Safety Profile of Neoadjuvant Chemoimmunotherapy with Nivolumab for Patients with Resectable NSCLC in the Real-world (CReGYT-04 Neo-Venus).2023 · BACKGROUND: This real-world study aimed to investigate feasibility and profile of adverse events (AEs) associated with neoadjuvant chemoimmunotherapy in patients with resectable non-small cell lung cancer (NSCLC) in the real-world. METHODS: We conducted a multicenter retrospective study using real-world data of patients with resectable stage II-III NSCLC treated with neoadjuvant chemoimmunotherapy with nivolumab between March 2023 and July 2024 at 29 Japanese institutions. The safety, AE profiles, and risk factors for grade 3 or higher AEs were evaluated. RESULTS: A total of 126 patients were analyzed. In the neoadjuvant phase, grade 3 or higher treatment-related AEs and immune-related AEs (irAEs) occurred in 36 (28.6%) and 12 (9.5%) patients, respectively. One patient (0.8%) died from a neoadjuvant treatment-related AE of cytokine storm and subsequent multi-organ failure. Definitive surgery after neoadjuvant treatment was performed in 114 patients (90.5%), with only one death within 90 days of surgery. Half of endocrine-related irAEs occurred in the postoperative phase. Among the demographic characteristics, a history of coronary artery disease (CAD) was a significant risk factor for grade 3 or higher treatment-related AEs (odds ratio [OR] = 16.556, [95% confidence interval [CI] = 1.698-161.479], P = 0.016) and irAEs (OR = 10.196, [95% CI = 1.193-87.166], P = 0.034). CONCLUSIONS: Real-world data from the era of neoadjuvant chemoimmunotherapy showed feasibility consistent with the results of randomized controlled trials. The incidence of grade 3 or higher AEs was not particularly high but was clinically significant, and a history of CAD may be a predictor.
