• Janjan NA, Lutz ST, Bedwinek JM, Hartsell WF, Ng A, Pieters RS Jr, Ratanatharathorn V, Silberstein EB, Taub RJ, Yasko AW, Expert Panel on Radiation Oncology--Bone Metastases. ACR Appropriateness Criteria® bone metastasis. [online publication]. Reston (VA): American College of Radiology (ACR); 2008. 26 p. [108 references]

This is the current release of the guideline.

This guideline updates a previous version: American College of Radiology (ACR), Expert Panel on Radiation Oncology-Bone Metastasis Work Group. Bone metastases. Reston (VA): American College of Radiology (ACR); 2003. 28 p. (ACR appropriateness criteria).

The appropriateness criteria are reviewed annually and updated by the panels as needed, depending on introduction of new and highly significant scientific evidence.

ACR Appropriateness Criteria®

Clinical Condition: Bone Metastases

Variant 1: 62-year-old man with prostate cancer. Kamofsky performance status (KPS) 90. Two years after surgical resection of prostate and adjuvant hormonal therapy, rising prostate-specific antigen (PSA) level found in routine follow-up. Asymptomatic bone metastasis in right femoral neck; lesion 1.5 cm in size; minimal invasion of bone cortex. No other metastatic disease. (See Appendix 1 in the original guideline document for additional information on expert panel's conclusions.)

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 2: 42-year-old woman with estrogen receptor (ER) negative/progesterone receptor (PR) negative breast cancer. KPS 90. Patient developed a symptomatic lytic bone metastasis in right femoral neck; the metastasis was 1.5 cm in size; minimal invasion of bone cortex. Diffuse asymptomatic bone metastases noted on bone scan with rising carcinoembryonic antigen (CEA). (See Appendix 1 in the original guideline document for additional information on expert panel's conclusions.)

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 3: 55-year-old woman with ER positive/PR positive breast cancer. KPS 80, with no prior history of spine radiation. Patient developed symptomatic vertebral metastases at T12, L1, and L2 without canal involvement. Diffuse asymptomatic bone metastases noted on bone scan with rising CEA. (See Appendix 1 in the original guideline document for additional information on expert panel's conclusions.)

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field

Variant 4: 55-year-old woman with ER positive/PR positive breast cancer. KPS 80 and no prior history of spine radiation. Patient developed symptomatic vertebral metastases at T12, L1, and L2 with canal involvement; moderate weakness in the lower extremities. Diffuse asymptomatic bone metastases noted on bone scan with rising CEA. Past history includes multiple prior cycles of chemo/HT and bisphosphonates. (See Appendix 1 in the original guideline document for additional information on expert panel's conclusions.)

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 5: 55-year-old patient with lung cancer. KPS 70. Prior external beam radiation for a Pancoast tumor, including vertebral levels C7-T4. Symptomatic vertebral metastases; paraspinous soft-tissue extension present from T6-10; spinal cord involvement and mild weakness. Diffuse metastatic disease noted on bone scan; multiple small liver metastases evident on CT of abdomen. (See Appendix 1 in the original guideline document for additional information on expert panel's conclusions.)

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 6: 55-year-old patient with lung cancer. KPS 90. Prior external beam radiation for a Pancoast tumor, including vertebral levels C7-T4. Follow-up bone scan is negative; whole body PET/CT demonstrates uptake in liver, L3, L4, left humerus, and multiple ribs; CT biopsy of symptomatic left humerus confirms metastatic lung cancer. Radiograph of left humerus demonstrates lytic 1 cm lesion with 50% erosion of cortex. Serum calcium normal. (See Appendix 1 in the original guideline document for additional information on expert panel's conclusions.)

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 7: 72-year-old man with non-small-cell lung cancer, 2 years status post right upper lobectomy. KPS 80. Previous radiation to the T5-T8 spine 10 months ago to 30 Gy in 10 fractions. Now with debilitating pain from recurrent disease at T7, no canal involvement. Diffuse asymptomatic bone metastasis, stable on bone scan. No visceral metastases. (See Appendix 1 in the original guideline document for additional information on expert panel's conclusions.)

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 8: 56-year-old woman with breast cancer diagnosed 3 years ago. KPS 90. Now with painful, solitary, biopsy-proven metastasis in the T4 vertebral body. No canal involvement. No other sites of metastatic disease. ER/PR positive.

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 9: The following factors should be considered with regard to treatment recommendations for bone metastases.

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Summary

The previous American College of Radiology (ACR) Appropriateness Criteria® on Bone Metastases published in 2003 primarily addressed issues related to radiation fractionation, and acknowledged the emerging use of bisphosphonates into clinical practice. This guideline addresses the issues that have continued to loom over the American health care system. While new therapeutic options are needed in cancer therapy, what is also needed is better utilization of health care resources. With regard to the emergence of bisphosphonate therapy, the previous guideline stated that:

"Bisphosphonates therapy is expensive, must be continued indefinitely and does not abolish the risk of skeletal complications, but merely delays their onset. It is unlikely that studies on bisphosphonates and radionuclides will be reserved for patients who are refractory to chemotherapy or have too many lesions for local field radiation therapy. Already many investigators have shown a prejudice to use these systemic agents earlier in the course of disease or as a prevention measure. Unfortunately this will impede the initiation of studies that will help to establish which patients should qualify for these systemic treatments. To complicate matters even further is the hypothesis that earlier treatment with these agents will be more cost-effective, despite the initial higher cost."

The development of therapies such as bisphosphonates is important to advancing options for palliative care. However, studies should define clear indications and the specific benefit to the patient. Trials should determine when to start and stop the therapy, and the appropriate patient populations to receive the therapy. Toxicities, such as renal impairment and osteonecrosis of the jaw with bisphosphonates, need to be clearly evaluated relative to those of other therapeutic modalities and overall survival. Cost-utility analyses need to be performed for palliative care endpoints that include efficacy, efficiency, and functional outcomes compared to other available therapies. Clinical trials that include these criteria are critical to future practice guidelines development.

The key question is not what can be done, but what should be done. In sum, more may not be best for the patient. It is recognized that health care professionals are facing tremendous conflicting pressures in clinical practice. Among these pressures are often unrealistic expectations for outcomes demanded by an internet-savvy public, changing rules, and declining reimbursement for inpatient and outpatient care from Medicare and other payors, pressures to see more patients with a declining workforce, and litigation. While warnings regarding a crisis in American health care have been discussed for almost two decades, the time clock is running out. The demographics in America are not amenable to a short-term fix, since the baby-boomer population is beginning to reach retirement age. Currently, more than two-thirds of the Federal budget is designated for entitlements, leaving little ability to increase further spending on health care, which now already consumes over 15% of the American gross domestic product.

It is clear that health care practices that do not provide added clinical benefit, defined as improving the patient's quality of life, must be abandoned. An additional 2 weeks of overall survival while suffering from disease does not represent clinical benefit. More consideration must be given to expenditures of time, energy, and the personal finances of the patient and caregivers. It must be recognized that each intervention a patient undergoes requires effort and has side effects that consume, often precious, time in recovery.

The treatment of bone metastases represents a paradigm for evaluating palliative care in terms of symptom relief, toxicities of therapy, and the financial burden to the patient, caregivers, and society. Despite enormous expenditures to treat metastases, overall survival rates have not changed significantly, patients continue to suffer symptoms of the disease, and aggressive therapeutic approaches often are pursued throughout the course of metastatic disease that incur toxicity in approximately 25% of patients. This approach is inconsistent with the goals of palliative care, which should efficiently provide comfort, using antineoplastic therapies and/or supportive care with the fewest treatment-related side effects, recognizing that the patient will die from the disease. Research is necessary in therapeutic strategies that explore efficient multidisciplinary schedules for bone metastases to relieve symptoms and the burdens of therapy. Given the extreme pressures on the American health care system, changes in clinical practice are also necessary. These changes should be supported by guideline development, and by education of health care professionals and the American public.

Abbreviations

• CEA, carcinoembryonic antigen
• CT, computed tomography
• EBRT, external beam radiation therapy
• ER, estrogen receptor
• HT, hormonal therapy
• IMRT, intensity-modulated radiation therapy
• KPS, Karnofsky performance status
• PR, progesterone receptor
• PET, positron emission tomography
• PSA, prostate-specific antigen
• SVC, superior vena cava

None provided

The recommendations are based on analysis of the current literature and expert panel consensus.

• Janjan NA, Lutz ST, Bedwinek JM, Hartsell WF, Ng A, Pieters RS Jr, Ratanatharathorn V, Silberstein EB, Taub RJ, Yasko AW, Expert Panel on Radiation Oncology--Bone Metastases. ACR Appropriateness Criteria® bone metastasis. [online publication]. Reston (VA): American College of Radiology (ACR); 2008. 26 p. [108 references]

Not applicable: The guideline was not adapted from another source.

1996 Sep (revised 2008)

American College of Radiology - Medical Specialty Society

The American College of Radiology (ACR) provided the funding and the resources for these ACR Appropriateness Criteria®.

Committee on Appropriateness Criteria, Expert Panel on Radiation Oncology–Bone Metastases

Panel Members: Nora A. Janjan, MD; Stephen T. Lutz, MD, MS; John M. Bedwinek, MD; William F. Hartsell, MD; Andrea Ng, MD; Richard S. Pieters, Jr, MD; Vaneerat Ratanatharathorn, MD; Edward B. Silberstein, MD; Robert J. Taub, MD; Alan W. Yasko, MD

Not stated

This is the current release of the guideline.

This guideline updates a previous version: American College of Radiology (ACR), Expert Panel on Radiation Oncology-Bone Metastasis Work Group. Bone metastases. Reston (VA): American College of Radiology (ACR); 2003. 28 p. (ACR appropriateness criteria).

The appropriateness criteria are reviewed annually and updated by the panels as needed, depending on introduction of new and highly significant scientific evidence.

None available

This summary was completed by ECRI on March 25, 1999. The information was verified by the guideline developer on September 9, 1999. The summary was updated on February 12, 2002. The information was verified again by the guideline developer on March 25, 2002. This NGC summary was updated by ECRI most recently on November 12, 2004. The information was verified by the guideline developer on December 21, 2004. This NGC summary was updated by ECRI Institute on August 13, 2009.