Three versus six weeks of corticosteroids for mild immune-related pneumonitis: a randomized trial.

No randomized trials have addressed this issue.

目前尚无随机试验解决这一问题。

Background

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.

确定3周皮质类固醇递减是否不劣于指南推荐的6周递减，以实现轻度（不良事件通用术语标准等级1-2）免疫相关性肺炎患者的短期治疗成功。

Methods

Patients with mild immune-related pneumonitis were assigned to either a 3-week or 6-week corticosteroid regimen.

轻度免疫相关性肺炎患者被分配到3周或6周的皮质类固醇治疗方案。

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.

主要终点是8周时的治疗成功率，定义为静息室内空气SpO2 ≥ 90%，且无需因肺炎恶化而增加或延长类固醇治疗。

measurements_and_main_results

Overall, 106 patients were randomly assigned (median age = 72 years; grade 2, 73%).

共有106名患者被随机分配（中位年龄=72岁；2级，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% CI, -29.0% to -7.9%; P = .621) of the 3-week regimen.

3周组和6周组的治疗成功率分别为66.7%和85.2%，并未显示出3周方案的非劣效性（差异= -18.5个百分点；80% CI, -29.0%至-7.9%；P = .621）。

A predefined exploratory analysis indicated superiority of the 6-week regimen (P = .013).

一项预先设定的探索性分析表明6周方案的优越性（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.

在3周组和6周组中，分别有12%和24%的患者出现了3级或更高级别的不良事件；然而，所有这些不良事件均可以通过临床干预得到管理。

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).

使用King's Brief Interstitial Lung Disease评分从基线开始，3周组和6周组的生活质量总分平均变化分别为4.78和6.28（组间差异=-1.50个百分点；95%置信区间，-5.91至2.91）。

Overall survivalwas comparable between the groups (hazard ratio= 1.03; 95% CI, 0.46-2.29; P = .95).

两组之间的总生存率是可比的（风险比=1.03；95%置信区间，0.46-2.29；P=0.95）。

Conclusions

This study establishes the 6-week corticosteroid regimen as an evidence-based standard for treating ICI-related pneumonitis.

本研究确立了6周皮质类固醇方案作为治疗ICI相关性肺炎的循证标准。