Short report: Bi-weekly 2-day schedule of high-dose folinic acid, 5-fluorouracil bolus and infusion in pretreated advanced epithelial ovarian cancer: A phase II study

Abstract

Twenty patients with documented progression after two or three cisplatin-based regimens for advanced epithelial ovarian carcinoma were treated with high-dose folinic acid (200 mg/m2), 5-fluorouracil bolus (400 mg/m2) and continuous infusion (600 mg/m2) for two consecutive days every two weeks. One clinically complete and two partial responses were observed in 16 evaluable patients, with 5 remaining stable. Median survival was 9 months. Toxicity was mild. This combination achieved a 19% (95% confidence interval 4%-46%) response rate in heavily pretreated cisplatin-resistant patients.

High-dose 5-fluorouracil and leucovorin as second-line chemotherapy in patients with platinum-resistant epithelial ovarian cancer

“…In our study, no objective response was document ed; 5 patients had stable disease and 9 showed progression. This outcome, i. e., no response and a median survival of 6.5 months, is worse than the results reported by Louvet et al [7]. In 16 evaluable patients they obtained 1 complete response and 2 partial responses.…”

“…One study suggests that a combination regimen involving continuous infusion of 5-FU is superior to bolus treatment with 5-FU [10], but another investigation shows no difference [2], A nonrandomized study in which 5-FU was given as a bolus and by continuous infusion in combination with leucovorin to 37 patients revealed a higher response rate and a longer median survival than those reported for former regimens [5]. Therefore, the push injection of 5-FU in combination with continuous infusion might explain the observed difference in outcome between our study and that of Louvet et al [7]. The dose of leucovorin is probably of less importance since high and low doses are equally effective in colorectal cancer [9].…”

“…In our study we infused 5-FU continuously (1200 mg/m2 per day for 2 days) weekly for 4 weeks and, thereafter, every 2 weeks. The dose of leucovorin used by Louvet et al [7] was 10-fold that given by us.…”

“…They found a response rate of 19% and a median survival of 9 months. Toxicity was minimal [7]. Herein we report the results of treatment with high-dose 5-FU in combination with leucovorin in similar patients with platinum-resistant ovarian cancer.…”

“…Leucovorin (folinic acid) stabilizes this complex [8], thereby enhancing the effect of 5-FU, as has been shown in colorectal cancer [9], Platinum resistance is thought to be caused by a mechanism other than the mode of action of 5-FU and leucovorin [4]. Recently, Lou vet et al [7] reported the results obtained using 5-FU and leucovorin in the treatment of patients with cisplatin-resistant ovarian cancer. They found a response rate of 19% and a median survival of 9 months.…”