Impact of the 12-gene recurrence score assay on deciding adjuvant chemotherapy for stage II and IIIA/B colon cancer: the SUNRISE-DI study

E Oki,J Watanabe,T Sato,Y Kagawa,Y Kuboki,M Ikeda,H Ueno,T Kato,T Kusumoto,T Masuishi,K Yamaguchi,A Kanazawa,T Nishina,H Uetake,T Yamanaka,T Yoshino

doi:10.1016/j.esmoop.2021.100146

Abstract

BackgroundRecent 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 methodsPatients 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.ResultsOverall, 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).ConclusionOur 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.

Highlights

We report the results of a multicenter, prospective, observational study (SUNRISE-DI) to evaluate whether the 12-gene recurrence score (12-Recurrence score (RS)) assay allowed a more detailed risk stratification of patients with stage IIIA/B and II colon cancer, helped physicians to make a recommendation for adjuvant chemotherapy, and led to tailoring the treatment of each patient in the current ‘post-International Duration Evaluation of Adjuvant Therapy (IDEA) collaboration’ era
11 patients were excluded before the pre-assay questionnaire due to ineligible staging (n 1⁄4 9), main tumor location in the rectum (n 1⁄4 1), and double cancer (n 1⁄4 1); 19 patients were excluded due to start of adjuvant chemotherapy before availability of the 12-RS results (n 1⁄4 8); tumor sampling failure (n 1⁄4 3); inappropriateness to continue the study (n 1⁄4 1), patient withdrawal (n 1⁄4 1); and deficient mismatch repair (MMR) known before post-assay assessment (n 1⁄4 6)
Among patients with stage IIIA/B cancer, 67.4% were deemed to be at low risk and 32.6% at high risk of recurrence according to the IDEA classification

Summary

Introduction

Adjuvant chemotherapy is the standard of care after complete surgical resection for stage III and high-risk stage II colon cancer.[1,2,3,4] Several guidelines have stated thatVolume 6 - Issue 3 - 2021 preferred regimens involve a fluoropyrimidine-based adjuvant treatment with or without oxaliplatin.[5,6]Conventionally, the recommended duration of adjuvant chemotherapy had been 6 months.[1,7,8,9] The recent combined analysis by the International Duration Evaluation of Adjuvant Therapy (IDEA) collaboration for stage III colon cancer, including the Japanese ACHIEVE trial, suggested that shortening the oxaliplatin-based adjuvant chemotherapy may be possible. 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. 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).

Methods

Results

Conclusion