IMPRESS-Norway: improving public cancer care by implementing precision medicine in Norway; inclusion rates and preliminary results.

IF 2.7 3区 医学 Q3 ONCOLOGY Acta Oncologica Pub Date : 2024-05-23 DOI:10.2340/1651-226X.2024.28322
Katarina Puco, Gro Live Fagereng, Sigmund Brabrand, Pitt Niehusmann, Egil Støre Blix, Eli Sihn Samdal Steinskog, Åse Haug, Cecilie Fredvik Torkildsen, Irja Alida Oppedal, Sebastian Meltzer, Åsmund Flobak, Kajsa Anna Margareta Johansson, Line Bjørge, Geir Olav Hjortland, Astrid Dalhaug, Jo-Åsmund Lund, Bjørnar Gilje, Marte Grønlie Cameron, Randi Hovland, Ragnhild S Falk, Sigbjørn Smeland, Hege Elisabeth Giercksky Russnes, Kjetil Taskén, Åslaug Helland
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Abstract

Background and purpose: In Norway, comprehensive molecular tumour profiling is implemented as part of the public healthcare system. A substantial number of tumours harbour potentially targetable molecular alterations. Therapy outcomes may improve if targeted treatments are matched with actionable genomic alterations. In the IMPRESS-Norway trial (NCT04817956), patients are treated with drugs outside the labelled indication based on their tumours molecular profile.

Patients and methods: IMPRESS-Norway is a national, prospective, non-randomised, precision cancer medicine trial, offering treatment to patients with advanced-stage disease, progressing on standard treatment. Comprehensive next-generation sequencing, TruSight Oncology 500, is used for screening. Patients with tumours harbouring molecular alterations with matched targeted therapies available in IMPRESS-Norway, are offered treatment. Currently, 24 drugs are available in the study. Primary study endpoints are percentage of patients offered treatment in the trial, and disease control rate (DCR) defined as complete or partial response or stable disease in evaluable patients at 16 weeks (W16) of treatment. Secondary endpoint presented is DCR in all treated patients.

Results: Between April 2021 and October 2023, 1,167 patients were screened, and an actionable mutation with matching drug was identified for 358 patients. By the data cut off 186 patients have initiated treatment, 170 had a minimum follow-up time of 16 weeks, and 145 also had evaluable disease. In patients with evaluable disease, the DCR was 40% (58/145). Secondary endpoint analysis of DCR in all treated patients, showed DCR of 34% (58/170).

Interpretation: Precision cancer medicine demonstrates encouraging clinical effect in a subset of patients included in the IMPRESS-Norway trial.

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IMPRESS-Norway: Improving Public cancer care by implementing precision medicine in Norway; inclusion rates and preliminary results.
背景和目的:在挪威,全面的肿瘤分子图谱分析是公共医疗系统的一部分。大量肿瘤都存在潜在的靶向分子改变。如果靶向治疗与可操作的基因组改变相匹配,治疗效果可能会有所改善。在 IMPRESS-Norway 试验(NCT04817956)中,患者将根据其肿瘤分子特征接受标示适应症之外的药物治疗:IMPRESS-Norway是一项全国性、前瞻性、非随机的精准癌症医学试验,为接受标准治疗后病情进展的晚期患者提供治疗。采用新一代综合测序技术 TruSight Oncology 500 进行筛查。如果患者的肿瘤存在分子改变,而 IMPRESS-Norway 提供了匹配的靶向疗法,那么患者就可以接受治疗。目前,有 24 种药物可用于该研究。主要研究终点是在试验中获得治疗的患者比例,以及疾病控制率(DCR),定义为治疗 16 周(W16)后可评估患者的完全或部分应答或疾病稳定。次要终点是所有接受治疗患者的疾病控制率:2021 年 4 月至 2023 年 10 月期间,共筛查了 1,167 名患者,为 358 名患者确定了可操作的突变和匹配药物。截至数据截止日,186 名患者已开始治疗,170 名患者的随访时间最短为 16 周,145 名患者的病情可评估。在病情可评估的患者中,DCR 为 40%(58/145)。次要终点分析显示,所有接受治疗的患者的DCR为34%(58/170):癌症精准医疗在IMPRESS-Norway试验的部分患者中取得了令人鼓舞的临床效果。
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来源期刊
Acta Oncologica
Acta Oncologica 医学-肿瘤学
CiteScore
4.30
自引率
3.20%
发文量
301
审稿时长
3 months
期刊介绍: Acta Oncologica is a journal for the clinical oncologist and accepts articles within all fields of clinical cancer research. Articles on tumour pathology, experimental oncology, radiobiology, cancer epidemiology and medical radio physics are also welcome, especially if they have a clinical aim or interest. Scientific articles on cancer nursing and psychological or social aspects of cancer are also welcomed. Extensive material may be published as Supplements, for which special conditions apply.
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