紫杉醇卡铂联合重组人血管内皮抑制素注射液治疗晚期非小细胞肺癌的疗效及生活质量分析

A multicenter, randomized, double-blind, placebo-controlled safety study to evaluate the clinical effects and quality of life of paclitaxel-carboplatin （ PC ） alone or combined with endostar for advanced non-small cell lung cancer （ NSCLC ）

目的比较泰素、卡铂（TC）联合重组人血管内皮抑制素注射液（商品名恩度@）与TC方案治疗晚期非小细胞肺癌（NSCLC）的疗效、生活质量及安全性。方法采用前瞻性、多中心、随机、双盲、安慰剂对照临床研究。共126例晚期初治NSCLC患者入组，TC联合恩度治疗组63例，TC对照组63例。所有入组患者在研究结束后继续随访至疾病进展和死亡。结果恩度治疗组的客观缓解率（ORR）为39．3％，对照组的ORR为23．0％（P=0．078）。恩度治疗组和对照组24周的尤进展生存率分别为78．3％和58．8％（P=0．017），疾病进展风险比为0．35（95％置信区间0．13～0．90，P=0．030）。恩度治疗组和对照组的中位疾病进展时间（TTP）分别为7．1个月和6．3个月（P〉0．05）。恩度治疗组的中位生存期（mOS）为17．6个月（95％CI为13．4—21．7个月），对照组为15．8个月（95％CI为9．4—22．9个月），差异无统计学意义（P〉0．05）。恩度治疗组治疗后生活质量评分（LCSS患者量表）有所改善，对照组患者在完成2个周期和3个周期治疗后，生活质量改善。恩度治疗组完成1个周期治疗后，其生活质量评分与基线差异有统计学意义（P=0．028），对照组差异也有统计学意义（P=0．036），表明恩度治疗组在治疗初期更能改善患者的生活质量。恩度治疗组和对照组不良反应及严重不良反应发生率比较，差异无统计学意义（P〉0．05）。结论与单纯化疗相比，TC联合恩度一线治疗晚期NSCLC可降低早期疾病进展风险比（24周），提高ORR（P=0．078）。TC联合恩度方案具有较好的安全性及耐受性好，患者治疗前后生活质量有所改善，未增加严重不良反应发生率。

Objective 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）. Methods 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. Results 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 O. 13 to 0.90, P = 0. 030）. The median time to progression （TIP） 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 ）. Conclusions 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.