西妥昔单抗联合治疗头颈部鳞状细胞癌的临床与经济性研究进展

Clinical and economic research progress of cetuximab combination therapy for squamous cell carcinoma of head and neck

头颈癌是全球第六大常见的癌症,绝大多数是鳞状细胞癌,患者确诊时已为局部晚期,超过半数患者在2年内将会发生局部复发或远处转移。西妥昔单抗作为全球首个靶向表皮生长因子受体的IgG1单克隆抗体,于2020年3月在中国获批复发性或转移性头颈部鳞癌新适应证。本文通过对西妥昔单抗联合治疗头颈部鳞状细胞癌的国内外临床及经济性研究进行分析,为该药物在中国临床应用及医保决策提供参考。通过系统检索国内外文献,纳入RCT研究12篇、成本效果分析6篇。临床研究结果证实了西妥昔单抗加到铂类治疗方案中的疗效与安全性,但并没有研究证明其可替代铂类治疗方案。经济性研究结果并未得出一致结论,中国的研究表明西妥昔单抗联合治疗并不是头颈部鳞状细胞癌患者经济性的选择。由于该适应证还未进入医保,头颈癌患者用药仍然受限,建议新适应证尽早通过谈判进入医保,提高患者用药可及性。

Head and neck cancers are the sixth most common cancer worldwide,the vast majority of which are squamous cell carcinomas.The patients were diagnosed as locally advanced disease,up to 50%of which have developed loco-regional relapse or distant metastasis within 2 years.As the world’s first IgG1 monoclonal antibody targeting EGFR,cetuximab was approved to be applied in recurrent or metastatic squamous cell carcinoma of head and neck as a new indication in China in March 2020.This paper analyzes the clinical and economic research progress of cetuximab combination therapy for squamous cell carcinoma of head and neck at home and abroad,providing a reference for the clinical application of this drug in China and medical insurance decisions.By systematically searching the domestic and foreign literatures,12 RCTs and 6 cost-effectiveness analysis literatures were included.The results of clinical studies have confirmed the efficacy and safety of cetuximab added to platinum-based regimens,but no studies have demonstrated the feasibility of its replacement of platinum-based regimens.The results of the economic studies failed to reach a consistent conclusion,and the study in China indicated that cetuximab combination therapy was not an economic option for patients with squamous cell carcinoma of head and neck.However,since this indication has not yet entered medical insurance,the medication for patients with head and neck cancers is still limited.It is recommended that new indication should enter medical insurance through negotiation as soon as possible to improve the accessibility of medication for patients.