长春瑞滨加顺铂联合COX-2抑制剂治疗晚期非小细胞肺癌临床分析

A Phase Ⅱ Study of Vinorelbine/Cisplatin with or without Cox-2 Inhibitor in First-Line Treatment of Non-small Cell Lung Cancer

目的探讨长春瑞滨加顺铂(NP方案)联合COX-2抑制剂(塞来昔布)一线治疗晚期非小细胞肺癌(NSCLC)的临床疗效和不良反应,以及COX-2受体表达高低不同对患者预后的影响。方法入组晚期NSCLC初治患者,采用免疫组化方法检测其标本中COX-2受体是否为高表达(阳性)或低表达(阴性),随机分为试验组或对照组(各30例),分别给予塞来昔布400mg,2次/日联合NP方案化疗或单纯化疗,至少2周期。结果试验组与对照组的有效率(RR)分别为43.3%和40%,中位生存期(MST)分别为9.8和9.5月(P>0.05),不良反应主要为恶心呕吐、骨髓抑制等,两组无显著差异;受体表达阳性组及阴性组RR分别为42.1%和40.9%(P>0.05),MST为9.9和9.4月;在受体表达阳性患者中,联合组和单纯化疗组的RR分别为45%和38.9%,MST分别为10.1和9.6月(P>0.05)。结论NP方案联合塞来昔布一线治疗晚期NSCLC较单纯化疗相比,未能显著增加疗效及生存期,不良反应相似;COX-2受体表达程度对预后影响有待进一步研究。

Objective To investigate the efficacy and safety of vinorelbine/cisplatin（NP） with COX-2 inhibitor（celecoxib） in the first-line treatment of non-small cell lung cancer（NSCLC）. Methods Sixty patients with NSCLC were randomly assigned to receive NP regimen with or without celecoxib 400 mg twice daily, for 2 cycles at least, meanwhile the expression of COX-2 receptor from their specimen were detected by IHC. Results Response rate（RR） were 43. 3% for patients treated with celecoxib and 40% for those treated with chemotherapy alone, Median survival time（MST） were 9. 8 and 9. 5 months respectively（P〉0. 05）. The main toxicities in the two arms were nausea and vomitting, myelosuppression, without any significant difference. Conclusion Compared with NP alone, celecoxib combined with NP was not able to improve efficacy or prolong survival, nor did it increase toxicities.