在 III 期非小细胞肺癌患者中，与单纯放化疗相比，放化疗后使用度伐利尤单抗治疗与接受单纯放化疗的历史队列比较：一项真实世界多中心研究。
Durvalumab therapy following chemoradiation compared with a historical cohort treated with chemoradiation alone in patients with stage III non-small cell lung cancer: A real-world multicentre study.
机构信息
Centre de Recherche Du Centre Hospitalier de L'Université de Montréal (CRCHUM), 900, Rue Saint-Denis, Pavillon R, H2X 0A9, Montreal, Quebec, Canada; Department of Hematology and Oncology, Centre Hospitalier de L'Université de Montréal (CHUM), 1051, Rue Sanguinet, H2X 3E4, Montreal, Quebec, Canada.
Princess Margaret Cancer Centre, University Health Network (UNH), 610 University Ave, M5G 2C1, Toronto, Ontario, Canada.
出版信息
Eur J Cancer. 2021 Jan;142:83-91. doi: 10.1016/j.ejca.2020.10.008. Epub 2020 Nov 24.
BACKGROUND
The PACIFIC trial demonstrated that durvalumab therapy following chemoradiation (CRT) was associated with improved overall survival (OS) in patients with stage III non-small cell lung cancer (NSCLC). It is unclear whether the results obtained as part of randomised controlled trials are a reflection of real-world (RW) data. Several questions remain unanswered with regard to RW durvalumab use, such as optimal time to durvalumab initiation, incidence of pneumonitis and response in PD-L1 subgroups.
METHODS
In this multicentre retrospective analysis, 147 patients with stage III NSCLC treated with CRT followed by durvalumab were compared with a historical cohort of 121 patients treated with CRT alone. Survival curves were estimated using the Kaplan-Meier method and compared with the log-rank test in univariate analysis. Multivariate analysis was performed to evaluate the effect of standard prognostic factors for durvalumab use.
RESULTS
Median OS was not reached in the durvalumab group, compared with 26.9 months in the historical group (hazard ratio [HR]: 0.56, 95% confidence interval [CI]: 0.37-0.85, p = 0.001). In the durvalumab group, our data suggest improved 12-month OS in patients with PD-L1 expression ≥50% (100% vs 86%, HR: 0.25, 95% CI: 0.11-0.58, p = 0.007). There was no difference in OS between patients with a PD-L1 expression of 1-49% and patients with PD-L1 expression <1%. Delay in durvalumab initiation beyond 42 days did not impact OS. Incidence of pneumonitis was similar in the durvalumab and historical groups. In the durvalumab group, patients who experienced any-grade pneumonitis had a lower 12-month OS than patients without pneumonitis (85% vs 95%, respectively; HR: 3.3, 95% CI: 1.2-9.0, p = 0.006).
CONCLUSIONS
This multicentre analysis suggests that PD-L1 expression ≥50% was associated with favourable OS in patients with stage III NSCLC treated with durvalumab after CRT, whereas the presence of pneumonitis represented a negative prognostic factor.
背景
PACIFIC 试验表明，在接受放化疗（CRT）后接受 durvalumab 治疗的 III 期非小细胞肺癌（NSCLC）患者中，总生存期（OS）得到改善。目前尚不清楚随机对照试验中获得的结果是否反映了真实世界（RW）的数据。关于 RW durvalumab 的使用，仍有几个问题尚未得到解答，例如 durvalumab 开始使用的最佳时间、肺炎的发生率和 PD-L1 亚组的反应。
方法
在这项多中心回顾性分析中，147 例接受 CRT 联合 durvalumab 治疗的 III 期 NSCLC 患者与 121 例仅接受 CRT 治疗的历史队列进行了比较。使用 Kaplan-Meier 方法估计生存曲线，并在单因素分析中使用对数秩检验进行比较。进行多因素分析以评估 durvalumab 使用的标准预后因素的影响。
结果
durvalumab 组中位 OS 未达到，而历史组为 26.9 个月（风险比 [HR]：0.56，95%置信区间 [CI]：0.37-0.85，p=0.001）。在 durvalumab 组，我们的数据表明 PD-L1 表达≥50%的患者 12 个月 OS 改善（100%比 86%，HR：0.25，95%CI：0.11-0.58，p=0.007）。PD-L1 表达为 1-49%的患者和 PD-L1 表达<1%的患者之间的 OS 无差异。durvalumab 起始延迟超过 42 天并不影响 OS。durvalumab 组和历史组的肺炎发生率相似。在 durvalumab 组中，经历任何级别的肺炎的患者 12 个月 OS 低于无肺炎的患者（分别为 85%和 95%，HR：3.3，95%CI：1.2-9.0，p=0.006）。
结论
这项多中心分析表明，在接受 CRT 后接受 durvalumab 治疗的 III 期 NSCLC 患者中，PD-L1 表达≥50%与有利的 OS 相关，而肺炎的存在则是一个负预后因素。
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