title: A joined analysis of two European Organization for the Research and Treatment of Cancer (EORTC) studies to evaluate the role of pegylated liposomal doxorubicin (Caelyx) in the treatment of elderly patients with metastatic breast cancer.
abstract: We have performed a retrospective analysis to evaluate the impact of age, using a 70 year cutoff, on the safety and efficacy of pegylated liposomal doxorubicin (Caelyx) given at 60 mg/m(2) every 6 weeks (treatment A) or 50 mg/m(2) every 4 weeks (treatment B) to 136 metastatic breast cancer patients in two EORTC trials, of whom 65 were 70 years of age or older. No difference in terms of toxicity was observed between younger and older patients treated with the 4-week schedule, while a higher incidence of hematological toxicity, anorexia, asthenia, and stomatitis was observed in older patients when the 6-week schedule was used. Antitumor activity was not affected by age. In the older cohort of patients, no dependence was found between the incidence of grade 3-4 toxicity or antitumor activity and patients' baseline performance status, number and severity of comorbidities, or number of concomitant medications. The higher therapeutic index of Caelyx 50 mg/m(2) every 4 weeks makes it, of the two dose schedules investigated, the preferred regimen in the elderly.
authors.affiliation: Sandro Pitigliani Medical Oncology Unit, Department of Oncology, Hospital of Prato, Prato, Italy. lbiganzoli@usl4.toscana.it
authors.forename: Laura
authors.initials: L
authors.lastname: Biganzoli
authors.forename: Robert
authors.initials: R
authors.lastname: Coleman
authors.forename: Alessandro
authors.initials: A
authors.lastname: Minisini
authors.forename: Anne
authors.initials: A
authors.lastname: Hamilton
authors.forename: Matti
authors.initials: M
authors.lastname: Aapro
authors.forename: Patrick
authors.initials: P
authors.lastname: Therasse
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Mottino
authors.forename: Jan
authors.initials: J
authors.lastname: Bogaerts
authors.forename: Martine
authors.initials: M
authors.lastname: Piccart
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D001943:Breast Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D015897:Comorbidity; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage* / Q000633:toxicity*; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D004317:Doxorubicin