title: A phase II study of sequential 5-fluorouracil, epirubicin and cyclophosphamide (FEC) and paclitaxel in advanced breast cancer (Protocol PV BC 97/01).
abstract: Sequential administration of the association of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) and paclitaxel could be better tolerated than the association of an anthracycline and paclitaxel while having a similar antitumour effect. 69 patients with advanced breast cancer previously untreated with anthracyclines or paclitaxel entered a phase II multicentre study in which FEC was followed by paclitaxel. Both regimens were administered 4 times every 21 days. The median follow-up is 20 months and 38/69 patients have died. Grade III-IV toxicity was acceptable. Leukopenia occurred in 26% of patients, thrombocytopenia in 2% and anaemia in 4%. One patient had reversible heart failure during FEC therapy. Peripheral neuropathy and arthralgia-myalgia occurred in 9% and 4% of patients, respectively and one patient had respiratory hypersensitivity during paclitaxel treatment. 9 patients did not complete therapy because of: treatment refusal (n = 1), cardiac toxicity (n = 1), early death during FEC chemotherapy (n = 1), major protocol violations (n = 4), hypersensitivity reaction (n = 1) and early death during paclitaxel chemotherapy (n = 1). The overall response rate was 65% (95% CI = 53-76), and 7% of patients had stable disease. Therapy was defined as having failed in 28% of patients because they were not evaluable (13%) or had progressive disease (15%). The median time to progression and survival are 13.2 and 23.5 months, respectively. Sequential FEC-paclitaxel is a suitable strategy for patients with metastatic breast cancer who have not been previously treated with anthracyclines and/or taxanes. In fact, it avoids major haematologic toxicity and has a good antitumour effect.
authors.affiliation: Medicina Interna ed Oncologia Medica, Università and IRCCS Policlinico S. Matteo, Pavia, 27100, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Riccardi
authors.forename: P
authors.initials: P
authors.lastname: Pugliese
authors.forename: M
authors.initials: M
authors.lastname: Danova
authors.forename: S
authors.initials: S
authors.lastname: Brugnatelli
authors.forename: D
authors.initials: D
authors.lastname: Grasso
authors.forename: M
authors.initials: M
authors.lastname: Giordano
authors.forename: G
authors.initials: G
authors.lastname: Bernardo
authors.forename: G
authors.initials: G
authors.lastname: Giardina
authors.forename: S
authors.initials: S
authors.lastname: Fava
authors.forename: G
authors.initials: G
authors.lastname: Montanari
authors.forename: C
authors.initials: C
authors.lastname: Pedrotti
authors.forename: G
authors.initials: G
authors.lastname: Trotti
authors.forename: E
authors.initials: E
authors.lastname: Rinaldi
authors.forename: M A
authors.initials: MA
authors.lastname: Poli
authors.forename: C
authors.initials: C
authors.lastname: Tinelli
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D016019:Survival Analysis
chemical_list: D015251:Epirubicin; D003520:Cyclophosphamide; D017239:Paclitaxel; D005472:Fluorouracil