Perioperative immunotherapy for stage II-III NSCLC patients: A retrospective real-world analysis.

Abstract

e20048 Background: Stage II-III non-small cell lung cancer (NSCLC) is often considered curable. However, in the perioperative chemotherapy era, the median event-free survival is only 18.4 months, indicating an urgent unmet clinical need. Globally, immune checkpoint inhibitors (ICIs) have been approved for perioperative treatment of NSCLC, supported by evidence from five key clinical studies. This study aims to present real-world data on the clinical outcomes and tolerability of perioperative immunotherapy. Methods: A retrospective study was conducted, including adult patients (≥18 years) with stage II-III NSCLC (AJCC 9th edition) treated at Tianjin Medical University General Hospital between 2019 and 2024. Patients were eligible if they underwent surgery and received perioperative treatment based on ICIs. The primary endpoint was complete pathological response (pCR), while secondary endpoints included objective response rate (ORR), event-free survival (EFS), overall survival (OS), and safety. Results: From January 2019 to September 2024, a total of 84 patients were included, and the baseline characteristics were presented in the table. In terms of treatment, 58 (69.0%) received Tislelizumab, 12 (14.3%) received Pembrolizumab, and 14 (16.7%) received other ICIs. After completing at least two cycles of neoadjuvant immunotherapy, the ORR was 56.0% (47/84) according to RECIST v1.1. The rate of complete (R0) resection reached 100%, with a pCR observed in 38.1% of patients. With a median follow-up of 15.4 months, the median EFS was 39.4 months (95% CI: 16.88-70.24), and the OS data were not yet mature. The incidence of treatment-related adverse events (TRAEs) of all grades during the neoadjuvant and adjuvant phases were 79.8% and 90.5%, respectively, with grade 3-4 adverse reactions occurring at rates of 9.5% and 10.7%. Conclusions: In real-world settings, patients undergoing perioperative immunotherapy often present with more complex baseline characteristics. Nevertheless, perioperative immunotherapy has been shown to significantly enhance the pathological response rate and deliver superior survival outcomes compared to historical data from chemotherapy alone. Baseline characteristics. Overall(N=84) Overall(N=84) Age, Median (range) 68 (48-82) Comorbidities Sex, Male 71 (84.5%) Cardiovascular System TNM stage Hypertension 31 (36.9%)  IIB 3 (3.6%) Coronary Artery Disease 4 (4.8%)  IIIA 46 (54.8%) Others 14 (16.7%)  IIIB 35 (41.7%) Respiratory System Histology History of Tuberculosis 2 (2.4%)  Squamous cell carcinoma 63 (75%) COPD 7 (8.3%)  Adenocarcinoma 20 (23.8%) Endocrine System  Others 1 (1.2%) Diabetes 8 (9.5%) COPD: Chronic Obstructive Pulmonary Disease.