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. Long-term responses in R/M HNSCC patients treated with nivolumab are rare but gradually increasing. For this patient group, our best estimate of the optimal time to end treatment is 3 years, as the PFS in this study reached a plateau at that timepoint.
对于复发/转移性头颈部鳞状细胞癌（R/M HNSCC）长期应答者，主动停用免疫检查点抑制剂治疗的最佳时机尚未明确。我们对246例接受纳武利尤单抗治疗的R/M HNSCC患者进行回顾性研究，以确定主动停用纳武利尤单抗治疗的最佳时机。我们分析了所有病例中无进展生存期（PFS）达到平台期的时间点，比较了19例（7.7%）持续治疗患者与227例（92.3%）已停药患者的预后，并评估了治疗持续时间及无治疗间隔期（TFI）。6年总生存率为11.8%（中位生存期12.1个月），6年无进展生存率为15.3%（中位无进展生存期3.0个月）。PFS曲线在3年内保持稳定。纳武利尤单抗治疗中位持续时间为2.9个月（范围0.03–81.9）：持续治疗组为41.8个月（5.6–81.9）；自主停药组为36.8个月（4.0–70.1）；毒性停药组为30.6个月（2.8–64.8）；疾病进展组为2.0个月（0.03–42.9）。自主停药组的TFI为15.1个月（0.6–61.6），毒性停药组为30.6个月（2.8–64.8）。接受纳武利尤单抗治疗的R/M HNSCC患者获得长期应答的情况虽少见但逐渐增多。针对此类患者群体，本研究PFS在3年时达到平台期，据此我们建议最佳治疗终止时间可考虑设定为3年。
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