尼妥珠单抗联合放疗±化疗用于局部晚期头颈部鳞状细胞癌的根治性治疗：一项随机对照试验的荟萃分析
Nimotuzumab combined with radiotherapy+/- chemotherapy for definitive treatment of locally advanced squamous cell carcinoma of head and neck: a metanalysis of randomized controlled trials.
作者信息
Guan Meng, Zhang Dan, Zhao Yue, Mao Mingdi, Shen Kang, Wang Xia, Bi Chun
机构信息
Department of Oncology, The First People's Hospital of Jiangxia District, Wuhan City and Union Jiangnan Hospital, Huazhong University of Science and Technology, Wuhan, China.
The First Clinical College of Xuzhou Medical University, Xuzhou, China.
出版信息
Front Oncol. 2024 Jun 13;14:1380428. doi: 10.3389/fonc.2024.1380428. eCollection 2024.
OBJECTIVES
To assess the efficacy and safety of nimotuzumab in combination with radiotherapy or chemoradiotherapy for locally advanced head and neck squamous cell carcinoma.
METHODS
Systematic searches were performed on PubMed, Web of Science, Embase, Cochrane Library, China National Knowledge Infrastructure, China Biomedical Medicine, Wanfang, VIP databases. Seven eligible randomized controlled trials (n = 1012) were selected through rigorous inclusion and exclusion criteria.
RESULTS
A total of 1012 cases were included. including 508 (50.2%) in the nimotuzumab combination treatment group; There were 504 cases (49.8%) in the control group. The results of meta-analysis showed that the overall survival (Hazard Ratio [HR]=0.75, 95% Confidence Interval [CI]: 0.62-0.90, P<0.05), progression-free survival (HR=0.69, 95% CI: 0.54-0.87, P<0.05), complete response rate (Risk Ratio [RR]=1.52, 95% CI: 1.24-1.86, P<0.05), and objective response rate (RR=1.32, 95% CI: 1.17-1.48, P<0.05) were significantly improved in the nimotuzumab combination treatment group compared with the control group. In terms of the incidence of adverse effects, only the incidence of rash was the nimotuzumab combination group higher than in the treatment alone group, and there was no significant difference between the remaining adverse reactions (neutropenia, anemia, nausea/vomiting, mucositis, dermatitis, dysphagia).
CONCLUSION
Nimotuzumab combined with radiotherapy or chemoradiotherapy is more effective than radiotherapy alone or chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck, and the safety profile is controllable. Therefore, the addition of nimotuzumab to treatment is expected to be an effective treatment option for this disease. However, more prospective randomized controlled trials are needed to fully explore the effectiveness of this treatment in patients with locally advanced head and neck squamous cell carcinoma.
SYSTEMATIC REVIEW REGISTRATION
identifier PROSPERO (CRD: 42022383313).
目的
评估尼妥珠单抗联合放疗或放化疗治疗局部晚期头颈部鳞状细胞癌的疗效和安全性。
方法
对PubMed、Web of Science、Embase、Cochrane图书馆、中国知网、中国生物医学文献数据库、万方数据库、维普数据库进行系统检索。通过严格的纳入和排除标准筛选出7项符合条件的随机对照试验（n = 1012）。
结果
共纳入1012例病例。其中尼妥珠单抗联合治疗组508例（50.2%）；对照组504例（49.8%）。荟萃分析结果显示，尼妥珠单抗联合治疗组的总生存期（风险比[HR]=0.75，95%置信区间[CI]：0.62 - 0.90，P<0.05）、无进展生存期（HR=0.69，95% CI：0.54 - 0.87，P<0.05）、完全缓解率（风险比[RR]=1.52，95% CI：1.24 - 1.86，P<0.05）和客观缓解率（RR=1.32，95% CI：1.17 - 1.48，P<0.05）均较对照组有显著改善。在不良反应发生率方面，仅皮疹发生率尼妥珠单抗联合组高于单纯治疗组，其余不良反应（中性粒细胞减少、贫血、恶心/呕吐、口腔黏膜炎、皮炎、吞咽困难）两组间无显著差异。
结论
尼妥珠单抗联合放疗或放化疗治疗局部晚期头颈部鳞状细胞癌比单纯放疗或放化疗更有效，且安全性可控。因此，加用尼妥珠单抗有望成为该病的有效治疗选择。然而，需要更多前瞻性随机对照试验来充分探索这种治疗方法对局部晚期头颈部鳞状细胞癌患者的有效性。
系统评价注册
标识符PROSPERO（CRD：42022383313）
Zotero 插件