Radiation therapy alone versus radiation therapy plus radiofrequency ablation/vertebral augmentation for spine metastasis: study protocol for a randomized controlled trial.

BACKGROUND: Spine metastasis is a common occurrence in cancer patients and results in pain, neurologic deficits, decline in performance status, disability, inferior quality of life (QOL), and reduction in ability to receive cancer-directed therapies. Conventional external beam radiation therapy (EBRT) is associated with modest rates of pain relief, high rates of disease recurrence, low response rates for those with radioresistant histologies, and limited improvement in neurologic deficits. The addition of radiofrequency ablation/percutaneous vertebral augmentation (RFA/PVA) to index sites together with EBRT may improve pain response rates and corresponding quality of life. METHODS/DESIGN: This is a single-center, prospective, randomized, controlled trial in patients with spine metastasis from T5-L5, stratified according to tumor type (radioresistant vs. radiosensitive) in which patients in each stratum will be randomized in a 2:1 ratio to either RFA/PVA and EBRT or EBRT alone. All patients will be treated with EBRT to a dose of 20-30 Gy in 5-10 fractions. The target parameters will be measured and recorded at the baseline clinic visit, and daily at home with collection of weekly measurements at 1, 2, and 3 weeks after treatment, and at 3, 6, 12, and 24 months following treatment with imaging and QOL assessments. DISCUSSION: The primary objective of this randomized trial is to determine whether RFA/PVA in addition to EBRT improves pain control compared to palliative EBRT alone for patients with spine metastasis, defined as complete or partial pain relief (measured using the Numerical Rating Pain Scale [NRPS]) at 3 months. Secondary objectives include determining whether combined modality treatment improves the rapidity of pain response, duration of pain response, patient reported pain impact, health utility, and overall QOL. TRIAL REGISTRATION: ClinicalTrials.gov NCT04375891 . Registered on 5 May 2020.

Palliative Care Consultation Trends Among Hospitalized Patients With Advanced Cancer in the United States, 2005 to 2014.

BACKGROUND:: Although palliative care services are increasing in the United States, disparities exist in access and utilization. Hence, we explored these factors in hospitalized patients with advanced cancers using the National Inpatient Sample (NIS). METHODS:: This was a retrospective analysis of NIS data, 2005 to 2014, and included patients ≥18 years with advanced cancers with and without palliative care consultations. Both χ2 and independent t tests were used for categorical and continuous variables. Multivariate logistic regressions were used for identifying factors associated with palliative care consultations. RESULTS:: Palliative care consultations were recorded in 9.9% of 4 732 172 weighted advanced cancer hospitalizations and increased from 3.0% to 15.5% during 2005 to 2014 (relative increase, 172.2%, Ptrend < .01). Factors associated with higher palliative care consultations were increasing age, ≥80 years (odds ratio [OR]: 1.47; 95% confidence interval [CI]: 1.38-1.56); black race (OR: 1.21; 95% CI: 1.14-1.28); private insurance coverage (OR: 1.10; 95% CI: 1.02-1.18); West region (OR: 1.15; 95% CI: 1.01-1.33); large hospitals (OR: 1.19; 95% CI: 1.02-1.34); high income (OR: 1.08; 95% CI: 1.08-1.17); do-not-resuscitate (dying patients) status (OR: 10.55; 95% CI: 10.14-10.99); and in-hospital radiotherapy (OR: 1.13; 95% CI: 1.06-1.21). Palliative care consultations were lower in patients with chemotherapy (OR: 0.71; 95% CI: 0.60-0.84). CONCLUSION:: Many demographic, socioeconomic, health-care, and geographic disparities were identified in palliative care consultations. Additionally, palliative care resources were underutilized by hospitalized patients with advanced cancers and commonly utilized by patients who are dying. Health-care providers and policy makers should focus on these disparities in order to improve palliative care use.