연구성과 홍보

EClinicalMedicine. 2025 Jun 4:84:103282.

Title : Adjuvant pembrolizumab therapy for completely resected stage I lung adenocarcinoma with micropapillary or solid histological subtypes: a single-center, single-arm, phase 2 trial

Authors : Jhingook Kim1*, Yeong Hak Bang2,3,4, Sehhoon Park2,5, Hyun-Ae Jung2, Jong-Mu Sun2, Jin Seok Ahn2, Myung-Ju Ahn2, Yeong Jeong Jeon1, Junghee Lee1, Jong Ho Cho1, Hong Kwan Kim1,6, Yong Soo Choi1, Jae Ill Zo1, Young Mog Shim1, Jung Hee Kang1, Jinseon Lee1, Yoon-La Choi4,5,6,7, Joungho Han7, Soohyun Hwang7,8, Ho Yun Lee4,5,9, Se-Hoon Lee2,4,5*

Affiliations :

1Department of Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

2Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

3Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.

4Department of Digital Health, Samsung Advanced Institute of Health Sciences and Technology, Sungkyunkwan University, Seoul, Republic of Korea.

5Department of Health Sciences and Technology, Samsung Advanced Institute of Health Sciences and Technology, Sungkyunkwan University, Seoul, Republic of Korea.

6Department of Clinical Research and Evaluation, Samsung Advanced Institute of Health Sciences and Technology, Sungkyunkwan University, Seoul, Republic of Korea.

7Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

8Lunit, Seoul, Republic of Korea.

9Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

DOI: 10.1016/j.eclinm.2025.103282.

Abstract :

Background: This study aimed to evaluate the efficacy and safety of adjuvant pembrolizumab in patients with completely resected stage I lung adenocarcinoma with micropapillary or solid-pattern (MPSOL).

Methods: This was a single-center, single-arm phase 2 study (ClinicalTrials.gov identifier: NCT03254004). Key eligibility criteria included patients with stage I lung adenocarcinoma (per the American Joint Committee on Cancer 8th edition; primary tumor of <4 cm and without nodal metastasis), characterized by MPSOL histological subtype upon postsurgical pathological examination Patients were treated with pembrolizumab 200 mg every 3 weeks for 1 year or until disease recurrence or intolerable toxicity. The primary endpoint was 3-year disease-free survival (DFS), defined as the time from surgery to recurrence or death from any cause. Secondary endpoints included overall survival and safety.

Findings: Between September 17, 2018, and February 10, 2022, 70 patients were enrolled. At a median follow-up of 45·0 months, the 3-year disease-free survival (DFS) was 83·2%, meeting the survival endpoint of >80%. Patients with EGFR mutations showed significantly poorer DFS than those with EGFR wild-type (hazard ratio [HR]: 5·01 [95% confidence interval (CI): 1·11-22·70], P = 0·036), although no significant differences were noted according to age, smoking status, tumor size, and PD-L1 tumor proportion score. Grade 3 or 4 treatment-related adverse events (AEs) occurred in 6 patients (8·6%). Thirteen AEs led to treatment discontinuation and the majority of these AEs resolved upon discontinuation and subsequent steroid treatment.

Interpretation: Adjuvant pembrolizumab exhibited promising clinical efficacy in patients with stage I lung MPSOL, particularly those with EGFR-wild type, and exhibited tolerable safety.