RELAY 研究：厄洛替尼联合雷莫芦单抗对比厄洛替尼联合安慰剂一线治疗 EGFR 突变的转移性非小细胞肺癌的欧洲/美国亚组分析
RELAY, ramucirumab plus erlotinib versus placebo plus erlotinib in patients with untreated, EGFR-mutated, metastatic non-small cell lung cancer: Europe/United States subset analysis.
机构信息
Hospital doce de Octubre, Medical Oncology Department Thoracic Cancer and Early Drug Development Unit, Madrid, Spain.
Department of Oncology, University of Turin, AOU San Luigi, Orbassano, Italy.
出版信息
Cancer Treat Res Commun. 2021;27:100378. doi: 10.1016/j.ctarc.2021.100378. Epub 2021 Apr 19.
BACKGROUND
In EGFR mutation-positive NSCLC, dual EGFR/VEGFR inhibition compared to EGFR alone increases anti-tumor efficacy. The Phase III RELAY trial demonstrated superior PFS for ramucirumab plus erlotinib (RAM + ERL) over placebo plus erlotinib (PBO + ERL) (HR 0.591 [95% CI 0.461-0.760], p<0.0001). EGFR mutated NSCLC is less prevalent in Western versus Asian patients. This prespecified analysis evaluates efficacy and safety of RAM + ERL in EU and US patients enrolled in RELAY.
PATIENTS AND METHODS
Patients were randomized 1:1 to ERL + RAM (10 mg/kg IV) or PBO Q2W. Treatment continued until unacceptable toxicity or progressive disease. Patients were stratified by geographic region (East Asia vs "other" [EU/US and Canada (EU/US)]). Objectives included PFS, ORR, DoR, OS, PFS2, safety and biomarker analysis.
RESULTS
EU/US subset included 113/449 (25.9%) patients (58 RAM + ERL, 55 PBO + ERL). RAM + ERL improved PFS (20.6 vs 10.9 months, HR 0.605 [95% CI: 0.362-1.010]). ORR and DCR were similar, but median DoR was longer with RAM + ERL (18.0 vs 10.1 months, HR 0.527 [95% CI: 0.296-0.939]). OS and PFS2 were immature at data cut-off (censoring rates 81.0-81.8% and 67.3-79.3%, respectively). Most commonly reported Grade ≥3 TEAE for RAM + ERL was hypertension (17 [29.8%]) and for PBO + ERL, dermatitis acneiform (5 [9.1%]).
CONCLUSION
EU/US subset analysis showed improved efficacy outcomes for RAM + ERL and a safety profile consistent with the overall population. Ramucirumab is a safe and effective addition to standard-of-care EGFR-TKI for EGFR mutation-positive metastatic NSCLC.
背景
在 EGFR 突变阳性 NSCLC 中，与单独使用 EGFR 相比，双重 EGFR/VEGFR 抑制可提高抗肿瘤疗效。III 期 RELAY 试验表明，雷莫芦单抗联合厄洛替尼（RAM+ERL）与安慰剂联合厄洛替尼（PBO+ERL）相比，无进展生存期（PFS）有显著改善（HR 0.591[95%CI 0.461-0.760]，p<0.0001）。与亚洲患者相比，西方患者中 EGFR 突变型 NSCLC 的发病率较低。本预先设定的分析评估了 RAM+ERL 在 RELAY 入组的欧盟和美国患者中的疗效和安全性。
患者和方法
患者以 1:1 的比例随机分配至 ERL+RAM（10mg/kg IV）或 PBO Q2W。治疗持续到不可接受的毒性或疾病进展。患者按地理区域（东亚与“其他”[欧盟/美国和加拿大（欧盟/美国）]）分层。主要终点包括 PFS、ORR、DoR、OS、PFS2、安全性和生物标志物分析。
结果
欧盟/美国亚组包括 113/449（25.9%）例患者（58 例 RAM+ERL，55 例 PBO+ERL）。RAM+ERL 改善了 PFS（20.6 与 10.9 个月，HR 0.605[95%CI：0.362-1.010]）。ORR 和 DCR 相似，但 RAM+ERL 的中位 DoR 更长（18.0 与 10.1 个月，HR 0.527[95%CI：0.296-0.939]）。OS 和 PFS2 数据截止时仍不成熟（截止率分别为 81.0-81.8%和 67.3-79.3%）。RAM+ERL 最常见的≥3 级治疗相关不良事件是高血压（17 例[29.8%]），而 PBO+ERL 最常见的是痤疮样皮炎（5 例[9.1%]）。
结论
欧盟/美国亚组分析显示，RAM+ERL 可改善疗效，安全性与总体人群一致。雷莫芦单抗联合标准 EGFR-TKI 是 EGFR 突变阳性转移性 NSCLC 的一种安全有效的治疗选择。
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