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Clinical Trial
. 2002 Dec;21(12):1350-3.

[Phase III clinical study of a new anticancer drug atofluding]

[Article in Chinese]
Qing Li  1 , Feng-yi Feng, Jun Han, Guang-jie Sui, Yan-guang Zhu, Yang Zhang, Zhen-hua Zhang, Li Li, Ping-hui Wang, Mei-zhen Zhou, Ying-chao Zhang
Affiliations
  • PMID: 12520746
Clinical Trial

[Phase III clinical study of a new anticancer drug atofluding]

[Article in Chinese]
Qing Li et al. Ai Zheng. 2002 Dec.

Abstract

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.

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