title: Mitoxantrone, fluorouracil plus L-leucovorin, and vinorelbine in pretreated advanced breast cancer.
abstract: The combination chemotherapy including mitoxantrone, fluorouracil and leucovorin has proven to be effective and well-tolerated in advanced breast cancer (ABC). No data are available on the association with navelbine, a new vinka alkaloid, which has demonstrated high activity in ABC. The trial was designed to evaluate feasibility and efficacy of the association of vinorelbine to mitoxantrone, fluorouracil and L-leucovorin in patients who failed a previous regimen for ABC or who relapsed within 6 months of adjuvant chemotherapy. The schedule was as follows: mitoxantrone 6 mg/m2 days 1 and 8; L-leucovorin 250 mg/m2 days 1 and 8, fluorouracil 600 mg/m2 days 1 and 8, vinorelbine 25 mg/m2 days 1 and 8, cycles being repeated every 21 days. Twenty-five patients were enrolled and are evaluable for response and side effects. One hundred cycles of therapy have been delivered (median/patient, 4 cycles). In 41 cycles a delay was required and in 38 cycles it was necessary to administer granulocyte colony-stimulating factor for neutropenia. Seven partial remissions (28%; 95% confidence interval, 12-49%), 10 stabilizations of disease and 8 progressions were observed. Although grade 4 neutropenia was observed in 44% of the patients, no grade 3-4 infections were observed. Nonhematologic toxicities were mild or moderate and included alopecia, mucositis and phlebitis. In conclusion, the schedule employed, although correlated with a moderate activity, does not seem to be superior to other regimens with mitoxantrone, fluorouracil, and leucovorin.
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D007970:Leukopenia / Q000139:chemically induced; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D009503:Neutropenia / Q000139:chemically induced; D012074:Remission Induction; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D008942:Mitoxantrone; D002955:Leucovorin; D000077235:Vinorelbine; D005472:Fluorouracil