Impact of the 12-Gene Colon Cancer Assay on Clinical Decision Making for Adjuvant Therapy in Stage II Colon Cancer Patients

Abstract

Testing significantly affected adjuvant treatment in T3 MMR-P stage II colon cancer in clinical practice. The study is limited by its design, which compared treatment recommendations pretesting to actual treatments received post-testing, lack of a control group, and nonassessment of confounding factors that may have affected treatment decisions.

Oncotype DX® colon cancer assay for prediction of recurrence risk in patients with stage II and III colon cancer: A review of the evidence

“…Pre-assay, 121 (45%) patients received recommendation for chemotherapy; post-assay, 75 (28%) actually received chemotherapy. Changes in treatment intensity were generally consistent with the Recurrence Score results with increased treatment intensity observed more often at higher scores and decreased intensity at lower scores [24]. Consistent with prior results, in this first international study of the role of the 12-gene assay in clinical decision making, the use of the 12-gene assay had an impact on treatment decisions in Israel, with an overall net reduction in chemotherapy use.…”

“…The impact of the 12-gene colon cancer assay results on stage II colon cancer in clinical practice was evaluated after the first two years of use in a survey of medical oncologists [22]. Subsequently, two prospective studies examined the impact of the assay on clinical decision making at multiple centers within the Mayo Clinic Cancer Research Consortium network [23], and in patients from the Clalit Health Services in Israel [24].…”

Recurrence‐associated gene signature optimizes recurrence‐free survival prediction of colorectal cancer

“…As a new diagnostic test for determining the likelihood of recurrence in stage II colon cancer patients after surgical resection, Onco-typeDX colon cancer assay has been commercially available worldwide since 2010 Webber et al, 2010). Specially, the effectiveness of the Oncotype DX colon cancer assay has been validated in a prospective multicenter study for the prediction of recurrence risk in stage II colon cancer patients (Brenner et al, 2016;Srivastava et al, 2014). Yothers et al (2013) also found that incorporating the Onco-typeDX colon cancer assay might better inform adjuvant therapy decisions in stage II and III colon cancer.…”

The Prognostic Yield of Biomarkers Harvested in Chemotherapy-Naive stage II Colon Cancer: Can We Separate the Wheat from the Chaff?

“…Molecular traits are already at the foundations of the currently proposed high-risk criteria are inaccurate (20). Much energy has been put into gene panels that would yield better prognostic and predictive tools for risk assessment (21)(22)(23), but the results are thus far disappointing, with no panels having reached widespread incorporation in clinical practice. The same goes for most other proposed prognostic systems (9,19,(24)(25)(26).…”