Clinical outcomes of recurrent or metastatic head and neck cancer after failure of platinum and nivolumab: a multicenter retrospective study

BACKGROUND: Platinum and anti-PD-1 antibodies are the front-line systemic therapy for recurrent or metastatic head and neck squamous cell carcinoma (RM-HNSCC). However, limited data are available on clinical outcomes and appropriate regimens for patients with RM-HNSCC following treatment failure with these agents. PATIENTS AND METHODS: We retrospectively analyzed the clinical data of patients with RM-HNSCC from 10 Japanese institutions in whom platinum and nivolumab treatment failed. RESULTS: Of the 480 patients included in the study, 236 were treated with the best supportive care and had a median overall survival of 3.1 months. The remaining 244 patients received salvage-line chemotherapy, which was paclitaxel + cetuximab in 72 (30%), paclitaxel or docetaxel in 89 (36%), and tegafur/gimeracil/oteracil in 48 (20%); the respective objective response rates were 54.9%, 27.9%, and 25.5%, with median progression-free survival of 5.4 months and median overall survival of 13.0 months. Multivariable analysis identified disease stabilization or response on prior nivolumab and paclitaxel + cetuximab as salvage-line chemotherapy to be associated with encouraging progression-free and overall survival. CONCLUSION: This study sheds light on clinical outcomes and prognostic factors in patients with RM-HNSCC after failure of platinum and anti-PD-1 antibody therapy. The findings provide essential baseline data for future therapeutic development in salvage-line settings.