摘要
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: Atofloding (ATFU) is a new derivative of 5 fluorouracil. The phase I and II clinical study have been finished.The current study was a phase III clinical trail of ATFU. The aim of this study was to evaluate the efficacy, toxicity of ATFU combination chemotherapy and compare with ftorafur (FT 207) in patients with gastric cancer,colorectal,esophageal cancer,and liver cancer. Methods: A multicenter, open randomized controlled trial was carried out. A total of 320 patients with gastric cancer, colorectal, esophageal cancer and liver cancer were randomized into ATFU group (study group) and FT207 group (control group) (a ratio of 2∶1),treated with MMC+VP 16+ATFU (FT 207),DDP+HCPT+ATFU (FT 207),DDP+VDS+ATFU(FT 207),and ADM+MMC+ATFU (FT 207) regimen, respectively. The same dosage of combine drugs were used in the two groups. Results: The response rates of the study group (213 cases) and the control group (107 cases) were 17.1% and 7.9% in gastric cancer (P >0.05), 16.7% and 9.4% in colorectal cancer (P >0.05), 20.0% and 24.6% in esophageal cancer (P >0.05),5.0% and 9.0% in liver cancer (P >0.05), respectively. The major adverse effects were mylosuppression and gastrointestinal reactions which frequency and intensity had no statistical difference in the two groups. Conclusion: ATFU combination chemotherapy is effective and similar to FT207 in the efficiency and adverse effects for treatment of advanced GI cancers.
出处
《癌症》
SCIE
CAS
CSCD
北大核心
2002年第12期1350-1353,共4页
Chinese Journal of Cancer
