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.

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.