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Biologic determinants of tumor recurrence in stage II colon cancer: validation study of the 12-gene recurrence score in cancer and leukemia group B (CALGB) 9581.

Publication ,  Journal Article
Venook, AP; Niedzwiecki, D; Lopatin, M; Ye, X; Lee, M; Friedman, PN; Frankel, W; Clark-Langone, K; Millward, C; Shak, S; Goldberg, RM ...
Published in: J Clin Oncol
May 10, 2013

PURPOSE: A greater understanding of the biology of tumor recurrence should improve adjuvant treatment decision making. We conducted a validation study of the 12-gene recurrence score (RS), a quantitative assay integrating stromal response and cell cycle gene expression, in tumor specimens from patients enrolled onto Cancer and Leukemia Group B (CALGB) 9581. PATIENTS AND METHODS: CALGB 9581 randomly assigned 1,713 patients with stage II colon cancer to treatment with edrecolomab or observation and found no survival difference. The analysis reported here included all patients with available tissue and recurrence (n = 162) and a random (approximately 1:3) selection of nonrecurring patients. RS was assessed in 690 formalin-fixed paraffin-embedded tumor samples with quantitative reverse transcriptase polymerase chain reaction by using prespecified genes and a previously validated algorithm. Association of RS and recurrence was analyzed by weighted Cox proportional hazards regression. RESULTS: Continuous RS was significantly associated with risk of recurrence (P = .013) as was mismatch repair (MMR) gene deficiency (P = .044). In multivariate analyses, RS was the strongest predictor of recurrence (P = .004), independent of T stage, MMR, number of nodes examined, grade, and lymphovascular invasion. In T3 MMR-intact (MMR-I) patients, prespecified low and high RS groups had average 5-year recurrence risks of 13% (95% CI, 10% to 16%) and 21% (95% CI, 16% to 26%), respectively. CONCLUSION: The 12-gene RS predicts recurrence in stage II colon cancer in CALGB 9581. This is consistent with the importance of stromal response and cell cycle gene expression in colon tumor recurrence. RS appears to be most discerning for patients with T3 MMR-I tumors, although markers such as grade and lymphovascular invasion did not add value in this subset of patients.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

May 10, 2013

Volume

31

Issue

14

Start / End Page

1775 / 1781

Location

United States

Related Subject Headings

  • Risk Factors
  • Risk Assessment
  • Reverse Transcriptase Polymerase Chain Reaction
  • Randomized Controlled Trials as Topic
  • Proportional Hazards Models
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Neoplasm Recurrence, Local
  • Neoplasm Grading
  • Multivariate Analysis
 

Citation

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Venook, A. P., Niedzwiecki, D., Lopatin, M., Ye, X., Lee, M., Friedman, P. N., … Bertagnolli, M. M. (2013). Biologic determinants of tumor recurrence in stage II colon cancer: validation study of the 12-gene recurrence score in cancer and leukemia group B (CALGB) 9581. J Clin Oncol, 31(14), 1775–1781. https://doi.org/10.1200/JCO.2012.45.1096
Venook, Alan P., Donna Niedzwiecki, Margarita Lopatin, Xing Ye, Mark Lee, Paula N. Friedman, Wendy Frankel, et al. “Biologic determinants of tumor recurrence in stage II colon cancer: validation study of the 12-gene recurrence score in cancer and leukemia group B (CALGB) 9581.J Clin Oncol 31, no. 14 (May 10, 2013): 1775–81. https://doi.org/10.1200/JCO.2012.45.1096.
Venook AP, Niedzwiecki D, Lopatin M, Ye X, Lee M, Friedman PN, et al. Biologic determinants of tumor recurrence in stage II colon cancer: validation study of the 12-gene recurrence score in cancer and leukemia group B (CALGB) 9581. J Clin Oncol. 2013 May 10;31(14):1775–81.
Venook, Alan P., et al. “Biologic determinants of tumor recurrence in stage II colon cancer: validation study of the 12-gene recurrence score in cancer and leukemia group B (CALGB) 9581.J Clin Oncol, vol. 31, no. 14, May 2013, pp. 1775–81. Pubmed, doi:10.1200/JCO.2012.45.1096.
Venook AP, Niedzwiecki D, Lopatin M, Ye X, Lee M, Friedman PN, Frankel W, Clark-Langone K, Millward C, Shak S, Goldberg RM, Mahmoud NN, Warren RS, Schilsky RL, Bertagnolli MM. Biologic determinants of tumor recurrence in stage II colon cancer: validation study of the 12-gene recurrence score in cancer and leukemia group B (CALGB) 9581. J Clin Oncol. 2013 May 10;31(14):1775–1781.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

May 10, 2013

Volume

31

Issue

14

Start / End Page

1775 / 1781

Location

United States

Related Subject Headings

  • Risk Factors
  • Risk Assessment
  • Reverse Transcriptase Polymerase Chain Reaction
  • Randomized Controlled Trials as Topic
  • Proportional Hazards Models
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Neoplasm Recurrence, Local
  • Neoplasm Grading
  • Multivariate Analysis