Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

What is the comparative effectiveness of various local treatments for (1) localized non-small-cell lung cancer (stage T1 or T2a) compared to stereotactic body radiotherapy in those who are not surgical candidates and (2) unresectable metastases to the lung from various solid tumors? Does the comparative effectiveness vary depending on the reason(s) for a tumor being unresectable, such as various comorbid conditions including pulmonary disease?

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:

A number of interventions have been used for treatment of these malignant lung lesions. These include the following: Radiofrequency ablation Radiation therapy including stereotactic body radiotherapy, intensity-modulated radiation therapy (IMRT), proton beam therapy, and brachytherapy.

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.)

In general, these patients are middle-aged or older. As such, they may have a number of comorbid illnesses which can impact treatment choices. The presence of coexisting lung impairment can further complicate the decisions about treatment. These patients may often have cardiac disease as well. The need to fully understand relative risks and benefits is key in this clinical situation.

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

Important subgroups are based on the reasons that lesions are not resectable; that is, those whose disease is not resectable due to various comorbid conditions, i.e., the patient is not an operative candidate.

In those with disease metastatic to the lung, the role of treating these metastases must be put in the context of total disease burden and the potential impact of metastatic disease in other organs.

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

Patient survival, quality of life, and palliation of symptoms.

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

Treatment toxicity and complications of the procedure, including impact on existing comorbid conditions.

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

• Elderly

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

Treatment of localized, but unresectable, non-small-cell lung cancer (NSCLC) is a common problem in clinical care. Surgical resection, when possible, is considered the preferred approach and has demonstrated the best potential for prolonged survival. However, many patients are not candidate for surgical resection. While stereotactic body radiotherapy is considered by many to be a preferred approach for these patients, there are multiple approaches, including radiofrequency ablation and other types of radiation therapy that are also considered options in some cases.

Patients with solid tumors, such as breast and colon cancer, may also present with metastatic disease that is localized to (or predominantly affects) the lung. In these cases, a surgical approach may not be an option for multiple reasons including the number and locations of tumors. Thus, various local treatments, such as radiofrequency ablation, have been evaluated in the treatment of this commonly occurring situation,.

In studying relative risks and benefits for treatments of these lung tumors, it will likely be important to factor in the reason a tumor is unresectable. Patients with unresectable tumors due to anatomic reasons (e.g. location or number of tumors) may have different outcomes that those whose tumors are unresectable because comorbid illness precludes a standard surgical approach.

In evaluating the comparative effectiveness in metastatic disease, it is critical to evaluate patient-related outcomes and not focus only on lung-lesion-related outcomes. This is necessary because in these patients metastatic disease may develop in other parts of the body and the overall impact of treating the lung lesions may be unknown.

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.)

BlueCross and BlueShield Plans have used an evidence-based approach to medical policy for over twenty years. In reviewing evidence related to these two clinical conditions, while various technologies have been utilized there is a need to understand the comparative effectiveness of these many alternatives. Patients need to understand the relative benefits and risks of these interventions. Proton beam radiation therapy is an emerging technique for this application; data for its potential use are particularly important.

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 if one or more of these technologies is the best choice for specific types of patients. The role of these various therapies in those whose lesions are unresectable due to serious comorbid illness is a question of particular interest, as is the question about the approach to tumor metastatic to lung.

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 policies.

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.

Not applicable

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 policies.

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. 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.