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

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.