一线奥希替尼治疗表皮生长因子受体突变阳性晚期 NSCLC 的全貌：真实世界的疗效、安全性、进展模式和治疗后疗法（Reiwa 研究）

IF 3 Q2 ONCOLOGY

JTO Clinical and Research Reports Pub Date : 2024-09-07 DOI:10.1016/j.jtocrr.2024.100720

Kageaki Watanabe MD , Yukio Hosomi MD, PhD , Katsuhiko Naoki MD, PhD , Yoshiro Nakahara MD, PhD , Yoko Tsukita MD, PhD , Hirotaka Matsumoto MD, PhD , Kiyotaka Yoh MD , Yasuhito Fujisaka MD, PhD , Satoshi Takahashi MD, PhD , Saori Takata MD, PhD , Kazuhiro Usui MD, PhD , Kazuma Kishi MD, PhD , Go Naka MD, PhD , Shu Tamano MSS , Kohei Uemura PhD , Hideo Kunitoh MD, PhD

{"title":"一线奥希替尼治疗表皮生长因子受体突变阳性晚期 NSCLC 的全貌：真实世界的疗效、安全性、进展模式和治疗后疗法（Reiwa 研究）","authors":"Kageaki Watanabe MD , Yukio Hosomi MD, PhD , Katsuhiko Naoki MD, PhD , Yoshiro Nakahara MD, PhD , Yoko Tsukita MD, PhD , Hirotaka Matsumoto MD, PhD , Kiyotaka Yoh MD , Yasuhito Fujisaka MD, PhD , Satoshi Takahashi MD, PhD , Saori Takata MD, PhD , Kazuhiro Usui MD, PhD , Kazuma Kishi MD, PhD , Go Naka MD, PhD , Shu Tamano MSS , Kohei Uemura PhD , Hideo Kunitoh MD, PhD","doi":"10.1016/j.jtocrr.2024.100720","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><div>Osimertinib is used as the first-line treatment for EGFR mutation-positive NSCLC. Nevertheless, its efficacy and safety in clinical practice remain to be fully elucidated and the pattern of progression and the optimal subsequent treatment after osimertinib remains unclear.</div></div><div><h3>Methods</h3><div>This was a multicenter prospective observational study. EGFR mutation-positive patients with NSCLC who started first-line osimertinib from September 2018 to August 2020 were enrolled and followed up until August 2022.</div></div><div><h3>Results</h3><div>A total of 583 patients received osimertinib. The median progression-free and overall survival were 20.0 (95% confidence interval [CI]: 17.6–21.7) months and 41.0 (95% CI: 37.1–44.1) months, respectively. Grade 3 or worse adverse events were observed in 136 patients (23.3%). Progression patterns were categorized as central nervous system only, oligo-progression, and multiple organs on the basis of the Response Evaluation Criteria in Solid Tumors—progressive disease and occurred in 37 (10.8%), 156 (45.4%), and 151 patients (43.9%). The patient’s condition on progression was asymptomatic in 195 patients (56.7%). Osimertinib was continued in 163 patients (47.4%) after confirming progression. In clinically stable population with progressive disease (n = 247), survival after progression was 13.3 (95% CI: 10.9–16.4) months for those who continued osimertinib beyond progressive disease (n = 124), and 24.1 (95% CI: 17.7–34.0) months for those who discontinued osimertinib (n = 123) (hazard ratio = 2.01, 95% CI: 1.38–2.91, <em>p</em> = 0.0002). Platinum plus pemetrexed had the best overall survival benefits after osimertinib.</div></div><div><h3>Conclusions</h3><div>First-line osimertinib was found to have good effectiveness comparable to that reported in pivotal studies. Nevertheless, osimertinib should be discontinued among those who develop progression.</div></div><div><h3>Trial registration number</h3><div>UMIN000038683</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"5 11","pages":"Article 100720"},"PeriodicalIF":3.0000,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The Whole Picture of First-Line Osimertinib for EGFR Mutation-Positive Advanced NSCLC: Real-World Efficacy, Safety, Progression Pattern, and Posttreatment Therapy (Reiwa Study)\",\"authors\":\"Kageaki Watanabe MD , Yukio Hosomi MD, PhD , Katsuhiko Naoki MD, PhD , Yoshiro Nakahara MD, PhD , Yoko Tsukita MD, PhD , Hirotaka Matsumoto MD, PhD , Kiyotaka Yoh MD , Yasuhito Fujisaka MD, PhD , Satoshi Takahashi MD, PhD , Saori Takata MD, PhD , Kazuhiro Usui MD, PhD , Kazuma Kishi MD, PhD , Go Naka MD, PhD , Shu Tamano MSS , Kohei Uemura PhD , Hideo Kunitoh MD, PhD\",\"doi\":\"10.1016/j.jtocrr.2024.100720\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><div>Osimertinib is used as the first-line treatment for EGFR mutation-positive NSCLC. Nevertheless, its efficacy and safety in clinical practice remain to be fully elucidated and the pattern of progression and the optimal subsequent treatment after osimertinib remains unclear.</div></div><div><h3>Methods</h3><div>This was a multicenter prospective observational study. EGFR mutation-positive patients with NSCLC who started first-line osimertinib from September 2018 to August 2020 were enrolled and followed up until August 2022.</div></div><div><h3>Results</h3><div>A total of 583 patients received osimertinib. The median progression-free and overall survival were 20.0 (95% confidence interval [CI]: 17.6–21.7) months and 41.0 (95% CI: 37.1–44.1) months, respectively. Grade 3 or worse adverse events were observed in 136 patients (23.3%). Progression patterns were categorized as central nervous system only, oligo-progression, and multiple organs on the basis of the Response Evaluation Criteria in Solid Tumors—progressive disease and occurred in 37 (10.8%), 156 (45.4%), and 151 patients (43.9%). The patient’s condition on progression was asymptomatic in 195 patients (56.7%). Osimertinib was continued in 163 patients (47.4%) after confirming progression. In clinically stable population with progressive disease (n = 247), survival after progression was 13.3 (95% CI: 10.9–16.4) months for those who continued osimertinib beyond progressive disease (n = 124), and 24.1 (95% CI: 17.7–34.0) months for those who discontinued osimertinib (n = 123) (hazard ratio = 2.01, 95% CI: 1.38–2.91, <em>p</em> = 0.0002). Platinum plus pemetrexed had the best overall survival benefits after osimertinib.</div></div><div><h3>Conclusions</h3><div>First-line osimertinib was found to have good effectiveness comparable to that reported in pivotal studies. Nevertheless, osimertinib should be discontinued among those who develop progression.</div></div><div><h3>Trial registration number</h3><div>UMIN000038683</div></div>\",\"PeriodicalId\":17675,\"journal\":{\"name\":\"JTO Clinical and Research Reports\",\"volume\":\"5 11\",\"pages\":\"Article 100720\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2024-09-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JTO Clinical and Research Reports\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2666364324000900\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JTO Clinical and Research Reports","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2666364324000900","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

导言奥希替尼是表皮生长因子受体突变阳性NSCLC的一线治疗药物。然而，其在临床实践中的疗效和安全性仍有待充分阐明，奥希替尼治疗后的进展模式和最佳后续治疗方法仍不明确。入组2018年9月至2020年8月开始一线奥希替尼治疗的EGFR突变阳性NSCLC患者，并随访至2022年8月。结果共有583名患者接受了奥希替尼治疗。中位无进展生存期和总生存期分别为20.0个月（95%置信区间[CI]：17.6-21.7）和41.0个月（95% CI：37.1-44.1）。136名患者（23.3%）出现了3级或更严重的不良反应。根据实体瘤进展性疾病的反应评估标准，进展模式分为仅中枢神经系统、少部分进展和多器官进展，分别有37名患者（10.8%）、156名患者（45.4%）和151名患者（43.9%）出现进展。195名患者（56.7%）在病情进展时无症状。163名患者（47.4%）在确认病情进展后继续服用奥希替尼。在病情进展的临床稳定人群（n = 247）中，病情进展后继续使用奥希替尼者（n = 124）的生存期为13.3个月（95% CI：10.9-16.4），停用奥希替尼者（n = 123）的生存期为24.1个月（95% CI：17.7-34.0）（危险比 = 2.01，95% CI：1.38-2.91，p = 0.0002）。在奥希替尼治疗后，铂类加培美曲塞的总生存率最高。尽管如此，奥希替尼仍应停用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

The Whole Picture of First-Line Osimertinib for EGFR Mutation-Positive Advanced NSCLC: Real-World Efficacy, Safety, Progression Pattern, and Posttreatment Therapy (Reiwa Study)

Introduction

Osimertinib is used as the first-line treatment for EGFR mutation-positive NSCLC. Nevertheless, its efficacy and safety in clinical practice remain to be fully elucidated and the pattern of progression and the optimal subsequent treatment after osimertinib remains unclear.

Methods

This was a multicenter prospective observational study. EGFR mutation-positive patients with NSCLC who started first-line osimertinib from September 2018 to August 2020 were enrolled and followed up until August 2022.

Results

A total of 583 patients received osimertinib. The median progression-free and overall survival were 20.0 (95% confidence interval [CI]: 17.6–21.7) months and 41.0 (95% CI: 37.1–44.1) months, respectively. Grade 3 or worse adverse events were observed in 136 patients (23.3%). Progression patterns were categorized as central nervous system only, oligo-progression, and multiple organs on the basis of the Response Evaluation Criteria in Solid Tumors—progressive disease and occurred in 37 (10.8%), 156 (45.4%), and 151 patients (43.9%). The patient’s condition on progression was asymptomatic in 195 patients (56.7%). Osimertinib was continued in 163 patients (47.4%) after confirming progression. In clinically stable population with progressive disease (n = 247), survival after progression was 13.3 (95% CI: 10.9–16.4) months for those who continued osimertinib beyond progressive disease (n = 124), and 24.1 (95% CI: 17.7–34.0) months for those who discontinued osimertinib (n = 123) (hazard ratio = 2.01, 95% CI: 1.38–2.91, p = 0.0002). Platinum plus pemetrexed had the best overall survival benefits after osimertinib.

Conclusions

First-line osimertinib was found to have good effectiveness comparable to that reported in pivotal studies. Nevertheless, osimertinib should be discontinued among those who develop progression.