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 rectal cancer, what is the comparative effectiveness of neoadjuvant (preoperative) radiation therapy plus surgery versus surgery alone to reduce risk of local recurrence and improve net health outcome?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

Preoperative radiation therapy plus surgery versus surgery alone. Surgery may involve local or mesorectal excision of the primary tumor, depending on stage of disease.

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 rectal cancer

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Patients with resectable rectal cancer without any evidence of distant disease. Factors for consideration include location of the tumor, number of lymph nodes removed.

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

Improvements in rates of local recurrence, overall survival, and quality of life.

Describe any health-related risks, side effects, or harms that you are concerned about.

Acute and late adverse effects of irradiation (e.g., acute toxicity, gastrointestinal

complications); increased risk of hospital admissions.

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.?

yes

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

• Low income groups
• Minority groups
• Women
• Elderly
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

Local recurrence is a serious problem in the treatment of rectal cancer, since it is responsible for substantial morbidity and death. Local recurrence is also difficult to treat. There is a high incidence of local recurrence (15 to 45 percent) after conventional surgery. Neoadjuvant radiotherapy has been used in an attempt to improve local control and survival after surgery. There is discrepancy between trial results on the effects of neoadjuvant radiotherapy on overall survival.

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 a 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 or comparative effectiveness review. There is at present a need to identify the patient subgroups at high risk for local failure who would benefit from pre-operative radiotherapy, and to identify those at low risk for local failure after surgery alone to prevent unnecessary radiation and its potential side effects.

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.)

yes

If yes, please explain:

It is uncertain whether all patients with primary resectable rectal cancer should receive preoperative radiotherapy (i.e., which patients benefit most from radiation therapy), as well as the dose of radiation used.

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.

Being age 40 years or older is one of the risk factors for developing rectal cancer. Among all racial groups in the United States, African Americans have the highest sporadic colorectal cancer incidence and mortality rates.* * It is difficult to separate epidemiological considerations of rectal cancer from those of colon cancer because epidemiological studies often consider colon and rectal cancer (i.e., colorectal cancer) together (National Cancer Institute (PDQ®). Rectal cancer treatment (2010)).

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)

A report would inform clinical decision-making for patients, payers and providers.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

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.