Han Bao-hui, Xiu Qing-yu, Wang Hui-min, Shen Jie, Gu Ai-qin, Luo Yi, Bai Chun-xue, Guo Shu-liang, Liu Wen-chao, Zhuang Zhi-xiang, Zhang Yang, Zhao Yi-zhuo, Jiang Li-yan, Shi Chun-lei, Jin Bo, Zhou Jian-ying, Jin Xian-qiao
Shanghai Chest Hospital, Shanghai,China.
Zhonghua Zhong Liu Za Zhi. 2011 Nov;33(11):854-9.
To analyze the efficacy and quality of life and safety for paclitaxel and carboplatin (TC) and TC combined with endostar in the treatment of advanced non-small cell lung cancer (NSCLC).
This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical study. A total of 126 cases of untreated advanced NSCLC were enrolled in this study. There were 63 patients in the TC control arm and TC combined endostar arm, respectively. All enrolled patients were continuously followed-up for disease progression and death.
The objective response rate (ORR) of TC combined with endostar arm was 39.3%, and that of TC control arm was 23.0%, P = 0.078. The progression-free survival rates for TC combined with endostar arm and TC control arm were 78.3% and 58.8%, respectively, in 24 weeks (P = 0.017). The hazard ratio for the risk of disease progression was 0.35 (95%CI 0.13 to 0.90, P = 0.030). The median time to progression (TTP) of the TC combined with endostar arm was 7.1 months and TC arm 6.3 months (P > 0.05). The follow-up results showed that the median survival time (mOS) of the TC + Endostar arm was 17.6 months; (95%CI 13.4 to 21.7 months), and the TC + placebo arm 15.8 months (95%CI 9.4 to 22.9 months) (P > 0.05). The quality of life scores (LCSS patient scale) after treatment of the TC combined with endostar arm was improved, and that of the TC group was improved after completion of two cycles and three cycles of treatment. The quality of life scores compared with baseline after the completion of one cycle treatment was significantly improved for both the TC combined with endostar arm (P = 0.028 and), and TC arm (P = 0.036). It Indicated that TC combined with endostar treatment improved the patient's quality of life in the early treatment. The difference of adverse and serious adverse event rates between the two groups was not significant (P > 0.05).
Compared with TC alone treatmrnt, TC combined with endostar treatment can reduce the risk of disease progression at early time (24 weeks), increase the ORR, and can be used as first-line treatment for advanced NSCLC. The TC combined with endostar treatment has good safety and tolerability, improves the quality of life, and not increases serious adverse effects and toxicity for patients with advanced NSCLC.
分析紫杉醇联合卡铂（TC）及TC联合恩度治疗晚期非小细胞肺癌（NSCLC）的疗效、生活质量及安全性。
这是一项前瞻性、多中心、随机、双盲、安慰剂对照的临床研究。本研究共纳入126例未经治疗的晚期NSCLC患者。TC对照组和TC联合恩度组分别有63例患者。所有纳入患者均持续随访疾病进展和死亡情况。
TC联合恩度组的客观缓解率（ORR）为39.3%，TC对照组为23.0%，P = 0.078。24周时，TC联合恩度组和TC对照组的无进展生存率分别为78.3%和58.8%（P = 0.017）。疾病进展风险的风险比为0.35（95%CI 0.13至0.90，P = 0.030）。TC联合恩度组的中位进展时间（TTP）为7.1个月，TC组为6.3个月（P>0.05）。随访结果显示，TC+恩度组的中位生存时间（mOS）为17.6个月；（95%CI 13.4至21.7个月），TC+安慰剂组为15.8个月（95%CI 9.4至22.9个月）（P>0.05）。TC联合恩度组治疗后的生活质量评分（LCSS患者量表）有所改善，TC组在完成两个周期和三个周期治疗后生活质量评分有所改善。TC联合恩度组和TC组在完成一个周期治疗后与基线相比的生活质量评分均显著提高（P = 0.028和P = 0.036）。这表明TC联合恩度治疗在早期治疗中改善了患者的生活质量。两组不良事件和严重不良事件发生率的差异无统计学意义（P>0.05）。
与单纯TC治疗相比，TC联合恩度治疗可降低早期（24周）疾病进展风险，提高ORR，可作为晚期NSCLC的一线治疗方案。TC联合恩度治疗具有良好的安全性和耐受性，可改善生活质量，且不会增加晚期NSCLC患者的严重不良反应和毒性。
