Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer.
Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer.
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DOI：
10.1038/bjc.1995.114
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发表时间：
1995-03
影响因子：
8.8
通讯作者：
Kouri, M
中科院分区：
文献类型：
--
作者：
Pyrhonen, S;Kuitunen, T;Nyandoto, P;Kouri, M
在不可切除或转移性胃癌患者中进行了一项III期随机研究，比较了氟尿嘧啶、表阿霉素和甲氨蝶呤（FEMTX）与最佳支持治疗的治疗效果。在1986年7月至1992年6月期间，41例患者随机接受FEMTX或最佳支持治疗。MTX以1500 mg m-2的剂量静脉内（i.v.）随后在第1天1小时后静脉注射5-FU 1500 mg m-2; 24小时后开始甲酰四氢叶酸补救（每6小时口服30 mg，持续48小时），并在第15天静脉注射表阿霉素60 mg m-2。此外，两组都接受了含有维生素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）。在前2个月内，治疗组1例患者和对照组11例患者观察到疼痛加重。化疗组的WHO III/IV级毒性反应为恶心/呕吐40%，腹泻10%，口腔炎15%，白细胞减少50%，血小板减少10%。1例可能的治疗相关死亡是由于败血症。FEMTX组的中位进展时间为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），即中位生存期为12.3个月（95% CI 7.1 - 15.6个月）vs 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，在晚期胃癌患者中的有效率为29%，并且还延长了患者的生存期。它可用作测试新的试验用组合的参考治疗。
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.