title: Docetaxel combined with vinorelbine: phase I results and new study designs.
abstract: This was a phase I dose-finding and pharmacokinetic study of vinorelbine (Navelbine) and docetaxel (Taxotere) as first-line chemotherapy for metastatic breast cancer. Vinorelbine dose, 20 or 22.5 mg/m2, on days 1 and 5, was followed on day 1 by docetaxel every 21 days, in doses increasing from 60 to 100 mg/m2. Two maximum tolerated doses were reached, the first at 75 mg/m2 of docetaxel and 22.5 mg/m2 of vinorelbine, and the second at 100 mg/m2 of docetaxel and 20 mg/m2 of vinorelbine. Symptomatic peripheral neuropathy was not observed. The recommended doses for phase II studies are 75 to 85 mg/m2 of docetaxel on day 1 and 20 mg/m2 of vinorelbine on days 1 and 5, every 3 weeks. The treatment regimen, which included 3-day corticosteroid prophylaxis, resulted in only mild fluid retention. Responses were seen at all dose levels, with an 80% overall response rate at the higher recommended dose; the overall response rate for patients at all dose levels was 66%. A high rate of response, including a complete response, was observed in patients with liver metastases.
authors.affiliation: Medical Oncology Department, Centre René Gauducheau, CRLCC Nantes-Atlantique, Nantes-St Herblain, France.
authors.forename: P
authors.initials: P
authors.lastname: Fumoleau
authors.forename: R
authors.initials: R
authors.lastname: Féty
authors.forename: V
authors.initials: V
authors.lastname: Delecroix
authors.forename: G
authors.initials: G
authors.lastname: Perrocheau
authors.forename: N
authors.initials: N
authors.lastname: Azli
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy*; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004347:Drug Interactions; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000556:secondary; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D012107:Research Design; D043823:Taxoids; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D017239:Paclitaxel; D000077235:Vinorelbine