阿帕替尼联合替吉奥胶囊一线治疗晚期非小细胞肺癌的效果观察

Observation on the effect of apatinib combined with S-1 as first-line treatment of advanced non-small cell lung cancer

目的探讨阿帕替尼联合替吉奥胶囊一线治疗无敏感基因突变或基因状态不明的晚期非小细胞肺癌的效果及安全性。方法选择2015年4月至2017年4月河北省秦皇岛市第一医院肿瘤科收治的晚期无敏感基因突变或基因状态不明的非小细胞肺癌104例作为观察对象,所有患者均拒绝静脉化疗,入选的104例患者采用数字法按1:1随机分入治疗组(阿帕替尼联合替吉奥胶囊组)和对照组(替吉奥胶囊组),但治疗组2例患者因个人原因后转入对照组。即阿帕替尼联合替吉奥胶囊组50例,替吉奥胶囊组54例。整个治疗观察过程中评价两组患者的疗效及不良反应。结果治疗组和对照组的客观缓解率分别为48.0%(24/50)与27.8%(15/54)(χ2=4.530,P=0.033),疾病控制率分别为82.0%(41/50)与74.1%(40/54)(χ^2=0.947,P=0.331),中位无进展生存时间(PFS)分别为6.6个月和3.4个月(t=25.555,P=0.000),中位总生存时间(OS)分别为16.0个月和10.5个月(t=59.439,P=0.000),治疗组和对照组患者总的不良反应发生率分别为82.0%(41/50)与70.4%(38/54)(χ^2=1.923,P=0.166),其中≥3级的不良反应分别为18.0%(9/50)与13.0%(7/54)(χ^2=0.506,P=0.477),两组均无治疗相关不良反应导致的死亡发生。结论阿帕替尼联合替吉奥胶囊治疗无敏感基因突变或突变状态不明的晚期非小细胞肺癌具有较好的近期疗效和远期疗效,不良反应可耐受,可用于不愿意接受静脉化疗的患者的一线治疗。

Objective To explore the efficacy and safety of apatinib combined with S-1 in patients with advanced NSCLC without sensitive gene mutation or unknown mutation status. Methods One hundred and four patients with advanced NSCLC without sensitive gene mutation or unknown mutation status were selected from the oncology department of the First Hospital of Qinhuangdao City, Hebei Province from April 2015 to April 2017.All patients refused intravenous chemotherapy.One hundred and four patients were randomly divided into treatment group (apatinib combined with S-1 group) and control group (S-1 alone group) by 1: 1 digital method.However, two patients in the treatment group transferred to the control group for personal reasons.There is 50 cases in apatinib combined with S-1 group and 54 cases in S-1 group.The efficacy and adverse reactions of the two groups were evaluated. Results The objective remission rate was 48.0%(24/50) and 27.8%(15/54)(χ2=4.530, P=0.033), the disease control rate was 82.0%(41/50) and 74.1%(40/54)(χ2=0.947, P=0.331), the median PFS was 6.6 months and 3.4 months (t=25.555, P=0.000), the median OS was 16.0 months and 10.5 months (t=59.439, P=0.000), respectively.The overall incidence of adverse reactions was 82.0%(41/50) and 70.4%(38/54) respectively (χ2=1.923, P=0.166), of which 18.0%(9/50) and 13.0%(7/54) were more than grade 3 respectively (χ2=0.506, P=0.477). There was no death caused by treatment-related adverse reactions in both groups. Conclusion Appatinib combined with S-1 capsule has good short-term and long-term efficacy in the treatment of advanced non-small cell lung cancer without gene mutation or unknown mutation.The adverse reactions are tolerable and can be used as first-line treatment for patients unwilling to receive intravenous chemotherapy.