Introduction: In the phase 3 PACIFIC study of patients with unresectable stage III NSCLC without progression after chemoradiotherapy, durvalumab demonstrated significant improvements versus placebo in the primary end points of progression-free survival (hazard ratio [HR] = 0.52, 95% confidence interval [CI]: 0.42–65, p < 0.0001) and overall survival (OS) (HR = 0.68, 95% CI: 0.53–0.87, p = 0.00251), with manageable safety and no detrimental effect on patient-reported outcomes. Here, we report 3-year OS rates for all patients randomized in the PACIFIC study. Methods: Patients, stratified by age, sex, and smoking history, were randomized (2:1) to receive durvalumab, 10 mg/kg intravenously every 2 weeks, or placebo for up to 12 months. OS was analyzed by using a stratified log-rank test in the intention-to-treat population. Medians and rates at 12, 24, and 36 months were estimated by the Kaplan-Meier method. Results: As of January 31, 2019, 48.2% of patients had died (44.1% and 56.5% in the durvalumab and placebo groups, respectively). The median duration of follow-up was 33.3 months. The updated OS remained consistent with that previously reported (stratified HR = 0.69 [95% CI: 0.55– 0.86]); the median OS was not reached with durvalumab but was 29.1 months with placebo. The 12-, 24- and 36- month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively. All secondary outcomes examined showed improvements consistent with previous analyses. Conclusions: Updated OS data from PACIFIC, including 3-year survival rates, demonstrate the long-term clinical benefit with durvalumab after chemoradiotherapy and further establish the PACIFIC regimen as the standard of care in this population.

中文翻译：

---

简要报告：durvalumab 在 III 期 NSCLC 放化疗后的三年总生存期 - 来自 PACIFIC 的更新

简介：在对放化疗后无进展的不可切除 III 期 NSCLC 患者进行的 3 期 PACIFIC 研究中，durvalumab 在主要终点无进展生存期（风险比 [HR] = 0.52，95% 置信区间 [ CI]：0.42–65, p < 0.0001) 和总生存期 (OS) (HR = 0.68, 95% CI: 0.53–0.87, p = 0.00251)，安全性可控，对患者报告的结果没有不利影响。在这里，我们报告了在 PACIFIC 研究中随机分配的所有患者的 3 年 OS 率。方法：将患者按年龄、性别和吸烟史分层，随机 (2:1) 接受 durvalumab，每 2 周静脉注射 10 mg/kg，或安慰剂治疗长达 12 个月。在意向治疗人群中使用分层对数秩检验分析 OS。中位数和比率为 12，用 Kaplan-Meier 方法估计 24 个月和 36 个月。结果：截至 2019 年 1 月 31 日，48.2% 的患者死亡（durvalumab 组和安慰剂组分别为 44.1% 和 56.5%）。中位随访时间为 33.3 个月。更新后的 OS 与之前报道的 OS 保持一致（分层 HR = 0.69 [95% CI: 0.55–0.86]）；Durvalumab 未达到中位 OS，但安慰剂为 29.1 个月。Durvalumab 和安慰剂组的 12、24 和 36 个月 OS 率分别为 83.1% 和 74.6%、66.3% 和 55.3% 和 57.0% 和 43.5%。检查的所有次要结果都显示出与先前分析一致的改善。结论：来自 PACIFIC 的更新 OS 数据，包括 3 年生存率，