Real-world treatment sequences and outcomes in recurrent/metastatic head and neck squamous cell carcinoma in France (TERENCE study).

BACKGROUND: Recurrent and/or metastatic head and neck squamous cell carcinoma (R/M SCCHN) is aggressive, with limited therapeutic options. Guidelines recommend immunotherapy (IO) or cetuximab ± chemotherapy 1st-line, depending on patient/tumour characteristics. Data on subsequent treatment sequencing are limited. We investigated treatment sequences for R/M SCCHN in France. METHODS: Patients with R/M SCCHN who received 1st-line pembrolizumab or cetuximab (November 2020-December 2022) were identified retrospectively from a hospital discharge database, which covers 85% of the French population. Treatment sequences, overall survival (OS) and time to next treatment or death (TTNT-D) were analysed. Outcomes were compared between sequences of interest (pembrolizumab-based 1st-line followed by cetuximab ± chemotherapy, or vice versa). RESULTS: Of 4757 patients who received 1st-line IO or cetuximab, 2529 (53%) received 2nd-line. Fewer patients who received IO-based vs. cetuximab-based 1st-line treatment received 2nd-line (45.4% vs. 61.5%): more on 1st-line IO reached end of follow-up without 2nd-line (26.6% vs. 8.2%). 2nd-line/subsequent treatments were heterogeneous. For patients receiving ≥1 treatment line, median OS was 13.2 months overall (15.4 months for patients receiving ≥2 lines). For 1,742 patients who received sequences of interest, there were no significant differences between 1st-line IO vs. cetuximab for OS (hazard ratio [HR] 0.98, [95%CI 0.90, 1.11], p=0.84) or TTNT-D (HR 0.92 [0.83, 1.03]. p=0.15). CONCLUSIONS: In this nationwide cohort study, OS did not differ significantly between patients who received IO followed by cetuximab vs. cetuximab followed by IO. These findings support flexibility in treatment sequencing and highlight the need for further research to optimize treatment strategies.