Abstract / Summary
Abstract 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, n = 25). After PSM, 22 well‐balanced pairs were identified with no significant differences in baseline characteristics between the two groups. The median follow‐up time was 29.80 months (95% confidence interval [ CI ]: 25.83–33.77) in the CCRT group and 30.23 months (95% CI : 25.07–35.40) in the NCCRT group. In the overall cohort, the 2‐year EFS and OS rates were 74.1% vs 60.6% and 85.6% vs 83.6%, respectively. In the matched cohort, the 2‐year EFS and OS rates were 73.8% vs 58.3% (log‐rank p = 0.087) and 86.2% vs 82.5% (log‐rank p = 0.342), respectively. Univariate analysis revealed that the platelet‐to‐lymphocyte ratio (PLR) and hemoglobin‐albumin‐lymphocyte‐platelet (HALP) score were significantly associated with OS in the CCRT group ( p = 0.019 and p = 0.009, respectively). Treatment‐related adverse events were predominantly grades 1–2, including radiodermatitis, oral mucositis, and hematological toxicities, with no significant increase in severe toxicities in the NCCRT group. 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.