| 論文種別 | 原著(症例報告除く) |
| 言語種別 | 英語 |
| 査読の有無 | その他(不明) |
| 表題 | Phase II study of ramucirumab plus erlotinib for treatment-naïve patients with EGFR-mutant non-squamous non-small cell lung cancer and pleural effusion (RELAY-Effusion). |
| 掲載誌名 | 正式名：Lung cancer (Amsterdam, Netherlands) 略 称：Lung Cancer ISSNコード：18728332/01695002 |
| 掲載区分 | 国外 |
| 巻・号・頁 | pp.Online ahead of print |
| 著者・共著者 | Hiroyasu Kaneda, Motoko Tachihara, Yukihiro Toi, Shoichi Kuyama, Eiki Ichihara, Yasuhito Fujisaka, Koichi Azuma, Takayasu Kurata, Akihito Kubo, Hisashi Tanaka, Tadaaki Yamada, Toshihide Yokoyama, Takahide Kato, Ken Yamamoto, Nobuyuki Katakami, Ryota Kawai, Hisako Yoshida, Ayumi Shintani, Kenji Sawa, Tomoya Kawaguchi |
| 発行年月 | 2026/05 |
| 概要 | INTRODUCTION:Malignant pleural effusion (MPE) develops in approximately 30-40% of patients with non-small cell lung cancer (NSCLC), including those harboring epidermal growth factor receptor (EGFR) mutations, and is generally associated with reduced responsiveness to EGFR tyrosine kinase inhibitors. This study aimed to investigate the efficacy of ramucirumab in the context of MPE, which remains unexplored.METHODS:In this single-arm, multicenter, phase II study, we enrolled treatment-naïve patients with EGFR-mutant NSCLC complicated by MPE. They received ramucirumab (10 mg/kg) every 2 weeks plus erlotinib (150 mg) daily until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), overall survival (OS), and safety.RESULTS:Forty patients were enrolled between December 2021 and December 2023 (median follow-up, 29.5 months). The median PFS and OS were 12.9 (95% confidence interval [CI], 7.3-16.7) and 36.3 (95% CI: 28.5- not available [NA]) months, respectively, with a 12-month OS rate of 87.5% and ORR of 77.5% (95% CI, 61.5-89.2%). The median drainage-free survival was 33.0 months (95% CI: 26.0-NA). Treatment-related adverse events occurred in 85% of patients (grade 5 = 0%; grade 3 or 4 = 22.5%); the most common were acneiform dermatitis (60.0%), decreased appetite (30.0%), increased aspartate aminotransferase concentration (25.0%), paronychia (22.5%), hypertension (22.5%), proteinuria (22.5%), and anemia (22.5%).CONCLUSIONS:Although the primary endpoint was not met, the combination provided durable control of MPE and was well tolerated, suggesting potential value in symptom-focused management of this high-risk subgroup.CLINICAL TRIAL REGISTRATION:Japan Registry of Clinical Trials (jRCTs051210138). |
| DOI | 10.1016/j.lungcan.2026.109432 |
| PMID | 42096800 |