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Cover of Gene Expression Profiling for Predicting Outcomes in Stage II Colon Cancer

Gene Expression Profiling for Predicting Outcomes in Stage II Colon Cancer

Technical Briefs, No. 13

Investigators: , MD, , PGDipInf, and , PhD.

Blue Cross and Blue Shield Association Technology Evaluation Center, Evidence-based Practice Center
Rockville (MD): Agency for Healthcare Research and Quality (US); .
Report No.: 12(13)-EHC143-EF

Structured Abstract

Background:

While adjuvant chemotherapy is recommended in patients with stage III colon cancer, its role in stage II disease is unclear. In treating 100 stage II patients with adjuvant chemotherapy, three or four will benefit, while others will suffer significant adverse effects. Research is underway to improve this decisionmaking. Gene expression profiling (GEP) is one of the techniques being studied.

Purpose:

The objective of this Technical Brief is to provide a summary of the state of the science on use of GEP in predicting outcomes, including benefit from adjuvant chemotherapy, in patients with stage II colon cancer. This Brief also summarizes key uncertainties.

Methods:

Four guiding questions were used to frame this Technical Brief. A scan of the published literature through May 2012 identified studies describing the relationship between GEPs and outcomes in stage II colon cancer. Other sources included the U.S. Food and Drug Administration Web site, Key Informants, clinical trial Web sites, and scan of the grey literature.

Findings:

Results have been published for GEP assays in stage II colon cancer; 13 GEP assays for prognosis, one GEP for prediction (reduced tumor recurrence from adjuvant therapy), and one microRNA profile for prognosis. Five GEP assays are available commercially. Published studies have not provided information related to clinical utility, the effect that using the GEP result in patient care has on net health outcome. Limited information was found for analytic validity. The current evidence does not provide the type of information needed to answer major questions about use of GEP assays in these patients.

Conclusion:

Although information is emerging about use of GEP assays to inform the decision about use of adjuvant chemotherapy in patients with stage II colon cancer, studies to date have not provided the type of information needed to address major uncertainties.

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2007-10058-I, Prepared by: Blue Cross and Blue Shield Association Technology Evaluation Center, Evidence-based Practice Center, Chicago, IL

Suggested citation:

Black ER, Falzon L, Aronson N. Gene Expression Profiling for Predicting Outcomes in Stage II Colon Cancer. Technical Brief. No. 13. (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-2007-0058-I.) Rockville, MD: Agency for Healthcare Research and Quality. December 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm.

This report is based on research conducted by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10058-I). The findings and conclusions in this document are those of the author(s), who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, that is, in the context of available resources and circumstances presented by individual patients.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.

1

540 Gaither Road, Rockville, MD 20850; www​.ahrq.gov

Bookshelf ID: NBK115808PMID: 23326902

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