Pyrhönen S, Kuitunen T, Nyandoto P, Kouri M
Department of Radiotherapy and Oncology, Helsinki University Central Hospital, Finland.
Br J Cancer. 1995 Mar;71(3):587-91. doi: 10.1038/bjc.1995.114.
A phase III randomised study, comparing treatment with fluorouracil, epidoxorubicin and methotrexate (FEMTX) with the best supportive care, was conducted in patients with unresectable or metastatic gastric cancer. During the period from July 1986 to June 1992, 41 patients were randomised to receive FEMTX or best supportive care. MTX was given in a dose of 1500 mg m-2 intravenously (i.v.) followed after 1 h by 5-FU 1500 mg m-2 i.v. on day 1; leucovorin rescue was started after 24 h (30 mg orally every 6 h for 48 h) and epidoxorubicin 60 mg m-2 i.v. was administered on day 15. In addition both groups received tablets containing vitamins A and E. Response rates for FEMTX were as follows: complete response (CR), 19% (4/21); partial response (PR), 10% (2/21); no change (NC), 33% (7/21); and progressive disease (PD), 24% (5/21). Response rates in the control group were: NC, 20% (4/20); and PD, 80% (16/20). Increased pain was observed in one patient in the treated group and in 11 patients in the control group within the first 2 months. WHO grade III/IV toxicity in the chemotherapy group was as follows: nausea/vomiting 40%, diarrhoea 10%, stomatitis 15%, leucopenia 50% and thrombocytopenia 10%. One possible treatment-related death was due to sepsis. The median time to progression in the FEMTX group was 5.4 months [95% confidence interval (CI) 3.1-11.7 months], but only 1.7 months in the control group (95% CI 1.2-2.7 months) (P = 0.0013). Similarly, the FEMTX group displayed significantly (P = 0.0006) prolonged survival compared with the control group, i.e. median survival 12.3 months (95% CI 7.1-15.6 months) vs 3.1 months (95% CI 1.6-4.6 months). In conclusion, FEMTX combined with vitamin A and E is a fairly well-tolerated treatment, giving a response rate of 29% in patients with advanced gastric cancer, and also prolonging patients' survival. It can be used as a reference treatment in testing new investigational combinations.
一项III期随机研究，比较氟尿嘧啶、表柔比星和甲氨蝶呤（FEMTX）治疗与最佳支持治疗，在不可切除或转移性胃癌患者中进行。在1986年7月至1992年6月期间，41例患者被随机分配接受FEMTX或最佳支持治疗。甲氨蝶呤剂量为1500mg/m²静脉注射（i.v.），1小时后在第1天给予氟尿嘧啶1500mg/m²静脉注射；24小时后开始亚叶酸解救（每6小时口服30mg，共48小时），表柔比星60mg/m²静脉注射在第15天给药。此外，两组均接受含维生素A和E的片剂。FEMTX的缓解率如下：完全缓解（CR），19%（4/21）；部分缓解（PR），10%（2/21）；无变化（NC），33%（7/21）；疾病进展（PD），24%（5/21）。对照组的缓解率为：NC，20%（4/20）；PD，80%（16/20）。在治疗组的1例患者和对照组的11例患者中，在最初2个月内观察到疼痛加重。化疗组的WHO III/IV级毒性如下：恶心/呕吐40%，腹泻10%，口腔炎15%，白细胞减少50%，血小板减少10%。1例可能与治疗相关的死亡归因于败血症。FEMTX组的疾病进展中位时间为5.4个月[95%置信区间（CI）3.1 - 11.7个月]，而对照组仅为1.7个月（95% CI 1.2 - 2.7个月）（P = 0.0013）。同样，与对照组相比，FEMTX组的生存期显著延长（P = 0.0006），即中位生存期12.3个月（95% CI 7.1 - 15.6个月）对3.1个月（95% CI 1.6 - 4.6个月）。总之，FEMTX联合维生素A和E是一种耐受性相当好的治疗方法，晚期胃癌患者的缓解率为29%，同时也延长了患者的生存期。它可作为测试新研究组合的参考治疗方法。
