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Topic Suggestion Description

View Topic Suggestion Disposition (PDF) 60 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 early stage breast cancer, what is the comparative effectiveness of alternative methods for post-lumpectomy radiation therapy (whole-breast vs. partial breast; accelerated vs. conventional fractionation) in improving 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:
1. Accelerated partial breast irradiation (APBI) vs. whole breast irradiation.
APBI technologies include interstitial brachytherapy, balloon brachytherapy, combined brachytherapy (interstitial and balloon), external beam radiotherapy (with either 3D-conformal or intensity-modulated methodologies), and intraoperative radiotherapy. These techniques vary in the dose distribution and other factors and should not be considered interchangeable without evidence to support that supposition.
2. Accelerated vs. conventional whole breast irradiation (e.g., 3-week vs. 5-week schedule)
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.)
Adult women with breast cancer at low risk of recurrence undergoing breast-conserving surgery. Factors associated with lower risk include no or few positive lymph nodes, relatively small tumor size (e.g., < 2 cm), older age, ER-positive tumors, and others. The specific criteria have varied across studies and practices.
Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)
Part of the rationale for the development of APBI was that some women were avoiding radiation therapy following breast-conserving surgery, despite strong evidence and recommendations in favor of doing so. Studies have shown that minority women and those living further from treatment facilities are less likely to undergo radiotherapy. These groups should be examined separately, to the degree permitted by the available data. Which women in general should be eligible for APBI has been a subject of controversy and continues to be examined in clinical trials (e.g., the National Surgical Adjuvant Breast and Bowel Project and the Radiation Therapy Oncology Group (NSABP B-39/RTOG 0413; see www.rtog.org) trial).
Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)
Greater convenience with possibly greater use of radiation therapy, leading to increased disease-free and overall survival; improved cosmesis; reduced radiation-related side effects to the rest of the breast and nearby tissues.
Describe any health-related risks, side effects, or harms that you are concerned about.
Radiation-induced side effects, higher recurrence, reduced survival (overall, disease-free).

Adverse events associated with specific APBI methods, such as the need to explant the balloon brachytherapy device and use an alternative radiotherapy technique.

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

Importance

Describe why this topic is important.
Breast cancer is a common disease. Treatment of patients with breast cancer accounts for about a third of the workload of radiotherapy departments in some parts of the world.
For women with early stage disease, survival after breast-conserving therapy (surgery plus conventional whole breast irradiation) has been shown to be equivalent to survival after mastectomy. But it is not known whether changing one of these components—namely the target field and fractionation for radiotherapy—will change the overall effectiveness. The changes are being proposed primarily to increase convenience and possibly adherence to recommendations for radiotherapy. Any changes in practice could potentially affect recurrence rates for a large number of women.
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 is an important issue that was prioritized by a multi-disciplinary stakeholder panel (including patient advocates/representatives) convened to identify and select research questions of importance for systematic review.
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:
There has been substantial controversy in the field about the potential benefits and harms of accelerated and/or partial breast irradiation, including whether they yield equivalent or better outcomes than conventional, whole breast irradiation. Outcomes
include disease-free and overall survival and radiation-induced side effects, including
cosmesis; Nevertheless, APBI is presently being widely adopted.

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.
Women from minority groups and those living further from treatment centers have been less likely to receive radiotherapy after breast-conserving surgery

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 Technology Evaluation Center
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.