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

Author:

Park Cheol-Kyu1ORCID,Jeon Nakyung23ORCID,Park Hwa-Kyung1ORCID,Oh Hyung-Joo1ORCID,Kim Young-Chul1,Jeon Ha-Lim4ORCID,Kim Yong-Hyub5,Ahn Sung-Ja5,Oh In-Jae1ORCID

Affiliation:

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

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

3. Research Institute for Drug Development, Pusan National University, Busan 46241, Republic of Korea

4. College of Pharmacy, Jeonbuk National University, Jeonju 54896, Republic of Korea

5. Department of Radiation Oncology, Chonnam National University Medical School, Chonnam National University Hwasun Hospital, Hwasun 58128, Republic of Korea

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.

Funder

Korean government

Chonnam National University Hwasun Hospital Institute for Biomedical Science

Chonnam National University Hospital Biomedical Research Institute

Publisher

MDPI AG

Subject

Cancer Research,Oncology

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