5-fluorouracil versus folinic acid and 5-fluorouracil in advanced, hormone-resistant prostate cancer: A prospective, randomized pilot trial

Objectives: Results of cytotoxic chemotherapy for hormone-resistant prostate cancer are not impressive. One of the substances which seems to have a therapeutic benefit is 5-fluorouracil (5-FU). The effect of 5-FU can be modulated by addition of folinic acid (FA). We tested in a prospective, randomized phase II trial monotherapy with 5-FU versus the combination of 5-FU and high-dose FA. Methods: 25 patients received 600 mg/m(2) 5-FU, and 24 patients 400 mg/m(2) FA plus 600 or 400 mg/m(2) 5-FU, They were treated for two cycles for 5 days in a 21-day interval followed by a weekly single-day application until progression occurred, Pain remission, toxicity, time to progression and survival were evaluated. Results: Both regimens led to a pain remission in nearly 70% of the patients, Mucosal side effects Like diarrhea and stomatitis occurred more often in the combination arm, whereas leukopenias were more frequent in the monotherapy arm, We observed no statistically significant difference between the two treatment arms regarding time to progression and survival, Conclusions: Although both regimens led to a pain remission, side effects are too severe to recommend these protocols for standard treatment of hormone-resistant prostate cancer.