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

e18002 Background: 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 or without nimotuzumab in this postoperative population. Methods: LA-HNSCC patients with high-risk features after surgery were stratified: those with extranodal extension (ENE) or positive/insufficient margins received nimotuzumab plus CCRT (NCCRT; extremely high-risk), while those with other high-risk factors (e.g., pT3–4, N2–3) received CCRT alone (intermediate high-risk). All received intensity-modulated radiotherapy with weekly cisplatin. Overall survival (OS) was the primary endpoint; event-free survival (EFS) and safety were secondary. Results: A total of 75 patients were enrolled (CCRT: n=50; NCCRT: n=25). 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. The 2-year EFS rates were 74.1% and 60.6%, and the 2-year OS rates were 85.6% and 83.6%, respectively. Univariate analysis revealed that the platelet-to-lymphocyte ratio (PLR) and the 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 grade 1–2, including radiodermatitis, oral mucositis, and hematologic toxicities, with no significant increase in severe toxicities observed in the NCCRT group. Conclusions: Risk-stratified adjuvant CCRT with or without nimotuzumab demonstrates promising efficacy and acceptable safety in high-risk postoperative LA-HNSCC. PLR and HALP may serve as prognostic biomarkers in intermediate-risk patients, aiding postoperative surveillance.