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EGFR-TKIs治疗晚期EGFR敏感突变的非小细胞肺癌原发灶早期SBRT对比晚期SBRT的疗效差异

Effect of EFGR-TKI on early SBRT versus late SBRT in primary non-small cell lung cancer with advanced EGFR-sensitive mutations

投稿时间：2024-07-06 修订日期：2024-09-02

DOI：

中文关键词: EGFR突变体部立体定向放疗晚期非小细胞肺癌无进展生存期远期生存 T790M突变

英文关键词:EGFR mutation Body stereotactic radiotherapy Advanced non-small cell lung cancer Progression-free survival Long-term survival T790M mutation 1.引言

基金项目:浙江省公益基础项目：LGF21H160027 浙江省医药卫生科技计划项目（2024KY1829）

作者	单位	邮编
顾娉郡	温州医科大学附属台州医院放疗科	317000
汤幸妮	温州医科大学附属台州医院放疗科
郑佳禧	温州医科大学附属台州医院放疗科
蔡高科	温州医科大学附属台州医院放疗科
朱健	温州医科大学附属台州医院放疗科
邓国忠	温州医科大学附属台州医院放疗科
杨海华^*	温州医科大学附属台州医院放疗科	317000

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中文摘要:

[摘要] 目的探讨晚期EGFR敏感突变的NSCLC在一代靶向治疗基础上，原发灶局部SBRT干预的时机。方法本回顾性研究评估了2016年9月至2022年11月在浙江省台州医院确诊的晚期NSCLC患者。患者根据前瞻性单臂II期临床试验(ChiCTR-OIN-17013920)标准进行匹配，包括那些在一代EGFR-TKI治疗后因原发灶进展而接受SBRT治疗的患者。研究比较了早SBRT（开始TKI治疗一个月内）与晚（原发灶进展时）SBRT干预的疗效，评估了无进展生存期（PFS）、总体生存期（OS）、副作用（AE）及耐药后T790M突变的发生率。结果本研究共纳入68例患者，其中早SBRT组41例，晚SBRT组27例。两组在年龄、性别、吸烟史、ECOG评分、EGFR突变类型、TNM分期、转移个数及部位上无统计学差异。早SBRT组的中位PFS为15.23个月，对比无局部处理的10.20个月（P=0.13），但差异无统计学意义。早SBRT组与晚SBRT组的总PFS分别为15.23个月和18.20个月（P=0.54），中位OS分别为27.90个月和36.61个月（P=0.54），两组均无统计学差异。两组均未见3级及以上的副作用，2级及以下的毒副作用无统计学差异。早SBRT组耐药进展后T790M突变的发生率为58.5%（24/41），晚SBRT组为33.3%（9/27），P=0.05，具有统计学差异。结论 EGFR敏感突变型NSCLC患者接受第一代EGFR-TKI治疗后，早期SBRT和晚期SBRT的PFS、OS、毒副反应没有显著差异。耐药后在早SBRT组比晚SBRT组T790M突变的机率更多，需要进一步研究。 [关键词] EGFR突变；体部立体定向放疗；晚期非小细胞肺癌；无进展生存期；远期生存；T790M突变

英文摘要:

[Abstract] Objective To determine the optimal timing for local SBRT intervention in advanced NSCLC with EGFR-sensitive mutations undergoing first-generation EGFR-TKI therapy. Methods This retrospective study evaluated advanced NSCLC patients diagnosed at Taizhou Hospital, Zhejiang Province, between September 2016 and November 2022. Patients were matched based on a prospective single-arm Phase II clinical trial (ChiCTR-OIN-17013920) and included those who underwent SBRT for primary lesion progression following first-generation EGFR-TKI therapy. The study compared early (within one month of starting TKI) versus late (upon primary lesion progression) SBRT intervention, evaluating progression-free survival (PFS), overall survival (OS), adverse effects (AEs), and the incidence of T790M mutations after resistance. Results The study included 68 patients: 41 in the early SBRT group and 27 in the late SBRT group. Baseline characteristics, including age, gender, smoking history, ECOG performance status, EGFR mutation type, TNM stage, number of metastases, and sites of metastasis, were comparable between the groups. The median PFS for early SBRT was 15.23 months, compared to 10.20 months for those without local treatment (P=0.13), and 18.20 months for late SBRT (P=0.54). The median OS was 27.90 months for early SBRT and 36.61 months for late SBRT (P=0.54). No grade 3 or higher adverse effects were observed, and grade 2 or lower toxicities were comparable between groups. The incidence of T790M mutations after resistance was significantly higher in the early SBRT group (58.5%, 24/41) compared to the late SBRT group (33.3%, 9/27) (P=0.05). Conclusion In EGFR-sensitive NSCLC patients treated with first-generation EGFR-TKIs, early SBRT showed no significant differences in OS, PFS, or adverse effects compared to late SBRT. However, early SBRT was associated with a higher incidence of T790M mutations after resistance，warranting further investigation. [Key words] EGFR mutation; Body stereotactic radiotherapy; Advanced non-small cell lung cancer; Progression-free survival; Long-term survival; T790M mutation

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