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Medline ® Abstract for Reference 117

of 'Adjuvant chemotherapy for resected stage II colon cancer'

12-Gene Recurrence Score Assay Stratifies the Recurrence Risk in Stage II/III Colon Cancer With Surgery Alone: The SUNRISE Study.
Yamanaka T, Oki E, Yamazaki K, Yamaguchi K, Muro K, Uetake H, Sato T, Nishina T, Ikeda M, Kato T, Kanazawa A, Kusumoto T, Chao C, Lopatin M, Krishnakumar J, Bailey H, Akagi K, Ochiai A, Ohtsu A, Ohashi Y, Yoshino T
J Clin Oncol. 2016 Aug;34(24):2906-13.
PURPOSE: The 12-gene Recurrence Score assay has been validated in resected stage II colon cancer treated with or without chemotherapy and resected stage III disease treated with chemotherapy. This study evaluated the 12-gene Recurrence Score assay for stage II and III colon cancer withoutchemotherapy to reveal the natural course of recurrence risk in stage III disease.
METHODS: A cohort-sampling design was used. From 1,487 consecutive patients with stage II to III disease who had surgery alone, 630 patients were sampled for inclusion with a 1:2 ratio of recurrence and nonrecurrence. Sampling was stratified by stage (II v III). The assay was performed on formalin-fixed, paraffin-embedded primary cancer tissue. Association of the Recurrence Score result with recurrence-free interval (RFI) was assessed by using weighted Cox proportional hazards regression.
RESULTS: Overall, 597 of 630 patients were analyzable-247 patients had stage II, and 350 had stage III colon cancer. The continuous Recurrence Score was significantly associated with RFI after adjustment for disease stage (hazard ratio for a 25-unit increase in Recurrence Score, 2.05; 95% CI, 1.47 to 2.86; P<.001). With respect to prespecified subgroups, as defined by low (<30), intermediate (30 to 40), and high (≥41) Recurrence Score risk groups, patients with stage II disease in the high-risk group had a 5-year risk of recurrence similar to patients with stage IIIA to IIIB disease in the low-risk group (19% v 20%), whereas patients with stage IIIA to IIIB disease in the high-risk group had a recurrence risk similar to that of patients with stage IIIC disease in the low-risk group (approximately 38%).
CONCLUSION: To our knowledge, this study provides the first validation of the 12-gene Recurrence Score assay in stage III colon cancer without chemotherapy and showed the heterogeneity of recurrence risks in stage III as well as in stage II colon cancer.
Takeharu Yamanaka, National Cancer Center; Atsushi Ochiai, Atsushi Ohtsu, and Takayuki Yoshino, National Cancer Center Hospital East Chiba, Japan; Takeharu Yamanaka, Yokohama City University, Yokohama; Eiji Oki, Kyushu University; Tetsuya Kusumoto, National Kyushu Medical Center, Fukuoka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka; Kensei Yamaguchi and Kiwamu Akagi, Saitama Cancer Center, Saitama; Kensei Yamaguchi, Cancer Institute Hospital of Japanese Foundation for Cancer Research; Hiroyuki Uetake, Tokyo Medical and Dental University; Yasuo Ohashi, Chuo University, Tokyo; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Takeo Sato, Kitasato University School of Medicine, Kanagawa; Tomohiro Nishina, National Hospital Organization Shikoku Cancer Center, Matsuyama; Masataka Ikeda, Osaka National Hospital; Akiyoshi Kanazawa, Kitano Hospital, Osaka; Takeshi Kato, Kansai Rosai Hospital, Amagasaki, Japan; Calvin Chao, Margarita Lopatin, Jayadevi Krishnakumar, and Helen Bailey, Genomic Health, Redwood City, CA.