title: Combined epirubicin and vinorelbine as first-line therapy in metastatic breast cancer: a pilot study performed by the Danish Breast Cancer Cooperative Group.
abstract: This pilot study investigated the tolerability and efficacy of increasing doses of epirubicin and vinorelbine as first-line chemotherapy for metastatic breast cancer. Acute toxicity was manageable at all dose levels for combinations of epirubicin 60-90 mg/m2 on day 1 and vinorelbine 15-25 mg/m2 on days 1 and 8 repeated every 3 weeks. Myelotoxicity was the most frequent toxic event, with a significant increase in grade 4 leukopenia from 0% at dose level 1 (60+15 mg/m2) to 26% at dose level 6 (90+25 mg/m2). Signs of acute or chronic cardiotoxicity grades 2-4 were seen in 15% of the patients and included arrhythmia and decreased function. No significant association was established between dose and nonhematological toxicity. Objective responses were observed in 49 of the 99 evaluable patients (49.5%, 95% CI 39.9-59.2), 18 being complete and 31 partial responses. Responses were observed at all six dose levels. In conclusion, acute toxicity was manageable at all dose levels for combinations of epirubicin 60-90 mg/m2 on day 1 and vinorelbine 15-25 mg/m2 on days 1 and 8. In the treatment of advanced breast cancer, improvement of the antitumor efficacy by the addition of vinorelbine to epirubicin remains to be demonstrated in a randomized phase III trial.
authors.affiliation: Department of Oncology, The Finsen Center, Rigshospitalet Bldg. 5012, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark. ejlertsen@rh.dk
authors.forename: B
authors.initials: B
authors.lastname: Ejlertsen
authors.forename: I
authors.initials: I
authors.lastname: Højris
authors.forename: S
authors.initials: S
authors.lastname: Hansen
authors.forename: K
authors.initials: K
authors.lastname: Møholt
authors.forename: B
authors.initials: B
authors.lastname: Kristensen
authors.forename: H T
authors.initials: HT
authors.lastname: Mouridsen
authors.forename: J
authors.initials: J
authors.lastname: Andersen
authors.forename: C
authors.initials: C
authors.lastname: Rose
authors.forename: M
authors.initials: M
authors.lastname: Kjaer
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000633:toxicity; D001943:Breast Neoplasms / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D064420:Drug-Related Side Effects and Adverse Reactions; D015251:Epirubicin / Q000008:administration & dosage / Q000633:toxicity; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000628:therapy*; D010865:Pilot Projects; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000633:toxicity; D000077235:Vinorelbine
chemical_list: D015251:Epirubicin; D014747:Vinblastine; D000077235:Vinorelbine