国产奈达铂治疗恶性肿瘤II期临床研究

Phase II clinical study of nedaplatin in treating malignant tumor

目的 观察国产奈达铂单药及联合其他化疗药物治疗非小细胞肺癌、食管癌、鼻咽癌的疗效及不良反应。方法 单盲随机对照II期临床研究。入组共 4 3例 ,单药组 4例 ,联合化疗组 39例 (治疗组2 1例 ,对照组 18例 )。奈达铂 80～ 10 0mg/m2 ,加入 5 0 0ml生理盐水中静滴 2小时 ,每 3～ 4周重复。结果 入组 4 3例 ,能评价疗效的 4 2例。非小细胞肺癌治疗组 13例 ,PR 3例 ,有效率 2 3% ;对照组 12例 ,PR 3例 ,有效率 2 5 % ,二组无差异。食管癌治疗组 6例 ,PR 2例 ,有效率 33.3% ;对照组 5例 ,PR 1例 ,有效率 2 0 %。鼻咽癌治疗组 1例达SD ,对照组 1例达PR。非小细胞肺癌单药 4例 ,疗效均为SD。毒副反应单药组轻微 ,联合化疗组二组相似 ,但治疗组无肾功能毒性。结论 奈达铂对非小细胞肺癌、食管癌有一定疗效 ,在非小细胞肺癌疗效与顺铂相近 ,在食管癌中疗效优于顺铂 ,且无肾毒性。

Objective We performed this study to assess the therapeutic responses and side effects of domestic nedaplatin in treating non-small-cell lung cancer, esophageal cancer and nasopharyngeal cancer. Methods Randomized controlled phase II clinical study. 43 patients were studied. 4 patients were treated only with nedaplatin. 39 patients were treated with nedaplatin and other drugs (21 patients were in therapy group and 18 patients were in control group). Nedaplatin was administered at a dose of 80～100mg/m 2 whit 500ml of saline by slow drip infusion for 120 minutes, at intervals of 3～4 weeks. Results 43 patients were studied and 42 patients were evaluable. Of patients with non-small-cell lung cancer, partial response rate was 23% (3/13) in patients treated with nedaplatin and VDS; patial response rate was 25% (3/12) in patients treated with cisplatin and VDS. There was no significant difference between two groups. Of patients with esophageal cancer, partial response rate was 33.3% (2/6) in patients treated with nedaplatin and 5-Fu; partial response rate was 20% (1/5) in patients treated with cisplatin and nedaplatin. Of patients with nasopharyngeal cancer, one patients treated with nedaplatin and 5-Fu was SD; one patients treated with cisplatin and 5-Fu was SD. 4 patients with non-small-cell lung cancer who were treated only with nedaplatin were SD. The adverse side effect was slight in patients treated only with nedaplatin. To patients treated with combination therapy, the adverse side effect was similar between two groups, however, there were no renal toxicity in patients treated with nedaplatin. Conclusion Nedaplatin is efficacious for non-small-cell lung cancer and esophageal cancer. Its effect is similar to cisplatin in treating non-small-cell lung cancer and better than cisplatin in treating esophageal cancer. The renal toxicity of nedaplatin is mild.