12-Gene Recurrence Score assay stratifies the recurrence risk in stage II/III colon cancer with surgery alone: The sunrise study

Takeharu Yamanaka, Eiji Oki, Kentaro Yamazaki, Kensei Yamaguchi, Kei Muro, Hiroyuki Uetake, Takeo Sato, Tomohiro Nishina, Masataka Ikeda, Takeshi Kato, Akiyoshi Kanazawa, Tetsuya Kusumoto, Calvin Chao, Margarita Lopatin, Jayadevi Krishnakumar, Helen Bailey, Kiwamu Akagi, Atsushi Ochiai, Atsushi Ohtsu, Yasuo OhashiTakayuki Yoshino

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31 Citations (Scopus)

Abstract

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 without chemotherapy 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 patientswith 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.

Original languageEnglish
Pages (from-to)2906-2913
Number of pages8
JournalJournal of Clinical Oncology
Volume34
Issue number24
DOIs
Publication statusPublished - Aug 20 2016

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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    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., ... Yoshino, T. (2016). 12-Gene Recurrence Score assay stratifies the recurrence risk in stage II/III colon cancer with surgery alone: The sunrise study. Journal of Clinical Oncology, 34(24), 2906-2913. https://doi.org/10.1200/JCO.2016.67.0414