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一项采用历史对照的倾向匹配回顾性比较研究,以确定度伐利尤单抗在不可切除的 III 期非小细胞肺癌同步放化疗后的真实世界有效性。

A Propensity-Matched Retrospective Comparative Study with Historical Control to Determine the Real-World Effectiveness of Durvalumab after Concurrent Chemoradiotherapy in Unresectable Stage III Non-Small Cell Lung Cancer.

作者信息

Park Cheol-Kyu, Jeon Nakyung, Park Hwa-Kyung, Oh Hyung-Joo, Kim Young-Chul, Jeon Ha-Lim, Kim Yong-Hyub, Ahn Sung-Ja, Oh In-Jae

机构信息

Department of Internal Medicine, Chonnam National University Medical School, Chonnam National University Hwasun Hospital, Hwasun 58128, Republic of Korea.

College of Pharmacy, Pusan National University, Busan 46241, Republic of Korea.

出版信息

Cancers (Basel). 2023 Mar 5;15(5):1606. doi: 10.3390/cancers15051606.

Abstract

This study aimed to add real-world evidence to the literature regarding the effectiveness and safety of durvalumab consolidation (DC) after concurrent chemoradiotherapy (CCRT) in the treatment of unresectable stage III non-small cell lung cancer (NSCLC). Using a hospital-based NSCLC patient registry and propensity score matching in a 2:1 ratio, we conducted a retrospective cohort study of patients with unresectable stage III NSCLC who completed CCRT with and without DC. The co-primary endpoints were 2-year progression-free survival and overall survival. For the safety evaluation, we evaluated the risk of any adverse events requiring systemic antibiotics or steroids. Of 386 eligible patients, 222 patients-including 74 in the DC group-were included in the analysis after propensity score matching. Compared with CCRT alone, CCRT with DC was associated with increased progression-free survival (median: 13.3 vs. 7.6 months, hazard ratio[HR]: 0.63, 95% confidence interval[CI]: 0.42-0.96) and overall survival (HR: 0.47, 95% CI: 0.27-0.82) without an increased risk of adverse events requiring systemic antibiotics or steroids. While there were differences in patient characteristics between the present real-world study and the pivotal randomized controlled trial, we demonstrated significant survival benefits and tolerable safety with DC after the completion of CCRT.

摘要

本研究旨在为同步放化疗(CCRT)后使用度伐利尤单抗巩固治疗(DC)在不可切除的III期非小细胞肺癌(NSCLC)治疗中的有效性和安全性相关文献增添真实世界证据。我们利用基于医院的NSCLC患者登记系统,并按2:1的比例进行倾向评分匹配,对完成CCRT且接受或未接受DC的不可切除III期NSCLC患者进行了一项回顾性队列研究。共同主要终点为2年无进展生存期和总生存期。对于安全性评估,我们评估了需要全身使用抗生素或类固醇的任何不良事件的风险。在386例符合条件的患者中,222例患者(包括DC组中的74例)在倾向评分匹配后纳入分析。与单纯CCRT相比,CCRT联合DC与无进展生存期延长(中位数:13.3个月对7.6个月,风险比[HR]:0.63,95%置信区间[CI]:0.42 - 0.96)和总生存期延长(HR:0.47,95%CI:0.27 - 0.82)相关,且需要全身使用抗生素或类固醇的不良事件风险未增加。虽然本真实世界研究与关键随机对照试验的患者特征存在差异,但我们证明了CCRT完成后使用DC具有显著的生存获益和可耐受的安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1861/10000649/319158723fd1/cancers-15-01606-g001.jpg

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