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.

Informations de copyright

Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Disclosure EO reports receiving honoraria for lecturing from Chugai Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co., Ltd, Bayer Yakuhin Japan, Eli Lilly, Yakult Honsha Co., Ltd, Takeda Pharmaceutical Co., Ltd, ONO Pharmaceutical Co., Ltd, and Merck Biopharma Co., Ltd, outside the submitted work. JW reports receiving honoraria for lecturing from Johnson and Johnson and Medtronic Co., Ltd, outside the submitted work. YK reports receiving honoraria for lecturing from Chugai Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co., Ltd, Bayer Yakuhin Japan, Eli Lilly, Yakult Honsha Co., Ltd, Takeda Pharmaceutical Co., Ltd, ONO Pharmaceutical Co., Ltd, and Merck Biopharma Co., Ltd, outside the submitted work. YK reports receiving honoraria from Taiho Pharmaceutical Co., Ltd, ONO Pharmaceutical Co., Ltd, Bayer Yakuhin Japan, Sanofi, and Eli Lilly, and receiving honoraria for consultancy/advisory roles from Takeda and Boehringer Ingelheim, receiving research funding from Taiho Pharmaceutical Co., Ltd, Takeda Pharmaceutical Co., Ltd, ONO Pharmaceutical Co., Ltd, AstraZeneca, Daiichi-Sankyo, Boehringer Ingelheim, Incyte, Amgen, Chugai Pharmaceutical Co., Ltd, and GlaxoSmithKline, outside the submitted work. MI reports receiving honoraria for consultancy/advisory roles from Daiichi-Sankyo, Pfizer Inc, Bayer Yakuhin, Taiho Pharmaceutical Co., Ltd, Chugai Pharmaceutical Co., Ltd, Eli Lilly and Merck Biopharma Co., Ltd, outside the submitted work. TK reports receiving research funding from ONO Pharmaceutical Co., Ltd, Chugai Pharmaceutical Co., Ltd, Takeda Pharmaceutical Co., Ltd, Eli Lilly, and Bayer Yakuhin, outside the submitted work. TM reports receiving honoraria from Chugai Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co., Ltd, Bayer Yakuhin Japan, Eli Lilly, Yakult Honsha Co., Ltd, Takeda Pharmaceutical Co., Ltd, Sanofi, and Merck Biopharma Co., Ltd, receiving research funding from Merck Sharp & Dohme (MSD), Daiichi-Sankyo, and ONO Pharmaceutical Co., Ltd, outside the submitted work. KY reports receiving honoraria for lecturing from Sanofi, Taiho Pharmaceutical Co., Ltd, Yakult Honsha Co., Ltd, and ONO Pharmaceutical Co., Ltd, receiving research funding from Chugai Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co., Ltd, Eli Lilly, and Takeda Pharmaceutical Co., outside the submitted work. TN reports receiving honoraria from Chugai Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co., Ltd, ONO Pharmaceutical Co., Ltd, Bristol-Myers Squibb, and Eli Lilly, receiving research funding from Taiho Pharmaceutical Co., Ltd, Chugai Pharmaceutical Co., Ltd, Daiichi-Sankyo, MSD, ONO Pharmaceutical Co., Ltd, Bristol-Myers Squibb, Eli Lilly, and Sumitomo Dainippon Pharmaceutical Co., Ltd, outside the submitted work. TY reports receiving honoraria from Chugai Pharmaceutical Co., Takeda Pharmaceutical Co., Ltd, Bayer Yakuhin Japan, and Boehringer-Ingelheim, receiving research funding from Chugai Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co., Ltd, Takeda Pharmaceutical Co., and Daiichi-Sankyo, outside the submitted work. TY reports receiving research funding from ONO Pharmaceutical Co., Daiichi-Sankyo, Parexel, Sumitomo Dainippon Pharmaceutical Co., Ltd, Chugai Pharmaceutical Co., Ltd, Sanofi, MSD, and GlaxoSmithKline, outside the submitted work. All authors have declared no conflicts of interest. Data sharing Data are available upon reasonable request.