Patient-Reported Outcomes With Consolidation Durvalumab Versus Placebo After Concurrent Chemoradiotherapy in Limited-Stage SCLC: Results From the Phase 3 ADRIATIC Trial.

We report the patient-reported outcomes.

我们报告了患者报告的结果。

Methods

Patients received durvalumab, durvalumab-tremelimumab, or placebo every 4 weeks for up to 24 months.

患者每4周接受一次durvalumab、durvalumab-tremelimumab或安慰剂治疗，最多持续24个月。

Patient-reported global health status/quality of life (QoL), functioning, and symptoms, assessed using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30-item and QoL Questionnaire-Lung Cancer 13-item (secondary end points), are reported for durvalumab and placebo only; the durvalumab-tremelimumab arm remained blinded at this analysis.

使用欧洲癌症研究与治疗组织生活质量问卷核心30项和肺癌13项问卷评估的患者报告的整体健康状况/生活质量（QoL）、功能和症状（次要终点）仅报告durvalumab和安慰剂组的数据；durvalumab-tremelimumab组在本次分析中仍保持盲态。

Change from baseline (for prespecified key scales), time to deterioration (TTD), and improvement rates (all scales) were evaluated.

评估了基线变化（对于预设的关键量表）、恶化时间（TTD）和改善率（所有量表）。

A score change of more than or equal to 10 from baseline was considered a clinically meaningful deterioration or improvement.

基线得分变化大于或等于10分被认为具有临床意义的恶化或改善。

Analyses were not alpha controlled.

分析未进行α校正。

Results

In both arms (durvalumab, n = 264; placebo, n = 266), mean score changes in prespecified key scales from baseline up to 24 months were small and not clinically meaningful.

在两个治疗组（durvalumab组，n=264；安慰剂组，n=266）中，从基线至24个月预设关键量表的平均得分变化很小，且不具有临床意义。

There were no between-arm differences in TTD except for arm or shoulder pain (longer with durvalumab versus placebo [median TTD: 25.7 versus 9.1 mo; hazard ratio: 0.70 (95% confidence interval: 0.51-0.94)]) and similar improvement rates between arms for most scales; a higher improvement rate for chest pain was observed with durvalumab versus placebo (odds ratio: 2.28 [95% confidence interval: 1.08-4.95]).

除了臂部或肩部疼痛外，两组之间在TTD（至疾病进展时间）上没有差异（durvalumab组比安慰剂组长[中位TTD：25.7个月对比9.1个月；风险比：0.70（95%置信区间：0.51-0.94）]），大多数量表上两组的改善率相似；与安慰剂相比，durvalumab组的胸痛改善率更高（优势比：2.28 [95%置信区间：1.08-4.95]）。

Conclusions

Consolidation durvalumab after concurrent chemoradiotherapy did not compromise patients' global health status/QoL, functioning, or symptoms versus placebo, further supporting this treatment regimen as the new standard of care for limited-stage SCLC.

在同时进行化疗和放疗后，使用durvalumab巩固治疗并未损害患者的全球健康状况/生活质量、功能或症状，与安慰剂相比，进一步支持将此治疗方案作为局限性小细胞肺癌的新标准治疗。