长春瑞滨软胶囊节拍化疗联合阿帕替尼三线对驱动基因阴性晚期非小细胞肺癌的临床观察

Clinical Observation on Metronomic Oral Vinorelbine Chemotherapy Combined with Apatinib as Third-line or Above Treatment for Driver Gene-Negative Advanced Non-small Cell Lung Cancer Patients

目的探讨长春瑞滨软胶囊节拍化疗联合阿帕替尼三线及以上治疗对驱动基因阴性晚期非小细胞肺癌(NSCLC)的疗效及安全性。方法选取2015年1月-2018年3月收治的二线及以上治疗失败的晚期NSCLC患者54例为研究对象,随机分为两组,每组27例。对照组采用长春瑞滨软胶囊节拍化疗,观察组采用长春瑞滨软胶囊节拍化疗联合阿帕替尼治疗。结果对照组PR 2例、SD 12例、RR为7.4%、DCR为51.9%,观察组PR 8例、SD 13例、RR为29.6%、DCR为77.8%,观察组RR、DCR均显著高于对照组(P<0.05);观察组腺癌患者RR、DCR均显著高于对照组腺癌患者(P<0.05),两组间鳞癌患者的临床疗效无显著差异(P>0.05)。观察组高血压、蛋白尿的发生率分别为44.4%、37.0%,显著高于对照组的0%、3.7%,差异有统计学意义(P<0.05);两组患者白细胞减少、血小板减少、腹泻、恶心、呕吐、肝脏毒性的发生率比较,差异无统计学意义(P>0.05);两组患者均未发生IIIIV级不良反应,且不良反应均可耐受。观察组中位PFS为5.0个月,对照组为3.3个月,差异有统计学意义(P<0.05)。结论长春瑞滨软胶囊节拍化疗联合阿帕替尼三线及以上治疗可提高驱动基因阴性晚期NSCLC患者的有效率,且患者均可耐受。

Objective To investigate the efficacy and safety of metronomic oral vinorelbine chemotherapy combined with apatinib as third-line or above treatment regimen for driver gene-negative advanced non-small cell lung cancer(NSCLC).Methods Fifty-four patients with the clinical stageⅣNSCLC who were failed from the second-line treatment were enrolled during January 2015 and March 2018.They were randomly divided into two groups,27 cases in each group.Patients in observation group were treated with metronomic oral vinorelbine combined with apatinib,while patients in control group had metronomic oral vinorelbine alone.Result In the observation group,8 cases had partial remission(PR),and 13 cases had disease stable(SD).The observation group achieved a response rate(RR)of 29.6%,and a disease control rate(DCR)of 77.8%.In control group,2 cases had PR,and 12 cases had SD.The RR was 7.4%,and the DCR was 51.9%in the control group.The RR and DCR were both significantly higher in observation group than in control group(P<0.05).What's more,the patients with adenocarcinoma in the observation group had higher RR and DCR than those in the control group(P<0.05),but those with squamous carcinoma had no statistical differences in clinical efficiency between the two groups(P>0.05).The incidence of hypertension and proteinuria in the observation group was respectively 44.4%and 37.0%,both higher than that of the control group(respectively 0%and 3.7%)(P<0.05).The incidence of adverse events such as leukocyte and platelet decline,diarrhea,nausea,vomiting and liver toxicity was similar in the two groups(P>0.05).Neither groups had gradeⅢ-Ⅳadverse reactions associated with treatment.All adverse reactions were tolerable.The medium progression-free survival of the observation group was 5.0 months,longer than that of control group(3.3 months)(P<0.05).Conclusion Vinorelbine metronomic chemotherapy combined with apatinib had high efficiency,good safety and reasonable cost for patients with driver gene-negative NSCLC after second-line or above treatment.