重组人血管内皮抑制素联合TP和GP方案治疗晚期非小细胞肺癌31例临床观察

Endostar combined with TP or GP regimen in advanced non-small cell lung cancer patients

目的:观察重组人血管内皮抑制素(恩度)联合TP及GP方案治疗晚期非小细胞肺癌(NSCLC)的疗效和毒副反应。方法:经病理学检查证实的31例ⅢB期和Ⅳ期NSCLC患者,包括鳞癌11例,腺癌18例,腺鳞癌2例,均采用恩度加常规化疗联合治疗,其中联合TP方案19例,联合GP方案12例。恩度剂量为15mg/次,加入生理盐水500ml中静滴3～4小时,第1～14天连续给药;TP方案为紫杉醇(PTX)150mg/m2第1天,顺铂(CDDP)25mg/m2第2～4天;GP方案为吉西他滨(GEM)1000mg/m2第1、8天,CDDP25mg/m2第2～4天,均为21天1周期。所有患者至少完成2个周期,根据WHO疗效评定及毒副反应分级标准,观察其近期疗效、1年生存率、疾病进展时间及毒副反应。结果:31例晚期NSCLC患者中,获得CR1例(3.2%),PR12例(38.7%),SD10例(32.3%),PD8例(25.8%),总有效率为41.9%,中位TTP为4.2个月,1年生存率为39.3%。毒副反应主要为血液学、消化道毒性等。发生Ⅲ～Ⅳ度中性粒细胞减少10例(32.3%),Ⅲ～Ⅳ度血小板减少5例(16.1%),Ⅲ～Ⅳ度呕吐3例(9.7%),发生Ⅰ度及Ⅱ度血压升高各1例,肝功能损害7例,全组无心律失常及出血发生。结论:恩度联合TP及GP方案化疗治疗晚期NSCLC近期客观疗效较高,安全性好,但远期疗效仍需进一步观察。

Objective：To observe the efficacy and safety of rh-endostatin injection（endostar） combined with TP（ paclitaxel puls cisplatin）or GP（ gemeitabine plus cisplatin） regimen in patients with advanced non-small cell lung cancer（NSCLC）. Methods： Thirty-one histologically confirmed stage Ⅲ B and Ⅳ NSCLC patients were enrolled in the group, including 11 cases with squamouscell carcinoma,18 cases with adenocarcinoma and 2 cases with adenosquamous carcinoma. There were 19 patients administrated with endostar puls TP regimen （endostar 15mg solved in 500ml of normal saline was slowly dropped from day 1 to 14, paclitaxel 150mg/m^2 day 1, cisplatin 25mg/m^2 day 2 to 4, repeated 21 days） and the others were administrated with endostar puls GP regimen （ endostar 15rag solved in 500ml of normal saline was slowly dropped from day 1 to 14, gemcitabine 1 000mg/m^2 day 1 and 8,cisplatin 25mg/m^2 day2 to 4, repeated 21 days）. All patients shoud completed 2 cycles at least. The goals were the therapeutic effects, one year survival rate, the median time to progress and adverse reactions. Results： Among 31 cases, there were 1 case CR（3.2% ） , 12 cases PR （38.7%） , 10 cases SD（32.3% ） and 8 cases PD（25.8% ）. Overall response rate was 41.9% , median TTP was 4.2 months and one years survival rate was 39. 3%. The G3-G4 toxicities including neutropenia 10 caees （32. 3% ）, thrombocytopenia 5 cases （16. 1% ）, vomiting 3 cases（9. 7% ）. Two cases occurrenced G1 and G2 blood pressure set-up differently and 7 cases oecurrenced liver function injury. Arrhythmia and hemorrhage had no occurenced. Conclusion：Endostar combined TP or GP regimen were effective and safe in treatment of advanced NSCLC. These results deserved further investigations.