Korean Real-World Data on Patients With Unresectable Stage III NSCLC Treated With Durvalumab After Chemoradiotherapy: PACIFIC-KR

Cheol-Kyu Park; Hyung-Joo Oh; Young-Chul Kim; Yong-Hyub Kim; Sung-Ja Ahn; Won Gi Jeong; Jeong Yeop Lee; Jae Cheol Lee; Chang Min Choi; Wonjun Ji; Si Yeol Song; Juwhan Choi; Sung Yong Lee; Hakyoung Kim; Shin Yup Lee; Jongmoo Park; Seong Hoon Yoon; Ji Hyeon Joo; In-Jae Oh

doi:10.1016/j.jtho.2023.04.008

Korean Real-World Data on Patients With Unresectable Stage III NSCLC Treated With Durvalumab After Chemoradiotherapy: PACIFIC-KR

J Thorac Oncol. 2023 Aug;18(8):1042-1054. doi: 10.1016/j.jtho.2023.04.008. Epub 2023 Apr 20.

Authors

Cheol-Kyu Park¹, Hyung-Joo Oh¹, Young-Chul Kim¹, Yong-Hyub Kim², Sung-Ja Ahn², Won Gi Jeong³, Jeong Yeop Lee³, Jae Cheol Lee⁴, Chang Min Choi⁵, Wonjun Ji⁵, Si Yeol Song⁶, Juwhan Choi⁷, Sung Yong Lee⁷, Hakyoung Kim⁸, Shin Yup Lee⁹, Jongmoo Park¹⁰, Seong Hoon Yoon¹¹, Ji Hyeon Joo¹², In-Jae Oh¹³

Affiliations

¹ Department of Internal Medicine, Chonnam National University Medical School and Hwasun Hospital, Jeonnam, Republic of Korea.
² Department of Radiation Oncology, Chonnam National University Medical School and Hwasun Hospital, Jeonnam, Republic of Korea.
³ Department of Radiology, Chonnam National University Medical School and Hwasun Hospital, Jeonnam, Republic of Korea.
⁴ Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
⁵ Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
⁶ Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
⁷ Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.
⁸ Department of Radiation Oncology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.
⁹ Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.
¹⁰ Department of Radiation Oncology, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.
¹¹ Department of Internal Medicine, Pusan National University School of Medicine, Yangsan Hospital, Gyeongnam, Republic of Korea.
¹² Department of Radiation Oncology, Pusan National University School of Medicine, Yangsan Hospital, Gyeongnam, Republic of Korea.
¹³ Department of Internal Medicine, Chonnam National University Medical School and Hwasun Hospital, Jeonnam, Republic of Korea. Electronic address: droij@jnu.ac.kr.

PMID: 37085032
DOI: 10.1016/j.jtho.2023.04.008

Abstract

Introduction: 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 NSCLC.

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

Results: 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% confidence interval: 16.5-35.4) and the 1-, 2-, and 3-year rwPFS rates were 59.4%, 51.8%, and 43.5%, respectively. The median overall survival was not mature, and objective response rate of DC was 51.0%. High programmed death-ligand 1 expression (≥50%) and development of RP requiring steroid treatment were significantly associated with longer (p = 0.043) and shorter rwPFS (p = 0.036), 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 was the most significant risk factor for the development of RP requiring steroid treatment (OR 44.76, 95% CI: 8.89-225.43, p < 0.001) and irAEs (OR 2.85, 95% CI: 1.27-6.41, p = 0.011).

Conclusions: Compared with the outcome of the PACIFIC trial, these real-world data revealed 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.

Keywords: Chemoradiotherapy; Durvalumab; Non–small cell lung cancer; Real-world data.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Carcinoma, Non-Small-Cell Lung* / drug therapy
Chemoradiotherapy
Humans
Lung Neoplasms* / drug therapy
Radiation Pneumonitis*
Republic of Korea / epidemiology
Steroids

Substances

durvalumab
Steroids