Treatment of advanced breast cancer with 5-fluorouracil and high-dose folinic acid: preliminary results.

Twenty-eight patients with advanced breast cancer, all previously treated with hormonotherapy and/or chemotherapy, entered this study. Treatment was comprised of 5-day courses of folinic acid (200 mg/m2/day by i.v. bolus injection) and 5-fluorouracil, given immediately afterwards at a dose of 340-370-400 mg/m2/day according to toxicity. Cycles were repeated every 28 days. The remission rate was 60.7% (17/28): 10.7% CR (complete) (3/28), 50% PR (partial) (14/28), while 35% (1/28) had no change. Fourteen out of 23 patients previously treated with 5-FU also responded. The median duration of remission was about 6 months. Hematological toxicity was mild, while gastroenteric and ocular side-effects were important, even if not life-threatening. These data suggest that 5-FU combined with high-doses of folinic acid is effective in advanced breast cancer.