12 months were eligible. Thirty patients were enrolled from April 2002 to October 2004. Median age was 74.8 years (range, 70–90). Male/female ratio was 1.72. At inclusion, comorbidities were reported in all but one patient, Cumulative Illness Rating Scale for Geriatrics comorbidity mean index was 1.47, and 66% of patients had cardiovascular disease. The median daily IM dose was 392 mg (range, 256–445). IM was interrupted in patients with severe comorbidities. Treatment discontinuation was observed in 36.6% of patients. Cumulative incidence of complete cytogenetic response was 71.4 and 78.5% at 12 and 24 months, respectively. A high level of sustained responses was observed in patients with mild or moderate comorbidities. Seven-year estimated overall survival was 80.8% (95% CI: 59.0–91.7). Two-thirds of the patients were still on long-term therapy at cut-off, and no patients had died from progression. This trial was registered at http://www.clinicaltrials.gov as # NCT00219765. Am. J. Hematol. 2013. © 2012 Wiley Periodicals, Inc.