奥西替尼二线治疗EGFR突变型晚期非小细胞肺癌的疗效观察  

A study on the efficacy of osimertinib as the second-line treatment for patients with EGFR-mutant advanced non-small cell lung cancer

作　　者：施玥 姜莹莹 陈槿 施雨萌 陈芊颖 田海霞 陈诚[3] 史美琪 沈波[1] 周国仁[1] 王晓华[1] 冯继锋[1] SHI Yue;JIANG Yingying;CHEN Jin;SHI Yumeng;CHEN Qianying;TIAN Haixia;CHEN Cheng;SHI Meiqi;SHEN Bo;ZHOU Guoren;WANG Xiaohua;FENG Jifeng(Department of Oncology, the Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing 210009, China)

机构地区：[1]南京医科大学附属肿瘤医院(江苏省肿瘤医院)江苏省肿瘤防治研究所肿瘤内科,南京210009 [2]中国药科大学基础药学理科基地,210009 [3]南京医科大学附属肿瘤医院放疗科,210009

出　　处：《临床肿瘤学杂志》2022年第3期221-226,共6页Chinese Clinical Oncology

摘　　要：目的评价奥西替尼二线治疗表皮生长因子受体(EGFR)突变型晚期非小细胞肺癌(NSCLC)的疗效,对治疗前转移部位、耐药后进展部位与疗效间的关系进行探讨。方法收集2017年1月1日至2019年1月1日67例经1~2代EGFR-酪氨酸激酶抑制剂(EGFR-TKI)治疗和50例一线化疗后进展的晚期NSCLC患者。全组患者均存在EGFR外显子20 T790M突变阳性,均给予奥西替尼(80 mg口服,每天1次)治疗直至疾病进展或出现不可耐受的不良反应;分析总体及不同亚组间患者的疗效。结果截至2020年10月31日,117例奥西替尼受试者中有28例仍服用奥西替尼,用药最长时间达43.2个月;治疗后进展89例,其中45例死亡。全组中位无进展生存期(PFS)达15.2(95%CI:12.352~18.114)个月,中位总生存期(OS)未达。亚组分析显示,性别、一线治疗方案和治疗前转移病灶部位与PFS有关(P<0.05);一线治疗方案、EGFR突变类型和治疗前原发灶外转移类型与OS有关(P<0.05)。存在肺内转移、胸膜转移、胸水肿瘤脱落细胞、肝转移、淋巴结转移和骨转移均会缩短受试者的中位PFS(P<0.05),存在肺内转移、淋巴结转移、肝转移和骨转移会缩短受试者的中位OS(P<0.05)。进展病灶部位不同的受试者在中位PFS和死亡比例上也存在差异,但无统计学意义(P>0.05),其中以骨转移为进展部位的患者死亡比例最高(75.0%),而肾上腺转移出现进展的患者中位PFS最短(7.1个月)。结论奥西替尼对EGFR突变阳性晚期NSCLC患者二线治疗表现出良好的疗效。一线治疗使用EGFR-TKI序贯奥西替尼比一线化疗序贯奥西替尼治疗的PFS更长,治疗前肺内与肺外均有转移者预后不良,进展部位对疗效的影响有限。Objective To evaluate the efficacy of osimertinib as the second-line treatment for patients with epidermal growth factor receptor(EGFR)-mutant advanced non-small cell lung cancer(NSCLC),and to explore the relationship of location of metastasis before treatment and progression after drug resistance with the efficacy.Methods From January 1,2017 to January 1,2019,67 patients with advanced NSCLC who were treated with 1-2 generation EGFR-tyrosine kinase inhibitor(TKI)and 50 patients who developed drug resistance after first-line chemotherapy were included.EGFR exon T790M was mutant in all 117 patients.Osimertinib 80 mg was orally administrated once a day until the disease progressed or intolerable adverse reactions were observed.Curative effects of the whole group and different subgroups were analyzed.Results As of October 31,2020,28 of 117 patients still took osimertinib,with the longest duration of 43.2 months.Eighty-nine cases progressed after treatment,and 45 cases of them died.The median progression-free survival(PFS)of the whole group was 15.2(95%CI:12.352-18.114)months and the median overall survival(OS)was not reached.Subgroup analysis showed that gender,the first-line treatment,and the location of the metastatic lesions before treatment had impacts on PFS(P<0.05).The first-line treatment,EGFR mutation type and primary extrafocal metastasis type before treatment were related to OS(P<0.05).The presence of intrapulmonary metastasis,pleural metastasis,pleural effusion tumor exfoliated cells,liver metastasis,lymph node metastasis and bone metastasis shortened median PFS(P<0.05),and the presence of intrapulmonary metastasis,lymph node metastasis,liver metastasis and bone metastasis shortened median OS(P<0.05).There were also differences in median PFS and death rate among patients with different location of progressive lesions,but there was no significant difference(P>0.05).The death rate of patients with bone metastasis was the highest(75.0%),while the median PFS of patients bearing adrenal metastasis was the short

关 键 词：非小细胞肺癌 奥西替尼 表皮生长因子受体酪氨酸激酶抑制剂 靶向治疗 肿瘤转移 

分 类 号：R734.2[医药卫生—肿瘤]