重组人血管内皮抑制素联合VP方案治疗晚期非小细胞肺癌的疗效研究

Effect of Recombinant Human Endostatin Combined with VP Regimen on Advanced Non- small Cell Lung Cancer

目的评价重组人血管内皮抑制素联合VP方案（长春地辛和顺铂）治疗晚期非小细胞肺癌（NSCLC）的疗效。方法选取天门市第一人民医院2008年1月—2010年3月收治的晚期NSCLC患者51例,采用重组人血管内皮抑制素联合VP方案进行治疗。观察患者近期疗效、毒副作用、疾病无进展时间（PFS）、总生存时间（OS）,随访截止时间为2014年10月。结果本组51例患者完全缓解（CR）0例,部分缓解（PR）15例（29.41%）,疾病稳定（SD）22例（43.14%）,疾病进展（PD）14例（27.45%）,临床有效率（RR）为29.41%,临床获益率（CBR）为72.55%。不同性别、功能状态评分（PS评分）、病理类型、临床分期患者RR、CBR比较,差异均无统计学意义（P〉0.05）。所有患者随访率为100%,中位PFS为6.9个月〔95%CI（5.4,7.8）〕,中位OS为11.3个月〔95%CI（10.2,12.7）〕;1年、2年、3年生存率分别为40.7%、22.4%、9.7%。单因素分析结果显示,不同性别、病理类型患者中位PFS及不同性别、病理类型、临床分期患者中位OS比较,差异均无统计学意义（P〉0.05）;PS评分0-1分、临床分期ⅢA期、近期疗效CR＋PR患者中位PFS长于PS评分2分、临床分期Ⅲ-Ⅳ期、近期疗效SD或PD患者,PS评分0-1分、近期疗效CR＋PR患者中位OS长于PS评分2分、近期疗效SD或PD患者（P〈0.05）。Cox回归模型分析结果显示,性别、PS评分、病理类型、临床分期、近期疗效对PFS、OS的影响均无统计学意义（P〉0.05）。所有患者治疗期间耐受良好,未出现治疗相关性死亡,主要毒副作用为骨髓抑制、消化道反应、肝肾功能异常等。结论重组人血管内皮抑制素联合VP方案治疗晚期NSCLC的疗效确切,安全性较高,有利于延长患者PFS和OS,且不受性别、PS评分、病理类型、临床分期、近期疗效等影响。

Objective To evaluate the effect of recombinant human endostatin combined with VP regimen （vindesine and cisplatin） on advanced non - small cell lung cancer. Methods A total of 51 patients with advanced non - small cell lung cancer were selected in the First People＇s Hospital of Tianmen from January 2008 to March 2010, all of them received recombinant human endostatin combined with VP regimen. Recent therapeutic effect, incidence of toxic and side effects, progression-free survival （PFS） and overall survival （OS） were observed, the follow- up deadline was October 2014. Results Of the 51 cases, no one got complete remission, 15 cases got partial remission （ accounting for 29.41% ）, 22 cases got stable disease （ accounting for 43.14% ） , 14 cases got progressive disease （ accounting for 27.45% ） , the clinical effective rate （RR） was 29. 41%, the clinical benefit rate （CRB） was 72. 55%. No statistically significant differences of RR or CBR was found in patients with different gender, PS score, pathological types or clinical stages （P 〉 0. 05 ）. The follow - up rate was 100%, the median PFS was 6.9 months [95%CI （5.4, 7.8）], median OS was 11.3 months [95%CI （10.2, 12. 7）], the 1 - year, 2 - year, 3 - year survival rate was 40. 7%, 22.4%, 9.7%, respectively. Univariate analysis showed that, no statistically significant differences of median PFS was found in patients with different gender or pathological types, nor was median OS in patients with different gender, pathological types or clinical stages （ P 〉 0.05 ） ; median PFS of patients with PS score at 0to 1, clinical stage at ⅢA, complete remission or partial remission was statistically significantly longer than that of patients with PS score at 2, clinical stage at Ⅲ to Ⅳ, stable disease or progressive disease, respectively （ P 〈 0. 05 ） ; median OS of patients with score at 0 to 1, complete remission or partial remission was statistically significantly longer than that of patients with PS score at 2, stable disease or progressive disease, respectively （P 〈 0.05）. Cox regression model analysis showed that, gender, PS score, pathological types, clinical stages and short - term curative effect had no statistically significant impact on PFS or OS （P 〉0. 05）. No one occurred treatment - related deaths, all of them had good tolerance, and the main toxic and side effects included myelosuppression, gastrointestinal reactions, liver and kidney dysfunction. Conclusion Recombinant hunmn endostatin combined with VP regimen has certain curative effect and high safety in treating advanced non - small cell lung cancer, is helpful to lengthen the PFS and OS, and did not affected by gender, PS score, pathological types, clinical stages or short - term curative effect.