Zhang Yi-Fei, Yu Yong-Feng, Lu Shun
Shanghai Lung Tumor Clinical Medical Center, Chest Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200030, China.
Zhonghua Yi Xue Za Zhi. 2009 Jun 9;89(22):1544-8.
To compare the therapeutic efficacies and toxicities of single-agent docetaxel or docetaxel plus platinum combination agent in patients with advanced non-small cell lung cancer (NSCLC) so as to provide rationales for standard second-line chemotherapy.
The clinical data from 152 patients with NSCLC who were admitted into Chest Hospital Affiliated to Shanghai Jiaotong University, from January 2004 to May 2008 were retrospectively analyzed. Forty patients were treated with single-agent docetaxel (single-agent group, 16 and 24 patients with stages IIIb and IV disease respectively; 32 patients with PS score 0-1 before treatment and 8 patients with PS score 2 before treatment), and 112 patients were treated with docetaxel plus platinum combination agent (combination group, 29 and 83 patients with stage IIIb and IV disease respectively; 98 patients with PS score 0-1 before treatment and 14 patients with PS score 2 before treatment). Primary end point was overall survival (OS), and secondary end point were progression-free survival time (PFS), disease control rate (DCR), one-year survival, and drug toxicity. Survival analysis was evaluated by Kaplan-Meier. Single factor analysis and Cox regression model were done to analyze the relationship between the influencing factors and the prognosis of disease.
The median PFS of the single-agent group was 3.0 months, significantly shorter than that of the combination group (4.2 months, P = 0.048). However, no statistical differences were found in OS, DCR or one-year survival between the two groups (all P > 0.05). The most common grade 3 to 4 toxicities were leukopenia (32.5% for single-agent group, and 56.2% for combination group, P = 0.000), and gastro-intestinal toxicity (0 for single-agent group, and 4.5% for combination group, P = 0.000). Single factor analysis showed that the factors including radiotherapeutic history, operative history, PS score before treatment, clinical stage, and response to second-line treatment influenced the prognosis of NSCLC (all P < 0.05). Cox regression analysis demonstrated operative history (HR = 0.428, 95% CI: 0.261-0.701), PS score before treatment (HR = 1.919, 95% CI: 0.999-3.685), clinical stage (HR = 2.297, 95% CI: 1.427-3.696) and response to second-line treatment (HR = 0.318, 95% CI: 0.177-0.571) had effects on survival.
To those well-selected patients, docetaxel plus platinum combination agent as the second-line treatment of advanced NSCLC significantly prolongs the progression-free survival. But such a regimen is more toxic and does not improve the response rate and overall survival.
比较多西他赛单药或多西他赛联合铂类药物治疗晚期非小细胞肺癌（NSCLC）的疗效及毒性，为规范二线化疗提供依据。
回顾性分析2004年1月至2008年5月上海交通大学附属胸科医院收治的152例NSCLC患者的临床资料。40例患者接受多西他赛单药治疗（单药组，Ⅲb期和Ⅳ期患者分别为16例和24例；治疗前PS评分为0 - 1分的患者32例，PS评分为2分的患者8例），112例患者接受多西他赛联合铂类药物治疗（联合组，Ⅲb期和Ⅳ期患者分别为29例和83例；治疗前PS评分为0 - 1分的患者98例，PS评分为2分的患者14例）。主要终点为总生存期（OS），次要终点为无进展生存期（PFS）、疾病控制率（DCR）、一年生存率及药物毒性。采用Kaplan-Meier法进行生存分析。采用单因素分析和Cox回归模型分析影响因素与疾病预后的关系。
单药组的中位PFS为3.0个月，显著短于联合组（4.2个月，P = 0.048）。然而，两组在OS、DCR或一年生存率方面均未发现统计学差异（均P > 0.05）。最常见的3 - 4级毒性反应为白细胞减少（单药组为32.5%，联合组为5
