国产奈达铂治疗晚期食管癌的II期临床试验

[Phase II clinical trial of home-produced Nedaplatin in treating advanced esophageal carcinoma].

作者信息

Xu Rui-Hua, Shi Yan-Xia, Guan Zhong-Zhen, Jiang Wen-Qi, Huang He, Ma Zhi-Yong, Wang Jian-Hua, Hu Xiao-Hua, Xie Wei-Min, Li Xing-Geng, Liu Ya-Li, Pan Liang-Xi, Dai Ai-Di, Zhuang Wu, Zhang Chun

机构信息

State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, 510060, P. R. China.

出版信息

Ai Zheng. 2006 Dec;25(12):1565-8.

PMID:17166388

Abstract

BACKGROUND & 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.

摘要

背景与目的

奈达铂是一种含有机铂的第二代抗癌药。国外临床研究表明，奈达铂是一种广谱高效的抗癌药，尤其对食管癌的治疗效果显著。但国产奈达铂在中国的治疗效果及毒性尚不明确。本研究旨在评价国产奈达铂在中国食管癌治疗中的疗效，并观察其毒性。

方法

进行一项多中心、II期、前瞻性临床试验。纳入初治食管癌患者并随机分为试验组和对照组。试验组患者接受国产奈达铂联合5-氟尿嘧啶（5-FU）治疗；对照组患者接受顺铂（DDP）联合5-FU治疗。

结果

共纳入52例患者，试验组30例，对照组22例。试验组27例可评价疗效，所有病例均可评价毒性；对照组所有病例均可评价疗效和毒性。试验组的有效率显著高于对照组（29.62%对22.72%，P<0.05）。试验组完全缓解（CR）率为18.51%，对照组为4.55%。在考虑骨髓抑制时，两组贫血发生率相似；但试验组中性粒细胞减少和血小板减少的发生率高于对照组，尤其是III-IV级血小板减少（20.68%对0%，P<0.01）。试验组胃肠道反应发生率低于对照组。两组在肝毒性、肾毒性、心脏毒性、周围神经毒性和脱发方面无显著差异。