title: Mitoxantrone, folinic acid, 5-fluorouracil and prednisone as first-line chemotherapy for advanced breast carcinoma. A phase II study.
abstract: The purpose of this prospective clinical trial was an attempt to find an effective and relatively non-toxic schedule for patients with metastatic breast cancer who decline to receive aggressive cytotoxic chemotherapy. A total of 36 patients with disseminated breast cancer were treated with mitoxantrone 8 mg/m2 intravenously (i.v.) day 1, folinic acid 400 mg/m2 in a 2-h i.v. infusion with 5-fluorouracil 500 mg/m2 as an i.v. bolus 1 h later, days 1 and 8 at 3-week intervals plus prednisone 20 mg/m2 orally daily with diminishing doses over several weeks. Objective regressions were observed in 24/36 (67%) patients, 9 being complete (25%). Responses were seen at all disease sites, mainly pleural/lung, bone and liver. The median duration of response was 8 months (range 4-25+) and the median survival 12 months (range 3-26+). Myelosuppression, mainly leucopenia and thrombocytopenia, was the major toxicity but without complications. Other toxicities included mild or moderate nausea and/or vomiting (50%), stomatitis (33%) and diarrhoea (11%). Alopecia was minimal. No cases of cardiotoxicity were detected. The substantial response rate obtained with this relatively well tolerated regimen against advanced breast cancer warrants its assessment in a larger number of patients.
authors.affiliation: Núcleo de Investigação Oncológica, Clinica Oncológica VIII, Lisboa, Portugal.
authors.forename: J
authors.initials: J
authors.lastname: Carmo-Pereira
authors.forename: F O
authors.initials: FO
authors.lastname: Costa
authors.forename: E
authors.initials: E
authors.lastname: Henriques
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D011241:Prednisone / Q000008:administration & dosage; D011379:Prognosis; D011446:Prospective Studies; D013921:Thrombocytopenia / Q000139:chemically induced; D013997:Time Factors
chemical_list: D008942:Mitoxantrone; D002955:Leucovorin; D005472:Fluorouracil; D011241:Prednisone