Radiation Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo and University of Pavia, Pavia, Italy.
Institute of Oncology, Sheba Medical Centre, Ramat Gan; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
ESMO Open. 2024 Jun;9(6):103464. doi: 10.1016/j.esmoop.2024.103464. Epub 2024 Jun 3.
Based on the findings of the PACIFIC trial, consolidation durvalumab following platinum-based chemoradiotherapy (CRT) is a global standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC). An earlier analysis from the ongoing PACIFIC-R study (NCT03798535) demonstrated the effectiveness of this regimen in terms of progression-free survival (PFS). Here, we report the first planned overall survival (OS) analysis.
PACIFIC-R is an observational/non-interventional, retrospective study of patients with unresectable, stage III NSCLC who started durvalumab (10 mg/kg intravenously every 2 weeks) within an AstraZeneca-initiated early access program between September 2017 and December 2018. Primary endpoints are OS and investigator-assessed PFS, estimated using the Kaplan-Meier method.
By 30 November 2021, the full analysis set included 1154 participants from 10 countries (median follow-up in censored patients: 38.7 months). Median OS was not reached, and the 3-year OS rate was 63.2% (95% confidence interval 60.3% to 65.9%). Three-year OS rates were numerically higher among patients with programmed death-ligand 1 (PD-L1) expression on ≥1% versus <1% of tumor cells (TCs; 67.0% versus 54.4%) and patients who received concurrent CRT (cCRT) versus sequential CRT (sCRT) (64.8% versus 57.9%).
PACIFIC-R data continue to provide evidence for the effectiveness of consolidation durvalumab after CRT in a large, diverse, real-world population. Better outcomes were observed among patients with PD-L1 TCs ≥1% and patients who received cCRT. Nevertheless, encouraging outcomes were still observed among patients with TCs <1% and patients who received sCRT, supporting use of consolidation durvalumab in a broad population of patients with unresectable, stage III NSCLC.
基于 PACIFIC 试验的结果，在铂类为基础的放化疗（CRT）后进行巩固性 durvalumab 治疗是不可切除的 III 期非小细胞肺癌（NSCLC）患者的全球标准治疗方法。来自正在进行的 PACIFIC-R 研究（NCT03798535）的早期分析表明，该方案在无进展生存期（PFS）方面是有效的。在这里，我们报告了首次计划的总生存期（OS）分析。
PACIFIC-R 是一项观察性/非干预性、回顾性研究，纳入了 2017 年 9 月至 2018 年 12 月期间在阿斯利康发起的早期准入计划中开始使用 durvalumab（10mg/kg，每 2 周静脉注射一次）的不可切除的 III 期 NSCLC 患者。主要终点是 OS 和研究者评估的 PFS，使用 Kaplan-Meier 方法估计。
截至 2021 年 11 月 30 日，全分析集包括来自 10 个国家的 1154 名参与者（在删失患者中中位随访时间：38.7 个月）。中位 OS 未达到，3 年 OS 率为 63.2%（95%置信区间 60.3%至 65.9%）。肿瘤细胞（TCs）上 PD-L1 表达≥1%的患者和接受同步放化疗（cCRT）的患者与 TCs<1%的患者和接受序贯放化疗（sCRT）的患者相比，3 年 OS 率更高（分别为 67.0%和 54.4%）。
PACIFIC-R 数据继续为 CRT 后巩固性 durvalumab 在大型、多样化的真实世界人群中的有效性提供证据。在 PD-L1 TCs≥1%的患者和接受 cCRT 的患者中观察到更好的结果。然而，在 TCs<1%的患者和接受 sCRT 的患者中仍然观察到令人鼓舞的结果，支持在不可切除的 III 期 NSCLC 广泛患者人群中使用巩固性 durvalumab。
