Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Progression-Free Survival and Treatment-Free Interval in Head and Neck Cancer With Long-Term Response to Nivolumab: Timing of Active Discontinuation

Version 1 : Received: 25 June 2024 / Approved: 26 June 2024 / Online: 26 June 2024 (10:47:37 CEST)

How to cite: Matsuo, M.; Masuda, M.; Yamauchi, M.; Hashimoto, K.; Kogo, R.; Sato, M.; Masuda, S.; Nakagawa, T. Progression-Free Survival and Treatment-Free Interval in Head and Neck Cancer With Long-Term Response to Nivolumab: Timing of Active Discontinuation. Preprints 2024, 2024061840. https://doi.org/10.20944/preprints202406.1840.v1 Matsuo, M.; Masuda, M.; Yamauchi, M.; Hashimoto, K.; Kogo, R.; Sato, M.; Masuda, S.; Nakagawa, T. Progression-Free Survival and Treatment-Free Interval in Head and Neck Cancer With Long-Term Response to Nivolumab: Timing of Active Discontinuation. Preprints 2024, 2024061840. https://doi.org/10.20944/preprints202406.1840.v1

Abstract

The optimal timing for actively discontinuing immune checkpoint inhibitor therapy in long-term responders with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) remains unresolved. We conducted a retrospective study of 246 patients with R/M HNSCC treated with nivolumab to determine the optimal timing to actively discontinue nivolumab therapy. We examined the point at which progression-free survival (PFS) plateaued in all cases. We compared the prognosis of 19 (7.7%) ongoing cases and 227 (92.3%) discontinued cases and analyzed treatment duration and treatment-free interval (TFI). The 6-year overall survival was 11.8% (median, 12.1), and the 6-year PFS was 15.3% (median, 3.0). The PFS curve remained stable for 3 years. The median duration of nivolumab treatment was 2.9 months (range, 0.03–81.9): Ongoing group, 41.8 (5.6–81.9); Decision group, 36.8 (4.0–70.1); Toxicity group, 30.6 (2.8–64.8); and progressive disease group, 2.0 (0.03–42.9). TFI in the Decision group was 15.1 months (0.6–61.6) and 30.6 months (2.8–64.8) in the Toxicity group. Limited number of long-term responders in R/M HNSCC cases treated with nivolumab exists. Given that PFS plateaued at 3 years, we propose that the optimal duration of treatment for this subset of patients is 3 years.

Keywords

recurrent/metastatic head and neck squamous cell carcinoma; nivolumab; long-term responder; active treatment discontinuation; timing

Subject

Medicine and Pharmacology, Otolaryngology

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