• Silberstein EB, Buscombe JR, McEwan A, Taylor AT Jr. Procedure guideline for palliative treatment of painful bone metastases, 3.0. Reston (VA): Society of Nuclear Medicine; 2003 Jan 25. 8 p. [17 references]

This is the current release of the guideline.

This guideline updates a previous version: Society of Nuclear Medicine. Procedure guideline for bone pain treatment, 2.0. Reston (VA): Society of Nuclear Medicine; 1999 Feb. 26 p. (Society of Nuclear Medicine procedure guidelines; no. 2.0).

Bone pain due to osteoblastic metastases

Evaluation
Treatment

Nuclear Medicine
Oncology
Radiology

Allied Health Personnel
Physicians

• To assist nuclear medicine practitioners in evaluating patients who might be candidates for ³²P-sodium phosphate, ⁸⁹Sr-chloride, or ¹⁵³Sm-lexidronam (¹⁵³Sm-EDTMP) radiopharmaceutical treatment of bone pain resulting from osteoblastic metastases
• To provide information for performing this treatment and to assist in understanding the sequelae of therapy

Patients with bone pain resulting from a metastatic malignancy that has involved multiple skeletal sites and has evoked an osteoblastic response on bone scintigraphy

Radiopharmaceutical treatment of bone pain with ³²P-sodium phosphate, ⁸⁹Sr-chloride, or ¹⁵³Sm-lexidronam

• Palliation of bone pain
• Safety/adverse effects of treatment

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

Literature searches were performed. In addition, references known to experts and references from the nuclear medicine community were considered.

Not stated

Not stated

Not applicable

Systematic Review

Not stated

Expert Consensus

Drafts of the guideline were submitted to members of the Guideline Development subcommittee (methodologists) and the Task Force (subject experts). These reviewers indicated on a line-by-line basis any suggestions or recommendations for the revision of the guideline. The percentage of agreement for all reviewers was calculated for each revision and compiled by the Society of Nuclear Medicine (SNM) central office. It is expected that the percentage of agreement will increase with each revision.

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

Internal Peer Review

When the Task Force and Guideline Development Subcommittee completed their edits, draft procedure guidelines were distributed to the Society of Nuclear Medicine (SNM) Sample Review Group for comment. (The SNM Sample Review Group is a cross-section of approximately 100 nuclear medicine practitioners representing every field of specialization).

The guideline was approved by the SNM Commission on Health Care Policy, the Board of Directors, and the House of Delegates.

The updated guideline was approved January 25^th, 2003.

Background Information and Definitions

1. Definitions
   1. ⁸⁹Sr therapy means the intravenous injection of the radionuclide ⁸⁹Sr as strontium chloride. ⁸⁹Sr-chloride emits a beta particle with maximum energy 1.46 MeV, mean energy 0.58 MeV, average soft-tissue range 2.4 mm, and 0.01% abundant gamma emission with a photopeak of 0.91 MeV. It has a 50.5-d physical half-life.
   2. ¹⁵³Sm-lexidronam therapy means the intravenous injection of the radionuclide ¹⁵³Sm chelated to ethylene diamine tetramethylene phosphonate. ¹⁵³Sm emits a beta particle with maximum energy 0.81 MeV, mean energy 0.23 MeV, average soft-tissue range 0.6 mm, and 28% abundant gamma emission with a photopeak of 0.103 MeV. It has a 1.9-d physical half-life.
   3. ³²P therapy means the intravenous injection or oral administration of the radionuclide ³²P as sodium phosphate. ³²P-sodium phosphate emits a beta particle with maximum energy of 1.71 MeV, mean energy 0.70 MeV, average soft-tissue range 3.0 mm, and no gamma emission. It has a 14.3-d physical half-life.
   4. "Osteoblastic" or "osteoblastic metastases" means a focus or foci of increased activity on bone scintigraphy caused by osseous reaction to tumor in bone. These may appear osteoblastic or osteolytic on radiographs.
2. Background

   Intravenous injection of ⁸⁹Sr-chloride and ¹⁵³Sm-lexidronam and intravenous or oral administration of ³²P-sodium phosphate have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of bone pain resulting from osteoblastic metastasis as defined by bone scan. Physicians involved in treating such patients should have an understanding of the natural history of the disease process and should be able to collaborate closely with the physician (or group of physicians) handling the overall management of the patient's disease.

   The administration of these agents falls under the guidelines of the Nuclear Regulatory Commission (NRC), Title 10 CFR Part 35.300 or Agreement State Institutional License. Institutional licenses must specifically list individuals licensed to use Section 35.300 materials.

   As other radiopharmaceuticals are approved by the FDA for the treatment of bone pain resulting from osteoblastic metastases, they will be added to the guideline.

Common Indications

³²P-sodium phosphate, ⁸⁹Sr-chloride, and ¹⁵³Sm-lexidronam (and the other unsealed beta or conversion electron-emitting radiopharmaceuticals under development or approved in countries outside the United States, e.g., ¹⁸⁶Re-etidronate) are indicated for the treatment of bone pain resulting from a metastatic malignancy that has involved multiple skeletal sites and has evoked an osteoblastic response on bone scintigraphy. Where there is danger of either spinal cord compression from vertebral metastases or pathologic fracture in the extremities, ³²P-sodium phosphate, ⁸⁹Sr-chloride, or ¹⁵³Sm-lexidronam therapy should only be used in conjunction with other forms of management directed at these complications and after management of the acute presentation.

Procedure

The detailed procedure recommendations in the guideline address the following areas: facility/personnel; patient preparation; information pertinent to performing the procedure (i.e., important data that the physician should have about the patient at the time the exam is performed and interpreted); instructions for patients; precautions; information regarding the radiopharmaceutical (i.e., ranges of administered activity, organ receiving the largest radiation dose, effective dose), image acquisition; guidelines for measuring the activity of ³²P-Sodium Phosphate, ⁸⁹Sr-Chloride, or ¹⁵³Sm-Lexidronam to be administered; interventions; processing; interpretation/reporting; quality control; and sources of error.

None provided

The type of evidence supporting the recommendations is not specifically stated.

³²P-sodium phosphate, ⁸⁹Sr-chloride, or ¹⁵³Sm-lexidronam has a 25 to 80% probability (depending on how the subjective pain response is measured) of reducing bone pain resulting cancer spread in bone, but the chance of relieving pain completely is low but real.

The patient should be told that the two most common side effects are:

• An increase in bone pain ("flare") occurring most often within 72 hours of injection but, rarely, up to 21 days after injection and lasting 2 to 5 days. Flare is unusual after the second week and can be treated by increasing doses of analgesia, if required.
• The likelihood that the leukocyte and platelet counts may decrease by 30 to 70% of baseline values or possibly to even to lower levels which could lead to infection if leukocytes are too low or bleeding if the platelets are too low. Bleeding or the risk of bleeding could require platelet transfusion. Marrow replacement by tumor, ³²P-sodium phosphate, ⁸⁹Sr-chloride, or ¹⁵³Sm-lexidronam therapy, chemotherapy and external beam radiotherapy have additive effects on myelosuppression, and the presence of two or more of these risk factors increases the possibility of clinically significant marrow suppression.

Pregnancy and breast feeding are absolute contraindications to therapy.

• The Society of Nuclear Medicine has written and approved guidelines to promote the cost-effective use of high quality nuclear medicine procedures. These generic recommendations cannot be applied to all patients in all practice settings. The guidelines should not be deemed inclusive of all proper procedures or exclusive of other procedures reasonably directed to obtaining the same results. The spectrum of patients seen in a specialized practice setting may be quite different than the spectrum of patients seen in a more general practice setting. The appropriateness of a procedure will depend in part on the prevalence of disease in the patient population. In addition, the resources available to care for patients may vary greatly from one medical facility to another. For these reasons, guidelines cannot be rigidly applied.
• Advances in medicine occur at a rapid rate. The date of a guideline should always be considered in determining its current applicability.

An implementation strategy was not provided.

End of Life Care
Living with Illness

Effectiveness

• Silberstein EB, Buscombe JR, McEwan A, Taylor AT Jr. Procedure guideline for palliative treatment of painful bone metastases, 3.0. Reston (VA): Society of Nuclear Medicine; 2003 Jan 25. 8 p. [17 references]

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

1999 Feb (updated 2003 Jun 20)

Society of Nuclear Medicine, Inc - Medical Specialty Society

Society of Nuclear Medicine (SNM)

Task Force

Authors: Edward B. Silberstein, MD (University of Cincinnati Medical Center, Cincinnati, OH); John R. Buscombe, MD (Royal Free Hospital, London, UK); Alexander McEwan, MD (Cross Cancer Institute, Edmonton, Alberta, Canada); and Andrew T. Taylor, Jr., MD (Emory University School of Medicine, Atlanta, GA)

Not stated

This is the current release of the guideline.

This guideline updates a previous version: Society of Nuclear Medicine. Procedure guideline for bone pain treatment, 2.0. Reston (VA): Society of Nuclear Medicine; 1999 Feb. 26 p. (Society of Nuclear Medicine procedure guidelines; no. 2.0).

None available

This summary was completed by ECRI on May 20, 1999. It was verified by the guideline developer as of May 26, 1999. This summary was updated by ECRI on April 14, 2005.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.