Background: Nivolumab is the standard treatment for platinum-refractory recurrent/metastatic head and neck squamous cell carcinoma (R/M-HNSCC). Several studies have reported the efficacy of paclitaxel plus cetuximab (PC) combination therapy in this patient population.
Methods: We conducted a retrospective analysis of patients with platinum-refractory R/M-HNSCC treated with nivolumab or PC at our institution between January 2015 and March 2022. Eligibility criteria included histologically confirmed HNSCC, ECOG performance status (PS) 0-2, with platinum-refractory R/M disease, defined as recurrence or disease progression within 6 months after platinum-based definitive chemoradiotherapy.
Results: The baseline characteristics of the 56 patients (21 PC/35 nivolumab) were ECOG PS 1-2 (76/54%), metastatic sites ≥ 2 (33/46%), local recurrence (62/23%), and median tumor size (43.2/26.2 mm). Median progression-free survival (mPFS) tended to favor PC over nivolumab (4.3/2.7 months, hazard ratio [HR]: 0.7, p = 0.41), and median overall survival tended to be inferior for PC (8.0/23.2 months, HR: 1.58, p = 0.20). Similar results were obtained after adjusting for several relevant factors. The objective response rate was numerically higher with PC (31/19%). Grade 3/4 adverse events were more frequent with PC (29/6%), and the most prevalent were leukopenia (19%) for PC and liver dysfunction (6%) for nivolumab. Subsequent treatment with PC and nivolumab was administered to 75% and 72% of patients, respectively; the mPFS of these patients was significantly lower with PC (1.6/9.2 months, HR: 9.9, p < 0.001).
Conclusion: Both PC and nivolumab are viable treatment options for platinum-refractory R/M-HNSCC, though their efficacy and safety profiles should be carefully considered.
Keywords: Cetuximab; Chemoradiotherapy; Head and neck cancer; Nivolumab; Paclitaxel.
© 2025. The Author(s) under exclusive licence to Japan Society of Clinical Oncology.