Skip Navigation
AHRQ--Agency for Healthcare Research and Quality: Advancing Excellence in Health Care

Topic Suggestion Description

View Topic Suggestion Disposition (PDF) 133 kB

Date submitted: June 01, 2011

Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.
For patients with colon cancer, what is the comparative effectiveness of multi-parameter gene expression assays (e.g., Oncotype DX® colon cancer test*) versus standard clinical and pathological risk factors for predicting disease recurrence and guiding decisions on adjuvant therapy?
*At this writing, this assay is the primary focus for a comparative effectiveness review; other multi-gene assays for predicting disease recurrence, where available, will be addressed at the time of the review.
Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)
If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:
Multi-gene assays (e.g., 12-gene expression test*), versus standard clinical and pathological risk factors (e.g., tumor size, extent of lymph node involvement, carcinoembryonic antigen (CEA) levels).

*Oncotype DX® colon cancer test; Genomic Health, Inc., Redwood City, CA
What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)
Adults with colon cancer following surgery.
Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)
Stage II or III disease; Number of lymph nodes removed; Elevated CEA levels.
Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)
Improvements in overall survival and quality of life from optimal treatment; improvements in recurrence-free interval and/or disease-free survival; and decreased adverse effects from unnecessary or ineffective treatment.
Describe any health-related risks, side effects, or harms that you are concerned about.
Harms to the patient associated either from not treating when therapy is necessary, treating when therapy is unnecessary or unlikely to yield benefit, or treating with the wrong therapeutic regimen.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?
Which priority area(s) and population(s) does this topic apply to? (check all that apply)
EHC Priority Conditions (updated in 2008)
  • Cancer
AHRQ Priority Populations
  • Women
  • Elderly
Federal Health Care Program
  • Medicaid
  • Medicare


Describe why this topic is important.
The majority of patients with stage II colon cancer are cured by surgery alone, and the absolute benefit of adjuvant chemotherapy for the patient population is small. Those patients who are most likely to benefit from chemotherapy are difficult to identify by standard clinical and pathological risk factors. For example, the finding that patients with stage IIB disease have a worse prognosis than patients with stage IIIA disease indicates the need to develop better tools.

The limitations of the current staging system may interfere with the capacity to deliver optimal clinical care, given that the decision to administer adjuvant chemotherapy after surgery is mostly based on this classification system.

There are multiple molecular biomarkers that have been investigated to identify subsets of patients with a higher or lower risk of recurrence and the benefit that they may derive from adjuvant treatment. The Oncotype DX® Colon Cancer Assay, for example, is a new diagnostic test for determining the likelihood of recurrence in stage II colon cancer patients after surgical resection using fixed paraffin embedded (FPE) primary colon tumor tissue. These multi-gene assays could potentially improve the clinical management of patients with early-stage colon cancer by better identifying those with high risk of recurrence and therefore most likely to benefit from adjuvant therapy.
What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)
This topic was given high priority by a multi-disciplinary stakeholder panel (including patient advocates/representatives) convened to identify and select important research questions on cancer amenable to systematic review. Many multi-gene assays have been investigated to determine their roles as prognostic or predictive biomarkers in the setting of adjuvant therapy for colon cancer. Although various candidates have been proposed, the results have either been contradictory or insufficiently robust.
Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)
If yes, please explain:
The clinical and pathological features used to identify high-risk disease are not well-established, and the patients for whom the benefits of adjuvant chemotherapy would most likely outweigh the harms cannot be identified with certainty.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?
A report would inform clinical decision-making for patients, payers and providers.
Describe the timeframe in which an answer to your question is needed.
Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.
An especially significant burden on elderly patients and their caregivers is associated with cancer recurrence or progression.

Nominator Information

Other Information About You: (optional)
Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)
  • Other
Are you making a suggestion as an individual or on behalf of an organization?
Organization - BlueCross BlueShield Association
Please tell us how you heard about the Effective Health Care Program
The BlueCross BlueShield Association Technology Evaluation Center is an Evidence-based Practice Center of AHRQ.