Guideline Statement

Multiple prospective randomized trials have shown pain relief equivalency for dosing schema, including 30 Gy in ten fractions, 24 Gy in six fractions, 20 Gy in five fractions, and a single 8-Gy fraction for patients with previously unirradiated painful bone metastases. Fractionated radiotherapy (RT) courses have been associated with an 8% repeat treatment rate to the same anatomic site because of recurrent pain vs. 20% after a single fraction; however, the single fraction treatment approach optimizes patient and caregiver convenience.

Guideline Statement

Although many of the studies presented in Table 1 in the original guideline document did not delineate treatment relief by spinal vs. nonspinal metastases, the Task Force could find no evidence from reviewing the data to suggest that a single 8-Gy fraction provided inferior pain relief compared with a more prolonged RT course in painful spinal sites, although single fractionation has been associated with a 20% incidence of repeat treatment vs. 8% with fractionated RT. The set up and prescription points for treatment should follow those outlined by the International Consensus on Palliative Radiotherapy Endpoints for future clinical trials in bone metastases to minimize the risk and allow for consistent reporting of treatment results. The Task Force does not believe that any additional trials are needed to confirm the use of single-fraction RT in these circumstances.

Guideline Statement

The Task Force did not find any suggestions from the available data that single-fraction therapy produces unacceptable rates of long-term side effects that might limit this fractionation scheme for patients with painful bone metastases. Numerous prospective, randomized trials have failed to show any significant difference in long-term toxicity between a single 8-Gy fraction and more prolonged RT courses for uncomplicated, painful bone metastases. No additional studies are suggested to confirm this recommendation at this time.

Guideline Statement

Although no specific trial has been completed to define the criteria for the repeat treatment of patients with recurrent symptoms of metastatic disease, most trials have included the option of repeat treatment (see Table 2 in the original guideline document). The rates of repeat treatment have been 20% with single-fraction palliative RT schedules compared with 8% with lengthier RT courses. The Task Force recommends that, whenever possible, patients should be included in prospective randomized trials to further define the appropriate use of RT in the setting of recurrent cancer symptoms.

Guideline Statement

Sites of recurrent pain in spinal bones can be successfully palliated with external beam RT (EBRT) repeat treatment, although the available data do not allow for conclusive statements regarding dosing and fractionation. Care must be taken when the re-irradiated volume contains the spinal cord, and it might be appropriate to sum the biologically effective doses from the initial and repeat treatment regimens to estimate the risk of radiation myelopathy. The Task Force recommends that these patients be treated within the available clinical trial.

Guideline Statement

Stereotactic body RT (SBRT) is a technology that delivers high doses to metastatic spinal disease with a steep dose gradient that might allow superior sparing of the adjacent neural structures, including the spinal cord and cauda equina. The published efficacy and safety data for SBRT have mostly been from retrospective single-institution studies, and some of the measured endpoints in these studies were different from those used to evaluate other treatment types (see Tables 3, 4, and 5 in the original guideline document). Given that the complexities of dosing and target delineation for SBRT have yet to be fully defined, the Task Force strongly suggests that these patients be treated only within available clinical trials and that SBRT should not be the primary treatment of vertebral bone lesions causing spinal cord compression.

Guideline Statement

Although no definitive data are yet available to specify the proper patient selection criteria or radiation dose for recurrent painful lesions of the spine, some early data have suggested that repeat treatment to spinal lesions with SBRT might be feasible, effective, and safe, although the Task Force believes that the use of this approach should be limited to the setting of clinical trial participation.

Surgery and EBRT for Spinal Cord Compression

Guideline Statement

The available data have suggested that surgery does not obviate the need for postoperative EBRT for patients with spinal cord compression (see Table 6 in the original guideline document). The choice of surgical decompression should be made by an interdisciplinary team that includes a neurosurgeon, with the performance status, primary tumor site, extent and distribution of metastases, and expected survival taken into account (see Table 7 in the original guideline document). The optimal dosing of postoperative EBRT could not be determined from the available data. However, longer schedules, such as 30 Gy in ten fractions, have been the most commonly used because the intent will be to eradicate microscopic residual disease rather than relieve symptoms through partial tumor regression with palliative radiation schedules. No reports have been published regarding the use of single fraction palliative EBRT in the postoperative setting. Eligible patients with spinal cord compression should be considered for available RT dose fractionation trials.

Radiopharmaceuticals and EBRT

Guideline Statement

The Task Force recognized that radiopharmaceuticals are an important, and often underused, palliative care option for multifocal bone metastases. The available data do not suggest that the use of systemic radiopharmaceuticals obviates the need for palliative EBRT for bone metastases. However, radiopharmaceutical use has most commonly been limited to circumstances of osteoblastic metastases documented by a technetium-99 bone scan, for certain malignant histologic types, and in cases in which the number of anatomic sites of pain is too great to reasonably be treated with standard EBRT (see Table 8 in the original guideline document). Additional prospective studies should address the prophylactic use of systemic radiopharmaceuticals in patients with limited bone metastases, as well as the possible combination of radiopharmaceuticals with other systemic agents such as bisphosphonates or chemotherapy.

Does the Use of Bisphosphonates Obviate the Need for EBRT for Painful Bone Metastasis?

Guideline Statement

The Task Force believes that the use of bisphosphonates does not obviate the need for EBRT for those patients with painful, uncomplicated bone metastases. Several prospective studies have suggested that the concurrent delivery of EBRT and bisphosphonates successfully palliates bone pain and promotes re-ossification of the damaged bone, with an acceptable risk of toxicity (see Table 9 in the original guideline document). However, it has not been shown that the combination is better than EBRT alone when pain relief has been the measured variable. The Task Force strongly recommends that large prospective, randomized trials be undertaken to more fully delineate the optimum RT fractionation and mode of delivery (EBRT vs. radiopharmaceuticals), the dose and duration of bisphosphonate therapy, and the scheduling of this treatment combination.

Kyphoplasty or Vertebroplasty and EBRT

Guideline Statement

No prospective data are available to suggest that the use of either kyphoplasty or vertebroplasty obviates the need for EBRT in the management of painful bone metastases. Kyphoplasty and vertebroplasty have theoretically shown the most promise in patients with metastatic spinal disease causing instability of the vertebral body, although the lack of completed prospective studies should limit their standard use (see Table 10 in the original guideline document). Small series of patients have been treated with kyphoplasty or vertebroplasty plus EBRT, stereotactic radiosurgery, or interstitial samarium-153. However, the results do not allow for definitive statements regarding the use of these combined regimens. Future prospective trials of vertebroplasty and kyphoplasty should address questions such as proper patient selection, efficacy, toxicity, and timing in relation to radiotherapeutic interventions.