多西他赛联合奈达铂与多西他赛单药二线治疗晚期非小细胞肺癌的临床研究

Comparison of the efficacy of nedaplatin combined with docetaxel and docetaxel alone as a second line treatment for advanced non-small cell lung cancer

目的 比较多西他赛联合奈达铂与多西他赛单药二线治疗晚期非小细胞肺癌（NSCLC）的疗效及毒副反应.方法 58例晚期NSCLC患者中,接受多西他赛联合奈达铂治疗（联合组）20例,多两他赛单药二线治疗（单药组）38例.评价两组患者的疗效、无进展生存时间（PFS）、中位生存时间（MST）和毒副反应.结果 联合组与单药组患者的中位PFS分别为4.35和4.0个月,差异有统计学意义（P＜0.05）.联合组与单药组患者的MST分别为13.5和10.6个月,1年生存率分别为29.0%和22.0%,疾病控制率分别为50.0%和47.4%,差异均无统计学意义（P＞0.05）.联合组中,鳞癌与非鳞癌患者的PFS差异无统计学意义（P＞0.05）.联合组与单药组患者的3度以上骨髓抑制发生率分别为15.0%和10.5%（P=0.003）,两组患者均无明显的胃肠道及肾脏毒性反应发生.结论 与多西他赛单药相比,多西他赛联合奈达铂二线治疗晚期NSCLC可提高疾病控制率,延长中位PFS,未增加明显毒副反应.

Objective To compare the curative effect, safety and survival of Nedaplatin combined with dcetaxel and docetaxel alone as a second line treatment for advanced NSCLC. Methods From Sep 2005 to Mar 2009, fifty-eight patients with NSCLC treated in the Shanghai Chest Hospital who failed firstline chemotherapy and receiving docetaxel or docetaxel combined with nedaplatin were retrospectively analyzed. Survival analysis was evaluated by Kaplan-Meier and Log-Rank test. There were 20 patients in the combination group, and 38 in the single-agent group. Results The PFS was 4.35 months for combination group and 4.0 months for single-agent group, there was a significant diference between the two groups（P 〈0.05）. The mean survival time and 1-year survival rate were 13.5 months vs. 10.6 months and 29.0% vs.22.0%, respectively, with no significant diference. The Hematological toxicity in the combination group was higher than that in the single-agent group, 15.0% vs. 10.5%（P =0. 003）, and no renal toxicity was noted in this study. Conclusions Compared with the treatment with docetaxel alone, Nedaplatin combined with docetaxel as a second line treatment for NSCLC has a better curative effect and acceptable toxicity.