Background: Consolidation therapy with durvalumab after definitive chemoradiotherapy (CRT) has become the standard care for patients with stage III non-small-cell lung cancer (NSCLC) following the PACIFIC trial. However, real-world data evaluating outcomes under routine clinical conditions remain limited, particularly in European cohorts. Methods: In this retrospective single-center study, we analyzed clinical data from 72 patients with stage III NSCLC treated with definitive CRT between 2017 and 2022. The patients were stratified by receipt of durvalumab consolidation. Univariable and multivariable Cox regression models were used to assess overall survival (OS) and progression-free survival (PFS). Stepwise variable selection based on the Akaike Information Criterion (AIC) was used to construct an optimized multivariable model. A sensitivity analysis with adjustment for treatment period (2017–2018 vs. 2019–2022) was conducted to account for the introduction of durvalumab into routine clinical practice. Results: Among 72 patients, 35 received durvalumab and 37 did not. The median OS was 2.08 years; the 3- and 5-year OS rates were 38.6% and 30.3%, respectively. Multivariable regression revealed significantly improved OS associated with Karnofsky performance status (KPS) > 80% (HR 0.29,p= 0.003), Charlson Comorbidity Index (CCI) ≤ 2 (HR 0.39,p= 0.009), and durvalumab treatment (HR 3.99,p= 0.008). PD-L1 expression ≥ 1% showed a trend toward improved OS (HR 3.72,p= 0.063). The median progression-free survival (PFS) for the total cohort was 1.17 years. The estimated 3- and 5-year PFS rates were 31.1% and 26.3%, respectively. Patients treated with durvalumab had a longer median PFS (20.5 months) compared to those without durvalumab (12.0 months). In the multivariable analysis, KPS > 80% (HR 0.29,p< 0.001), CCI ≤ 2 (HR 0.53,p= 0.048), and durvalumab treatment (HR 2.81,p= 0.023) were significantly associated with improved PFS. A sensitivity analysis adjusting for treatment period—reflecting the introduction of durvalumab into routine clinical practice from 2019—confirmed the robustness of these findings. Conclusions: Our findings support the clinical benefit of durvalumab consolidation following CRT in a real-world population, especially in patients with good performance status and low comorbidity burden. These results confirm and extend the PACIFIC trial findings into routine clinical practice, highlighting the prognostic value of functional status and comorbidity alongside PD-L1 expression.
背景：根据PACIFIC试验结果，根治性放化疗后采用度伐利尤单抗进行巩固治疗已成为III期非小细胞肺癌患者的标准治疗方案。然而，在常规临床条件下评估疗效的真实世界数据仍然有限，特别是在欧洲人群中。方法：在这项回顾性单中心研究中，我们分析了2017年至2022年间接受根治性放化疗的72例III期非小细胞肺癌患者的临床资料。根据是否接受度伐利尤单抗巩固治疗对患者进行分层。采用单变量和多变量Cox回归模型评估总生存期和无进展生存期。基于赤池信息准则进行逐步变量选择以构建优化多变量模型。为考虑度伐利尤单抗进入常规临床实践的时间因素，按治疗时期（2017-2018年 vs. 2019-2022年）进行敏感性分析。结果：72例患者中，35例接受度伐利尤单抗治疗，37例未接受。中位总生存期为2.08年；3年和5年总生存率分别为38.6%和30.3%。多变量回归分析显示，卡氏功能状态评分＞80%、查尔森合并症指数≤2以及度伐利尤单抗治疗均与总生存期显著改善相关。程序性死亡配体1表达≥1%显示出改善总生存期的趋势。全队列中位无进展生存期为1.17年，预估3年和5年无进展生存率分别为31.1%和26.3%。接受度伐利尤单抗治疗的患者中位无进展生存期较未接受者延长。多变量分析表明，卡氏功能状态评分＞80%、查尔森合并症指数≤2以及度伐利尤单抗治疗均与无进展生存期显著改善相关。针对治疗时期的敏感性分析证实了这些结果的稳健性。结论：本研究结果支持在真实世界人群中，根治性放化疗后使用度伐利尤单抗巩固治疗具有临床获益，特别是在功能状态良好且合并症负担较低的患者中。这些结果证实并将PACIFIC试验发现延伸至常规临床实践，同时凸显了功能状态、合并症与程序性死亡配体1表达的预后价值。
肿瘤(癌症)患者之家