沙利度胺联合NP方案治疗晚期非小细胞肺癌的临床研究

 目的　研究沙利度胺联合NP方案治疗晚期非小细胞肺癌（NSCLC）的疗效，观察患者治疗前后外周血中血管内皮生长因子（VEGF）、碱性成纤维细胞生长因子（bFGF）的变化。方法　经病理学或细胞学确诊的Ⅲ／Ⅳ期NSCLC的初治或未采用NP方案化疗的复治患者57例，随机分为治疗组（NP方案+沙利度胺）36例和对照组（NP方案）21例。采用酶联免疫吸附实验（ELISA）检测VEGF、bFGF的水平。结果　治疗组有效（RR＝CR＋PR）为44.4 %（16／36），临床受益（CBR）为77.8 %（28／36）；对照组RR为23.8 %（5／21）， CBR为42.9 %（9／21）。两组RR及CBR比较差异无统计学意义（P＞0.05）。治疗组中位肿瘤进展时间（TTP）5.1 个月，对照组为 3.0个月，与对照组比较，治疗组中位TTP延长（P＝0.05）。治疗组CBR的患者血清VEGF水平显著下降（P＜0.05）。对照组CBR的患者治疗前后血清VEGF对比差异无统计学意义（P＞0.05）。两组临床进展的患者治疗后血清VEGF水平均比治疗前升高（P＜0.05）。两组CBR者治疗后血清bFGF均有所下降，但均无统计学意义（P＞0.05）。两组临床进展的患者治疗后血清bFGF水平均比治疗前明显升高，差异有统计学意义（P＜0.05）。结论　沙利度胺联合NP方案能显著延长晚期NSCLC患者中位TTP，提高患者的RR及CBR。沙利度胺联合NP方案具有协同作用，且不明显增加化疗的不良反应；根据血清VEGF水平可推测病情进展；VEGF和bFGF在NSCLC血管形成过程中具有协同作用；血清VEGF和bFGF水平可能作为NSCLC患者疗效及预后的预测指标。

Clinical study of thalidomide combined with NP regimen for advanced non-small cell lung cancer

Objective To evaluate the efficacy of thalidomide combined with NP regimen in treatment of non-small cell lung cancer (NSCLC) and to analyse the change of VEGF and bFGF in peripheral blood in patients with advanced NSCLC. Methods 57 patients with advanced NSCLC were divided randomly into NP plus thalidomide treatment group and NP contrast group,and VEGF and bFGF were measured by ELISA. Results The response rate was 44.4 % in trial group and 23.8% in control group (P>0.05). The clinical benefit rate were 77.8% in trial group and 42.9% in control group (P>0.05). The median TIP was 5.1 months and 3.0 months for trial group and control group respectively(P=0.05). Patients in benefit in trial group had a remarkable decrease in the number of VEGF (P<0.05) while patients in benefit in control group had a little decrease in the number of VEGF (P>0.05). Patients out of benefit in trial group and control group had a increase in the number of VEGF (P<0.05). Patients in benefit in trial group and control group had a tendency of decrease in the number of bFGF (P>0.05) while patients out of benefit in trial group and control group had a remarkable increase in the number of bFGF(P<0.05). Conclusion The addition of thalidomide to NP regimen results in significantly and clinically meaningful improvement in response rate, median time to tumor progression, and clinical benefit rate compared with NP alone in advanced NSCLC patients.Thalidomide in combination with chemotherapy shows a favorable toxic profile in advanced cancer patients.VEGF and bFGF can be detected in patients with advanced NSCLC.