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Association Between Results of a Gene Expression Signature Assay and Recurrence-Free Interval in Patients With Stage II Colon Cancer in Cancer and Leukemia Group B 9581 (Alliance).
Niedzwiecki, Donna; Frankel, Wendy L; Venook, Alan P; Ye, Xing; Friedman, Paula N; Goldberg, Richard M; Mayer, Robert J; Colacchio, Thomas Anthony; Mulligan, Jude Marie; Davison, Timothy S; O'Brien, Eamonn; Kerr, Peter; Johnston, Patrick G; Kennedy, Richard D; Harkin, D Paul; Schilsky, Richard L; Bertagnolli, Monica M; Warren, Robert S; Innocenti, Federico.
Afiliação
  • Niedzwiecki D; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Frankel WL; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Venook AP; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Ye X; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Friedman PN; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Goldberg RM; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Mayer RJ; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Colacchio TA; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Mulligan JM; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Davison TS; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • O'Brien E; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Kerr P; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Johnston PG; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Kennedy RD; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Harkin DP; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Schilsky RL; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Bertagnolli MM; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Warren RS; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
  • Innocenti F; Donna Niedzwiecki and Xing Ye, Duke University, Durham; Federico Innocenti, University of North Carolina at Chapel Hill, Chapel Hill, NC; Wendy L. Frankel and Richard M. Goldberg, The Ohio State University, Columbus, OH; Alan P. Venook and Robert S. Warren, University of California-San Francisco, Sa
J Clin Oncol ; 34(25): 3047-53, 2016 09 01.
Article em En | MEDLINE | ID: mdl-27432924
ABSTRACT

PURPOSE:

Conventional staging methods are inadequate to identify patients with stage II colon cancer (CC) who are at high risk of recurrence after surgery with curative intent. ColDx is a gene expression, microarray-based assay shown to be independently prognostic for recurrence-free interval (RFI) and overall survival in CC. The objective of this study was to further validate ColDx using formalin-fixed, paraffin-embedded specimens collected as part of the Alliance phase III trial, C9581. PATIENTS AND

METHODS:

C9581 evaluated edrecolomab versus observation in patients with stage II CC and reported no survival benefit. Under an initial case-cohort sampling design, a randomly selected subcohort (RS) comprised 514 patients from 901 eligible patients with available tissue. Forty-nine additional patients with recurrence events were included in the analysis. Final analysis comprised 393 patients 360 RS (58 events) and 33 non-RS events. Risk status was determined for each patient by ColDx. The Self-Prentice method was used to test the association between the resulting ColDx risk score and RFI adjusting for standard prognostic variables.

RESULTS:

Fifty-five percent of patients (216 of 393) were classified as high risk. After adjustment for prognostic variables that included mismatch repair (MMR) deficiency, ColDx high-risk patients exhibited significantly worse RFI (multivariable hazard ratio, 2.13; 95% CI, 1.3 to 3.5; P < .01). Age and MMR status were marginally significant. RFI at 5 years for patients classified as high risk was 82% (95% CI, 79% to 85%), compared with 91% (95% CI, 89% to 93%) for patients classified as low risk.

CONCLUSION:

ColDx is associated with RFI in the C9581 subsample in the presence of other prognostic factors, including MMR deficiency. ColDx could be incorporated with the traditional clinical markers of risk to refine patient prognosis.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias do Colo / Recidiva Local de Neoplasia Tipo de estudo: Clinical_trials / Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Oncol Ano de publicação: 2016 Tipo de documento: Article
Texto completo
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PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias do Colo / Recidiva Local de Neoplasia Tipo de estudo: Clinical_trials / Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Oncol Ano de publicação: 2016 Tipo de documento: Article