重组人血管内皮抑制素联合化疗治疗晚期非小细胞肺癌的临床研究

Clinical study of endostar combined with chemotherapy in the treatment of advanced non-small cell lung cancer

目的观察重组人血管内皮抑制素(恩度)联合化疗治疗晚期非小细胞肺癌的近期临床疗效及毒副作用。方法 2008年5月至2010年1月就诊非小细胞肺癌患者20例,初治或复治,病理结果为腺癌11例,鳞癌7例,其它2例。采用恩度联合化疗治疗,恩度使用方法为15 mg/次1,次/d,连续14 d,每月重复使用。其中联合吉西他滨+顺铂方案、长春瑞宾+顺铂方案、多西他赛+卡铂方案、紫杉醇+卡铂方案、培美曲赛+顺铂方案各4例。以完全缓解(CR)、部分缓解(PR)、稳定(SD)和病情进展(PD)为近期疗效评价指标;远期疗效评价指标包括中位肿瘤进展时间(mTTP)、中位生存时间(MST)和1年生存率;评价其安全性。结果 20例患者均可进行客观疗效评价及安全性评价,CR 0例,PR7例,SD 9例,PD 4例,客观有效率(RR)为35%,疾病控制率(DCR)为70%;mTTP为198天,MST为2 190 d,1年生存率81.8%。毒副作用中骨髓抑制和Ⅰ～Ⅱ度的胃肠道反应占大多数,考虑可能为化疗相关。结论恩度与其他化疗药联合使用治疗晚期非小细胞肺癌显示出一定的抗肿瘤活性,安全有效,耐受性好,临床收益率高,具有较好的临床应用前景。

Objective To observe the short - term effects and toxity of endostar for non - small cell lung cancer （ NSCLC ）. Methods From May 2008 to Janurary 2009, 20 advanced NSCLC patients received endostar combined with chemotherapy. The pathological type included adenocarcinoma in 11 cases,squamous carcinoma in 7 cases, and other type in 2 cases. The dosage of 7.5mg/m^2 （ 15rag/ time） of endostar was slowly intravenously dropped from day 1 to day 14, repeated monthly. Twenty cases were equally devided in to 5 groups treated by endostar plus gemcitabine and cisplatin （GP）, navelbine and cisplatin （NP）, paclitaxal and carboplatin （PC）, docetaxel and carboplatin （DC）, and pemetrexed and cisplatin （ PP）, respectively. The CR, PR, SD and PD were evaluated for the short - term efficacy. Long - term efficacy evaluation included progression - free survival, median survival time, median time to progression and one - year survival rate. Safety was evaluated according to NCI CTC 3.0 version criteria. Results Safety and efficacy evaluation was performed in all 20 cases. Of the 20 patients, 0,7,9, and 4 had CR, PR, SD, and PD respectively. The objective response rate （ORR） and the disease control rate （DCR） were 35% and 70%, respectively. The median survival time was 2190 days and the median time to progression was 198 days. The 1 - year survival rate was 81.8%. Major toxicities in- cluded neutropenia, anaemia and gastrointestinal symptoms, which were mainly correlated with the chemotherapy regimen. Conclusion Endostar in combination with the chemotherapy for NSCLC does show the anti - tumor activity. The combination treatment can be tolerated with a high clinically beneficial rate in patients with NSCLC and may be a promising regimen.