| 阿美替尼二线治疗晚期非小细胞肺癌的疗效观察 |
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| 引用本文： | 矫晨晨,周 非,陈文秀,梁东海,厉彦子,吕红英.阿美替尼二线治疗晚期非小细胞肺癌的疗效观察[J].现代肿瘤医学,2022,0(24):4462-4466. |
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| 作者姓名： | 矫晨晨 周 非 陈文秀 梁东海 厉彦子 吕红英 |
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| 作者单位： | 青岛大学附属医院肿瘤放疗科， 山东 青岛 266000 |
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| 基金项目： | 吴阶平医学基金会项目（编号:320.6750.2020-01-3） |
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| 摘 要： | 目的:探究使用阿美替尼二线治疗驱动基因阳性非小细胞肺癌（non-small cell lung cancer,NSCLC）患者的疗效及安全性并分析影响患者疗效的相关因素。方法:共收集72例2020年03月至2021年03月于我院接受阿美替尼二线治疗的EGFR敏感突变IV期NSCLC患者的临床资料，最终回顾性分析了59例患者使用阿美替尼二线治疗的疗效、安全性及疗效的影响因素。结果:阿美替尼二线治疗IV期EGFR阳性突变NSCLC患者整体中位无进展生存期（mPFS）为12.0个月（95%CI:9.02个月~14.97个月），客观缓解率（ORR）为42.4%，疾病控制率（DCR）为94.9%，其中，T790M阳性突变的患者mPFS为16.0个月（95%CI:13.2个月~18.7个月），无突变者mPFS为8.0个月（95%CI:5.8个月~10.2个月），差异有统计学意义（P<0.001)，而患者是否有T790M突变在ORR、DCR均无显著差异（P>0.05）。基因突变类型上，EGFR 19外显子缺失突变的患者mPFS为11.5个月，21外显子L858R突变患者mPFS为10.0个月，二者差异无显著性，而这两种常见突变与罕见突变的mPFS（12.0个月 vs 5.0个月）差异则具有显著性（P=0.015）。是否肺外转移（9.0个月 vs 14.0个月，P=0.044）也是影响阿美替尼二线治疗疗效的因素，但性别、年龄、是否手术、是否吸烟、是否脑转移在mPFS上的差异无显著性。COX回归分析示T790M阴性、罕见突变、肺外转移是影响阿美替尼疗效的独立危险因素。应用阿美替尼总不良反应发生率为62.7%，三级不良反应发生率为3.4%，无严重的三四级或致死性不良反应发生。结论:阿美替尼治疗EGFR突变的NSCLC患者效果较好，T790M阳性突变、EGFR常见突变及无肺外转移患者可获得更长的PFS且用药耐受性良好。
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| 关 键 词： | 非小细胞肺癌 表皮生长因子受体 阿美替尼 |
The efficacy of almonertinib in the second-line treatment of patients with NSCLC harboring EGFR mutations |
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| JIAO Chenchen,ZHOU Fei,CHEN Wenxiu,LIANG Donghai,LI Yanzi,LYU Hongying.The efficacy of almonertinib in the second-line treatment of patients with NSCLC harboring EGFR mutations[J].Journal of Modern Oncology,2022,0(24):4462-4466. |
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| Authors: | JIAO Chenchen ZHOU Fei CHEN Wenxiu LIANG Donghai LI Yanzi LYU Hongying |
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| Affiliation: | Department of Oncology Radiotherapy,the Affiliated Hospital of Qingdao University,Shandong Qingdao 266000,China. |
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| Abstract: | Objective:To evaluate the efficacy and safety of almonertinib in the second-line treatment of patients with non-small cell lung cancer (NSCLC) harboring EGFR mutations,and to analyze the influence factors.Methods:The clinical data of 72 patients with EGFR-mutant NSCLC who received almonertinib as the second-line treatment in our hospital from March 2020 to March 2021 were collected.Finally,we retrospectively analyzed the efficacy and safety of 59 patients.Results:In this study,EGFR-mutant NSCLC patients exhibited an objective response rate (ORR) of 42.4%,a disease control rates (DCR) of 94.9%,which showed no significant difference according to the mutation of T790M (P>0.05).The median progression-free survival (mPFS) was 12.0 months (95%CI:9.02~14.97 months).Compared with T790M-negative,patients with T790M-positive mutation showed a higher mPFS (16.0 months vs 8.0 months),which has statistical sense(P<0.001).Although no significant difference on the PFS between exon 19 deletion mutation (11.5 months) and 21 exon L858R mutation (10.0 months) groups were observed,the common mutation type exhibited a significant higher PFS than uncommon mutation (12.0 months vs 5.0 months) (P=0.015).Multivariate COX-regression analysis showed that T790M-negative,rare mutation types and extrapulmonary metastasis were independent risk factors affecting the survival of almonertinib.With or without extrapulmonary metastasis is also a factor affecting the curative effect of almonertinib second-line treatment(9.0 months vs 14.0 months,P=0.044).However,there was no statistically significant difference in gender,age,surgery history,smoking history and brain metastasis (P>0.05).The incidence of total adverse reactions and serious adverse reactions was 62.7% (37/59) and 3.4% (2/59) respectively.No fatal adverse reactions occurred.Conclusion:Almonertinib is efficacious as the second-line treatment of NSCLC patients with EGFR-positive mutations.Patients with T790M-mutation,common EGFR mutation (exon 19,21 mutation) and without extrapulmonary metastasis can obtain higher PFS,and the adverse reactions are tolerable. |
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| Keywords: | NSCLC EGFR-TKI almonertinib |
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