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


CONCLUSIONS
ATFU combination chemotherapy is effective and similar to FT207 in the efficiency and adverse effects for treatment of advanced GI cancers.
Li
Qing
Q
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing 100021, P. R. China.
Feng
Feng-yi
FY
Han
Jun
J
Sui
Guang-jie
GJ
Zhu
Yan-guang
YG
Zhang
Yang
Y
Zhang
Zhen-hua
ZH
Li
Li
L
Wang
Ping-hui
PH
Zhou
Mei-zhen
MZ
Zhang
Ying-chao
YC
D000328:Adult; D000368:Aged; D000740:Anemia / Q000209:etiology; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D006801:Humans; D007970:Leukopenia / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D013921:Thrombocytopenia / Q000209:etiology; D016896:Treatment Outcome
D000970:Antineoplastic Agents; C475762:atofluding; D005472:Fluorouracil