Defining precision: The precision medicine initiative TRIALS NCI-MPACT and NCI-MATCH

• Published in: Current problems in cancer 2017-05, Vol.41 (3), p.182-193
• Main Authors: Coyne, Geraldine O’Sullivan, MD, PhD, Takebe, Naoko, MD, PhD, Chen, Alice P., MD
• Format: Article
• Language: English
• Subjects: Actionable mutation; Anticancer; Antineoplastic Agents - therapeutic use; Clinical Trials as Topic; Gene Expression Profiling - methods; Genomics; Hematology, Oncology and Palliative Medicine; High-Throughput Nucleotide Sequencing; Humans; Intersectoral Collaboration; Molecular Targeted Therapy - methods; Molecular Targeted Therapy - trends; Mutation; National Cancer Institute (U.S.); Neoplasms - drug therapy; Neoplasms - genetics; Neoplasms - pathology; Precision medicine; Precision Medicine - methods; Precision Medicine - trends; United States
• ISSN: 0147-0272; 1535-6345
• DOI: 10.1016/j.currproblcancer.2017.02.001

Abstract ‘Precision′ trials, using rationally incorporated biomarker targets and molecularly selective anti-cancer agents, have become of great interest to both patients and their physicians. In the endeavor to test the cornerstone premise of precision oncotherapy, that is, determining if modulating a specific molecular aberration in a patient′s tumor with a correspondingly specific therapeutic agent improves clinical outcomes, the design of clinical trials with embedded genomic characterization platforms which guide therapy are an increasing challenge. The NCI Precision Medicine Initiative is an unprecedented large interdisciplinary collaborative effort to conceptualize and test the feasibility of trials incorporating sequencing platforms and large scale bioinformatics processing that are not currently uniformly available to patients. NCI-MPACT and NCI-MATCH are two genomic to phenotypic trials under this NCI initiative, where treatment is selected according to pre-determined genetic alterations detected using next generation sequencing technology across a broad range of tumor types. In this review we will discuss the objectives and trial designs that have enabled the public-private partnerships required to complete the scale of both trials, as well as interim trial updates and strategic considerations that have driven data analysis and targeted therapy assignment, with the intent of elucidating further the benefits of this treatment approach for patients.