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The evidence framework for precision cancer medicine

Nature Reviews Clinical Oncology volume 15, pages 183–192 (2018)Cite this article

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Abstract

Precision cancer medicine (PCM) is a concept in which oncologists increasingly strive to tailor the use of targeted therapies in order to match the complexity of the cancer genome. This approach contradicts the historical framework used to support oncology practice that requires evidence from randomized controlled trials in order to change standards of care. This contrast demonstrates the irony of PCM: the therapies themselves are more precise than standard cytotoxic agents, although the clinical evidence supporting the benefits of these therapies is often considerably less precise. Nevertheless, the implementation of PCM should still be based on a framework of evidence-based development that supports clinical decision-making; this approach should not be simple off-label prescription of drugs following sequencing of a tumour biopsy sample. The clinical validation of increasingly complex diagnostic tests, the development of novel methods of evaluating efficacy, and the re-assessment of the standards of evidence sufficient to demonstrate the benefit of precision cancer therapies are all needed before PCM becomes the standard of care for patients with tumours harbouring genomic abnormalities of uncertain clinical significance.

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Author information

Authors and Affiliations

  1. Jeffrey A. Moscow is at Room 5W524, National Cancer Institute Shady Grove, 9609 Medical Center Drive, Bethesda, Maryland 20892–9739, USA.,

    Jeffrey A. Moscow

  2. Tito Fojo is at the Division of Haematology Oncology, Department of Medicine, Columbia University, Herbert Irving Pavilion 9–936, New York, New York 10032, USA; and the James J. Peters VA Medical Center, 130 West Kingsbridge Road, Bronx, New York 10468, USA.,

    Tito Fojo

  3. and the James J. Peters VA Medical Center, 130 West Kingsbridge Road, Bronx, New York 10468, USA.,

    Tito Fojo

  4. Richard L. Schilsky is at the American Society of Clinical Oncology, 2318 Mill Road, Suite 800, Alexandria, Virginia 22314, USA.,

    Richard L. Schilsky

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All authors made a substantial contribution to all aspects of the preparation of this manuscript.

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Correspondence to Jeffrey A. Moscow.

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Moscow, J., Fojo, T. & Schilsky, R. The evidence framework for precision cancer medicine. Nat Rev Clin Oncol 15, 183–192 (2018). https://doi.org/10.1038/nrclinonc.2017.186

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