title: Phase II evaluation of 5-fluorouracil and low-dose leucovorin in cisplatin-refractory advanced ovarian carcinoma.
abstract: Thirty-nine women with advanced, recurrent epithelial ovarian carcinoma who failed prior treatment with a platinum-based regimen were treated with leucovorin, 20 mg/m2 intravenously followed by 5-fluorouracil, 425 mg/m2 intravenously, daily for 5 consecutive days every 5 weeks in a phase II trial. Partial regressions were seen in 3 of 15 (20%) measurable disease patients, and objective regressions were seen in 3 of 14 (21%) evaluable/nonmeasurable disease patients. A 50% or greater decrease in CA-125 level was observed in 3 of 10 (30%) patients with no objectively evaluable or measurable disease. Overall objective response rate was 23% (95% confidence interval: 11 to 39%) in all 39 patients evaluated, with a median time to progression of 3 months and overall median survival of 7 months. Toxicities were acceptable and consisted of neutropenia, thrombocytopenia, stomatitis, and mild diarrhea. 5-Fluorouracil, as administered in this protocol, had modest antitumor activity in cisplatin-refractory ovarian carcinoma of short duration and minimal toxicity.
authors.affiliation: Department of Oncology, Mayo Clinic, Rochester, Minnesota 55905.
authors.forename: H J
authors.initials: HJ
authors.lastname: Long
authors.forename: R A
authors.initials: RA
authors.lastname: Nelimark
authors.forename: J Q
authors.initials: JQ
authors.lastname: Su
authors.forename: S C
authors.initials: SC
authors.lastname: Garneau
authors.forename: R
authors.initials: R
authors.lastname: Levitt
authors.forename: R M
authors.initials: RM
authors.lastname: Goldberg
authors.forename: M A
authors.initials: MA
authors.lastname: Poon
authors.forename: J W
authors.initials: JW
authors.lastname: Kugler
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007275:Injections, Intravenous; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*
chemical_list: D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil