Safety Profile of Neoadjuvant Chemoimmunotherapy With Nivolumab for Patients With Resectable Non-Small Cell Lung Cancer in the Real World (CReGYT-04 Neo-Venus).

[BACKGROUND] This real-world study investigated the 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 or 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 AEs were evaluated.

[RESULTS] A total of 126 patients were analyzed. In the neoadjuvant phase, grade ≥3 treatment-related AEs and immune-related AEs (irAEs) occurred in 36 (28.6%) and 12 (9.5%) patients, respectively. One patient (0.8%) died of a neoadjuvant treatment-related cytokine storm AE and subsequent multiorgan failure. Definitive surgery after neoadjuvant treatment was performed in 114 patients (90.5%), with only 1 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 was a significant risk factor for grade ≥3 treatment-related AEs (odds ratio, 16.556; 95% CI, 1.698-161.479; P = .016) and irAEs (odds ratio, 10.196; 95% CI, 1.193-87.166;, P = .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 AEs was not particularly high but was clinically significant, and a history of coronary artery disease may be a predictor.