{"title":"早期立体定向体外放射治疗可提高第一代表皮生长因子受体酪氨酸激酶抑制剂治疗表皮生长因子受体突变肺癌的无进展生存期：一项观察性队列研究。","authors":"Hailing Xu, Rongbin Qi, Chao Zhou, Yingying Yu, Ling Lin, Xiaomai Wu, Dongqing Lv","doi":"10.1177/17588359241290133","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Stereotactic body radiation therapy (SBRT) in treating non-small-cell lung cancer (NSCLC) exhibits a remarkable therapeutic efficacy. However, its effectiveness in overcoming resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) in patients with advanced EGFR mutations (EGFRm) NSCLC remains uncertain.</p><p><strong>Objective: </strong>We aimed to analyze the effect of SBRT on patients with first-line EGFR-TKIs.</p><p><strong>Design and methods: </strong>Eligible patients with advanced NSCLC initially diagnosed with EGFRm were enrolled. Patients in the EGFR-TKIs group received only the first-generation EGFR-TKIs until disease progression or death, while the others in the EGFR-TKIs + SBRT group received EGFR-TKIs and early SBRT (dose of 40-60 Gy/5-8 F) targeting the primary lung tumor at 1 month after EGFR-TKIs. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were treatment-related adverse effects, overall survival (OS), and sites of initial failure.</p><p><strong>Results: </strong>A total of 184 advanced NSCLC patients with EGFRm were enrolled, including 39 patients in the EGFR-TKIs + SBRT group and 145 patients in the EGFR-TKIs group. The median PFS was 15.50 months in the EGFR-TKIs + SBRT group compared to 9.33 months in the EGFR-TKIs group (<i>p</i> = 0.0020). However, the median OS was 29.10 months in the EGFR-TKIs + SBRT group and 26.33 months in the EGFR-TKIs group, with no significant difference observed (<i>p</i> = 0.22). SBRT is an independent positive prognostic factor for PFS in advanced EGFRm NSCLC. EGFR exon 19 deletion mutation (16.33 vs 11.55 months, <i>p</i> = 0.0087) and fewer metastases (0-5) (31.94 vs 9.59 months, <i>p</i> = 0.0059) were associated with improved PFS in EGFR-TKIs + SBRT versus EGFR-TKIs. Combination therapy increased radiation pneumonitis mainly in Grades 1-2 (89.74% vs 0.0%). The EGFR-TKIs + SBRT group mainly had new site failure (57.10% vs 32.10%) rather than the original site failure.</p><p><strong>Conclusion: </strong>Early SBRT for primary lung tumors may overcome targeted resistance in advanced EGFRm NSCLC patients combined with EGFR-TKIs without serious toxicities, especially for EGFR exon 19-del.</p><p><strong>Trial registration: </strong>ChiCTR-OIN-17013920.</p>","PeriodicalId":23053,"journal":{"name":"Therapeutic Advances in Medical Oncology","volume":"16 ","pages":"17588359241290133"},"PeriodicalIF":4.3000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11536526/pdf/","citationCount":"0","resultStr":"{\"title\":\"Early stereotactic body radiation therapy improves progression-free survival of first-generation EGFR tyrosine kinase inhibitors in EGFR-mutated lung cancer: an observational cohort study.\",\"authors\":\"Hailing Xu, Rongbin Qi, Chao Zhou, Yingying Yu, Ling Lin, Xiaomai Wu, Dongqing Lv\",\"doi\":\"10.1177/17588359241290133\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Stereotactic body radiation therapy (SBRT) in treating non-small-cell lung cancer (NSCLC) exhibits a remarkable therapeutic efficacy. However, its effectiveness in overcoming resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) in patients with advanced EGFR mutations (EGFRm) NSCLC remains uncertain.</p><p><strong>Objective: </strong>We aimed to analyze the effect of SBRT on patients with first-line EGFR-TKIs.</p><p><strong>Design and methods: </strong>Eligible patients with advanced NSCLC initially diagnosed with EGFRm were enrolled. Patients in the EGFR-TKIs group received only the first-generation EGFR-TKIs until disease progression or death, while the others in the EGFR-TKIs + SBRT group received EGFR-TKIs and early SBRT (dose of 40-60 Gy/5-8 F) targeting the primary lung tumor at 1 month after EGFR-TKIs. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were treatment-related adverse effects, overall survival (OS), and sites of initial failure.</p><p><strong>Results: </strong>A total of 184 advanced NSCLC patients with EGFRm were enrolled, including 39 patients in the EGFR-TKIs + SBRT group and 145 patients in the EGFR-TKIs group. The median PFS was 15.50 months in the EGFR-TKIs + SBRT group compared to 9.33 months in the EGFR-TKIs group (<i>p</i> = 0.0020). However, the median OS was 29.10 months in the EGFR-TKIs + SBRT group and 26.33 months in the EGFR-TKIs group, with no significant difference observed (<i>p</i> = 0.22). SBRT is an independent positive prognostic factor for PFS in advanced EGFRm NSCLC. EGFR exon 19 deletion mutation (16.33 vs 11.55 months, <i>p</i> = 0.0087) and fewer metastases (0-5) (31.94 vs 9.59 months, <i>p</i> = 0.0059) were associated with improved PFS in EGFR-TKIs + SBRT versus EGFR-TKIs. Combination therapy increased radiation pneumonitis mainly in Grades 1-2 (89.74% vs 0.0%). The EGFR-TKIs + SBRT group mainly had new site failure (57.10% vs 32.10%) rather than the original site failure.</p><p><strong>Conclusion: </strong>Early SBRT for primary lung tumors may overcome targeted resistance in advanced EGFRm NSCLC patients combined with EGFR-TKIs without serious toxicities, especially for EGFR exon 19-del.</p><p><strong>Trial registration: </strong>ChiCTR-OIN-17013920.</p>\",\"PeriodicalId\":23053,\"journal\":{\"name\":\"Therapeutic Advances in Medical Oncology\",\"volume\":\"16 \",\"pages\":\"17588359241290133\"},\"PeriodicalIF\":4.3000,\"publicationDate\":\"2024-11-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11536526/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Medical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17588359241290133\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Medical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17588359241290133","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景：立体定向体放射治疗（SBRT）在治疗非小细胞肺癌（NSCLC）方面疗效显著。然而，它在克服表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs）对晚期表皮生长因子受体突变（EGFRm）NSCLC患者的耐药性方面的效果仍不确定：我们旨在分析SBRT对一线EGFR-TKIs患者的影响：初步诊断为 EGFRm 的晚期 NSCLC 患者均符合条件。EGFR-TKIs组患者仅接受第一代EGFR-TKIs治疗，直至疾病进展或死亡；EGFR-TKIs+SBRT组患者在接受EGFR-TKIs治疗1个月后接受EGFR-TKIs和针对原发肺肿瘤的早期SBRT（剂量为40-60 Gy/5-8 F）治疗。主要终点是无进展生存期（PFS），次要终点是治疗相关不良反应、总生存期（OS）和初始失败部位：共有184例EGFRm晚期NSCLC患者入组，其中EGFR-TKIs+SBRT组39例，EGFR-TKIs组145例。EGFR-TKIs + SBRT 组的中位 PFS 为 15.50 个月，而 EGFR-TKIs 组为 9.33 个月（p = 0.0020）。然而，EGFR-TKIs + SBRT 组的中位 OS 为 29.10 个月，EGFR-TKIs 组为 26.33 个月，未观察到显著差异（p = 0.22）。SBRT是晚期表皮生长因子受体（EGFRm）NSCLC患者PFS的一个独立积极预后因素。EGFR外显子19缺失突变（16.33个月 vs 11.55个月，p = 0.0087）和较少转移（0-5个）（31.94个月 vs 9.59个月，p = 0.0059）与EGFR-TKIs + SBRT与EGFR-TKIs的PFS改善相关。联合治疗增加了放射性肺炎，主要是在1-2级（89.74% vs 0.0%）。EGFR-TKIs+SBRT组主要出现新部位衰竭（57.10% vs 32.10%），而非原部位衰竭：结论：早期SBRT治疗原发性肺肿瘤可克服晚期EGFRm NSCLC患者联合EGFR-TKIs的靶向耐药，且无严重毒性反应，尤其是对EGFR外显子19-del患者：ChiCTR-OIN-17013920。
Early stereotactic body radiation therapy improves progression-free survival of first-generation EGFR tyrosine kinase inhibitors in EGFR-mutated lung cancer: an observational cohort study.
Background: Stereotactic body radiation therapy (SBRT) in treating non-small-cell lung cancer (NSCLC) exhibits a remarkable therapeutic efficacy. However, its effectiveness in overcoming resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) in patients with advanced EGFR mutations (EGFRm) NSCLC remains uncertain.
Objective: We aimed to analyze the effect of SBRT on patients with first-line EGFR-TKIs.
Design and methods: Eligible patients with advanced NSCLC initially diagnosed with EGFRm were enrolled. Patients in the EGFR-TKIs group received only the first-generation EGFR-TKIs until disease progression or death, while the others in the EGFR-TKIs + SBRT group received EGFR-TKIs and early SBRT (dose of 40-60 Gy/5-8 F) targeting the primary lung tumor at 1 month after EGFR-TKIs. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were treatment-related adverse effects, overall survival (OS), and sites of initial failure.
Results: A total of 184 advanced NSCLC patients with EGFRm were enrolled, including 39 patients in the EGFR-TKIs + SBRT group and 145 patients in the EGFR-TKIs group. The median PFS was 15.50 months in the EGFR-TKIs + SBRT group compared to 9.33 months in the EGFR-TKIs group (p = 0.0020). However, the median OS was 29.10 months in the EGFR-TKIs + SBRT group and 26.33 months in the EGFR-TKIs group, with no significant difference observed (p = 0.22). SBRT is an independent positive prognostic factor for PFS in advanced EGFRm NSCLC. EGFR exon 19 deletion mutation (16.33 vs 11.55 months, p = 0.0087) and fewer metastases (0-5) (31.94 vs 9.59 months, p = 0.0059) were associated with improved PFS in EGFR-TKIs + SBRT versus EGFR-TKIs. Combination therapy increased radiation pneumonitis mainly in Grades 1-2 (89.74% vs 0.0%). The EGFR-TKIs + SBRT group mainly had new site failure (57.10% vs 32.10%) rather than the original site failure.
Conclusion: Early SBRT for primary lung tumors may overcome targeted resistance in advanced EGFRm NSCLC patients combined with EGFR-TKIs without serious toxicities, especially for EGFR exon 19-del.
期刊介绍：
Therapeutic Advances in Medical Oncology is an open access, peer-reviewed journal delivering the highest quality articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of cancer. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in medical oncology, providing a forum in print and online for publishing the highest quality articles in this area. This journal is a member of the Committee on Publication Ethics (COPE).
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