title: [Combination of mitoxantrone-vinorelbine as first-line chemotherapy for metastatic breast carcinoma].
abstract: A phase II trial was performed to assess the efficacy and toxicity of the combination mitoxantrone (MXN) and vinorelbine (VNR) as first-line chemotherapy for metastatic breast cancer. Forty-one patients with metastatic disease or local relapse recruited between March 1991 and April 1993 received a first-line chemotherapy treatment consisting in 12 mg/m2 intravenous (IV) bolus of MXN on day 1 followed by a 20-minute perfusion of 25 mg/m2 of VNR on days 1 and 8. Cycles were repeated every 21 days until evidence of disease progression or of severe toxicity. Thirty-seven patients were evaluable for response and all 41 for toxicity. An objective response was observed in 19 patients (51%; 95% confidence interval, 45 to 74%). The response was complete in a further 11 (30%). Median time to treatment failure was 9 months. Median survival was 14 months. There were no treatment-related deaths. Limiting toxicity was myelosuppression. Leukopenia occurred in 29 patients (71%) and was grade 3 or 4 in nine of these (15%). Grade 2 or 3 anemia was encountered in six patients (15%), grade 1 thrombocytopenia in one, neurotoxicity (constipation) in two, and grade 2 or 3 alopecia in 12 (29%). Nausea/vomiting requiring antiemetic treatment was experienced by only two patients (5%). There were two cases of septicemia treated by antibiotic therapy in hospital.
authors.affiliation: Centre Antoine-Lacassagne, Nice, France.
authors.forename: J M
authors.initials: JM
authors.lastname: Ferrero
authors.forename: X
authors.initials: X
authors.lastname: Pivot
authors.forename: M
authors.initials: M
authors.lastname: Namer
authors.forename: J L
authors.initials: JL
authors.lastname: Wendling
authors.forename: M
authors.initials: M
authors.lastname: Frenay
authors.forename: E
authors.initials: E
authors.lastname: François
authors.forename: M
authors.initials: M
authors.lastname: Hoch
authors.forename: E
authors.initials: E
authors.lastname: Teissier
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D008942:Mitoxantrone; D000077235:Vinorelbine
vernacular_title: Association mitoxantrone-vinorelbine en première ligne thérapeutique dans le cancer du sein métastatique.