Impact of the 12-gene recurrence score assay on deciding adjuvant chemotherapy for stage II and IIIA/B colon cancer: the SUNRISE-DI study.
BACKGROUND
Recent advances in adjuvant chemotherapy for early colon cancer have widened physicians' recommendations on the regimen and duration (3 or 6 months) of the treatment. We conducted this prospective study to evaluate whether the 12-gene recurrence score (12-RS) assay affected physicians' recommendations on adjuvant treatment selection.


PATIENTS AND METHODS
Patients with stage IIIA/IIIB or stage II colon cancer were enrolled. After the patients discussed adjuvant treatment with their treating physicians, the physicians filled in the questionnaire before assay indicating the treatment recommendation. When the 12-RS assay results were available, the physicians again filled in the questionnaire after assay. The primary endpoint was the rate of change in treatment recommendations from before to after the assay, with a threshold rate of change being 20%. Patients with stage IIIA/B to II were enrolled in a ratio of 2 : 1.


RESULTS
Overall, the treatment recommendations changed in 40% of cases after obtaining 12-RS assay results. Recommendations were changed in 45% (80/178; 95% confidence interval, 37% to 53%; P < 0.001) and 30% (29/97; 95% confidence interval, 21% to 40%; P < 0.001) of patients with stage IIIA/B and II colon cancer, respectively. Patients with stage IIIA/B cancer had significantly more change than those with stage II cancer (P = 0.0148). From before to after the 12-RS assay, the percentage of patients whose physicians reported being confident in their treatment recommendations significantly increased from 54% to 81% in stage IIIA/B (P < 0.001) and from 65% to 83% in stage II (P < 0.001).


CONCLUSION
Our study confirmed the usefulness of the 12-RS assay in aiding the physician-patient decision-making process for tailoring adjuvant chemotherapy for stage IIIA/B colon cancer.
['Oki|E|E|', 'Watanabe|J|J|', 'Sato|T|T|', 'Kagawa|Y|Y|', 'Kuboki|Y|Y|', 'Ikeda|M|M|', 'Ueno|H|H|', 'Kato|T|T|', 'Kusumoto|T|T|', 'Masuishi|T|T|', 'Yamaguchi|K|K|', 'Kanazawa|A|A|', 'Nishina|T|T|', 'Uetake|H|H|', 'Yamanaka|T|T|', 'Yoshino|T|T|']
D001681:Biological Assay D017024:Chemotherapy, Adjuvant D003110:Colonic Neoplasms D006801:Humans D009364:Neoplasm Recurrence, Local D011446:Prospective Studies
adjuvant chemotherapy colon cancer 12-gene recurrence score (12-RS) treatment recommendation IDEA collaboration oncotype DX