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 cancer of the upper abdomen (eg, stomach, hepatobiliary tract, pancreas), the lower abdomen (eg, anorectal locations), or the pelvis, including but not limited to gynecologic (eg, cervical, uterine) locations, what are the relative clinical benefits and harms of intensity-modulated radiotherapy (IMRT) versus other radiotherapy methods (eg, 3-dimensional conformal radiotherapy, 3DCRT)?

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:

IMRT versus 3DCRT or other methods for delivering conformal RT

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.)

Potential patients include both sexes, all age ranges, and any cancer in the upper and lower abdomen, or pelvis, excluding prostate cancer, for which radiotherapy is used alone or as an adjuvant modality (with surgery or chemotherapy).

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

Not aware of any subgroup issues.

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

• Survival
• Quality of life
• Palliation

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

• Radiation damage to adjacent organs, particularly the small bowel, kidneys, bladder, liver, skin, and pelvic bone marrow
• High-grade (3-4) gastrointestinal toxicities that may limit delivery of the planned tumor radiation dose or chemoradiotherapy course

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

• Women
• Elderly

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

Radiation therapy (RT) is often used as part of a multimodality approach to therapy of patients who have a variety of cancers of the GI tract, gynecologic cancers, pancreatic carcinoma, anorectal cancers, and other locations within the abdominal and pelvic compartments. Although most of these cancers individually do not comprise numbers on the order of lung, breast, or colorectal disease, together they account for a substantial disease burden that is difficult to treat, in both sexes and any age group. For some sites, such as anal cancers, RT serves as the cornerstone of radical treatment; for others, such as rectal or esophageal, it is often used in the adjuvant setting.

The major goal of RT is to deliver an adequate dose of ionizing radiation to the tumor volume and its margins to eradicate the lesion, while sparing uninvolved tissues or organs to the extent possible. Over the past several decades, methods to plan and deliver radiation therapy have evolved in ways that permit more precise targeting of tumors with complex geometries. Most early trials used 2-dimensional treatment planning based on flat images, and radiation beams with cross-sections of uniform intensity that were sequentially aimed at the tumor along 2 or 3 intersecting axes. Collectively, these methods are termed “conventional external-beam radiation therapy” (CRT). Treatment planning evolved by using 3-dimensional images, usually from computed tomography (CT) scans, to delineate the tumor, its boundaries with adjacent normal tissue, and organs at risk for radiation damage. Radiation oncologists used these images, displayed from a “beam’s-eye view,” to shape each of several beams with compensators, blocks, or wedges to conform to the patient’s tumor geometry perpendicular to the beam’s axis. In the mid-1990s, 3D conformal methods were further developed to permit beam delivery with non-uniform cross-sectional intensity. This approach often relies on a device (a multileaf collimator, M

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 question arose from concerns voiced by BlueCross BlueShield Medical Plan Directors about the role of IMRT in treating abdominal and pelvic tumors versus other conformal RT modalities, in particular whether IMRT confers a survival or QoL benefit in the context of relative treatment-associated toxicities. The additional complexities of IMRT treatment planning and a steep learning curve are important considerations in weighing the merits of this versus other conformal RT methods.

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 which of these RT technologies is the best choice for specific types of cancers. The relative balance of clinical benefit (eg, survival) and toxicities is a key concern.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

BlueCross BlueShield Plan Medical Directors will use the results in the development of medical policy.

Describe the timeframe in which an answer to your question is needed.

Approximately 18 months.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

None.

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)

BlueCross BlueShield Plan Medical Directors will use the results in the development of medical policy.

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

BlueCross BlueShield Plans routinely use information issued by the EHC Program. The BlueCross BlueShield Association Technology Evaluation Center is an Evidence-based Practice Center of AHRQ. BCBS EPC staff were consulted in the preparation of this nomination. This topic nomination was based on input from the BlueCross BlueShield Plan Medical Directors.