Implementing precision cancer medicine in the public health services of Norway: the diagnostic infrastructure and a cost estimate.

Autor:	Ree AH; Department of Oncology, Akershus University Hospital, Lørenskog, Norway.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway., Russnes HG; Department of Pathology, Oslo University Hospital, Oslo, Norway.; Department of Cancer Genetics, Oslo University Hospital, Oslo, Norway., Heinrich D; Department of Oncology, Akershus University Hospital, Lørenskog, Norway., Dueland S; Department of Oncology, Oslo University Hospital, Oslo, Norway., Boye K; Department of Oncology, Oslo University Hospital, Oslo, Norway.; Department of Tumor Biology, Oslo University Hospital, Oslo, Norway., Nygaard V; Department of Tumor Biology, Oslo University Hospital, Oslo, Norway., Silwal-Pandit L; Department of Cancer Genetics, Oslo University Hospital, Oslo, Norway., Østrup O; Department of Cancer Genetics, Oslo University Hospital, Oslo, Norway., Hovig E; Department of Tumor Biology, Oslo University Hospital, Oslo, Norway.; Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway.; Institute of Computer Science, University of Oslo, Oslo, Norway.; Norwegian Cancer Genomics Consortium, Oslo, Norway., Nygaard V; Department of Core Facilities, Oslo University Hospital, Oslo, Norway., Rødland EA; Department of Cancer Genetics, Oslo University Hospital, Oslo, Norway., Nakken S; Department of Tumor Biology, Oslo University Hospital, Oslo, Norway.; Norwegian Cancer Genomics Consortium, Oslo, Norway., Øien JT; Department of Tumor Biology, Oslo University Hospital, Oslo, Norway., Johansen C; Department of Oncology, Akershus University Hospital, Lørenskog, Norway., Bergheim IR; Department of Cancer Genetics, Oslo University Hospital, Oslo, Norway., Skarpeteig V; Department of Cancer Genetics, Oslo University Hospital, Oslo, Norway., Sathermugathevan M; Department of Tumor Biology, Oslo University Hospital, Oslo, Norway., Sauer T; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Pathology, Akershus University Hospital, Lørenskog, Norway., Lund-Iversen M; Department of Pathology, Oslo University Hospital, Oslo, Norway., Beiske K; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Pathology, Oslo University Hospital, Oslo, Norway., Nasser S; Department of Radiology, Akershus University Hospital, Lørenskog, Norway., Julsrud L; Department of Radiology, Oslo University Hospital, Oslo, Norway., Reisse CH; Department of Radiology, Oslo University Hospital, Oslo, Norway., Ruud EA; Department of Radiology, Akershus University Hospital, Lørenskog, Norway., Flørenes VA; Department of Pathology, Oslo University Hospital, Oslo, Norway., Hagene KT; Department of Oncology, Oslo University Hospital, Oslo, Norway., Aas E; Institute of Health & Society, University of Oslo, Oslo, Norway.; Department of Health Services Research, Akershus University Hospital, Lørenskog, Norway., Lurås H; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Health Services Research, Akershus University Hospital, Lørenskog, Norway., Johnsen-Soriano S; Department of Oncology, Akershus University Hospital, Lørenskog, Norway.; Department of Tumor Biology, Oslo University Hospital, Oslo, Norway., Geitvik GA; Department of Cancer Genetics, Oslo University Hospital, Oslo, Norway., Lingjærde OC; Department of Cancer Genetics, Oslo University Hospital, Oslo, Norway.; Institute of Computer Science, University of Oslo, Oslo, Norway., Børresen-Dale AL; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Cancer Genetics, Oslo University Hospital, Oslo, Norway., Mælandsmo GM; Department of Tumor Biology, Oslo University Hospital, Oslo, Norway., Flatmark K; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Tumor Biology, Oslo University Hospital, Oslo, Norway.; Department of Gastroenterological Surgery, Oslo University Hospital, Oslo, Norway.
Jazyk:	angličtina
Zdroj:	ESMO open [ESMO Open] 2017 May 02; Vol. 2 (2), pp. e000158. Date of Electronic Publication: 2017 May 02 (Print Publication: 2017).
DOI:	10.1136/esmoopen-2017-000158
Abstrakt:	Objective: Through the conduct of an individual-based intervention study, the main purpose of this project was to build and evaluate the required infrastructure that may enable routine practice of precision cancer medicine in the public health services of Norway, including modelling of costs. Methods: An eligible patient had end-stage metastatic disease from a solid tumour. Metastatic tissue was analysed by DNA sequencing, using a 50-gene panel and a study-generated pipeline for analysis of sequence data, supplemented with fluorescence in situ hybridisation to cover relevant biomarkers. Cost estimations compared best supportive care, biomarker-agnostic treatment with a molecularly targeted agent and biomarker-based treatment with such a drug. These included costs for medication, outpatient clinic visits, admission from adverse events and the biomarker-based procedures. Results: The diagnostic procedures, which comprised sampling of metastatic tissue, mutation analysis and data interpretation at the Molecular Tumor Board before integration with clinical data at the Clinical Tumor Board, were completed in median 18 (8-39) days for the 22 study patients. The 23 invasive procedures (12 from liver, 6 from lung, 5 from other sites) caused a single adverse event (pneumothorax). Per patient, 0-5 mutations were detected in metastatic tumours; however, no actionable target case was identified for the current single-agent therapy approach. Based on the cost modelling, the biomarker-based approach was 2.5-fold more costly than best supportive care and 2.5-fold less costly than the biomarker-agnostic option. Conclusions: The first project phase established a comprehensive diagnostic infrastructure for precision cancer medicine, which enabled expedite and safe mutation profiling of metastatic tumours and data interpretation at multidisciplinary tumour boards for patients with end-stage cancer. Furthermore, it prepared for protocol amendments, recently approved by the designated authorities for the second study phase, allowing more comprehensive mutation analysis and opportunities to define therapy targets. Competing Interests: Competing interests: None declared.
Databáze:	MEDLINE
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