恩度联合紫杉醇和顺铂治疗晚期非小细胞肺癌的疗效及心血管毒性

The Therapeutic Effect and Cadiovascular Adverse Reaction of Endostar Combined with Paclitaxel and Cisplatin on Advanced Non-Small-Cell Lung Cancer

目的观察抗肿瘤新药重组人血管内皮抑素注射液恩度联合紫杉醇、顺铂治疗晚期非小细胞肺癌的疗效及心血管毒性。方法43例晚期非小细胞肺癌患者接受恩度联合紫杉醇和顺铂方案治疗,每3周为1个周期。用药1周期后评价毒性,2周期后评价疗效。结果总共完成的治疗周期数为166个,平均3.86个周期,完全缓解为4.6%(2/43),部分缓解为44.19%(19/43),总有效率为48.79%,疾病控制率为81.4%(35/43),一年生存率为51.2%;中位总生存期12.2月。有67.44%的患者(29/43)生活质量改善,仅14.0%(6/43)的患者出现生活质量下降。G3/4级的毒性有19例次,主要是血液学毒性,有5例在治疗后出现了心电图变化,表现为T波和ST-T段改变及一过性室上性心动过速;停药后自动恢复正常,行心脏彩超及心肌酶谱、肌钙蛋白等检查均无异常。6例出现了轻至中度血压升高,主要为既往有高血压的患者在用药期间出现的血压波动,1例出现重度高血压,多可以通过降压药物控制,未见长期血压升高者。结论恩度联合紫杉醇和顺铂方案一线治疗晚期非小细胞肺癌疗效可靠,对心血管的毒性可以耐受,该方案毒性低、安全性好。

Aim To observe the therapeutic effect and cadiovascular adverse reaction of rh-endostatin injection （YH-16, Endostar） combined with paclitaxel and cisplatin on advanced non-small-cell lung cancer （NSCLC）. Methods Endostar combined with paclitaxel and cisplatin were administrated to 43 advanced non-small-cell lung cancer cases of stage Ⅲ-Ⅳ. Every course lasted 3 weeks, and all cases were evaluated after 2 courses at least; and safety was evaluated after one course. Results The objective response rate （ORR ） was 48.79%（21/43 ） and disease control rate （DCR） was 81.4 % （ 35/43）, 1-year overall survival rate was 51.2%, median survival time was 12.2 months. The quality of life （ QOL ） were improved on 29 cases （ 67.44%） , decreased on 6 cases （6/43）. The occurrence rates of G3/4 toxicities were low, including neutropenia （11.63%, 5/43 ） , thrombocytopenia （6.98%, 3/43 ） , nausea/vomiting （4.65%, 2/43 ）. These toxicities were mainly related with the chemotherapy agents. Conclusion Endostar combined paclitaxel and cisplatin as the first line on advanced non-small-cell lung cancer is highly effective and safe. The QOL of patients with advanced tung cancer may be improved by endostar combined with the paclitaxel and cisplatin chemotherapy. It indicates that endostar has synergetic effects on some of cytotoxic agents or reverses tumor drug resistance such as paclitaxel and cisplatin. It is worthy of clinical generalization and further clinical observation.