重组人血管内皮抑制素联合化疗治疗46例晚期非小细胞肺癌的临床观察

Clinical study of chemotherapy combined with endostar in the treatment of 46 advanced non-small cell lung cancer

目的:观察重组人血管内皮抑制素(恩度)联合常规化疗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46例初治ⅢB和Ⅳ期NSCLC患者,包括鳞癌17例,腺癌23例,其他类型6例,均采用恩度联合常规化疗,其中联合TP方案12例,联合GP方案15例,联合NP方案19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:紫杉醇(PTX)175 mg/m2第1天,顺铂(CDDP)25 mg/m2第1～3天;GP方案:吉西他滨(GEM)1 000mg/m2第l、8天,CDDP 25 mg/m2第1～3天;NP方案:长春瑞滨(NVB)25 mg/m2第1、8天,CDDP25 mg/m2第1～3天。均21天为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、肿瘤进展时间(TTP)及毒副反应。结果:46例初治晚期NSCLC,获CR 2例(4.35%),PR 17例(36.96%),SD 14例(30.43%),PD 13例(28.26%),客观反应率(RR)为41.31%,疾病控制率(DCR)71.74%。中位TTP为5.1个月,1年生存率为38.2%。治疗相关毒副反应主要为食欲不振,疲乏,轻度的心脏毒副反应,包括心悸、胸闷、血压升高等,全组无心律失常及出血发生。骨髓抑制、Ⅰ～Ⅱ度胃肠道及外周神经毒性均可耐受。结论:恩度联合常规化疗方案治疗晚期NSCLC的近期客观疗效较高,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 or GP or NP regimen in patients with advanced non-small cell lung cancer（NSCLC）.Methods：Forty-six histologically confirmed stage ⅢB and Ⅳ NSCLC patients were enrolled in the group,including 17 cases with squamous cell carcinoma,23 cases with adenocarcinoma and 6 cases with other type of carcinoma.There were 12 patients administrated with endostar plus TP regimen（endostar 15mg/d solved in 500ml of normal saline was slowly dropped from day 1 to 14; paelitaxel 175mg/m2 day 1, cisplatin 25mg/m2 day 1 to 3, repeated 21 days） ; 15 patients were administrated with endostar plus GP regimen （endostar 15mg/d solved in 500ml of normal saline was slowly dropped from day 1 to 14,gemcitabine 1 000mg/m2 day 1 and 8, cisplatin 25mg/m2 dayl to 3, repeated 21 days） ; 19 patients were administrated with endostar plus NP regimen（ endostar 15mg/d solved in 500ml of normal saline was slowly dropped from day 1 to 14 ,vinorelbine 25mg/m2 day l and 8, cisplatin 25mg/m2 dayl to 3 ,repeated 21 days）. All patients shoud completed 2 cycles at least. The primary point were the therapeutic effects, one-year survival rate, the median time to progress and adverse reactions. Results： Among 46 cases,there were 2 cases CR（4. 35% ） , 17 cases PR（36.96% ）, 14 cases SD（30. 43% ） and 13 cases PD（28. 26% ）. ORR was 41.31%, DCR was 71.74% , mTTP was 5. 1 months and one-year survival was 38. 3%. The most common adverse effects were nausea and Vomiting, bone marrow suppression and fatigue. The G3-G4 toxicities including neutropenia 8 caces（ 17. 39% ）, thrombocytopenia 3 cases（6. 52% ）. Two cases occurrenced Gj and G2 blood pressure set-up and 2 cases occurrenced cardiopalmus. Arrhythmia and hemorrhage had no occurrence. Conclusion： Endostar combined chemotherapy were effective and safe in treatment of advanced NSCLC.These results deserved further investigations.