Purpose To present guidance for patients and physicians regarding the use of radiotherapy in the treatment of bone metastases according to current published evidence and complemented by expert opinion. Methods and Materials A systematic search of the National Library of Medicine’s PubMed database between 1998 and 2009 yielded 4,287 candidate original research articles potentially applicable to radiotherapy for bone metastases. A Task Force composed of all authors synthesized the published evidence and reached a consensus regarding the recommendations contained herein. Results The Task Force concluded that external beam radiotherapy continues to be the mainstay for the treatment of pain and/or prevention of the morbidity caused by bone metastases. Various fractionation schedules can provide significant palliation of symptoms and/or prevent the morbidity of bone metastases. The evidence for the safety and efficacy of repeat treatment to previously irradiated areas of peripheral bone metastases for pain was derived from both prospective studies and retrospective data, and it can be safe and effective. The use of stereotactic body radiotherapy holds theoretical promise in the treatment of new or recurrent spine lesions, although the Task Force recommended that its use be limited to highly selected patients and preferably within a prospective trial. Surgical decompression and postoperative radiotherapy is recommended for spinal cord compression or spinal instability in highly selected patients with sufficient performance status and life expectancy. The use of bisphosphonates, radionuclides, vertebroplasty, and kyphoplasty for the treatment or prevention of cancer-related symptoms does not obviate the need for external beam radiotherapy in appropriate patients. Conclusions Radiotherapy is a successful and time efficient method by which to palliate pain and/or prevent the morbidity of bone metastases. This Guideline reviews the available data to define its proper use and provide consensus views concerning contemporary controversies or unanswered questions that warrant prospective trial evaluation.

/pdf/palliative-radiotherapy-for-bone-metastases-an-astro-l7xc0ksgfi.pdf

Palliative radiotherapy for bone metastases: an ASTRO evidence-based guideline.

Bone metastases in advanced cancer frequently cause painful complications that impair patient physical activity and negatively affect quality of life. Pain is often underreported and poorly managed in these patients. The most commonly used pain assessment instruments are visual analogue scales, a single-item measure, and the Brief Pain Inventory Questionnaire-Short Form. The World Health Organization analgesic ladder and the Analgesic Quantification Algorithm are used to evaluate analgesic use. Bone-targeting agents, such as denosumab or bisphosphonates, prevent skeletal complications (i.e., radiation to bone, pathologic fractures, surgery to bone, and spinal cord compression) and can also improve pain outcomes in patients with metastatic bone disease. We have reviewed pain outcomes and analgesic use and reported pain data from an integrated analysis of randomized controlled studies of denosumab versus the bisphosphonate zoledronic acid (ZA) in patients with bone metastases from advanced solid tumors. Intravenous bisphosphonates improved pain outcomes in patients with bone metastases from solid tumors. Compared with ZA, denosumab further prevented pain worsening and delayed the need for treatment with strong opioids. In patients with no or mild pain at baseline, denosumab reduced the risk of increasing pain severity and delayed pain worsening along with the time to increased pain interference compared with ZA, suggesting that use of denosumab (with appropriate calcium and vitamin D supplementation) before patients develop bone pain may improve outcomes. These data also support the use of validated pain assessments to optimize treatment and reduce the burden of pain associated with metastatic bone disease.

/pdf/pain-outcomes-in-patients-with-bone-metastases-from-advanced-2ljtgxp57w.pdf

Pain Outcomes in Patients With Bone Metastases From Advanced Cancer: Assessment and Management With Bone-Targeting Agents

Radiotherapy is considered the treatment of choice for painful bone metastases. However, novel modalities of radiotherapy have emerged in the concept of oligometastasic disease. In addition, the increase of overall survival of patients with bone metastatic disease in the last decades due to systemic treatments has issued the silent topic of re-irradiation. The aim of this manuscript was to present a current thorough search of relevant literature. Originally, 6,087 articles revealed from PubMed database related to radiotherapy and bone metastases. The first objective was to identify prospective randomised phase III studies dealing with bone metastases and which treated primary with radiotherapy. Abstracts and non-English citations were excluded. Twenty-three phase III clinical trials, 17 prospective studies and eight meta-analysis/systemic reviews matching with these criteria, were identified. Eleven randomised studies were comparing single dose fraction to multi-fraction schedules of radiotherapy. The overall response rates and complete response rates were not significant between the two arms. Re-irradiations rates were significantly higher for the single dose fraction arms. Stereotactic radiotherapy showed excellent tumour control rates more than 80%. All trials showed the equivalence of either single or multi-fractionated radiotherapy for metastatic bone lesions. Stereotactic irradiation is feasible and safe for oligometastatic disease. However, it seems that the single fraction of 8 Gy is superior to 4 Gy, in terms of efficacy.

The role of radiotherapy in bone metastases: A critical review of current literature.

Introduction Hypofractionated stereotactic radiation therapy (HSRT) for vertebral metastases gives good results in terms of local control but increases the risk of fracture in the treated volume. Preclinical and clinical studies have shown that zoledronate not only reduces the risk of fracture and stimulates osteoclastic remodeling but also increases the immune response and radiosensitivity. This study aimed to evaluate the tolerability and effectiveness of zoledronate in association with radiation therapy. Patients and Methods We conducted a multicenter phase 1 study that combined HSRT (3 × 9 Gy) and zoledronate in patients with vertebral metastasis (NCT01219790). The principal objective was the absence of spinal cord adverse reactions at 1 year. The secondary objectives were acute tolerability, the presentation of a bone event, local tumor control, pain control, progression-free survival, and overall survival. Results Thirty patients (25 male, 5 female), median age 66 years, who were followed up for a median period of 19.2 months, received treatment for 49 vertebral metastases. A grade 3 acute mucosal adverse event occurred in 1 patient during the treatment and in 2 more at 1 month. No late neurologic adverse events were reported at 1 year. The mean pain scores diminished significantly at 1 month (1.35; P =.0125) and 3 months (0.77; P Conclusion The combination of zoledronate and HSRT in the treatment of vertebral metastasis is well tolerated and seems to reduce the rate of vertebral collapse, effectively relieve pain, and achieve good local tumor control with no late neurologic adverse effects.

High-Dose Hypofractionated Radiation Therapy for Noncompressive Vertebral Metastases in Combination With Zoledronate: A Phase 1 Study

Background. Pain caused by bone metastases is the most common symptom requiring the treatment in cancer patients. Bone metastases often present as the first evidence of disseminated disease, the most com- mon primary sites being breast, prostate, and lung. Important in palliative treatment is to reach a maximal effect with the minimal treatment. The aim of palliation for cancer patients is to increase the quality of their remaining life. Conclusions. The management of bone pain includes analgesics, local treatment (radiation, surgery) and systemic treatment (hormones, chemotherapy, radioisotopes and agents such as bisphosphonates). The treatment of bone cancer pain often requires a multidisciplinary approach. Radiotherapy remains the most important palliative treatment for localized bone pain. The treatment duration can generally be reduced to a single treatment with excellent and long-lasting palliative analgesic responses. The treatment should be individualized according to the patient’s clinical condition and life expectancy.

/pdf/radiotherapy-in-palliative-treatment-of-painful-bone-58hprrw3ii.pdf

Radiotherapy in palliative treatment of painful bone metastases

Objective To assess the effectiveness of a single dose of radio therapy (8 Gy vs. 6 Gy) plus zoledronic acid in cancer patients with bone metastases in treating pain; quality of life, time to onset of skeletal events and functional status. Material and methods A total of 139 patients from 22 Spanish hospitals were randomly assigned to: Group A, administered a single dose of 8 Gy+zoledronic acid (4 mg iv, in 15-min infusions), and Group B, administered a single dose of 6 Gy+zoledronic acid (4 mg iv, in 15-min infusions). The main variable was pain, which was assessed with the Visual Analogue Pain Scale (VAS) in supine, seated and standing positions. Results There was a total of 118 patients for intention to treat (n=67 in Group A and n=51 in Group B). The most frequent primary neoplasms were the lung (29.66%), prostate (22.03%) and breast (21.19%). Sixty patients were analysed per protocol, n=34 in group A and n=26 in group B. Improvements were observed in the VAS scores for pain in all three positions. The mean time to onset of the event was greater (p=0.0211) in Group A than in Group B (122 vs. 81.62 days). Functional status improved in Group A, and quality of life improved in both groups. Conclusion The two groups achieved similar levels of pain control in supine, seated and standing positions. Quality of

Randomised study of single dose (8 Gy vs. 6 Gy) of analgesic radiotherapy plus zoledronic acid in patients with bone metastases.

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Randomised study of single dose (8 Gy vs. 6 Gy) of analgesic radiotherapy plus zoledronic acid in patients with bone metastases.