Oncology Institute, Sheba Medical Center, Tel-Hashomer, Israel.
Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Thorac Cancer. 2022 Jun;13(12):1763-1771. doi: 10.1111/1759-7714.14452. Epub 2022 May 11.
Compare outcomes in patients with stage III non-small cell lung cancer (NSCLC) treated with chemoradiation and adjuvant durvalumab to historical controls treated with chemoradiation alone.
The records of patients with stage III NSCLC treated with definitive chemoradiation ± adjuvant durvalumab were reviewed retrospectively. Primary endpoints were progression free survival (PFS), overall survival (OS), and adverse events (AE).
Between September 2009 and September 2020, 215 patients were treated with concurrent chemoradiation (n = 144) or concurrent chemoradiation followed by adjuvant durvalumab (n = 71). Compared to historical controls, durvalumab use was associated with improved PFS: median (27 months vs. 10 months, p < 0.0001), 1-year (83.1% vs. 43.8, p < 0.0001); and improved OS; median (not reached vs. 24 months, p < 0.0001), 1-year (85.9% vs. 81.9%, p < 0.0001). Multivariate analysis showed adjuvant durvalumab was associated with increased OS (p = 0.005) and PFS (p = 0.001). Within the durvalumab group, only clinical stage IIIA versus IIIB/C was associated with improved OS (p = 0.049), but not PFS. There was no association between PFS or OS and Eastern Cooperative Oncology Group (ECOG) score, prior history of immune disease, programmed death-ligand 1 (PD-L1) receptor status, delay in starting durvalumab beyond 42 days, or development of an AE. During durvalumab treatment, 63 AE were reported in 52 patients with treatment discontinuation in 11. Pneumonitis was the most common AE reported (n = 35, 49%). Most AE were grade 1-2 (n = 57). Grade 3-4 AE were uncommon (n = 6) and none were grade 5.
Treatment with adjuvant durvalumab following chemoradiation was associated with improved PFS and OS compared to chemoradiation alone.
比较接受放化疗和辅助度伐利尤单抗治疗的 III 期非小细胞肺癌（NSCLC）患者与仅接受放化疗治疗的历史对照患者的结局。
回顾性分析了接受根治性放化疗±辅助度伐利尤单抗治疗的 III 期 NSCLC 患者的病历。主要终点为无进展生存期（PFS）、总生存期（OS）和不良事件（AE）。
2009 年 9 月至 2020 年 9 月，144 例患者接受同步放化疗（n=144）或同步放化疗后辅助度伐利尤单抗（n=71）治疗。与历史对照相比，度伐利尤单抗的使用与改善的 PFS 相关：中位（27 个月比 10 个月，p<0.0001），1 年（83.1%比 43.8%，p<0.0001）；和改善的 OS：中位（未达到比 24 个月，p<0.0001），1 年（85.9%比 81.9%，p<0.0001）。多变量分析显示，辅助度伐利尤单抗与 OS 增加相关（p=0.005）和 PFS 增加相关（p=0.001）。在度伐利尤单抗组中，仅临床 IIIA 期与 IIIB/C 期与 OS 改善相关（p=0.049），但与 PFS 无关。PFS 或 OS 与东部肿瘤协作组（ECOG）评分、既往免疫病史、程序性死亡配体 1（PD-L1）受体状态、度伐利尤单抗开始使用时间延迟超过 42 天或发生 AE 之间无相关性。在度伐利尤单抗治疗期间，52 例患者报告了 63 例 AE，其中 11 例停止治疗。最常见的 AE 为肺炎（n=35，49%）。大多数 AE 为 1-2 级（n=57）。3-4 级 AE 不常见（n=6），无 5 级 AE。
与单纯放化疗相比，放化疗后辅助度伐利尤单抗治疗与改善的 PFS 和 OS 相关。
