[Phase II clinical trial of home-produced Nedaplatin in treating advanced esophageal carcinoma].
OBJECTIVE
Nedaplatin is a second-generation anticancer drug containing organic platinum. Clinical researches in overseas showed that Nedaplatin is an anticancer drug with broad spectrum and high efficiency, especially in treating esophageal carcinoma. But the therapeutic efficacy and toxicity of home-produced Nedaplatin in China are unclear. This study was to evaluate the efficacy of home-produced Nedaplatin in China on esophageal carcinoma, and observe its toxicity.


METHODS
A multi-center, phase II, prospective clinical trial was conducted. Naive patients with esophageal carcinoma were enrolled and randomized into trial group and control group. The patients in trial group were treated with home-produced Nedaplatin plus 5-fluorouracil (5-FU); the patients in control group were treated with cisplatin (DDP) plus 5-FU.


RESULTS
A total of 52 patients were enrolled: 30 in trial group, and 22 in control group. For trial group, therapeutic efficacy was evaluable in 27 cases, and toxicity was evaluable in all cases; for control group, therapeutic efficacy and toxicity were evaluable in all cases. The response rate was significantly higher in trial group than in control group (29.62% vs. 22.72%, P<0.05). The complete remission (CR) rates were 18.51% in trial group and 4.55% in control group. When considering myelosuppression, the occurrence rate of anemia was similar in the 2 groups; but the occurrence rates of neutropenia and thrombocytopenia were higher in trial group than in control group, especially for grade III-IV thrombocytopenia (20.68% vs. 0%, P<0.01). The occurrence rate of gastrointestinal reaction was lower in trial group than in control group. There were no significant differences in hepatotoxicity, renal toxicity, heart toxicity, peripheral nerve toxicity, and alopecia between the 2 groups.


CONCLUSIONS
Nedaplatin is an effective platinum drug for esophageal carcinoma. The treatment efficacy of Nedaplatin plus 5-FU regimen is better than that of DDP plus 5-FU regimen. It has a good clinical tolerance. The main toxicity is myelosuppression, and thrombocytopenia is predominant.
Xu
Rui-Hua
RH
State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, 510060, P. R. China.
Shi
Yan-Xia
YX
Guan
Zhong-Zhen
ZZ
Jiang
Wen-Qi
WQ
Huang
He
H
Ma
Zhi-Yong
ZY
Wang
Jian-Hua
JH
Hu
Xiao-Hua
XH
Xie
Wei-Min
WM
Li
Xing-Geng
XG
Liu
Ya-Li
YL
Pan
Liang-Xi
LX
Dai
Ai-Di
AD
Zhuang
Wu
W
Zhang
Chun
C
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012074:Remission Induction; D013921:Thrombocytopenia / Q000139:chemically induced
D009944:Organoplatinum Compounds; C053989:nedaplatin; D005472:Fluorouracil