挪威印象:通过在挪威实施精准医疗来改善公共癌症护理;纳入率和初步结果。
IMPRESS-Norway: improving public cancer care by implementing precision medicine in Norway; inclusion rates and preliminary results.
机构信息
Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.
Department of Oncology, Oslo University Hospital, Oslo, Norway.
出版信息
Acta Oncol. 2024 May 23;63:379-384. doi: 10.2340/1651-226X.2024.28322.
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.
背景与目的
在挪威,全面的肿瘤分子谱分析作为公共医疗体系的一部分实施。大量肿瘤存在潜在的可靶向分子改变。如果将靶向治疗与可操作的基因组改变相匹配,治疗效果可能会改善。在 IMPRESS-Norway 试验(NCT04817956)中,根据肿瘤的分子谱,患者接受标签适应证之外的药物治疗。
患者与方法
IMPRESS-Norway 是一项全国性、前瞻性、非随机、精准癌症医学试验,为晚期疾病进展且标准治疗失败的患者提供治疗。使用全面的下一代测序 TruSight Oncology 500 进行筛选。为存在 IMPRESS-Norway 中可用的靶向治疗匹配的分子改变的患者提供治疗。目前,该研究中有 24 种药物可用。主要研究终点是在试验中接受治疗的患者比例和疾病控制率(DCR),定义为治疗 16 周(W16)时可评估患者的完全或部分缓解或稳定疾病。报告的次要终点是所有治疗患者的 DCR。
结果
2021 年 4 月至 2023 年 10 月,对 1167 名患者进行了筛选,其中 358 名患者确定了具有匹配药物的可操作突变。截至数据截止日期,186 名患者已开始治疗,170 名患者的随访时间至少为 16 周,145 名患者也有可评估的疾病。在可评估疾病的患者中,DCR 为 40%(58/145)。对所有接受治疗的患者的 DCR 进行二次终点分析,显示 DCR 为 34%(58/170)。
结论
在 IMPRESS-Norway 试验中纳入的部分患者中,精准癌症医学显示出令人鼓舞的临床效果。