The efficacy of concurrent chemoradiotherapy with or without nimotuzumab in high-risk patients with locally advanced head and neck squamous cell carcinoma post-surgery: A real-world study.

Purpose: Patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) harboring high-risk pathological features after radical surgery face high recurrence rates. This real-world study evaluated the efficacy and safety of concurrent chemoradiotherapy (CCRT) with and without nimotuzumab in this postoperative population. Methods: Patients with LA-HNSCC who had high-risk pathological features after surgery were stratified as follows: those with extranodal extension (ENE) or positive/insufficient margins received nimotuzumab plus CCRT (NCCRT; extremely high risk), whereas those with other high-risk factors (e.g., pT3-4 and N2-3) received CCRT alone (intermediate high risk). All patients underwent intensity-modulated radiotherapy with weekly cisplatin. Overall survival (OS) was the primary endpoint, and event-free survival (EFS) and safety were secondary endpoints. To minimize confounding bias due to non-randomized treatment allocation, propensity-score matching (PSM) was performed using a 1:1 nearest neighbor matching algorithm with a caliper width of 0.2 times the standard deviation of the propensity score. Results: A total of 75 patients were enrolled in this study (CCRT, n = 50; NCCRT, Conclusions: Risk-stratified adjuvant CCRT, with or without nimotuzumab, was associated with promising outcomes and acceptable safety in patients with high-risk postoperative LA-HNSCC. Thus, PLR and HALP may serve as candidate prognostic biomarkers for intermediate-risk patients and warrant further validation. These findings are hypothesis-generating and require confirmation in prospective randomized studies with dedicated control groups.