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背景与目的:阿托氟啶(atofluding,ATFU)是新一代氟尿嘧啶衍生物,其Ⅰ期和Ⅱ期临床试验已经完成,本文为该药的Ⅲ期临床研究,其目的是评价ATFU联合化疗对胃癌、结直肠癌、食管癌及肝癌的临床疗效和不良反应,并与呋喃氟尿嘧啶(ftorafur,FT207)比较。方法:多中心、开放、各中心内随机临床研究。胃癌、结直肠癌、食管癌及肝癌各设治疗组(ATFU)及对照组(FT207),按2∶1比例随机入组,分别采用MMC+VP-16+ATFU(FT207)、DDP+HCPT+ATFU(FT207)、DDP+VDS+ATFU(FT207)和ADM+MMC+ATFU(FT207)方案。两组所用剂量完全相同。结果:治疗组213例,对照组107例。在可评价疗效的病例中,治疗组和对照组对胃癌、结直肠癌、食管癌及肝癌的疗效分别为17.1%和7.9%、16.7%和9.4%、20.0%和28.6%、5.0%和9.0%。不良反应主要为骨髓抑制和胃肠道反应,两组发生的频率及程度基本相同,无统计学差异。结论:抗癌新药ATFU联合化疗对晚期消化系统肿瘤有一定的客观疗效,其有效率及不良反应与FT207联合化疗基本相同。
BACKGROUND & OBJECTIVE: ATFU is a new generation of fluorouracil derivatives. Phase I and II clinical trials have been completed. This article is a phase III clinical study of the drug to evaluate the effect of ATFU combined with chemotherapy on gastric cancer , Colorectal cancer, esophageal cancer and hepatocellular carcinoma. The clinical efficacy and adverse reactions were compared with ftorafur (FT207). Methods: Multi-center, open, randomized clinical studies within each center. ATFU and FT207 in gastric cancer, colorectal cancer, esophageal cancer and hepatocellular carcinoma were randomly divided into two groups according to the ratio of 2: 1, and were treated with MMC + VP-16 + ATFU (FT207), DDP + HCPT + ATFU (FT207), DDP + VDS + ATFU (FT207) and ADM + MMC + ATFU (FT207) solutions. The two groups used the same dose. Results: 213 cases in the treatment group and 107 cases in the control group. Among the evaluable curative effects, the curative effects of the treatment group and the control group on gastric cancer, colorectal cancer, esophageal cancer and liver cancer were 17.1% and 7.9%, 16.7% and 9.4%, 20.0% and 28.6%, 5.0% and 9.0%, respectively %. The main adverse reactions were myelosuppression and gastrointestinal reactions. The frequency and degree of occurrence of the two groups were basically the same, with no significant difference. Conclusion: The anti-cancer drug ATFU combined with chemotherapy has certain objective curative effect on advanced digestive system tumors. The effective rate and adverse reactions are basically the same as those of combination chemotherapy with FT207.