■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。
■在PubMed上进行了系统搜索,WebofScience,Embase,科克伦图书馆,中国国家知识基础设施,中国生物医学,万方,VIP数据库。通过严格的纳入和排除标准选择了7项符合条件的随机对照试验(n=1012)。
■共1012例。尼妥珠单抗联合治疗组508例(50.2%);对照组504例(49.8%)。荟萃分析结果显示总生存期(危险比[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),与对照组相比,尼妥珠单抗联合治疗组的客观缓解率(RR=1.32,95%CI:1.17-1.48,P<0.05)明显提高。在不良反应的发生率方面,只有尼妥珠单抗联合治疗组的皮疹发生率高于单独治疗组,其余不良反应(中性粒细胞减少,贫血,恶心/呕吐,粘膜炎,皮炎,吞咽困难)。
■尼妥珠单抗联合放疗或放化疗对局部晚期头颈部鳞状细胞癌的疗效优于单纯放疗或放化疗,安全状况是可控的。因此,在治疗中加入尼妥珠单抗有望成为本病的有效治疗选择.然而,需要更多的前瞻性随机对照试验来全面探讨这种治疗对局部晚期头颈部鳞状细胞癌患者的有效性.
■标识符PROSPERO(CRD:42022383313)。
UNASSIGNED: To assess the efficacy and safety of nimotuzumab in combination with
radiotherapy or chemoradiotherapy for locally advanced head and neck squamous cell carcinoma.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: identifier PROSPERO (CRD: 42022383313).