Phase Ⅲ Clinical Study of a New Anticancer Drug Atofluding
LI Qing1, FENG Feng yi1, HAN Jun2, SUI Guang jie3, ZHU Yan guang4, ZHANG Yang5, ZHANG Zhen hua6, LI Li7, WANG Ping hui8, ZHOU Mei zhen9, ZHANG Ying chao101. Cancer Hospital,Chinese Academy of Medical Sciences,Beijing 100021,P.R.China2. Shanxi Provincial Cancer Hospital,Xian 710061,P.R.China 3. Heilongjiang Provincial Cancer Hospital,Harbin 150040,P.R.China 4. Xijing Hospital of The Fourth Military Medical University,Xian 710032,P.R.China 5. The Second Clinical College of Dalian Medical University,Dalian 110121,P.R.China6. The First Affiliated Hospital of Xian Medical University,Xian 710061,P.R.China 7. The Affiliated Hospital of Shandong Medical University,Jinan 250012,P.R.China8. Cancer Hospital of Hunan Province,Changsha 410006,P.R.China9. Beijing Hospital,Beijing 100078,P.R.China 10. Cancer Hospital of Sichuan Province,Chengdu 610041,P.R.China
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.
【CateGory Index】： R969