Clinical Utility of Multigene Profiling Assays in Invasive Early-Stage Breast Cancer /

The tumour marker utility grading system, which was proposed in 1996 [1] and later refined in 2009 [2], provides a framework to evaluate the clinical utility of tumour markers, and was used to grade the levels of evidence of the prognostic and predictive studies that inform the following recommendations. [...] Interpretation of Evidence for Recommendation 4 Although there is evidence for the prognostic ability of Oncotype DX and Prosigna in node-positive patients, the clinical utility of the multigene profiling assays depends on potential benefit to the patients with node-positive disease. [...] Interpretation of Evidence for Recommendation 5 The ability to predict late recurrence and offer treatment for patients at risk for late recurrence is important; however, the evidence is currently insufficient to support the clinical utility of multigene profiling assays for this purpose. [...] By reviewing the clinical validity of these assays together, MOAC will also critically discuss the utility of these assays in the appropriate clinical contexts to determine their role in the care of Ontario patients. [...] The currency of each document is ensured through periodic review and evaluation of the scientific literature and, where appropriate, the addition of newer literature to the original evidence base.