Durvalumab治疗局部晚期不可切除的非小细胞肺癌-对照英国公布的试验数据对现实世界结果进行基准测试。

IF 4.4 2区医学 Q1 ONCOLOGY

Lung Cancer Pub Date : 2025-09-15 DOI:10.1016/j.lungcan.2025.108752

Laura Webster , Sarah Lawton , Emma Kipps , Katherine Thackray , Nadza Tokaca

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引用次数: 0

摘要

背景：根据PACIFIC试验数据，化疗后Durvalumab （CRT）适用于局部晚期，不可切除的非小细胞肺癌的治疗。国家健康和护理卓越研究所建议通过癌症药物基金（CDF）进行报销。使用NHS英格兰系统抗癌治疗（SACT）数据集，我们将现实世界的结果与太平洋试验的结果进行了比较。方法：从NHS英格兰Blueteq系统中确定2019年3月28日至2021年2月1日期间CDF申请durvalumab的患者，并与SACT相关联。主要终点是总生存期（OS）和首次后续治疗时间（TFST）。基线特征（包括性别、年龄、运动状态、疾病分期、组织学亚型和PD-L1表达）之间的比较使用log rank检验进行估计。结果：591例患者被纳入本分析（与太平洋患者相比n = 476）。中位年龄为67岁（PACIFIC 64y）， 59%为男性（PACIFIC 70%）。中位生存期为50个月（太平洋48个月）。中位TFST为38个月（太平洋22个月）。结论：结果与太平洋试验相当，表明试验数据可推广到现实世界。这项研究证明了基于人群的数据如何能够为常规护理的临床结果提供持续的评估。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Durvalumab in locally advanced unresectable non-small cell lung cancer – Benchmarking real-world outcomes in England against published trial data

Background

Durvalumab after chemoradiotherapy (CRT) is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer based on the PACIFIC trial data. The National Institute for Health and Care Excellence recommended reimbursement via the Cancer Drugs Fund (CDF). Using the NHS England Systemic Anti-Cancer Therapy (SACT) dataset, we compared real-world outcomes against those of the PACIFIC trial.

Methods

Patients with a CDF application for durvalumab between 28 March 2019 and 1 February 2021 were identified from the NHS England Blueteq system and linked to SACT. Primary endpoints were overall survival (OS) and Time to First Subsequent Therapy (TFST). Comparisons between baseline characteristics including gender, age, performance status, stage of disease, histological subtype and PD-L1 expression were estimated using the log rank test.

Results

591 patients were included in this analysis (compared with PACIFIC n = 476). Median age was 67 years (PACIFIC 64y), 59 % were male (PACIFIC 70 %). Median OS was 50 months (PACIFIC 48 months). Median TFST was 38 months (PACIFIC 22 months).

Conclusion

Outcomes are comparable to the PACIFIC trial suggesting the trial data are generalisable to the real-world setting. This study demonstrates how population-based data can provide continued evaluation of clinical outcomes in routine care.

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来源期刊

Lung Cancer 医学-呼吸系统

CiteScore

9.40

自引率

3.80%

发文量

407

审稿时长

25 days

期刊介绍： Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.