III Medical Department at the Paracelsus Medical University, Salzburg, Austria.
Salzburg Cancer Research Institute, Salzburg, Austria.
Anticancer Res. 2023 Mar;43(3):1273-1282. doi: 10.21873/anticanres.16274.
BACKGROUND/AIM: Pembrolizumab alone or combined with chemotherapy is now approved in PD-L1-positive patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Since real-world data are pending, our goal was to evaluate the efficacy and safety of immune checkpoint inhibitor (CPI) therapy in an unselected cohort of patients with SCCHN.
We analyzed 78 patients with recurrent or metastatic SCCHN from three Austrian cancer centers that received CPI therapy alone or with chemotherapy as palliative first-line systemic treatment for this retrospective study. Patient characteristics, details on treatment, and survival were analyzed by a chart-based review.
Of the 78 patients analyzed, 55 patients were treated with CPI alone (45 with Pembrolizumab, 10 with Nivolumab) and 23 patients received chemotherapy with a platinum and 5-FU in addition to CPI. With a median follow-up of twelve months, the median PFS of all patients was 4 months [95% confidence interval (CI)=2.2-5.8] and the median OS was 11 months (95% CI=7.1-14.9). The overall response and disease control rates were 20.5% and 46.1%, respectively. There was no statistically significant difference in clinical outcome between patient groups with a different combined positive score (CPS). The rate of reported immune related adverse events was comparable to existing data.
Our findings confirm the results of the KEYNOTE-048 trial that CPI therapy alone or together with chemotherapy is an effective treatment for patients with recurrent or metastatic CPS-positive SCCHN.
背景/目的：帕博利珠单抗单药或联合化疗现已获批用于治疗 PD-L1 阳性的复发性或转移性头颈部鳞状细胞癌（SCCHN）患者。鉴于目前尚无真实世界的数据，我们的目标是评估免疫检查点抑制剂（CPI）治疗在未经选择的 SCCHN 患者中的疗效和安全性。
我们分析了来自奥地利三家癌症中心的 78 例复发性或转移性 SCCHN 患者的资料，这些患者接受 CPI 单药治疗（45 例接受帕博利珠单抗治疗，10 例接受纳武利尤单抗治疗）或 CPI 联合化疗作为姑息性一线全身治疗。通过病历回顾分析患者特征、治疗细节和生存情况。
在分析的 78 例患者中，55 例患者接受 CPI 单药治疗（45 例接受帕博利珠单抗治疗，10 例接受纳武利尤单抗治疗），23 例患者接受化疗联合铂类和 5-FU 加用 CPI。中位随访 12 个月时，所有患者的中位无进展生存期（PFS）为 4 个月[95%置信区间（CI）=2.2-5.8]，中位总生存期（OS）为 11 个月（95%CI=7.1-14.9）。总缓解率和疾病控制率分别为 20.5%和 46.1%。不同联合阳性评分（CPS）患者组的临床结局无统计学差异。报告的免疫相关不良事件发生率与现有数据相当。
我们的研究结果证实了 KEYNOTE-048 试验的结果，即 CPI 单药或联合化疗是治疗复发性或转移性 CPS 阳性 SCCHN 患者的有效治疗方法。
