title: Long-term safety and efficacy of imatinib mesylate (Gleevec®) in elderly patients with chronic phase chronic myelogenous leukemia: results of the AFR04 study.
abstract: 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.
authors.affiliation: Department of Hematology and Oncology, Hôpital Mignot, Université Versailles Saint-Quentin-en-Yvelines, Le Chesnay, France. phrousselot@ch-versailles.fr
authors.forename: Philippe
authors.initials: P
authors.lastname: Rousselot
authors.forename: Pascale
authors.initials: P
authors.lastname: Cony-Makhoul
authors.forename: Franck
authors.initials: F
authors.lastname: Nicolini
authors.forename: François Xavier
authors.initials: FX
authors.lastname: Mahon
authors.forename: Christian
authors.initials: C
authors.lastname: Berthou
authors.forename: Delphine
authors.initials: D
authors.lastname: Réa
authors.forename: Josy
authors.initials: J
authors.lastname: Reiffers
authors.forename: Anne
authors.initials: A
authors.lastname: Bornand
authors.forename: Olivier
authors.initials: O
authors.lastname: Saint-Jean
authors.forename: Joelle
authors.initials: J
authors.lastname: Guilhot
authors.forename: François
authors.initials: F
authors.lastname: Guilhot
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001549:Benzamides; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011743:Pyrimidines / Q000008:administration & dosage* / Q000009:adverse effects; D015996:Survival Rate; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate