Reis Costa Denise, Winge-Main Anna K, Skog Anna, Tsuruda Kaitlyn M, Robsahm Trude Eid, Kulle Andreassen Bettina
Department of Research, The Cancer Registry of Norway, Norwegian Institute of Public Health, Oslo, Norway; Norwegian Research Centre for Women's Health, Oslo University Hospital, Oslo, Norway.
Department of Oncology, Oslo University Hospital, Oslo, Norway; Oslo University, Faculty of Medicine, Oslo, Norway.
Acta Oncol. 2024 Dec 17;63:965-973. doi: 10.2340/1651-226X.2024.41266.
Norway has one of the highest rates of cutaneous melanoma (CM) incidence and mortality globally. Immune checkpoint inhibitor (ICI) therapy for CM was introduced between 2014 and 2017 to improve treatment and patient prognosis, but knowledge about its clinical usage is limited. This study investigates patient's characteristics and treatment patterns in real-world practice compared to clinical trial results.
All adult (≥18) CM patients treated with ICI therapy in Norway from 2014 to 2021 were included, utilizing high-coverage data from multiple national registries to describe patients' health, socioeconomic factors, and treatment management, stratified by first ICI therapy. We compared patient and tumour characteristics with findings from five randomized controlled trials (RCTs).
Among 2,083 patients receiving ICI therapy, 975 (47%) received nivolumab as their first treatment in the metastatic setting. Patients on combination therapy were younger and had higher education and income levels compared to those on monotherapy. Overall, real-world patients were older and had a higher incidence of brain metastases than those in RCTs. Approximately, 1 in 5 patients would have been excluded from RCTs due to pre-existing autoimmune diseases. Targeted therapy was the most common secondary systemic treatment after first-line PD-1 inhibitors.
This study details ICI therapy in Norway, highlighting differences between real-world ICI users and clinical trial participants, raising questions about the effectiveness of this treatment for patients not eligible for trials.
挪威是全球皮肤黑色素瘤（CM）发病率和死亡率最高的国家之一。2014年至2017年间引入了用于CM的免疫检查点抑制剂（ICI）疗法，以改善治疗效果和患者预后，但关于其临床应用的知识有限。本研究调查了实际临床应用中患者的特征和治疗模式，并与临床试验结果进行比较。
纳入2014年至2021年在挪威接受ICI治疗的所有成年（≥18岁）CM患者，利用多个国家登记处的高覆盖数据来描述患者的健康状况、社会经济因素和治疗管理情况，并按首次ICI治疗进行分层。我们将患者和肿瘤特征与五项随机对照试验（RCT）的结果进行了比较。
在接受ICI治疗的2083例患者中，975例（47%）在转移性疾病背景下首次接受纳武单抗治疗。与接受单药治疗的患者相比，接受联合治疗的患者更年轻，教育程度和收入水平更高。总体而言，实际临床中的患者比RCT中的患者年龄更大，脑转移发生率更高。约五分之一的患者因既往存在自身免疫性疾病而被排除在RCT之外。靶向治疗是一线PD-1抑制剂治疗后最常见的二线全身治疗方法。
本研究详细介绍了挪威的ICI治疗情况，突出了实际应用ICI的患者与临床试验参与者之间的差异，引发了关于该治疗方法对不符合试验条件患者有效性的质疑。
