| 任一理,方勇,王钧,张磊,张贝贝,胡玲琴,李莉.晚期EGFR敏感突变型非小细胞肺癌的高龄患者埃克替尼治疗的临床数据分析[J].浙江中西医结合杂志,2021,31(10): |
| 晚期EGFR敏感突变型非小细胞肺癌的高龄患者埃克替尼治疗的临床数据分析 |
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| 投稿时间：2020-12-24 修订日期：2021-09-02 |
| DOI： |
| 中文关键词: 非小细胞肺癌 高龄 EGFR敏感突变 埃克替尼 |
| 英文关键词:NSCLC elderly sensitive EGFR mutation Icotinib. |
| 基金项目: |
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| 摘要点击次数: 769 |
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| 中文摘要: |
| 目的 高龄（≥75岁）患者在表皮细胞生长因子受体（epidermal growth factor receptor，EGFR）敏感突变型非小细胞肺癌（non small cell lung cancer,NSCLC）中的比例逐年升高，而使用酪氨酸激酶抑制剂（tyrosine kinase inhibitor，TKI）治疗这类患者的临床真实数据及资料非常匮乏。埃克替尼是针对EGFR突变的经典TKI药物，本研究回顾性分析埃克替尼在治疗高龄晚期EGFR敏感突变型NSCLC患者中的疗效及安全性。
方法 收集2013年8月至2019年12月期间曾在浙江大学医学院附属邵逸夫医院或者绍兴文理学院附属医院接受埃克替尼标准治疗的共167例高龄晚期EGFR敏感突变型NSCLC患者的临床病例资料，包括性别、年龄、EGFR突变类型、无进展生存期（progression-free survival，PFS）、总生存期（overall survival，OS）、不良反应等数据，并进行统计分析。
结果 共有167例高龄晚期EGFR敏感突变型NSCLC患者接受了埃克替尼的标准治疗，其中87例为EGFR 19外显子缺失突变，80例为EGFR 21外显子点突变。经统计分析发现，EGFR 19外显子缺失突变患者的中位无进展生存期（median progression-free survival，mPFS）比EGFR 21外显子点突变患者显著延长（10个月 vs 8.5个月, P<0.05）。而两种EGFR突变类型患者的客观缓解率（objective response rate，ORR）、疾病控制率（disease control rate，DCR）、中位总生存期（median overall survival，mOS）均无明显统计学差异（57.4％ vs 52.5％, P>0.05； 80.5％ vs 77.5％, P>0.05； 27个月 vs 20个月, P>0.05）。埃克替尼的主要不良反应有皮疹、腹泻、食欲减退、口腔溃疡，发生率分别为41.9%、19.2%、9.5%、5%。大部分为I至II度，毒副反应均可耐受。
结论 对于高龄晚期EGFR敏感突变非小细胞肺癌患者，埃克替尼具有良好的安全性，EGFR 19外显子缺失突变患者接受埃克替尼治疗的PFS优于EGFR 21外显子点突变患者。 |
| 英文摘要: |
| Objective The proportion of elderly patients(≥75 years) in non small cell lung cancer(NSCLC) patients harboring sensitive EGFR(epidermal growth factor receptor) mutant is increasing year by year,but there seldomly reports the related ‘real world’ of the clinical data with the treatment with TKI (tyrosine kinase inhibitor) in elderly sensitive EGFR mutant patients. Icotinib is a classic TKI drug for EGFR mutations.The retrospective study was investigated focusing on the safety and effect of the treatment with Icotinib of elderly advanced NSCLC patients(≥75 years)with sensitive EGFR mutations (exon 19 deletion and exon 21 point mutation).
Methods Clinical case data of 167 elderly advanced NSCLC patients harboring different types of EGFR mutations who were treated by Icotinib until disease progressed from August 2013 to December 2019 in Sir Run Run Shaw Hospital or Affiliated Hospital of Shaoxing University, including gender, age, EGFR mutation type, progression-free survival, overall survival, adverse reactions, etc, were collected and analyzed statistically.
Results A total of 167 elderly advanced NSCLC patients harboring different types of EGFR mutations were treated by Icotinib until disease progressed, 87 of them harbored EGFR 19 exon deletion mutation and 80 of them with EGFR 21 exon point mutation. Statistical analysis showed that median progression-free survival (mPFS) was significantly longer in patients with EGFR 19 exon deletion mutations than in patients with EGFR 21 exon point mutations（10个月 vs 8.5个月, P<0.05）. And there was no significant statistical difference in objective response rate (ORR), disease control rate (DCR), and median overall survival (mOS) of patients with two types of EGFR mutations（57.4％ vs 52.5％, P>0.05；80.5％ vs 77.5％, P>0.05；27个月 vs 20个月, P>0.05）.The adverse effects of Icotinib were mainly focus on skin rash, diarrhea, loss of appetite and oral ulcer, with CTC grade I or II, the incidence of each was 41.9%、19.2%、9.5%、5%. Most of them were mild or moderate, and well tolerated.
Conclusions For the elderly advanced NSCLC patients harboring different types of EGFR mutations, Icotinib is safe and effective. The mPFS of patients with EGFR 19 exon deletion mutation who received treatment with icotinib was superior than patients’ with EGFR 21 exon point mutation. |
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