韩国真实世界数据：放化疗后接受Durvalumab治疗的不可切除的III期非小细胞肺癌(NSCLC)患者

SCI 19 May 2023

Korean Real-world Data on Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC) Patients Treated with Durvalumab after Chemoradiotherapy: PACIFIC-KR

(J Thorac Oncol; IF:20.121)

Corresponding Author: In-Jae Oh, MD, PhD. Department of Internal Medicine, Chonnam National University Medical School and Hwasun Hospital, 322 Seoyang-ro, Hwasun, Jeonnam 58128, Republic of Korea. Tel.: 061-379-7617. Fax: 061-379-7619. E-mail: droij@jnu.ac.kr

Park C-K, Oh H-J, Kim Y-C, Kim Y-H, Ahn S-J, Jeong WG, Lee JY, Lee JC, Choi CM, Ji W, Song SY, Choi J, Lee SY, Kim H, Lee SY, Park J, Yoon SH, Joo JH, Oh I-J, Korean Real-world Data on Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC) Patients Treated with Durvalumab after Chemoradiotherapy: PACIFIC-KR, Journal of Thoracic Oncology (2023), doi: https://doi.org/10.1016/j.jtho.2023.04.008.

Introduction 研究背景

This study aimed to investigate real-world evidence for efficacy and safety of durvalumab consolidation (DC) after chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC).

本研究旨在探讨放化疗后durvalumab巩固治疗(DC)对不可切除的III期非小细胞肺癌(NSCLC)患者疗效和安全性的真实世界证据。

Methods 方法  

Patients with stage III NSCLC who started DC after CRT between September 2018 and December 2020 and were treated at five tertiary hospitals in Korea were included. The primary endpoint was real-world progression-free survival (rwPFS). Secondary endpoints were overall survival (OS), objective response rate (ORR), and adverse events including radiation pneumonitis (RP) and immune-related adverse events (irAEs).

纳入2018年9月至2020年12月在韩国5家三级医院接受CRT后开始DC的III期NSCLC患者。主要终点为真实世界无进展生存期(rwPFS)。次要研究终点为总生存期(OS)、客观缓解率(ORR)和不良反应，包括放射性肺炎(RP)和免疫相关不良反应(irAEs)。

Results 结果  

A total of 157 patients were enrolled. At the median follow-up of 19.1 months, median rwPFS of DC was 25.9 months (95% CI:16.5-35.4), and the 1-, 2-, and 3-year rwPFS rates were 59.4%, 51.8%, and 43.5%, respectively. The median OS were not mature, and ORR of DC was 51.0%. High PD-L1 expression (≥50%) and development of RP requiring steroid treatment were significantly associated with longer and shorter rwPFS, respectively. RP, RP requiring steroid treatment, and irAEs developed in 57 (36.3%), 42 (26.8%), and 53 (33.8%) patients, respectively. Among peripheral blood cell counts at the initiation of DC, a high derived monocyte-to-lymphocyte ratio (dMLR) was the most significant risk factor for the development of RP requiring steroid treatment and irAEs.

共纳入157例患者。中位随访19.1个月时，DC患者的中位rwPFS为25.9个月(95% CI:16.5 ~ 35.4)， 1、2、3年rwPFS率分别为59.4%、51.8%、43.5%。中位OS不成熟，DC患者ORR为51.0%。PD-L1高表达(≥50%)和需要激素治疗的RP分别与较长的rwPFS和较短的rwPFS显著相关。发生RP 57例(36.3%)，需要激素治疗的RP 42例(26.8%)，irAEs 53例(33.8%)。在DC初始治疗时的外周血细胞计数中，单核细胞与淋巴细胞比值(dMLR)是需要类固醇和irAEs治疗的RP发病的最显著的危险因素。

Conclusion 结论  

Compared with the outcome of the PACIFIC trial, this real-world data demonstrated favorable survival benefits of DC after CRT in patients with unresectable stage III NSCLC. Blood-based biomarkers could predict higher-grade RP and irAEs before the initiation of DC.

与PACIFIC研究结果相比，本研究在真实世界数据中显示了DC在不可切除的III期NSCLC患者CRT后具有良好的生存获益。血液生物标志物可以在DC治疗初始阶段预测更高级别的RP和irAEs。

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