吉西他滨合并顺铂治疗高龄非小细胞肺癌患者的疗效与安全性

Clinical effect and side reactions of elderly patients with advanced NSCLC by gemcitabine with cisplatin

目的 :本试验为一前瞻性对照研究 ,以吉西他滨 (商品名健择 ) 顺铂 2 8天方案 ,治疗大于 70岁和小于70岁的初治Ⅲb—Ⅳ期非小细胞肺癌 (NSCLC)患者 ,评价其疗效和安全性。方法 :治疗NSCLC病人共 6 7例 ,实际可评估 6 2例 ,A组 (>70岁 ) 30例 ,B组 (<70岁 ) 32例 ,以健择 10 0 0mg m2 ,第 1、8、15天给药 ,顺铂 80mg m2 在第2天给药 ,每 1周期为 2 8天。结果 :A、B两组的有效率分别为 5 6 6 7%(17 30 )、5 9 37%(19 32 ) ,在统计学上差异无显著性 (P >0 0 5 ) ;中位缓解期分别为 9 8个月和 10 2个月 ,中位生存期分别为 12个月和 13 2个月。统计学无显著性差异 (P >0 0 5 )。根据WHO毒性反应标准评价 ,无Ⅳ度骨髓毒发生 ,但有Ⅲ度骨髓毒性 ;血小板减少A、B两组各有 1例 (3 3%、3 1%) ,白细胞减少各有 1例 (3 3%、3 1%) ;非血液毒性 :WHOⅢ—Ⅳ度呕吐A组有 7例 ,B组有 8例 (2 1 9%和 2 2 9%) ,在统计学上两组差异无显著性 (P >0 0 5 )。结论 :吉西他滨 顺铂在治疗高龄初治Ⅲb—Ⅳ期非小细胞肺癌中 ,与非高龄患者有同样好的疗效和安全性。

Purpose:The trial investigated the activity and toxicity of gemcitabine in previously untreated elderly (>70 years) patients with advanced (stage Ⅲb-Ⅳ) non-small-cell lung cancer (NSCLC). Methods:67 patients with advanced NSCLC were entered into the study. 62 patients were evaluable for response. Patients aged over 70 years were entered into group A and those aged less than 70 years were entered into group B. Gemicitabine 1000 mg/m 2 was administered on the first, eighth and fifteenth day and DDP 80 mg/m 2 was administered on the second day. The therapy cycle comprise 28 days. Results:The efficacy of group A and B were 56.67% (17/30) and 59.37% (19/32) respectively (P>0 05). The median overall suvival time were 12 months in group A and 13.2 months in group B (P>0 05). Evaluation of toxicity shows no grade 4 hematologic toxicity. Grade 3 leukopenia occurred in 3.3% (1 case) in group A and 3.1% (1 case) in group B. Non-hematologic toxicity include vomit occurred in 21.88%(7 cases) in group A and 22.86%(8 cases) in group B(P>0 05) Conclusions:Our data show that gemicitabine with DDP is as active and well tolerated in previously untreated elderly (>70 years) patients with advanced NSCLC as in those less than 70 years.