| 邢如月,李梦梦,张国伟,等.阿美替尼治疗EGFR突变晚期非小细胞肺癌疗效及安全性分析[J].肿瘤学杂志,2022,28(6):472-478. |
| 阿美替尼治疗EGFR突变晚期非小细胞肺癌疗效及安全性分析 |
| Efficacy and Safety of Almonertinib for Patients with EGFR-mutant Non-small Cell Lung Cancer |
| 投稿时间：2022-02-07 |
| DOI：10.11735/j.issn.1671-170X.2022.06.B006 |
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| 中文关键词: 非小细胞肺癌 阿美替尼 表皮生长因子受体 T790M |
| 英文关键词:non-small cell lung cancer almonertinib epidermal growth factor receptor T790M |
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| 中文摘要: |
| 摘 要：［目的］ 评价阿美替尼在真实世界中治疗晚期非小细胞肺癌NSCLC患者的疗效与安全性。［方法］ 回顾性分析河南省肿瘤医院于2020年4月至2021年4月收治的100例接受阿美替尼治疗的EGFR突变晚期NSCLC患者的临床资料，采用Kaplan-Meier生存曲线分析无进展生存期(progression free survival，PFS)和总生存期(overall survival，OS)，采用Cox回归模型进行多因素分析和预后因素评估。［结果］ 一线接受阿美替尼治疗患者(n=45)的客观缓解率(objective response rate，ORR)为71%，中位PFS为16.7个月，中位OS未达到。 既往第一、二代EGFR-TKI治疗进展后接受阿美替尼治疗的患者(n=55)中，T790M(+)患者(n=12)的ORR为50.0%，mPFS为11.9个月，中位OS未达到；T790M(-)患者(n=35)的ORR为25.6%，中位PFS为10.8个月，中位OS未达到，差异均无统计学意义(P均>0.05)。患者出现的不良反应主要为肌酸激酶升高(28%)、皮疹(12%)、肝功能损伤(8%)、皮肤瘙痒(8%)、白细胞降低(7%)、贫血(6%)、腹泻(6%)和口腔炎(3%)，其中3级及以上不良反应发生率仅2%，均集中在血液学毒性。多因素Cox回归分析显示，肌酸激酶升高是中位PFS延长的重要预测因素(HR=0.176，P=0.001)。［结论］ 阿美替尼在EGFR突变NSCLC脑转移患者中表现出良好的疗效和安全性。既往EGFR-TKI进展后T790M(-)的患者如果拒绝化疗或化疗疗效较差，可以考虑将阿美替尼作为后续治疗选择之一。肌酸激酶升高是接受阿美替尼治疗的患者中位PFS延长的重要预测因素。 |
| 英文摘要: |
| Abstract：［Objective］ To evaluate the efficacy and safety of almonertinib for patients with EGFR-mutant non-small cell lung cancer(NSCLC). ［Methods］ The clinical data of 100 patients with EGFR-mutant advanced NSCLC treated with almonertinib in Henan Cancer Hospital from April 2020 to April 2021 were analyzed retrospectively. The progression free survival(PFS) and overall survival(OS) were analyzed by Kaplan-Meier survival curve， and the prognostic factors were analyzed by Cox regression model. ［Results］ The objective response rate(ORR) and median PFS of patients receiving first-line almonertinib treatment(n=45) were 71% and 16.7 months， respectively； while the median OS was not achieved. Among patients who received almonertinib after progression on prior EGFR-TKI therapy(n=55)， in T790M(+) patients(n=12) ， the ORR was 50.0%， median PFS was 11.9 months， and median OS was not reached；while in T790M(-) patients(n=35)， the ORR was 25.6%， median PFS was 10.8 months， and median OS was still not reached. There was no significant difference in the efficacy between T790M(+) and T790M(-) groups. The main adverse reactions were elevated creatine kinase(28%)， erythra(12%)， liver function damage(8%)， skin pruritus(8%)， leucopenia(7%)， anemia(6%)， diarrhea(6%) and stomatitis(3%)， the incidence of grade≥3 adverse reactions was 2%(2 cases of hematological toxicity). The multivariate Cox regression analysis revealed that elevated creatine kinase(HR=0.176， P=0.001) was an independent predictive factor for longer median PFS. ［Conclusion］ Almonertinib shows a good efficacy and safety in EGFR-mutant NSCLC patients with brain metastasis. For T790M(-) patients with progression after previous EGFR-TKI， if they refuse chemotherapy or the curative effect of chemotherapy is poor， almonertinib can considered as a treatment option. Elevated creatine kinase is a predictor of prolonged PFS in patients treated with almonertinib. |
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