TY - JOUR
T1 - 12-Gene Recurrence Score assay stratifies the recurrence risk in stage II/III colon cancer with surgery alone
T2 - The sunrise study
AU - Yamanaka, Takeharu
AU - Oki, Eiji
AU - Yamazaki, Kentaro
AU - Yamaguchi, Kensei
AU - Muro, Kei
AU - Uetake, Hiroyuki
AU - Sato, Takeo
AU - Nishina, Tomohiro
AU - Ikeda, Masataka
AU - Kato, Takeshi
AU - Kanazawa, Akiyoshi
AU - Kusumoto, Tetsuya
AU - Chao, Calvin
AU - Lopatin, Margarita
AU - Krishnakumar, Jayadevi
AU - Bailey, Helen
AU - Akagi, Kiwamu
AU - Ochiai, Atsushi
AU - Ohtsu, Atsushi
AU - Ohashi, Yasuo
AU - Yoshino, Takayuki
N1 - Publisher Copyright:
© 2016 by American Society of Clinical Oncology.
PY - 2016/8/20
Y1 - 2016/8/20
N2 - 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.
AB - 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.
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U2 - 10.1200/JCO.2016.67.0414
DO - 10.1200/JCO.2016.67.0414
M3 - Article
C2 - 27325854
AN - SCOPUS:84982094760
SN - 0732-183X
VL - 34
SP - 2906
EP - 2913
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 24
ER -
