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J Natl Cancer Inst. 2015 Nov 23;108(4). doi: 10.1093/jnci/djv362. Print 2016 Apr.

Treatment Algorithms Based on Tumor Molecular Profiling: The Essence of Precision Medicine Trials.

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Affiliations of authors:Department of Medical Oncology, Institut Curie , Paris & Saint-Cloud , France (CLT, MK, MA); EA7285 Versailles-St-Quentin-en-Yvelines University , France (CLT, RR); Investigational Cancer Therapeutics, M. D. Anderson Cancer Center , Houston, TX (AMT); Drug Development Program, Department of Medical Oncology and Hematology, Princess Margaret Hospital , Toronto , Canada (PB); Department of Genetics, Institut Curie , Paris , France (GP, CC, ER, IB); Department of Pathology, Institut Curie , Paris , France (AVS); Institut Curie / INSERM U900 , Paris , France (NS, XP); Department of Surgery, Institut Curie , Paris & Saint-Cloud , France (RR); Institut Curie, INSERM U830 , Paris , France (OD); EA7331, University of Paris-Descartes , Paris , France (IB).


With the advent of high-throughput molecular technologies, several precision medicine (PM) studies are currently ongoing that include molecular screening programs and PM clinical trials. Molecular profiling programs establish the molecular profile of patients' tumors with the aim to guide therapy based on identified molecular alterations. The aim of prospective PM clinical trials is to assess the clinical utility of tumor molecular profiling and to determine whether treatment selection based on molecular alterations produces superior outcomes compared with unselected treatment. These trials use treatment algorithms to assign patients to specific targeted therapies based on tumor molecular alterations. These algorithms should be governed by fixed rules to ensure standardization and reproducibility. Here, we summarize key molecular, biological, and technical criteria that, in our view, should be addressed when establishing treatment algorithms based on tumor molecular profiling for PM trials.

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