替吉奥胶囊治疗三线及以上晚期非小细胞肺癌的临床观察

Clinical observation of S-1 monotherapy as third-line or further-line treatment for advanced non-small cell lung cancer

目的观察替吉奥胶囊单药治疗晚期非小细胞肺癌(NSCLC)的临床疗效及不良反应。方法 60例经病理组织学确诊的二线或二线以上治疗失败的NSCLC,其中30例患者(A组)据体表面积口服替吉奥胶囊(80～120mg/d,分2次口服,d1～d14,21天为1周期),并给予最佳支持治疗,2周期后评价近期疗效和不良反应;其余30例患者(B组)仅接受最佳支持治疗。结果 A组无CR、PR病例,SD 18例,PD 12例,疾病控制率(CR+PR+SD)为60.0%(18/30)。主要不良反应为轻微的消化道反应及骨髓抑制。A组和B组的中位无进展生存期(PFS)分别为2.5个月和2.0个月,中位总生存期(OS)分别为5.0个月和3.0个月,两组差异均无统计学意义(P>0.05)。结论替吉奥胶囊单药治疗三线及以上晚期NSCLC有一定的疗效,不良反应可以耐受,安全性良好。

Objective To observe the efficacy and toxicity of an oral anticancer fluoropyrimidine derivative （ S-1 ） for previ- ously treated patients with advanced non-small cell lung cancer（NSCLC）. Methods Sixty advanced NSCLC patients received second- line or further-line chemotherapy previously were enrolled in this study. Thirty cases were given S-1 orally（ group A） , the dosage was taken according to body surface, ranging 80mg/d to 120mg/d. Twenty-one days was a cycle. The efficacy and toxicity were evaluated after 2-cycle treatment. Another thirty cases were received best supportive care only （ group B ）. Results In group A, there were no CR and PR case, SD was 18 cases, PD was 12 cases and the disease control rate was 60. 0% （18/30）. The toxicity was mild. The main side effects were gastrointestinal reaction and bone marrow suppression. The median progression free survival（PFS） of group A and group B were 2. 5 months and 2. 0 months, the median overall survival （OS） were 5.0 months and 3.0 months respectively. Be- tween the two groups, the PFS and OS was not statistically different. Conclusion S-1 exhibits modest activity and acceptable toxicity when was used as a third or subsequent line of chemotherapy in patients with advanced NSCLC.