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The standard treatment for spinal cord compression caused by metastatic cancer is corticosteroids and radiotherapy. The role of surgery has not been established. We assessed the efficacy of direct decompressive surgery. In this randomised, multi-institutional, non-blinded trial, we randomly assigned patients with spinal cord compression caused by metastatic cancer to either surgery followed by radiotherapy (n=50) or radiotherapy alone (n=51). Radiotherapy for both treatment groups was given in ten 3 Gy fractions. The primary endpoint was the ability to walk. Secondary endpoints were urinary continence, muscle strength and functional status, the need for corticosteroids and opioid analgesics, and survival time. All analyses were by intention to treat. After an interim analysis the study was stopped because the criterion of a predetermined early stopping rule was met. Thus, 123 patients were assessed for eligibility before the study closed and 101 were randomised. Significantly more patients in the surgery group (42/50, 84%) than in the radiotherapy group (29/51, 57%) were able to walk after treatment (odds ratio 6·2 [95% CI 2·0–19·8] p=0·001). Patients treated with surgery also retained the ability to walk significantly longer than did those with radiotherapy alone (median 122 days vs 13 days, p=0·003). 32 patients entered the study unable to walk; significantly more patients in the surgery group regained the ability to walk than patients in the radiation group (10/16 [62%] vs 3/16 [19%], p=0·01). The need for corticosteroids and opioid analgesics was significantly reduced in the surgical group. Direct decompressive surgery plus postoperative radiotherapy is superior to treatment with radiotherapy alone for patients with spinal cord compression caused by metastatic cancer.

Background For patients with spine metastases, stereotactic radiosurgery (SRS) provides excellent local control and pain response. Despite increasing use of this treatment modality, there is no consensus on the optimal dose and fractionation of spine SRS for efficacy and toxicity. We have initiated a single-center phase III randomized trial that compares two dose regimens with similar biological equivalent dose (BED) to determine the isolated effect of SRS fractionation on local control. Methods Patients with one to three cervical, thoracic, or lumbar spine metastases spanning no more than two contiguous vertebral levels in need of radiation will be eligible for enrollment. Patients will be assigned 1:1 to receive either 22 Gy in 1 fraction or 28 Gy in 2 fractions. Biased coin randomization will be used to randomly assign patients while balancing the following stratifying variables between the two treatment arms at baseline: gastrointestinal histology (yes/no), paraspinal tissue extension (yes/no), epidural compression (low-/high-grade), and number of sites treated (one to three). The primary endpoint is one-year local control, defined per Spine Response Assessment in Neuro-Oncology (SPINO) criteria. The secondary endpoints include patient-reported health-related quality of life (HRQOL), pain associated with the treated site, vertebral compression fracture (VCF), and two-year local control. Patients will be followed for these outcomes at one to two weeks, one month, three months, and six months after treatment, and every six months thereafter until 24 months after treatment. While on the study, patients will receive routine co-interventions as clinically indicated. Discussion The studies published thus far comparing the single- and multi-fraction SRS are lacking long-term local control outcomes and are limited by selection bias as well as single-fraction arms with higher BED, which is correlated with improved local control. Our study will isolate the effect of fractionation by comparing one-year local control in patients treated with single- and multi-fraction SRS with equivalent BED. We anticipate that the results of this, as well as secondary endpoints such as pain response, adverse effects, and quality of life will provide much-needed guidance regarding optimal dose and fractionation for both maximizing local control and minimizing toxicity. Clinical trial information NCT#06173401. Approved by Stanford Scientific Review Committee (study ID: BRN0060) on 9/12/2023 and Stanford Institutional Review Board (study ID: IRB-72248) on 11/14/2023

Introduction The primary goal of treatment in spinal metastasis is typically to extend patients’ lifespan as much as possible, and optimally to relieve the symptoms and so improve quality of life. It is crucial to avoid over- or under-treatment, according to each patient’s individual situation. Thus, this study aimed to identify significant prognostic factors for patients living with metastatic spine disease, and create a new nomogram for the prediction of survival rates. Methods Data from patients who had undergone operations for spinal metastasis between 2005 and 2016 were retrieved retrospectively, and randomized into training (70%) and validation groups (30%). A selection of pre-operative factors was analyzed using univariable and multivariable COX model for the training group. A nomogram was then developed using significant predictors in multivariable analysis. Accuracy was validated using a concordance index (C-index) and calibration curve for the training and validation groups, respectively. Results A total of 244 participants were enrolled, including 171 in the training group and 73 in the validation group. Primary tumor, Frankel Grade, Karnofsky Performance Score (KPS) and adjuvant therapy were found to be significant for predicting survival rates. A nomogram was developed by utilizing these predictors. The C-indexes for the two groups were 0.711 and 0.703 respectively. Moreover, a favorable consistency between the predicted and actual survival probabilities was demonstrated using calibration curves. Conclusions A user-friendly nomogram model for facilitating medical procedures during clinical encounters was established to aid clinical decision making for individual patients.

Background This was a prespecified secondary analysis of a randomized trial, which analyzed bone density following stereotactic body radiotherapy (SBRT) versus conventional three-dimensional conformal radiotherapy (3DCRT) as part of palliative management of painful spinal metastases. Methods Fifty-five patients were enrolled in this single-institutional randomized exploratory trial (NCT02358720). Participants were randomly assigned to receive SBRT (single-fraction 24 Gy) or 3DCRT (30 Gy/10 fractions). Quantitative bone density was evaluated at baseline, 3 and 6 months in both irradiated and unirradiated spinal bodies, along with rates of pathologic fractures and vertebral compression fractures. Results As compared to baseline, bone density became significantly higher at 3 and 6 months following SBRT by a median of 33.8% and 72.1%, respectively ( p  < 0.01 for both). These figures in the 3DCRT cohort were 32.9% and 41.2%, respectively ( p  < 0.01 for both). There were no statistical differences in bone density between SBRT and 3DCRT at 3 ( p  = 0.629) or 6 months ( p  = 0.327). Subgroup analysis of osteolytic metastases showed an increase in bone density relative to baseline in the SBRT (but not 3DCRT) arm. Bone density in unaffected vertebrae did not show substantial changes in either group. The 3-month incidence of new pathological fractures was 8.7% in the SBRT arm vs. 4.3% in the 3DCRT arm. Conclusions Despite high ablative doses in the SBRT arm, the significant increase in bone density after 3 and 6 months was similar to that of 3DCRT. Our trial demonstrated a moderate rate of subsequent pathological fracture after SBRT. Future randomized investigations with larger sample sizes are recommended. Trial registration www.clinicaltrials.gov : NCT02358720 on 9nd of February 2015.

This was a prespecified secondary analysis of a randomized trial, which analyzed quality of life (QOL), fatigue, and emotional distress following stereotactic body radiotherapy (SBRT) versus conventional three-dimensional conformal radiotherapy (3DCRT) as part of palliative management of painful spinal metastases. Fifty-five patients were enrolled in this single-institutional randomized exploratory phase II trial (NCT02358720). Participants were randomly assigned to receive SBRT (single-fraction 24 Gy) or 3DCRT (30 Gy/10 fractions). QOL (EORTC QLQ-BM22), fatigue (EORTC QLQ FA13), and emotional distress (QSC-R10) at the end of radiotherapy, along with 3- and 6-month follow-up were assessed. At all recorded time points, there were no significant QOL differences between cohorts, including painful sites, pain characteristics, functional impairment, or psychosocial aspects (p>0.05 for all). There were also no differences in all dimensions of fatigue between groups at each recorded time point (p>0.05 for all). Emotional distress was also similar at three (p=0.248) and six months (p=0.603). Although these results demonstrate that SBRT does not cause worse QOL deteriorations compared to 3DCRT, larger randomized investigations are recommended to corroborate these findings.

Background Radiofrequency ablation (RFA) of vertebral body metastases (VBM) has been reported as safe and effective in retrospective studies. This single-arm prospective multicenter clinical study evaluates RFA in the treatment of painful VBM. Methods Fifty patients with VBM were prospectively enrolled during a 13-month period at eight US centers under an IRB-approved study. Percutaneous RFA was performed under imaging guidance with cement augmentation at the discretion of the operator. Pain, disability and quality of life were evaluated at baseline, prior to discharge, days 3, 7, 30 and 90 using the Numerical Pain Rating Scale, Oswestry Disability Index (ODI), the Functional Assessment of Cancer Therapy-General 7 (FACT-G7) and Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain (FACT-BP). Adverse events were monitored throughout this time interval. Results Twenty-six male and 24 female patients (mean age 61.0) underwent 69 treatments (30 thoracic and 39 lumbar). Cement augmentation was performed in 96 % of reported levels. Significant improvement in mean scores for pain, disability and cancer-specific health-related quality of life from baseline to all time intervals was seen. NRPS improved from 5.9 to 2.1 ( p  < 0.0001). ODI improved from 52.9 to 37.0 ( p  < 0.08). FACT-G7 improved form 10.9 to 16.2 ( p  = 0.0001). FACT-BP improved from 22.6 to 38.9 ( p  < 0.001). No complications related to the procedure were reported. Conclusion RFA with cement augmentation safely and effectively reduces pain and disability rapidly, while increasing quality of life in patients suffering from vertebral body metastases.

Background The contribution of preoperative embolization in reducing intraoperative blood loss and its clinical importance are unclear. So, we aimed to compare the perioperative clinical outcomes based on whether preoperative embolization was performed and assess the role and safety of preoperative embolization in metastatic spinal cord compression (MSCC) patients. Methods We enrolled 52 patients (men, 37; women, 15) who underwent palliative decompression for MSCC. Demographic data, neurologic status, surgery-related data (operation time, estimated blood loss, and transfusion), complications, and survival time were recorded. Patients were categorized based on whether they received preoperative embolization: groups E (embolization) ( n  = 18) and NE (non-embolization) ( n  = 34) and the clinical parameters were compared. Subgroup analysis was performed specifically for cases of hypervascular tumors (23/52, 44%). Results The transfusion degree was greater in the NE group (4.6 pints) than in the E group (2.5 pints, P  = 0.025); the other parameters did not differ between the groups. However, massive bleeding (>2000 mL) was more frequent in the NE group (10/34) than in the E group (0/18, P  = 0.010). Subgroup analysis indicated that intraoperative blood loss was greater in the NE group (1988 mL) than in the E group (1095 mL, P  = 0.042) in hypervascular tumor patients. Although massive bleeding was more frequent among hypervascular tumor patients, 3 patients with non-hypervascularized tumors also exhibited massive bleeding ( P  = 0.087). Conclusions Intraoperative blood loss and perioperative transfusion can be reduced by preoperative embolization in MSCC patients. Neurologic recovery, operation time, and complications did not differ according to the application of embolization. As preoperative embolization is relatively safe and effective for controlling intraoperative bleeding without any neurologic deterioration, it is highly recommended for hypervascular tumors. Moreover, it may also be effective for non-hypervascular tumors as massive bleeding may be noted in some cases.

Background Spinal bone metastases are commonly diagnosed in cancer patients. The consequences are pain both at rest and under exercise, impairment of activities of daily life (ADL), reduced clinical performance, the risk of pathological fractures, and neurological deficits. The aim of this randomized, controlled pilot trial was to investigate the feasibility of muscle-training exercises in patients with spinal bone metastases under radiotherapy. Secondary endpoints were local control, pain response and survival. Methods This study was a prospective, randomized, monocentre, controlled explorative intervention trial to determine the multidimensional effects of exercises for strengthening the paravertebral muscles. On the days of radiation treatment, patients in the control group were physically treated in form of respiratory therapy. Sixty patients were randomized between September 2011 and March 2013 into one of the two groups: differentiated resistance training or physical measure with thirty patients in each group. Results The resistance training of the paravertebral muscles was feasible in 83.3% of patients (n = 25). Five patients died during the first three months. The exercise group experienced no measurable side effects. “Chair stand test” in the intervention group was significant enhanced with additionally improved analgesic efficiency. Patients in intervention group improved in pain score (VAS, 0–10) over the course (p < .001), and was significant better between groups (p = .003) after 3 months. The overall pain response showed no significant difference between groups (p = .158) There was no significant difference in overall and bone survival (survival from first diagnosed bone metastases to death). Conclusions Our trial demonstrated safety and feasibility of an isometric resistance training in patients with spinal bone metastases. The results offer a rationale for future large controlled investigations to confirm these findings. Trial registration Clinical trial identifier NCT01409720 .

Purpose To compare the effects of resistance training versus passive physical therapy on bone survival in the metastatic bone during radiation therapy (RT) as combined treatment in patients with spinal bone metastases. Secondly, to evaluate overall survival and progression-free-survival (PFS) as well as to quantify prognostic factors of bone survival after combined treatment. Methods In this randomized trial 60 patients were allocated from September 2011 until March 2013 into one of the two groups: resistance training (group A) or passive physical therapy (group B) with thirty patients in each group during RT. We estimated patient survival using Kaplan-Meier survival method. The Wald-test was used to evaluate the prognostic importance of pathological fracture, primary site, Karnofsky performance status, localization of metastases, number of metastases, and cerebral metastases. Results Median follow-up was 10 months (range 2–35). Bone survival showed no significant difference between groups ( p = .303). Additionally no difference between groups could be detected in overall survival ( p = .688) and PFS ( p = .295). Local bone progression was detected in 16.7 % in group B, no irradiated bone in group A showed a local progression over the course ( p = 0.019). In univariate analysis breast cancer, prostate cancer, and the presence of cerebral metastases had a significant impact on bone survival in group B, while no impact could be demonstrated in group A. Conclusions In this group of patients with spinal bone metastases we were able to show that guided resistance training of the paravertebral muscles had no essential impact on survival concomitant to RT. Importantly, no local bone progression in group A was detected, nevertheless no prognostic factor for combined treatment could be evaluated. Trial registration Clinical trial identifier NCT 01409720 . Registered 8 February 2011.

Background Standard radiotherapy is the treatment of first choice in patients with symptomatic spinal metastases, but is only moderately effective. Stereotactic body radiation therapy is increasingly used to treat spinal metastases, without randomized evidence of superiority over standard radiotherapy. The VERTICAL study aims to quantify the effect of stereotactic radiation therapy in patients with metastatic spinal disease. Methods/design This study follows the ‘cohort multiple Randomized Controlled Trial’ design. The VERTICAL study is conducted within the PRESENT cohort. In PRESENT, all patients with bone metastases referred for radiation therapy are enrolled. For each patient, clinical and patient-reported outcomes are captured at baseline and at regular intervals during follow-up. In addition, patients give informed consent to be offered experimental interventions. Within PRESENT, 110 patients are identified as a sub cohort of eligible patients (i.e. patients with unirradiated painful, mechanically stable spinal metastases who are able to undergo stereotactic radiation therapy). After a protocol amendment, also patients with non-spinal bony metastases are eligible. From the sub cohort, a random selection of patients is offered stereotactic radiation therapy ( n  = 55), which patients may accept or refuse. Only patients accepting stereotactic radiation therapy sign informed consent for the VERTICAL trial. Non-selected patients ( n  = 55) receive standard radiotherapy, and are not aware of them serving as controls. Primary endpoint is pain response after three months. Data will be analyzed by intention to treat, complemented by instrumental variable analysis in case of substantial refusal of the stereotactic radiation therapy in the intervention arm. Discussion This study is designed to quantify the treatment response after (stereotactic) radiation therapy in patients with symptomatic spinal metastases. This is the first randomized study in palliative care following the cohort multiple Randomized Controlled Trial design. This design addresses common difficulties associated with classic pragmatic randomized controlled trials, such as disappointment bias in patients allocated to the control arm, slow recruitment, and poor generalizability. Trial registration The Netherlands Trials Register number NL49316.041.14. ClinicalTrials.gov registration number NCT02364115 . Date of trial registration February 1, 2015.