替吉奥联合参一胶囊治疗二线或以上治疗失败NSCLC的疗效观察

Clinical observation of S-1 in combination with Shenyi capsule for advanced NSCLC patients received second-line or further-line chemotherapy previously

目的 观察替吉奥胶囊联合参一胶囊治疗已接受两种或多种化疗方案晚期非小细胞肺癌（NSCLC）的疗效及不良反应.方法 选择55例经二线或以上治疗失败的NSCLC,实验组（E组）36例按体表面积口服替吉奥胶囊,2次/d,分别于早饭后和晚饭后口服,连服14d,停药7d,21d为1个周期,同时服用参一胶囊.2个周期后评价近期疗效和不良反应.其余19例为对照组（C组）,仅口服参一胶囊.结果 E组完全缓解0例,部分缓解4例,稳定19例,进展13例,疾病控制率为63.9％,主要不良反应为骨髓抑制及消化道反应.E组和C组的中位无进展生存期分别为2.8个月和2.0个月,中位总生存期分别为6.0个月和4.3个月,两组比较差异均未见统计学意义.结论 替吉奥联合参一胶囊治疗二线或以上治疗失败NSCLC有一定的疗效,不良反应可以耐受,可作为放化疗失败的晚期NSCLC患者后续治疗的不错选择.

Objective To evaluate the effect and toxicity of S-1 in combination with Shenyi capsule for patients with advanced non-small cell lung cancer（NSCLC）,received two or more prior chemotherapy regimens.Methods Fifty-five advanced NSCLC patients received second-line or further-line chemotherapy previously were enrolled in this study.Thirty-six cases were given S-1 orally（group E）,the dosage was taken according to body surface,twice a day,after breakfast and dinner respectively,for 14 consecutive days,followed by a 7-day rest period,twenty-one days was a cycle,Shenyi capsule was administered orally at the same time.The effect and toxicity were evaluated after 2-cycle treatment.Another nineteen cases received Shenyi capsule only（group C）.Results In group E,there was no complete response（CR）,4 patients exhibited a partial response （PR）,19 patients with stable disease （SD） and 13 with progressive disease（PD）.The disease control rate（DCR =CR ＋ PR ＋ SD） was 63.9%.The main adverse reactions were bone marrow suppression and gastrointestinal reaction.The median progression free survival of group E and group C were 2.8 months and 2.0 months,the median overall survival were 6.0 months and 4.3 months respectively.Between the two groups,the PFS and OS was not statistically different.Conclusions For advanced NSCLC patients received second-line or further-line chemotherapy previously,S-1 in combination with Shenyi capsule has certain effect,its adverse reaction can be tolerated and it can be a good choice of the subsequent treatment after radiation and chemotherapy.