Feasibility and efficacy of oral 5-FU in combination with pembrolizumab and cisplatin as first-line therapy for recurrent/metastatic head and neck squamous cell carcinoma: A prospective observational study.

Abstract

e18009 Background: This study addresses the need for alternative treatments in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients who are unsuitable for infusional 5-FU. Tegafur-Uracil, a substitute for 5-fluorouracil, was evaluated in combination with cisplatin and pembrolizumab as a first-line therapy. Conducted across five oncology centers in Taiwan, the retrospective study included 48 patients treated between January 2021 and December 2022. Methods: The endpoints were progression-free survival (PFS), overall survival (OS), and overall response rate (ORR). Results: The median PFS was 15.1 months, and the median OS was 24.5 months. The ORR was 70%, with complete remission (CR) in 6% of patients and partial remission (PR) in 64%. Stable disease (SD) was observed in 13% of patients. Survival outcomes were significantly better for patients achieving an objective response (CR or PR) compared to those with SD or progressive disease (PD). The median OS varied: it was not reached for CR patients, 48.0 months for PR, 17.3 months for SD, and 6.0 months for PD. Conclusions: The findings suggest that Tegafur-Uracil combined with cisplatin and pembrolizumab offers a viable alternative for patients with poor baseline conditions, with an improved safety profile. Prospective studies are recommended to validate these results.