title: Weekly 5-fluorouracil and high-dose folinic acid in combination with epidoxorubicin as first-line therapy in advanced breast cancer: a phase II study.
abstract: A total of 25 patients with advanced breast cancer were treated weekly with i.v. 5-fluorouracil at 350 mg/m2, folinic acid at 500 mg/m2, and epidoxorubicin at 35 mg/m2 as first-line chemotherapy for a maximum of 18 cycles. In all, 24 patients were evaluable for response. Overall, 1 patient achieved a complete response and 11 patients showed a partial response, for an objective response rate of 50%; the median duration of response was 18.3+ months and median survival amounted to 18.8+ months. Side effects were generally mild, with grade II leukopenia occurring in 10 patients and grade III leukopenia, in 1 patient. Other toxicity included nausea and vomiting (82%), diarrhea (48%), stomatitis (48%), and alopecia (92%), all of which were mainly restricted to WHO grades I and II. Our results suggest that leucovorin modulation of 5-fluorouracil can safely be incorporated into combination chemotherapy with epidoxorubicin on the investigated schedule. The observed response rate appears comparable with that obtained with other first-line regimens.
authors.affiliation: Department of Internal Medicine, Karl Franzens University Graz, Austria.
authors.forename: H
authors.initials: H
authors.lastname: Stöger
authors.forename: T
authors.initials: T
authors.lastname: Bauernhofer
authors.forename: A K
authors.initials: AK
authors.lastname: Kasparek
authors.forename: M
authors.initials: M
authors.lastname: Schmid
authors.forename: R
authors.initials: R
authors.lastname: Moser
authors.forename: F
authors.initials: F
authors.lastname: Ploner
authors.forename: E
authors.initials: E
authors.lastname: Derstvenscheg
authors.forename: I
authors.initials: I
authors.lastname: Kuss
authors.forename: M
authors.initials: M
authors.lastname: Wilders-Truschnig
authors.forename: P
authors.initials: P
authors.lastname: Steindorfer
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged
chemical_list: D015251:Epirubicin; D002955:Leucovorin; D005472:Fluorouracil