{"title":"RELAY: ramucirumab联合厄洛替尼治疗转移性egfr突变的日本老年NSCLC患者的安全性和有效性。","authors":"Kazumi Nishino, Takashi Seto, Makoto Nishio, Kazuto Nishio, Kazuo Kasahara, Miyako Satouchi, Kiyotaka Yoh, Hidetoshi Hayashi, Sotaro Enatsu, Tomoko Matsui, Sunoj Chacko Varughese, Carla Visseren-Grul, Kazuhiko Nakagawa","doi":"10.1080/14796694.2025.2560225","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim: </strong>The global phase III RELAY trial demonstrated the efficacy of ramucirumab (RAM) plus erlotinib (ERL) in patients with untreated metastatic epidermal growth factor receptor (<i>EGFR</i>)-mutated non-small cell lung cancer (NSCLC). We present safety and efficacy profiles of RAM+ERL in Japanese elderly (aged ≥ 75 years) patients in RELAY.</p><p><strong>Methods: </strong>Patients were randomized (1:1) to RAM (10 mg/kg) or placebo (PL) intravenously every 2 weeks plus 150 mg/day ERL orally. Primary endpoint was progression-free survival (reported elsewhere). This report describes response rates, study drug exposure, dose adjustments, safety, and post-study treatment discontinuation therapies in Japanese elderly patients (RAM+ERL, n = 12; PL+ERL, n = 17).</p><p><strong>Results: </strong>Overall response rate was similar in RAM+ERL (83.3%) and PL+ERL (82.4%) arms. Median treatment duration of RAM and ERL was 6.0 and 15.4 months, respectively. Most patients had RAM and/or ERL dose adjustments. Adverse events, including grade ≥ 3 events, were similar in both treatment arms, although proteinuria occurred exclusively in the RAM+ERL arm (six patients; no grade ≥ 3 events). All patients received subsequent therapy after first-line study treatment; various subsequent therapies were used.</p><p><strong>Conclusion: </strong>These results suggest that RAM+ERL may be a suitable first-line treatment option for elderly patients with <i>EGFR</i>-mutated NSCLC.</p><p><strong>Clinical trial registration: </strong>www.clinicaltrials.gov identifier is NCT02411448.</p>","PeriodicalId":12672,"journal":{"name":"Future oncology","volume":" ","pages":"3197-3206"},"PeriodicalIF":2.6000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12520095/pdf/","citationCount":"0","resultStr":"{\"title\":\"RELAY: safety and efficacy of ramucirumab plus erlotinib in elderly Japanese patients with metastatic <i>EGFR</i>-mutated NSCLC.\",\"authors\":\"Kazumi Nishino, Takashi Seto, Makoto Nishio, Kazuto Nishio, Kazuo Kasahara, Miyako Satouchi, Kiyotaka Yoh, Hidetoshi Hayashi, Sotaro Enatsu, Tomoko Matsui, Sunoj Chacko Varughese, Carla Visseren-Grul, Kazuhiko Nakagawa\",\"doi\":\"10.1080/14796694.2025.2560225\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aim: </strong>The global phase III RELAY trial demonstrated the efficacy of ramucirumab (RAM) plus erlotinib (ERL) in patients with untreated metastatic epidermal growth factor receptor (<i>EGFR</i>)-mutated non-small cell lung cancer (NSCLC). We present safety and efficacy profiles of RAM+ERL in Japanese elderly (aged ≥ 75 years) patients in RELAY.</p><p><strong>Methods: </strong>Patients were randomized (1:1) to RAM (10 mg/kg) or placebo (PL) intravenously every 2 weeks plus 150 mg/day ERL orally. Primary endpoint was progression-free survival (reported elsewhere). This report describes response rates, study drug exposure, dose adjustments, safety, and post-study treatment discontinuation therapies in Japanese elderly patients (RAM+ERL, n = 12; PL+ERL, n = 17).</p><p><strong>Results: </strong>Overall response rate was similar in RAM+ERL (83.3%) and PL+ERL (82.4%) arms. Median treatment duration of RAM and ERL was 6.0 and 15.4 months, respectively. Most patients had RAM and/or ERL dose adjustments. Adverse events, including grade ≥ 3 events, were similar in both treatment arms, although proteinuria occurred exclusively in the RAM+ERL arm (six patients; no grade ≥ 3 events). All patients received subsequent therapy after first-line study treatment; various subsequent therapies were used.</p><p><strong>Conclusion: </strong>These results suggest that RAM+ERL may be a suitable first-line treatment option for elderly patients with <i>EGFR</i>-mutated NSCLC.</p><p><strong>Clinical trial registration: </strong>www.clinicaltrials.gov identifier is NCT02411448.</p>\",\"PeriodicalId\":12672,\"journal\":{\"name\":\"Future oncology\",\"volume\":\" \",\"pages\":\"3197-3206\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2025-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12520095/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Future oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/14796694.2025.2560225\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/9/25 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Future oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14796694.2025.2560225","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/9/25 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的：全球III期RELAY试验证明了ramucirumab （RAM）联合厄洛替尼（ERL）治疗未经治疗的转移性表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）患者的疗效。我们介绍了RAM+ERL在日本老年（年龄≥75岁）RELAY患者中的安全性和有效性。方法：将患者按1:1的比例随机分为RAM （10 mg/kg）或安慰剂（PL）两组，每2周静脉注射加口服ERL 150 mg/d。主要终点为无进展生存期（别处报道）。本报告描述了日本老年患者（RAM+ERL, n = 12; PL+ERL, n = 17）的反应率、研究药物暴露、剂量调整、安全性和研究后停药治疗。结果：RAM+ERL组和PL+ERL组的总有效率相似，分别为83.3%和82.4%。RAM和ERL的中位治疗时间分别为6.0和15.4个月。大多数患者进行了RAM和/或ERL剂量调整。不良事件，包括≥3级事件，在两个治疗组中相似，尽管蛋白尿只发生在RAM+ERL组（6例患者，没有≥3级事件）。所有患者在一线研究治疗后均接受后续治疗；随后使用了各种治疗方法。结论：这些结果提示RAM+ERL可能是egfr突变的老年非小细胞肺癌患者的一种合适的一线治疗选择。临床试验注册：www.clinicaltrials.gov标识符：NCT02411448。
RELAY: safety and efficacy of ramucirumab plus erlotinib in elderly Japanese patients with metastatic EGFR-mutated NSCLC.
Aim: The global phase III RELAY trial demonstrated the efficacy of ramucirumab (RAM) plus erlotinib (ERL) in patients with untreated metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). We present safety and efficacy profiles of RAM+ERL in Japanese elderly (aged ≥ 75 years) patients in RELAY.
Methods: Patients were randomized (1:1) to RAM (10 mg/kg) or placebo (PL) intravenously every 2 weeks plus 150 mg/day ERL orally. Primary endpoint was progression-free survival (reported elsewhere). This report describes response rates, study drug exposure, dose adjustments, safety, and post-study treatment discontinuation therapies in Japanese elderly patients (RAM+ERL, n = 12; PL+ERL, n = 17).
Results: Overall response rate was similar in RAM+ERL (83.3%) and PL+ERL (82.4%) arms. Median treatment duration of RAM and ERL was 6.0 and 15.4 months, respectively. Most patients had RAM and/or ERL dose adjustments. Adverse events, including grade ≥ 3 events, were similar in both treatment arms, although proteinuria occurred exclusively in the RAM+ERL arm (six patients; no grade ≥ 3 events). All patients received subsequent therapy after first-line study treatment; various subsequent therapies were used.
Conclusion: These results suggest that RAM+ERL may be a suitable first-line treatment option for elderly patients with EGFR-mutated NSCLC.
Clinical trial registration: www.clinicaltrials.gov identifier is NCT02411448.
期刊介绍：
Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community.
The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.
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