Real-world evaluation of nivolumab in patients with non-nasopharyngeal recurrent or metastatic head and neck cancer: A retrospective multi-center study by the Turkish Oncology Group (TOG).

Abstract

e18004 Background: Head and neck cancers (HNCs) represent a significant global health concern due to high morbidity and mortality rates. The prognosis for advanced or recurrent cases remains challenging. Nivolumab obtained approval for recurrent or metastatic HNC based on the Phase III CheckMate 141 trial. This study aimed to evaluate the real-world outcomes of nivolumab in patients with non-nasopharyngeal HNC. Methods: In this multicenter retrospective study, we analyzed 124 patients with recurrent or metastatic non-nasopharyngeal HNC who received nivolumab in the second-line setting and beyond. Data were collected from 22 different cancer centers across Turkey. The effectiveness and safety of the treatment and survival outcomes were evaluated. Results: The median follow-up duration was 7.5 months (3-66.1 months). Overall survival (OS) and progression-free survival (PFS) were determined to be 11.8 and 3.8 months, respectively. Nivolumab exhibited clinical responses, yielding an objective response rate (ORR) of 29.9% and a disease control rate (DCR) of 55.7%. Safety assessments consistently revealed a well-tolerated profile, with no reported instances of treatment discontinuation or mortality attributed to adverse side effects. Notably, several factors, including performance status, neutrophil-to-lymphocyte ratio, tumor location, and p16 positivity, emerged as prognostic indicators significantly associated with OS. Conclusions: Nivolumab is an effective and safe treatment option for patient with recurrent or metastatic non-nasopharyngeal HNC in real-world setting. [Table: see text]