安罗替尼联合AN方案一线治疗晚期EGFR、ALK及ROS1野生型肺腺癌的疗效

Clinical observation of Anlotinib combined with Pemetrexed and Nedaplatin in treating EGFR/ALK/ROS1 mutation-negative advanced lung adenocarcinoma

目的探讨安罗替尼联合AN方案一线治疗晚期野生型肺腺癌患者的有效性和安全性。方法收集肿瘤科诊治的ⅢB~Ⅳ期野生型[表皮生长因子受体(epidermal growth factor receptor,EGFR)、间变性淋巴瘤激酶(anaplastic lymphoma kinase,ALK)及ROS1基因均为野生型]的肺腺癌患者,观察组(接受安罗替尼+培美曲塞+奈达铂方案)患者22例,对照组(接受培美曲塞+奈达铂方案)患者26例。对两组患者进行疗效、不良反应观察。结果近期客观疗效对比,观察组的客观缓解率(ORR)和疾病控制率(DCR)分别为50%和86.4%,优于对照组的ORR(30.8%)和DCR(61.5%),但组间比较均差异无统计学意义(P>0.05)。观察组中位无进展生存时间(median progress-free survival,mPFS)较对照组延长1.54个月(9.38个月vs 7.84个月,P<0.05);观察组总生存期(overall survival,OS)较对照组延长1.06个月(11.52个月vs 10.46个月),但差异无统计学意义(P>0.05)。两组患者的治疗相关不良反应发生率对比,观察组在手足综合征、疲劳及高血压方面发生率高于对照组,且组间差异有统计学意义(P<0.05)。结论安罗替尼联合AN方案较AN方案一线治疗晚期野生型肺腺癌的近期疗效有获益趋势,可改善晚期野生型肺腺癌患者的一线治疗疾病控制时间,在总生存上尚未见获益。

Objective To evaluate the efficacy and adverse reactions of the chemotherapy by anlotinib combined with pemetrexed and nedaplatin in treating advanced lung adenocarcinoma.Methods Forty-eight patients with a confirmed diagnosis of StageⅢb-Ⅳadvanced lung adenocarcinoma[epidermal growth factor receptor(EGFR),anaplastic lymphoma kinase(ALK),and ROS1 gene mutation-negative]were included.All patients were diagnosed as lung adenocarcinoma by pathology or cytology.Among them,22 patients received combined treatment of anlotinib with pemetrexed and nedaplatin(treatment group),and 26 patients received pemetrexed and nedaplatin alone(control group).Results The objective response rate(ORR)(50%)and disease control rate(DCR)(86.4%)of the treatment group were higher than the ORR(30.8%)and DCR(61.5%)of the control group,but the differences were not statistical significant(P>0.05).The median progression free survival(mPFS)of the treatment group was 1.54 months longer than that of the control group(9.38 months vs.7.84 months,P<0.05).The OS of the treatment group was 1.06 months longer than that of the control group(11.52 months vs.10.46 months,P>0.05).The incidence of hand and foot syndrome,fatigue and hypertension in the treatment group was significantly higher than that in the control group(P<0.05).Conclusion Anlotinib combined with pemetrexed and nedaplatin in treating wild type advanced lung adenocarcinoma provides benefit in short-term efficacy,also improves the disease control time,but there is no benefit in the overall survival.