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

Jan 1, 2016, 00:00
10.1016/j.jval.2015.08.013
https://www.valueinhealthjournal.com/article/S1098-3015(15)04942-6/fulltext
Title : Impact of the 12-Gene Colon Cancer Assay on Clinical Decision Making for Adjuvant Therapy in Stage II Colon Cancer Patients
Citation : https://www.valueinhealthjournal.com/action/showCitFormats?pii=S1098-3015(15)04942-6&doi=10.1016/j.jval.2015.08.013
First page : 82
Section Title : Comparative Effectiveness Research/Health Technology Assessment (HTA)
Open access? : Yes
Section Order : 13

Objectives

To evaluate the impact of the 12-gene Colon Cancer Recurrence Score Assay—a clinically validated prognosticator in stage II colon cancer after surgical resection—on adjuvant treatment decisions in T3 mismatch repair proficient (MMR-P) stage II colon cancer in clinical practice.

Methods

This retrospective analysis included all patients with T3 MMR-P stage II colon cancer (Clalit Health Services members) with Recurrence Score results (time frame January 2011 to May 2012). Treatment recommendations pretesting were compared with the treatments received. Changes were categorized as decreased (to observation alone/removing oxaliplatin from the therapy) or increased (from observation alone/adding oxaliplatin to the therapy) intensity.

Results

The analysis included 269 patients; 58%, 32%, and 10% of the values were in the low ( 95% CI 30.0%–45.7%) score groups. The direction of the change was consistent with the assay result, with increased intensity more common in higher score values and decreased intensity more common in lower score values.

Conclusions

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.

Categories :
  • Clinical Outcomes
  • Clinical Outcomes Assessment
  • Diagnostics & Imaging
  • Gastrointestinal Disorders
  • Medical Technologies
  • Oncology
  • Specific Diseases & Conditions
Tags :
  • 12-gene colon cancer assay
  • adjuvant chemotherapy
  • colon cancer
  • decision impact
  • Oncotype DX
  • Recurrence Score
Regions :
  • Africa
  • Eastern and Central Europe
  • Middle East
  • Western Europe
ViH Article Tags :