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.

Prevalence of Cardiovascular Risk Factors Among Cancer Patients in the United States.

Background: Cancer and cardiovascular diseases (CVDs) are leading causes of morbidity and mortality. We analyzed national data to examine the prevalence of CVD risk factors among adult cancer survivors in the United States. Methods: Participants included adults ≥18 years of age from the National Health and Nutrition Examination Survey 2001-2002 to 2013-2014. CVD risk factors included hypertension, diabetes, dyslipidemia, obesity, smoking, and physical activity. Prevalence of 1, 2, or ≥3 CVD risk factors was compared between cancer and noncancer participants. All CVD risk factors were adjusted for age and smoking and additionally for sex. Differences in CVD risk factors among cancer and noncancer participants were identified using logistic regression analysis. Results: Among 35,379 eligible participants, 2906 (8.4%) had a history of cancer. The proportion of participants having a single CVD risk factor was lower among cancer survivors compared with noncancer participants (25.8% vs. 33.9%, P < 0.001). The proportions of participants having two CVD risk factors (33.5% vs. 24.6%, P < 0.001) and ≥3 CVD risk factors (27.4% vs. 16.4%, P < 0.001) were higher among cancer survivors. However, these associations lost significance upon adjusting for age. The odds of total hypertension (odds ratio [OR] 1.25, 95% confidence interval [CI]: 1.11-1.40) and total diabetes (OR 1.33, 95% CI: 1.08-1.65) were significantly higher among cancer survivors. Conclusions: Our study showed that adult cancer survivors in the United States had higher levels of CVD risk factors primarily due to age-related factors, in addition to cancer complications. There is a significant need for improved CVD risk assessment and prevention services for cancer survivors.