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)

التفاصيل البيبلوغرافية
العنوان: 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)
المؤلفون: Robert J. Mayer, Donna Niedzwiecki, Wendy L. Frankel, Eamonn J. O'Brien, Richard M. Goldberg, Paula N. Friedman, Peter Kerr, Timothy Davison, Patrick G. Johnston, Alan P. Venook, Xing Ye, Federico Innocenti, Thomas A. Colacchio, D. Paul Harkin, Richard L. Schilsky, Monica M. Bertagnolli, Richard D. Kennedy, Jude M. Mulligan, Robert S. Warren
المصدر: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol 34, iss 25
Niedzwiecki, D, Frankel, W L, Venook, A P, Ye, X, Friedman, P N, Goldberg, R M, Mayer, R J, Colacchio, T A, Mulligan, J M, Davison, T S, O'Brien, E, Kerr, P, Johnston, P G, Kennedy, R D, Harkin, D P, Schilsky, R L, Bertagnolli, M M, Warren, R S & Innocenti, F 2016, ' 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) ', Journal of Clinical Oncology, vol. 34, no. 25, pp. 3047 . https://doi.org/10.1200/JCO.2015.65.4699
بيانات النشر: American Society of Clinical Oncology (ASCO), 2016.
سنة النشر: 2016
مصطلحات موضوعية: Male, 0301 basic medicine, Oncology, Cancer Research, Edrecolomab, Kaplan-Meier Estimate, Group B, Cohort Studies, Antibodies, Monoclonal, Murine-Derived, 0302 clinical medicine, Stem Cell Research - Nonembryonic - Human, Monoclonal, Multicenter Studies as Topic, Oligonucleotide Array Sequence Analysis, Randomized Controlled Trials as Topic, Cancer, Antibodies, Monoclonal, ORIGINAL REPORTS, Middle Aged, Colo-Rectal Cancer, Phase III as Topic, Leukemia, Local, 030220 oncology & carcinogenesis, Colonic Neoplasms, Female, medicine.drug, Cohort study, Murine-Derived, medicine.medical_specialty, Clinical Sciences, Oncology and Carcinogenesis, Antibodies, Disease-Free Survival, 03 medical and health sciences, SDG 3 - Good Health and Well-being, Clinical Research, Internal medicine, medicine, Humans, Clinical Trials, Oncology & Carcinogenesis, Neoplasm Staging, Aged, business.industry, Gene Expression Profiling, Stem Cell Research, medicine.disease, Surgery, Gene expression profiling, Clinical trial, Neoplasm Recurrence, 030104 developmental biology, Clinical Trials, Phase III as Topic, Neoplasm Recurrence, Local, Digestive Diseases, business
الوصف: 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.
وصف الملف: application/pdf
تدمد: 1527-7755
0732-183X
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5cbb44c7ba41bfe8d3c66469e8fcb6ee
https://doi.org/10.1200/jco.2015.65.4699
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....5cbb44c7ba41bfe8d3c66469e8fcb6ee
قاعدة البيانات: OpenAIRE