Nimotuzumab Combined With Chemoradiotherapy in Head and Neck Squamous Cell Carcinoma and Nasopharyngeal Carcinoma: A Systematic Review and Meta-Analysis.

BACKGROUND: The benefit of adding nimotuzumab to chemoradiotherapy in head and neck squamous cell carcinoma is debated, and its role in nasopharyngeal carcinoma is even less defined. We evaluated the efficacy and safety of this combination in both diseases. METHODS: We searched PubMed, Web of Science, Embase, Cochrane Library, China National Knowledge Infrastructure, Wanfang, and VIP databases through May 2025 for randomized controlled trials and propensity score-matched retrospective studies comparing nimotuzumab plus chemoradiotherapy with chemoradiotherapy alone. Random-effects models were used to pool hazard ratios and risk ratios with 95% confidence intervals. RESULTS: Nine randomized trials (1142 patients) in non-nasopharyngeal head and neck squamous cell carcinoma showed that nimotuzumab improved overall survival (hazard ratio, 0.55; 95% confidence interval, 0.40-0.76) and progression-free survival (0.63; 0.53-0.76). Complete and objective response rates appeared higher with nimotuzumab, but both lost statistical significance after trim-and-fill adjustment for publication bias, indicating that these findings were largely driven by small-study effects. Grade 3-4 adverse events were comparable between arms. An exploratory analysis of nine nasopharyngeal carcinoma studies (2846 patients, predominantly retrospective) suggested a survival benefit. CONCLUSION: Nimotuzumab combined with chemoradiotherapy improves survival in head and neck squamous cell carcinoma without increasing severe toxicity. The nasopharyngeal carcinoma findings remain exploratory and require confirmation in prospective trials.