E Oki1, J Watanabe2, T Sato3, Y Kagawa4, Y Kuboki5, M Ikeda6, H Ueno7, T Kato8, T Kusumoto9, T Masuishi10, K Yamaguchi11, A Kanazawa12, T Nishina13, H Uetake14, T Yamanaka15, T Yoshino5. 1. Department of Surgery and Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan. 2. Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan. 3. Department of Colorectal Surgery, Kitasato University Hospital, Kanagawa, Japan. 4. Department of Surgery, Kansai Rosa Hospital, Hyogo, Japan. 5. Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan. 6. Department of Surgery, Hyogo College of Medicine, Hyogo, Japan. 7. Department of Surgery, National Defense Medical College, Saitama, Japan. 8. Department of Surgery, NHO Osaka National Hospital, Osaka, Japan. 9. Department of Gastroenterological Surgery, NHO National Kyushu Medical Center, Fukuoka, Japan. 10. Department of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan. 11. Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan. 12. Department of Gastroenterological Surgery, Shimane Prefectural Central Hospital, Shimane, Japan. 13. Department of Gastrointestinal Medical Oncology, NHO Shikoku Cancer Center, Ehime, Japan. 14. Department of Specialized Surgeries, Tokyo Medical and Dental University, Tokyo, Japan. 15. Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan. Electronic address: takeharu.yamanaka@gmail.com.
Abstract
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.
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.