| 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 | Three versus six weeks of corticosteroids for mild immune-related pneumonitis: a randomized trial. |
| 掲載誌名 | 正式名：American journal of respiratory and critical care medicine 略 称：Am J Respir Crit Care Med ISSNコード：15354970/1073449X |
| 掲載区分 | 国外 |
| 巻・号・頁 | pp.Online ahead of print |
| 著者・共著者 | Daichi Fujimoto, Mitsuhiro Abe, Kenta Murotani, Mihoko Imaji Onishi, Yuki Sato, Eisaku Miyauchi, Eri Takase, Hisashi Tanaka, Takashi Kijima, Yoshihiko Taniguchi, Ayumu Otsuki, Jun Sugisaka, Hiroshi Yokouchi, Daisuke Arai, Yoshihiko Sakata, Motohiro Tamiya, Satoru Miura, Hidekazu Suzuki, Hirotaka Matsumoto, Moon H Hwang, Teppei Yamaguchi, Asuka Okada, Satoshi Watanabe, Ryota Shibaki, Yuichiro Kikawa, Keisuke Tomii, Hiromitsu Sumikawa, Nobuyuki Yamamoto, Hiroaki Akamatsu |
| 発行年月 | 2026/07 |
| 概要 | RATIONALE:Optimal corticosteroid treatment duration for immune checkpoint inhibitor-related pneumonitis remains uncertain. No randomized trials have addressed this issue.OBJECTIVES:To determine whether a 3-week corticosteroid taper is noninferior to the guideline-recommended 6-week taper for short-term treatment success in patients with mild (Common Terminology Criteria for Adverse Events Grade 1-2) immune-related pneumonitis.METHODS:Patients with mild immune-related pneumonitis were assigned to either a 3-week or 6-week corticosteroid regimen. The primary endpoint was the treatment success rate at 8 weeks, defined as resting room-air SpO2 ≥ 90% without steroid escalation or prolongation due to pneumonitis worsening.MEASUREMENTS AND MAIN RESULTS:Overall, 106 patients were randomized (median age, 72 years; Grade 2, 73%). Treatment success rates were 66.7% and 85.2% in the 3- and 6-week groups, respectively, which did not demonstrate noninferiority (difference: -18.5 percentage points [80% confidence interval: -29.0% to - 7.9%] P = .621) of the 3-week regimen. A predefined exploratory analysis indicated superiority of the 6-week regimen (P = .013). Grade ≥ 3 adverse events occurred in 12% and 24% of the 3- and 6-week groups, respectively; however, all were manageable with clinical interventions. The total quality of life mean change using the King's Brief Interstitial Lung Disease score from baseline was 4.78 and 6.28 in the 3- and 6-week groups, respectively (between-group difference: -1.50 percentage points; 95% confidence interval: -5.91 to 2.91). Overall survival was comparable between the groups (hazard ratio: 1.03; 95% confidence interval: 0.46-2.29; P = .95).CONCLUSIONS:This study establishes the 6-week corticosteroid regimen as an evidence-based standard for treating ICI-related pneumonitis. |
| DOI | 10.1093/ajrccm/aamag349 |
| PMID | 42398004 |