title: 5-Fluorouracil and leucovorin therapy in patients with hormone refractory prostate cancer: an Eastern Cooperative Oncology Group phase II study (E1889).
abstract: This report is a multi-institutional phase II study designed to obtain the response rate, survival, and toxicity profile for patients having hormone-refractory prostate cancer. Patients who had bidimensionally measurable prostate carcinoma in first or second remission after previous hormonal therapy but no history of chemotherapy were eligible. Patients were treated with leucovorin, 20 mg/m2 intravenously, followed by 5-fluorouracil (5-FU), 425 mg/m2 intravenously daily for 5 days, with cycles repeated every 28 days. Of 38 eligible patients, 3 (7.9%) had partial responses to therapy and 20 (52.6%) had stable disease. Median survival was 11.6 months for all 38 patients and median time to progression was 4.4 months. Most of the serious side effects were gastrointestinal or hematologic and overall, 23 of 38 patients (60.5%) experienced at least one grade 3 or 4 treatment-related toxicity of any type, as measured by the National Cancer Institute common toxicity criteria. Five patients (13.2%) withdrew from the study because of adverse reactions from chemotherapy. We conclude that treatment of hormone-refractory prostate cancer patients with 5-FU and leucovorin chemotherapy produced few responses at the cost of significant side effects. Further investigation of this combination is not warranted in this setting.
authors.affiliation: University of Wisconsin, Madison 53792, USA.
authors.forename: J D
authors.initials: JD
authors.lastname: Berlin
authors.forename: K J
authors.initials: KJ
authors.lastname: Propert
authors.forename: D
authors.initials: D
authors.lastname: Trump
authors.forename: G
authors.initials: G
authors.lastname: Wilding
authors.forename: G
authors.initials: G
authors.lastname: Hudes
authors.forename: J
authors.initials: J
authors.lastname: Glick
authors.forename: P
authors.initials: P
authors.lastname: Burch
authors.forename: A
authors.initials: A
authors.lastname: Keller
authors.forename: P
authors.initials: P
authors.lastname: Loehrer
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000368:Aged; D000369:Aged, 80 and over; D000931:Antidotes / Q000008:administration & dosage*; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy*; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D016019:Survival Analysis
chemical_list: D000931:Antidotes; D000964:Antimetabolites, Antineoplastic; D002955:Leucovorin; D005472:Fluorouracil