摘要
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Summary
Background
Spinal stereotactic body radiation therapy (SBRT) is increasingly used to manage spinal metastases, yet the technique's effectiveness in controlling the symptom burden of spinal metastases has not been well described. We investigated the clinical benefit of SBRT for managing spinal metastases and reducing cancer-related symptoms.Methods
<p>149 patients with mechanically stable, non-cord-compressing spinal metastases (166 lesions) were given SBRT in a phase 1-2 study. Patients received a total dose of 27-30 Gy, typically in three fractions. Symptoms were measured before SBRT and at several time points up to 6 months after treatment, by the Brief Pain Inventory (BPI) and the M D Anderson Symptom Inventory (MDASI). The primary endpoint was frequency and duration of complete pain relief. The study is completed and is registered with , number .Findings
<p>Median follow-up was 15路9 months (IQR 9路5-30路3). The number of patients reporting no pain from bone metastases, as measured by the BPI, increased from 39 of 149 (26%) before SBRT to 55 of 102 (54%) 6 months after SBRT (p<0路0001). BPI-reported pain reduction from baseline to 4 weeks after SBRT was clinically meaningful (mean 3路4 [SD 2路9] on the BPI pain-at-its-worst item at baseline, 2路1 [2路4] at 4 weeks; effect size 0路47, p=0路00076). These improvements were accompanied by significant reduction in opioid use during the first 6 months after SBRT (43 [28路9%] of 149 patients with strong opioid use at baseline vs 20 [20路0%] of 100 at 6 months; p=0路011). Ordinal regression modelling showed that patients reported significant pain reduction according to the MDASI during the first 6 months after SBRT (p=0路00003), and significant reductions in a composite score of the six MDASI symptom interference with daily life items (p=0路0066). Only a few instances of non-neurological grade 3 toxicities occurred: nausea (one event), vomiting (one), diarrhoea (one), fatigue (one), dysphagia (one), neck pain (one), and diaphoresis (one); pain associated with severe tongue oedema and trismus occurred twice; and non-cardiac chest pain was reported three times. No grade 4 toxicities occurred. Progression-free survival after SBRT was 80路5%(95%CI 72路9-86路1) at 1 year and 72路4%(63路1-79路7) at 2 years.Interpretation
<p>SBRT is an effective primary or salvage treatment for mechanically stable spinal metastasis. Significant reductions in patient-reported pain and other symptoms were evident 6 months after SBRT, along with satisfactory progression-free survival and no late spinal cord toxicities.Funding
<p>National Cancer Institute of the US National Institutes of Health.
