Abstract:

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.

Key words: Immune checkpoint inhibitors, Recurrent/metastatic head and neck squamous cell carcinoma, Consensus