Long-term safety and efficacy of imatinib mesylate (Gleevec®) in elderly patients with chronic phase chronic myelogenous leukemia: results of the AFR04 study.

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.