Hydroxyurea, folinic acid, 5FU bolus and infusion (HLFP regimen) in advanced gastric cancer
摘要
Hydroxyurea (HU) enhances both 5FU and cisplatin. We designed a phase II study in advanced gastric cancer with the HLFP regimen, based on this dual modulation by HU. Regimen consisted in HU 1.5 to 2 g orally days 0, 1 and 2, folinic acid 200 mg/m2 in 2-h infusion, followed by 5FU 400 mg/m2 bolus and 600 mg/m2 22-h infusion days 1 & 2 every 14 days. Cisplatin was administered at 80 mg/m2 day 3 every 2 courses. 74 consecutive eligible pts were included (12 too early), this report concerns the first 62 pts (53 M/9 F, mean age 59.8 yrs, range 31-78). Initial PS (WHO) was 0 (17 pts), 1 (31) and 2 (14). 7 pts presented a locally advanced disease without melastases. The 55 remaining pts presented peritoneal carcinomatosis (24), liver (21), lymph nodes (32) or lung (8 pts) metastases, associated with local disease in 41. 800 courses were delivered. Toxicity (> WHO gr 2) was: vomiting (7 pts), neutropenia (8), with only 2 febrile neutropenia episodes, anemia (3), diarrhea (2), thrombocytopenia (1), alopecia (1) and mucositis (1). Maximal toxicity was gr 3-4 in 29%of pts. pts with non mesurable peritoneal carcinomatosis or local disease were not evaluable for response. 5 CR and 32 PR were observed in 52 mesurable pts (RR: 71.1%, 95%CI: $5.6-83.6%). $6%of pts had a gain of weight, 77%a rapid disappearance of symptoms. Median follow-up time is 18 months. Median progression-free and overall survival were 9 and 11 months respectively. This combination should be tested in phase III trials.