title: Evaluation of tolerability and efficacy of imatinib mesylate in elderly patients with chronic phase CML: ELDERGLI study.
abstract: Imatinib mesylate (IM) is the treatment of choice in patients with newly diagnosed chronic myeloid leukemia (CML), irrespectively of their age. Nevertheless, information regarding tolerability and responses in advanced-age patients, a subgroup in which co-morbidities and other factors may influence outcome, is scarce, since they were excluded from most clinical trials. In this observational study (ELDERGLI), information regarding demographics, concomitant medication, physical examination, performance status, hemogram, biochemistry, hematologic, cytogenetic and molecular responses, time to progression, adverse events (AE) and severe adverse events (SAE) were prospectively recorded in a series of 36 elderly patients with CML, with a median age of 76.6 years. Most patients had cardiovascular co-morbidities, especially hypertension. Regarding IM toxicity, around one third of patients required treatment interruptions because of adverse events, especially hematologic toxicity (66% of cases that needed dose interruptions). When analyzing non hematologic adverse events, the most frequent ones were superficial edemas and GI symptoms. Of note, 9 of patients experienced an infection episode during the follow-up, and 4 were diagnosed during the study period of another type of cancer. Finally, cardiovascular events were reported in 7 patients, most of them with prior cardiovascular risk factors. Regarding responses, after 12 months of imatinib therapy, the rate of complete hematologic response (CHR), complete cytogenetic response (CCyR) and major molecular response (MMolR) were 89%, 72% and 55% respectively. In summary, IM display, in advanced-age patients with chronic phase CML, an efficacy and safety profile comparable to younger patients.
authors.affiliation: Department of Hematology, Hospital Universitario de Salamanca, Salamanca, Spain.
authors.forename: Fermin M
authors.initials: FM
authors.lastname: Sánchez-Guijo
authors.forename: Soledad
authors.initials: S
authors.lastname: Durán
authors.forename: Josefina
authors.initials: J
authors.lastname: Galende
authors.forename: Concepción
authors.initials: C
authors.lastname: Boqué
authors.forename: José B
authors.initials: JB
authors.lastname: Nieto
authors.forename: Josep
authors.initials: J
authors.lastname: Balanzat
authors.forename: Antonio
authors.initials: A
authors.lastname: Gracia
authors.forename: Isabel
authors.initials: I
authors.lastname: García
authors.forename: Carmen
authors.initials: C
authors.lastname: Avellaneda-Molina
authors.forename: María-Victoria
authors.initials: MV
authors.lastname: Moreno
authors.forename: Elisa
authors.initials: E
authors.lastname: Luño-Fernandez
authors.forename: Mar
authors.initials: M
authors.lastname: Hermosilla
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Sanchez-Varela
authors.forename: Ana
authors.initials: A
authors.lastname: Dios
authors.forename: Pilar
authors.initials: P
authors.lastname: López-Garrido
authors.forename: Pilar
authors.initials: P
authors.lastname: Giraldo
authors.forename: Joan
authors.initials: J
authors.lastname: Bargay
authors.forename: José María
authors.initials: JM
authors.lastname: Domingo
authors.forename: Alfonso
authors.initials: A
authors.lastname: Soler
authors.forename: Ramón
authors.initials: R
authors.lastname: Salinas
authors.forename: Maria-Consuelo
authors.initials: MC
authors.lastname: del Cañizo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001549:Benzamides; D020732:Cytogenetic Analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000068877:Imatinib Mesylate; D015466:Leukemia, Myeloid, Chronic-Phase / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects* / Q000627:therapeutic use*; D011743:Pyrimidines / Q000009:adverse effects* / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate