title: Paclitaxel, epirubicin and cyclophosphamide combination in first-line treatment of metastatic breast cancer: a dose escalation study.
abstract: The purpose of this study was to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of combined paclitaxel, epirubicin and cyclophosphamide in patients with metastatic breast cancer. The dose of paclitaxel was planned to be escalated from 150 to 225 mg/m(2)in 25 mg/m(2) steps, while the doses of epirubicin and cyclophosphamide were fixed at 50 and 500 mg/m(2), respectively. Because of DLT, the dose of paclitaxel was maintained at 200 mg/m(2) and the dose of epirubicin was increased to 90 mg/m(2). The MTD was reached at a dose of paclitaxel and epirubicin of 200 and 75 mg/m(2), respectively. DLT were mainly febrile neutropenia and grade 4 neutropenia lasting for > or =7 days. Among the 35 evaluable patients, there were 2 (6%) complete responses and 19 (53%) partial responses for an overall response rate of 59% [95% confidence interval (CI): 41-74%]. The triplet paclitaxel/epirubicin/cyclophosphamide is an effective and well-tolerated combination worthy of further investigation in the treatment of patients with metastatic breast cancer.
authors.affiliation: Centre Oscar-Lambret, Lille, France. j-bonneterre@o-lambert.fr
authors.forename: Jacques
authors.initials: J
authors.lastname: Bonneterre
authors.forename: Michèle
authors.initials: M
authors.lastname: Tubiana-Hulin
authors.forename: Gilles
authors.initials: G
authors.lastname: Catimel
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003520:Cyclophosphamide / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced*; D006760:Hospitalization; D006801:Humans; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage; D013318:Stroke Volume / Q000187:drug effects; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000187:drug effects
chemical_list: D000903:Antibiotics, Antineoplastic; D018906:Antineoplastic Agents, Alkylating; D000972:Antineoplastic Agents, Phytogenic; D015251:Epirubicin; D003520:Cyclophosphamide; D017239:Paclitaxel