Impact of the 12-gene colon cancer assay on clinical decision making for adjuvant therapy in stage II colon cancer patients

Baruch Brenner, Ravit Geva, Megan Rothney, Alexander Beny, Ygael Dror, Mariana Steiner, Ayala Hubert, Efraim Idelevich, Alexander Gluzman, Ofer Purim, Einat Shacham-Shmueli, Katerina Shulman, Moshe Mishaeli, Sophia Man, Lior Soussan-Gutman, Haluk Tezcan, Calvin Chao, Adi Shani, Nicky Liebermann

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

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 (<30), intermediate (30-40), and high (≥41) score groups, respectively. In 102 patients (38%), treatment changed post-testing (decreased/increased intensity 76/26 patients). The overall impact was decreased chemotherapy use (45.0% to 27.9%; P < 0.001). Treatment changes occurred in all score groups, but more frequently in the high (change rate 63.0%; 95% confidence interval [CI] 42.3%-80.6%) than in the intermediate (30.6%; 95% CI 21.0%-41.5%) and low (37.6%; 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.

Original languageEnglish
Pages (from-to)82-87
Number of pages6
JournalValue in Health
Volume19
Issue number1
DOIs
StatePublished - 1 Jan 2016
Externally publishedYes

Keywords

  • 12-gene colon cancer assay
  • Oncotype DX
  • Recurrence Score
  • adjuvant chemotherapy
  • colon cancer
  • decision impact

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