尼妥珠单抗联合放化疗治疗头颈部鳞状细胞癌和鼻咽癌：系统评价与荟萃分析

文献信息

中文摘要

背景： 在头颈部鳞状细胞癌中，放化疗基础上加用尼妥珠单抗的获益仍存争议，其在鼻咽癌中的作用更不明确。我们评估了该联合方案在两种疾病中的疗效和安全性。
方法： 我们检索了截至2025年5月的PubMed、Web of Science、Embase、Cochrane Library、中国知网、万方和维普数据库，纳入比较尼妥珠单抗联合放化疗与单纯放化疗的随机对照试验和倾向性评分匹配的回顾性研究。采用随机效应模型合并风险比和风险比及其95%置信区间。
结果： 在非鼻咽头颈部鳞状细胞癌中，九项随机试验（1142例患者）显示尼妥珠单抗改善了总生存期（风险比，0.55；95%置信区间，0.40-0.76）和无进展生存期（0.63；0.53-0.76）。尼妥珠单抗组的完全缓解率和客观缓解率似乎更高，但在针对发表偏倚进行剪补法校正后，两者均失去统计学显著性，表明这些发现主要由小样本研究效应驱动。两组间3-4级不良事件相当。对九项鼻咽癌研究（2846例患者，主要为回顾性）的探索性分析提示存在生存获益。
结论： 尼妥珠单抗联合放化疗可改善头颈部鳞状细胞癌的生存，且不增加严重毒性。鼻咽癌的发现仍属探索性，需在前瞻性试验中加以证实。

英文摘要

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.