安罗替尼联合PP方案二线治疗EGFR突变T790M阴性晚期非小细胞肺腺癌的疗效及安全性评价

Efficacy and safety of anlotinib plus PP regimen as a second-line therapy for patients with advanced non-small cell lung adenocarcinoma

目的:探讨安罗替尼联合顺铂/培美曲塞(PP)方案在一线治疗后表皮生长因子受体(EGFR)突变T790M阴性的晚期非小细胞肺腺癌(NSCLC)患者的疗效及安全性。方法:回顾性分析宣城市人民医院2019年1月~2020年10月已接受一线治疗后EGFR突变T790M阴性的48名晚期NSCLC患者,分别接受安罗替尼联合PP方案(n=24)或单独PP化疗方案(n=24)作为二线治疗。比较两组患者的疗效、毒副反应、无进展生存期(PFS)和总生存期(OS)。结果:选取的48名患者被随机分配到联合治疗组和单独化疗组,两组的客观缓解率(ORR)分别为66.7%和37.5%,疾病控制率(DCR)分别为87.5%和54.2%,差异均有统计学意义(P<0.05)。相比于单独化疗组,联合治疗组PFS和OS分别达到7.7个月和13.1个月(P<0.001)。联合治疗组的常见不良反应包括高血压、蛋白尿和皮肤反应。与单纯化疗组相比,联合治疗组的Karnofsky功能状态(KPS)评分差异无统计学意义(P=0.556)。结论:安罗替尼联合PP化疗方案作为二线治疗,耐受性良好,可明显改善晚期NSCLC患者的PFS和OS,为晚期患者的二线治疗提供了新的选择。

Objective:To evaluate the efficacy and safety of anlotinib combined with PP regimen in advanced non-small cell lung adenocarcinoma(NSCLC) patients with EGFR mutation and T790 M negative after first-line treatment.Methods:Retrospective analysis was performed in 48 advanced NSCLC patients with EGFR mutation and T790 M-negative following first-line treatment in our hospital between January 2019 and October 2020.The eligible patients were randomly allocated to anlotinib plus PP chemotherapy group(n=24) or simple PP chemotherapy group(n=24),and underwent corresponding second-line regimen.The end points, including curative effect, adverse response, progression-free survival(PFS) and overall survival(OS),were compared between groups.Results:The objective response rate(ORR) and disease control rate(DCR) was 66.7% and 37.5%;87.5% and 54.2%,respectively for the two groups(all P<0.05).PFS and OS were 7.7 months and 13.1 months on average, respectively for patients undergone anlotinib plus PP chemotherapy compared to those treated by simple PP regimen( both P<0.001).Common adverse reactions in the combination therapy group included hypertension, proteinuria and skin reactions, yet KPS scores were not significantly different between groups(P=0.556).Conclusion:Anlotinib plus PP regimen can serve as a new option for the second-line chemotherapy of patients with advanced NSCLC,because this treatment regimen can be better tolerance and significantly improve the PFS and OS of such patients.