复发/转移性头颈部鳞癌免疫检查点抑制剂治疗专家共识(2024年版)

Expert consensus on immune checkpoint inhibitors treatment for recurrent/metastatic head and neck squamous cell carcinoma(2024 edition)

头颈部鳞状细胞癌(head and neck squamous cell carcinoma,HNSCC)是头颈部肿瘤最为常见的一种类型,具有较高的发病率和死亡率。随着帕博利珠单抗和纳武利尤单抗在国内相继获批用于复发/转移性(recurrent/metastatic,R/M)HNSCC的一线及后线治疗,免疫治疗已然成为R/MHNSCC的标准治疗。随着免疫检查点抑制剂(immunecheckpoint inhibitor,ICI)在临床中的广泛应用,生物标志物检测、不同人群免疫治疗方案的选择、免疫治疗效果的评估、免疫治疗不良反应(immunotherapy-related adverse event,irAE)的处理等也在不断规范和完善。中国临床肿瘤学会(Chinese Society of Clinical Oncology,CSCO)头颈肿瘤专家委员会和中国抗癌协会(China Anti-Cancer Association,CACA)头颈肿瘤专业委员会组织专家组进行深入探讨,共同制定了《复发/转移性头颈部鳞癌免疫检查点抑制剂治疗专家共识》,旨在形成相对规范统一的认识,更好地指导临床实践。经过多轮商议和探讨,专家组汇总出以下推荐意见。程序性死亡受体-配体1(programmed death-ligand 1,PD-L1)表达是抗程序性死亡受体1(programmed death-1,PD-1)单抗一线治疗R/M HNSCC的疗效预测生物标志物,推荐患者治疗前常规进行PD-L1联合阳性评分(combined positive score,CPS)检测。对于PD-L1CPS≥1的患者,推荐帕博利珠单抗联合铂类药物和5-FU,或者帕博利珠单抗单药作为一线治疗方案。关于帕博利珠单抗单药或联合化疗方案的选择,需结合患者的PD-L1 CPS评分(如CPS评分是否≥20)、肿瘤负荷或临床症状进行综合判断。对于PD-L1表达情况未知或PD-L1 CPS<1的患者,可选择帕博利珠单抗联合铂类药物和5-FU作为一线治疗方案。对于不适合使用5-FU的患者,可选择帕博利珠单抗联合铂类药物和紫杉类药物作为一线治疗方案。对于铂类药物耐药或复发/转移阶段含铂类药物治疗失败且既往未接受过抗PD-1单抗治疗的患者,推荐纳武利尤单抗或帕博利珠单抗作为后线治疗。对于无法耐受化疗且不适合接受抗PD-1单抗单药治疗的患者,可选择帕博利珠单抗或纳武利尤单抗联合西妥昔单抗作为一线或后线治疗方案。对于接受ICI的患者,推荐在治疗全程密切监测免疫相关不良反应的症状并及时作出判断,必要时进行多学科联合诊治。

Head and neck squamous cell carcinoma(HNSCC)is the most common head and neck tumor,characterized by high morbidity and high mortality.Since pembrolizumab and nivolumab were approved for the first line and platinum-refractory disease treatment of HNSCC,immunotherapy has become the standard of care for recurrent/metastatic(R/M)HNSCC.With the wide clinical application of immune checkpoint inhibitors,clinical guidance is needed on the use of these agents,including biomarker testing,appropriate patient selection,response assessment and adverse event management.To better guide the clinical treatment of R/M HNSCC patients on immune checkpoint inhibitors,the Chinese Society of Clinical Oncology(CSCO)and the China Anti-Cancer Association(CACA)convened an expert task force charged with developing consensus recommendations on these key aspects.This consensus serves as a guidance to standardize utilization of immunotherapy in HNSCC and to optimize clinical practice.After several rounds of discussion,the expert task force generated the following consensus recommendations.Programmed death-ligand 1(PD-L1)expression is a predictive biomarker of anti-programmed death-1(PD-1)first-line therapy for R/M HNSCC patients.It is recommended to routinely perform PD-L1 combined positive score(CPS)testing in patients before treatment.Pembrolizumab monotherapy or pembrolizumab in combination with platinum and 5-FU is recommended as first-line treatment for R/M HNSCC patients with PD-L1 CPS≥1.There is a need for a comprehensive consideration of PD-L1 CPS score(e.g.,if CPS≥20),tumor burden and clinical symptoms when those patients are treated with pembrolizumab monotherapy or pembrolizumab combination regimen.Pembrolizumab in combination with platinum and 5-FU could be the first-line treatment option for R/M HNSCC patients with PD-L1 unknown or PD-L1 CPS<1.Pembrolizumab in combination with platinum and taxane could be the first-line treatment option for patients who are intolerant of 5-FU.Nivolumab or pembrolizumab is recommended as the late-line treatment for platinum-resistant patients or patients who are platinum-refractory and have not previously received PD-1 inhibitors in R/M setting.For patients who are intolerant of chemotherapy and unsuitable for PD-1 inhibitor monotherapy,pembrolizumab or nivolumab in combination with cetuximab can be the treatment option as first-line or late-line therapy.For patients treated with immune checkpoint inhibitors,it is recommended to closely monitor the signs of adverse events during the whole course of treatment and use the multidisciplinary team(MDT)for treatment strategy if necessary.