紫杉醇＋顺铂方案联合沙利度胺治疗晚期非小细胞肺癌的临床研究

目的：观察紫杉醇＋顺铂（TP）方案联合沙利度胺治疗晚期非小细胞肺癌患者的疗效和安全性。方法：选择晚期非小细胞肺癌（NSCLC）患者110例，均为ⅢB-Ⅳ期患者，随机分为两组：治疗组55例，给予TP方案联合沙利度胺治疗，21d为一周期，并于化疗第一天起给予沙利度胺100mg／d，睡前顿服，若能耐受，一周后加至200mg／d，连续1：2服3个月；对照组55例，单纯TP方案化疗。所有病例均为初治患者，以前未进行过放化疗，入组的每例患者至少接受2个周期的治疗。结果：治疗组与对照组有效率分别为41．18％、37．74％，两组间差异无统计学意义（P〉0．05）；临床获益率分别为86．27％、69．81％，治疗组明显高于对照组（P〈0．05）；治疗组食欲增加率、体重增加率及KPS评分好转率均优于对照组（P〈0．05）。中位无进展生存时间（PFS）治疗组为7．45个月（5～26个月），对照组5．77个月（4～20个月）；中位总生存期（OS）治疗组为12．88个月（6～26个月），对照组为11．32个月（5～21个月）（P〈0．05）。两组Ⅲ-Ⅳ级不良反应均较少见，除Ⅲ一Ⅳ级恶心、呕吐发生率治疗组明显低于对照组外（P=0．03），余不良反应发生率两组无明显差异（P〉0．05）。沙利度胺最常见的不良反应嗜睡、便秘发生率低（10％～30％），不良反应较轻。结论：TP方案联合沙利度胺治疗晚期NSCLC未能明显提高近期疗效，但临床获益率、生活质量明显提高，生存期延长，无明显毒副作用，安全性高，值得临床推广应用。

Randomized study of thalidomide in combination with TP chemotherapy for the treatment of advanced non-small-cell lung cancer

AIM. To evaluate the efficacy and safety in the patients with advanced non-small cell lung cancer （NSCLC）, treated with thalido- mide combined with paclitaxel plus cis-platinum （TP） chemotherapy. METHODS. 110 patients with stages m B and IV NSCLC were divided randomly into two groups, the trial and the con- trol groups. The trial group were treated with thalidomide and TP chemotherapy, in which thalidomide was given 100 mg per night for the first week and then added to 200 mg per night for 3 months if tolerable. The control group were treated with TP chemotherapy only. All patients were treated primarily and received treatments for at least two periods, 21 days for one period. RESULTS. Of 110 assessable pa- tients, the overall response rate was 41.18% in the trial group and 37.74% in the control group （P〉0.05）. The clinical benefit rate was 86. 27% in the trial group and 69.81% in the con- trol group （P〈0. 05）. Besides, the trial group indicated considerable improvement as compared with the control group in the increased appetite rate, weight gain rate and the KPS score im- provement rate. The median PFS was 7.45 （5- 26） months for the trial group, and 5.77 （4-20）months for the control group （P〈0.05）; The median OS was 12.88 （6-26） months for the tri- al group, and 11.32 （5-21） months for the con- trol group （P%0.05）. The III -IV grade unto- ward effects were rare in both groups. Nausea, vomiting of III-IV grade incidence in the treat- ment group was significantly lower than the con- trol group （P=0.03）. But there were no signif- icant differences in the remaining toxicities be- tween the two groups （P〉0.05）. The most common untoward effects of thalidomide, som- nolence and constipation, were rare （incidence rate 10% -- 30%）. CONCLUSION： Though without considerable improvement in short term efficacy, TP regimen combined with thalidomide with high safety significantly improve clinical benefit rate, quality of life and free survival in patients with advanced NSCLC. Therefore the treatment of TP regimen combined with thalido- mide deserves clinical popularization.