Department of Dermatology, Montpellier University Hospital and Montpellier University, Montpellier, France.
Department of Dermatology, Nîmes University Hospital and Montpellier University, Nîmes, France.
J Cancer Res Clin Oncol. 2023 Jul;149(7):3549-3562. doi: 10.1007/s00432-022-04246-0. Epub 2022 Aug 12.
Anti-PD1 agents are currently recommended as first-line treatment in advanced cutaneous squamous cell carcinoma (acSCC) by updated European guidelines. Although acSCC frequently affects elderly patients with multiple comorbidities, this subset of patients is often excluded of registration clinical trials.
To assess anti-PD-1 efficacy and safety in elderly acSCC patients in real-life conditions and describe this specific population with oncogeriatric evaluation tools.
A multicenter retrospective study including acSCC patients at least 70 years old treated with PD-1 inhibitors was conducted in French referral centers. The primary endpoint was the overall response rate (ORR). Secondary endpoints included safety data, time to response (TTR), duration of response (DOR), overall survival (OS), and progression-free survival (PFS).
63 patients were included. ORR was 57.1% (95% CI 44.0-69.5), median TTR and DOR were 3 and 5.5 months respectively. Median OS was not reached (95% CI 12.5 months-not reached) at data cut-off after a median follow-up of 8 months while median PFS was 8 months. (95% CI 5 months-not reached). Grade 3-5 adverse effects occurred in 47.6% of patients. 41.3% of patients experienced degradation of ECOG performance status during anti-PD-1 treatment. Nutritional state worsened in 27% of patients and 57.1% lost weight during treatment.
In this particular subset of acSCC patients PD-1 inhibitors obtain results similar to those obtained in younger populations included in pivotal clinical trials, with acceptable safety. A specific oncogeriatric evaluation at treatment initiation and during follow-up appears important in this setting most notably to help manage toxicity.
欧洲最新指南建议将抗 PD-1 药物作为晚期皮肤鳞状细胞癌（acSCC）的一线治疗方法。尽管 acSCC 常影响患有多种合并症的老年患者，但这一亚组患者通常被排除在注册临床试验之外。
评估抗 PD-1 药物在真实环境中治疗老年 acSCC 患者的疗效和安全性，并使用肿瘤老年病学评估工具描述这一特定人群。
在法国转诊中心进行了一项多中心回顾性研究，纳入了至少 70 岁接受 PD-1 抑制剂治疗的 acSCC 患者。主要终点是总缓解率（ORR）。次要终点包括安全性数据、反应时间（TTR）、缓解持续时间（DOR）、总生存期（OS）和无进展生存期（PFS）。
共纳入 63 例患者。ORR 为 57.1%（95%CI 44.0-69.5），中位 TTR 和 DOR 分别为 3 个月和 5.5 个月。截至数据截止时，中位随访 8 个月后，中位 OS 未达到（95%CI 12.5 个月-未达到），而中位 PFS 为 8 个月（95%CI 5 个月-未达到）。47.6%的患者发生 3-5 级不良事件。41.3%的患者在抗 PD-1 治疗期间出现 ECOG 体能状态恶化。27%的患者营养状况恶化，57.1%的患者在治疗期间体重减轻。
在这一特定的 acSCC 患者亚组中，PD-1 抑制剂的疗效与关键性临床试验中纳入的年轻患者相似，安全性可接受。在这种情况下，治疗开始时和随访期间进行特定的肿瘤老年病学评估似乎很重要，尤其是有助于管理毒性。
