Effect of performance status on the therapeutic effect of nivolumab in recurrent or metastatic squamous cell carcinoma of the head and neck.

Abstract

Background: Systemic chemotherapy is the primary treatment strategy for recurrent or metastatic squamous cell carcinoma of the head and neck (RM-SCCHN). Therapeutic strategies are changing considerably with the introduction of molecular-targeted and immune checkpoint inhibitor (ICI) therapies in addition to conventional cytotoxic therapy. The CheckMate-141 and KEYNOTE-048 trials have enabled the use of ICIs as first-line treatment to improve the overall prognosis of RM-SCCHN. However, background factors affecting treatment responses, including performance status (PS), remain poorly defined. Therefore, we investigated the effect of PS in patients treated with nivolumab.

Methods: We retrospectively reviewed the treatment outcomes and backgrounds of 31 patients with RM-SCCHN who received nivolumab monotherapy between April 2017 and March 2023.

Results: The patient background was male/female = 29/2, median age was 68 years (range 39-85), PS0/1/2 = 14/15/2, and oral/oropharynx/hypopharynx/larynx = 2/12/12/5. Median overall survival was 8.0 months (95% confidence interval [CI]: 4.3-30.6 months), median progression-free survival was 3.0 months (95% CI 1.7-9.1 months), and objective response rate was 22.6% (95% CI 11.1-40.1%). Immune-related adverse events of grade 3 or higher were observed in three patients (9.7%). Eight (29.6%) of the 27 patients (excluding four patients who maintained complete response for over 2 years) were successfully transferred to post-treatment. In the multivariate analysis, Eastern Cooperative Oncology Group (ECOG) PS (Hazard Ratio: 9.87, 95% CI 1.79-54.56) was associated with poor survival.

Conclusion: The efficacy of nivolumab is reduced in patients with poor PS.