同步放化疗后接受度伐利尤单抗的局限性期小细胞肺癌患者的真实世界分析
Real-world analysis in patients with limited-stage small-cell lung cancer who received durvalumab after concurrent chemoradiotherapy.
作者
作者单位
- Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, China.
- Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Medical Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
- Key Laboratory of Molecular Oncology, Beijing, Key Laboratory of Carcinogenesis and Translational Research, Department of Thoracic Surgery I, Peking University Cancer Hospital & Institute, Beijing, China.
摘要
中文
III期、双盲、随机ADRIATIC试验确立了铂类同步放化疗（cCRT）后度伐利尤单抗维持治疗作为局限性期小细胞肺癌（LS-SCLC）患者的标准治疗。然而，关于度伐利尤单抗在该患者群体中疗效和安全性的真实世界证据仍然稀缺。因此，我们进行了一项回顾性真实世界分析，以评估cCRT后度伐利尤单抗巩固治疗在LS-SCLC患者中的临床有效性和安全性。这项回顾性、单中心、真实世界队列研究（NCT07050472）入组了2020年1月1日至2023年12月31日期间在北京大学肿瘤医院接受cCRT后度伐利尤单抗巩固治疗的LS-SCLC患者。主要终点是真实世界无进展生存期（rwPFS），定义为从度伐利尤单抗开始至研究者确认的疾病进展或全因死亡（以先发生者为准）的时间。次要终点包括2年rwPFS率、2年总生存（OS）率、度伐利尤单抗治疗持续时间（DoT）和安全性结局。共纳入45名符合条件的患者进行分析。中位年龄为57岁，大多数（93.3%）为III期疾病。胸部放疗在84.4%的患者中以54 Gy每日两次的剂量给予，在15.6%的患者中以45 Gy每日两次给予。68.9%的研究人群接受了预防性颅脑照射（PCI）。在数据截止日期（2025年6月27日），rwPFS的中位随访时间为53.6个月[95%置信区间（CI）：43.5-55.3]。度伐利尤单抗的中位DoT为13.0个月（95% CI：9.0-未达到）。中位rwPFS为18.6个月（95% CI：17.6-39.9），2年rwPFS率为46.7%（95% CI：31.7-60.3%）。中位OS未达到，2年OS率为80.3%（95% CI：68.9-93.5%）。导致度伐利尤单抗停药的不良事件（AEs）发生在17.8%的患者中。16名患者（35.6%）记录了免疫相关不良事件（irAEs），其中甲状腺功能减退（6名患者，13.3%）和肺炎（6名患者，13.3%）最为常见。两名患者（4.4%）出现3级肺炎。放射性肺炎的总体发生率为20%，未报告3-4级事件。所有患者均接受了容积旋转调强放疗（VMAT）。据我们所知，这是第一项针对中国LS-SCLC患者在cCRT后接受度伐利尤单抗巩固治疗的真实世界队列研究。我们的研究结果表明，该治疗策略在常规临床实践中产生了良好的临床有效性和可控的安全性，支持其作为该患者群体标准治疗的作用。
English
The phase III, double-blind, randomized ADRIATIC trial established durvalumab maintenance therapy following platinum-based concurrent chemoradiotherapy (cCRT) as the standard of care for patients with limited-stage small-cell lung cancer (LS-SCLC). However, real-world evidence regarding the efficacy and safety of durvalumab in this patient population remains scarce. We therefore conducted a retrospective real-world analysis to evaluate the clinical effectiveness and safety profile of durvalumab consolidation after cCRT in patients with LS-SCLC. This retrospective, single-center, real-world cohort study (NCT07050472) enrolled patients with LS-SCLC who received cCRT followed by durvalumab consolidation at Peking University Cancer Hospital between January 1, 2020, and December 31, 2023. The primary endpoint was real-world progression-free survival (rwPFS), defined as the time from the initiation of durvalumab to investigator-confirmed disease progression or all-cause death, whichever occurred first. Secondary endpoints included the 2-year rwPFS rate, 2-year overall survival (OS) rate, duration of durvalumab treatment (DoT), and safety outcomes. A total of 45 eligible patients were included in the analysis. The median age was 57 years, and the majority (93.3%) had stage III disease. Thoracic radiotherapy was administered as 54 Gy in twice-daily fractions in 84.4% of patients and as 45 Gy in twice-daily fractions in 15.6% of patients. Prophylactic cranial irradiation (PCI) was delivered to 68.9% of the study population. At the data cutoff date (June 27, 2025), the median follow-up for rwPFS was 53.6 months [95% confidence interval (CI): 43.5-55.3]. The median DoT of durvalumab was 13.0 months (95% CI: 9.0-not reached). The median rwPFS was 18.6 months (95% CI: 17.6-39.9), with a 2-year rwPFS rate of 46.7% (95% CI: 31.7-60.3%). Median OS was not reached, and the 2-year OS rate was 80.3% (95% CI: 68.9-93.5%). Adverse events (AEs) leading to durvalumab discontinuation occurred in 17.8% of patients. Immune-related AEs (irAEs) were documented in 16 patients (35.6%), with hypothyroidism (6 patients, 13.3%) and pneumonitis (6 patients, 13.3%) being the most common. Two patients (4.4%) developed grade 3 pneumonitis. The overall incidence of radiation pneumonitis was 20%, with no grade 3-4 events reported. All patients were treated with volumetric-modulated arc therapy (VMAT). To our knowledge, this is the first real-world cohort study investigating durvalumab consolidation after cCRT in Chinese patients with LS-SCLC. Our findings demonstrate that this treatment strategy yields favorable clinical effectiveness and a manageable safety profile in routine clinical practice, supporting its role as the standard of care for this patient population.
分类与指标
- 研究类型
- 临床研究
- 病种
- 肺癌
- JCR 分区
- Q2
- 影响因子
- 3.4
- 新锐分区
- 3区