安罗替尼在晚期非小细胞肺癌真实世界非一线治疗中的临床效果

Clinical effect of anlotinib in non-first-line therapy for advanced non-small cell lung cancer:a real-world study

目的探讨真实世界中安罗替尼非一线治疗晚期非小细胞肺癌(NSCLC)的安全性和有效性。方法采用真实世界研究方法,回顾性分析48例接受安罗替尼治疗2个周期以上的经一线或多线治疗失败的晚期NSCLC患者的临床资料。观察患者的主要指标[无进展生存期(PFS)]和次要指标[总生存时间(OS)、疾病控制率(DCR)和不良事件],分析影响NSCLC患者治疗后PFS的因素。结果 48例患者的中位PFS为6.5个月(95%CI:4.4~7.0),中位OS为9.9个月(95%CI:8.7~11.6), DCR为81.2%。安罗替尼常见的Ⅰ~Ⅱ级不良反应是食欲下降、疲劳、高血压、手足综合征,常见的Ⅲ级~Ⅳ级不良反应为高血压和手足综合征。Cox回归的结果显示,无脑转移、转移灶<3个和表皮生长因子受体(EGFR)突变阳性是NSCLC患者接受安罗替尼治疗后PFS延长的保护因素(均P<0.05)。结论安罗替尼在晚期NSCLC真实世界的二线及以上治疗中具有较好的疗效和安全性,其中无脑转移、转移病灶<3个、EGFR突变阳性的患者PFS获益更大。这或可为晚期NSCLC多线化疗、EGFR-酪氨酸激酶抑制治疗失败的患者提供新的治疗机会,延长生存时间。

Objective To investigate the safety and effectiveness of anlotinib in non-first-line therapy for advanced non-small cell lung cancer(NSCLC)in real world.Methods Using the real-world research method,the clinical data of 48 patients with advanced NSCLC,who were treated with anlotinib for at least two cycles and failed in first-line or multiline therapy,were analyzed retrospectively.The primary endpoint(progression-free survival[PFS])and secondary endpoints(overall survival[OS],disease control rate[DCR]and adverse events)of the patients were observed.The factors influencing the posttreatment PFS of NSCLC patients were analyzed.Results In the 48 patients,the median PFS was 6.5 months(95%CI 4.4-7.0),the median OS was 9.9 months(95%CI 8.7-11.6),and DCR was 81.2%.Anlotinib had common gradeⅠ-Ⅱadverse reactions including decreased appetite,fatigue,hypertension and hand-foot syndrome,and common gradeⅢ-Ⅳadverse reactions of hypertension and hand-foot syndrome.The results of Cox regression showed that absence of brain metastasis,number of metastasis<3,and epidermal growth factor receptor(EGFR)mutation-negative were the protective factors of prolonged PFS after anlotinib therapy in NSCLC patients(all P<0.05).Conclusion Anlotinib has preferable efficacy and safety in the second-line therapy and above for advanced NSCLC in real world,and patients without brain metastasis,with number of metastasis<3,or with EGFR mutation-negative gain more PFS benefits.It might provide a new treatment opportunity and prolong survival time for patients with advanced NSCLC failing in multiline chemotherapy or EGFR-tyrosine kinase inhibitor therapy.