Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan; Department of Otorhinolaryngology, Jikei University School of Medicine, Tokyo, Japan.
Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Oral Oncol. 2023 Dec;147:106615. doi: 10.1016/j.oraloncology.2023.106615. Epub 2023 Nov 4.
OBJECTIVES: Cetuximab-based chemotherapy is a standard 1st-line treatment for recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). However, few studies have reported survival data for a treatment sequence consisting of a PCE regimen (paclitaxel + carboplatin + cetuximab) followed by an immune checkpoint inhibitor. MATERIALS AND METHODS: We retrospectively assessed 37 patients with R/M SCCHN from the oral cavity, oropharynx, hypopharynx, and larynx who received PCE as 1st-line treatment followed by nivolumab as 2nd-line at the National Cancer Center Hospital East between December 2016 and July 2021. For comparison, we also analyzed 14 patients who did not receive nivolumab after PCE. RESULTS: Of the 37 patients who received nivolumab, overall response rate (ORR) by PCE was 48.6%, and median time to response and median progression-free survival (PFS) were 2.1 months (range: 0.8-4.8) and 4.4 months, respectively. In the nivolumab phase, ORR was 10.8%. 23 patients received 3rd-line therapy. Median PFS2, PFS3, and overall survival (OS) were 6.8, 11.6, and 19.5 months, respectively. Subgroup analysis by PD-L1 expression showed no significant difference in OS. Analysis of the comparison group revealed a trend toward improved OS in those who received nivolumab compared to those who did not (HR 0.47, 95%CI [0.19-1.13], p = 0.084). CONCLUSION: PCE followed by nivolumab shows a favorable survival outcome, representing the potential for rapid tumor response with PCE and extension of OS by the addition of nivolumab regardless of combined positive score.
目的：西妥昔单抗为基础的化疗是复发性和/或转移性头颈部鳞状细胞癌（R/M SCCHN）的标准一线治疗。然而，很少有研究报道过包含紫杉醇+卡铂+西妥昔单抗（PCE）方案治疗序贯免疫检查点抑制剂的生存数据。
材料与方法：我们回顾性评估了 2016 年 12 月至 2021 年 7 月在日本国立癌症中心医院东部接受 PCE 作为一线治疗，随后接受纳武利尤单抗作为二线治疗的 37 例来自口腔、口咽、下咽和喉的 R/M SCCHN 患者。为了比较，我们还分析了 14 例未接受 PCE 后纳武利尤单抗的患者。
结果：接受纳武利尤单抗治疗的 37 例患者中，PCE 的总体缓解率（ORR）为 48.6%，中位反应时间和中位无进展生存期（PFS）分别为 2.1 个月（范围：0.8-4.8）和 4.4 个月。纳武利尤单抗治疗阶段的 ORR 为 10.8%。23 例患者接受了三线治疗。中位 PFS2、PFS3 和总生存期（OS）分别为 6.8、11.6 和 19.5 个月。根据 PD-L1 表达的亚组分析，OS 无显著差异。对比组分析显示，与未接受纳武利尤单抗治疗的患者相比，接受纳武利尤单抗治疗的患者 OS 有改善趋势（HR 0.47，95%CI [0.19-1.13]，p=0.084）。
结论：PCE 序贯纳武利尤单抗治疗显示出良好的生存结果，代表 PCE 快速肿瘤缓解的潜力，以及无论联合阳性评分如何，纳武利尤单抗的加入均可延长 OS。
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