Example Queries II

What effects of selenium have been investigated?

	Outcome name
Asfour et al. (2006): Effect of high-dose sodium selenite therapy on polymorphonuclear leukocyte apoptosis in non-Hodgkin's lymphoma patients	Toxicity Ejection fraction
Büntzel et al. (2010): Limited effects of selenium in the prevention of radiation-associated toxicities - results of a randomized study in head neck cancer patients	Toxicity
Büntzel et al. (2010): Selenium Substitution During Radiotherapy of Solid Tumours - Laboratory Data from Two Observation Studies in Gynaecological and Head and Neck Cancer Patients	Selenium level
Goossens et al. (2016): Phase III randomised chemoprevention study with selenium on the recurrence of non-invasive urothelial carcinoma. The SELEnium and BLAdder cancer Trial	RFS (Recurrence-Free Survival) PFS (Progression-Free Survival) Selenium level
Jahangard-Rafsanjani et al. (2013): The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial	Haematological indices Length of hospital stay Incidence of acute GVHD (Graft-Versus-Host Disease) Mortality rate Non-haematological indices Selenium level Mucositis Fever
... further results

How does selenium influence survival in cancer?

	Results after intervention	Overall RoB judgment	Outcome specification
Goossens et al. (2016): Phase III randomised chemoprevention study with selenium on the recurrence of non-invasive urothelial carcinoma. The SELEnium and BLAdder cancer Trial	ITT: intervention arm n=43 (28%; 95% CI: 0.21, 0.35) and placebo arm n=45 (32%; 95% CI: 0.24, 0.40); HR: 0.85 (95% CI: 0.56, 1.29); p=0.44, not significant PP: (all participants remaining in the study after 3 months): intervention arm n=42 and placebo arm n=39 (28%; 95% CI: 0.20, 0.35); HR: 0.96 (95% CI: 0.62, 1.48)); p=0.85, not significant No influence of age, gender, nicotine consumption, stage, selenium concentration at baseline and hospital Remark: After 3 months: progression in 24 patients, median progression time 22 months in both arms; Patients in intervention arm had 48% more chance of progression than those in the placebo arm, but not statistically significant (HR = 1.48 (95% CI: 0.65, 3.38); p=0.35); Progression in the intervention arm 15x, placebo arm 14x ITT: HR: 0.97 (95% CI: 0.47, 2.00); p=0.93, not significant Significant difference in selenium concentration after 3 years (n=67 (55%)): 187.6 mg/dl ± 57.7 mg/dl intervention arm vs. 88.9 mg/dl ± 22.2 mg/dl placebo arm; p=0.00	some concerns some concerns some concerns	NA NA Measured at baseline and after 3 years
Karp et al. (2012): Randomized, double-blind, placebo-controlled, phase III chemoprevention trial of selenium supplementation in patients with resected stage I non-small-cell lung cancer: ECOG 5597	Intervention arm: 76.8% (SE, 1.6%) vs. placebo arm: 79.9% (SE, 2.1%); p=0.154 Note: Distribution significantly different for smoking status (p=0.027): active smokers or those who had quit within one year showed a 3-year OS of 85.5% (SE, 1.7%) and 5-year OS of 74.9% (SE, 2.4%), whereas participants who had never smoked showed a 3-year OS of 90% (SE, 2.8%) and a 5-year OS of 83.6% (SE, 3.6%); no difference for DFS; p=0.245 Collected in 865 patients in intervention arm and 477 in placebo arm: Grade 1-2 toxicity in intervention arm: 31% and placebo arm: 26% of subjects Grade ≥ 3 toxicity occurred in less than 2% of subjects in intervention arm and 3% in placebo arm n=1 patient in placebo arm had constitutional lethal toxicity no arm comparison performed Selenium level at baseline (n=1,022), year 2 (n=375), and year 4 (n=194): at baseline selenium level mostly in normal range, after 2 and 4 years significantly increased selenium concentration in the intervention arm Interim analysis October 2009: N=83 secondary lung tumors; Rate intervention arm: 1.91 per 100 persons per year vs. 1.36 in placebo arm; p=ns June 2011: N=252 secondary tumors in 224 patients, of which 98 (out of 97 patients) were lung cancer (38.9%); Lung cancer and other cancers (SPT) in intervention arm: 1.62 and 3.54 per 100 persons per year vs. placebo arm: 1.30 and 3.39 per 100 persons per year; p=0.294 5-year DFS: October 2009: Intervention arm: 72% vs. placebo arm: 78%, no significance values given June 2011: Intervention arm: 74.4% vs. placebo arm: 79.6%; p=0.69 Note: 5-year DFS rates with subdivision into low, average and high selenium concentration intervention vs. placebo: 75.5% (SE, 10.3%) vs. 72.9% (SE, 12.7%), 75.6% (SE, 2.27%) vs. 78.2% (SE, 3.3%), and 72.9% (SE, 4.5%) vs. 80.9% (SE, 5.2%)	low risk low risk low risk low risk	5-year OS NA NA DFS Randomization until secondary tumors or recurrence and 5-year DFS
Mix et al. (2015): Randomized phase II trial of selenomethionine as a modulator of efficacy and toxicity of chemoradiation in squamous cell carcinoma of the head and neck	Overall: No significant differences between arms (grade 3 intervention arm 2x, placebo arm 3x, no grade 4) Only one patient from the intervention arm did not reach CR and died After 12 months: No significant differences between arms After 12 months: No significant differences between arms No significant difference for week 6-8 post-treatment and Follow-up within a year Overall: Hearing dysfunction n=1 each in the intervention arm and placebo arm; elevated creatinine n=1 in the placebo arm; myelosuppression: anemia in the placebo arm n=1; leukopenia in the intervention arm n=3 and placebo arm n=2; dermatitis in the intervention arm n=2; dry mouth in the placebo arm n=2; dysgeusia in the intervention arm n=2, placebo arm n=1; odyno-/dysphagia in the intervention arm n=1, placebo arm n=2; oral/throat pain in the placebo arm n=2; mucus/sputum intervention arm n=3, placebo arm n=1	some concerns low risk low risk low risk some concerns some concerns	Grade 3 or 4 Complete response rate (CR) NA NA Measured with EORTC C-30 Version 3 and EORTC QLQ - H&N35 Other treatment-associated side effects such as xerostomia, renal impairment, hearing dysfunction, and myelosuppression
Muecke et al. (2010): Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncology	After 6 weeks post radiotherapy, levels between arms were comparable Overall incidence of grade 2 diarrhea: intervention arm 20.5% vs. control arm 44.5% (p = 0.04) No difference between arms No difference between arms Median follow-up of 49 months (range, 0-75): 5-year disease free survival in the intervention arm was 80.1% vs. 83.2% in the control arm, no significant difference; p = 0.74 Median follow-up of 51 months (range 6-75): 5-year overall survival in the intervention arm was 91.9% vs. 83.1% in the control arm, no significant difference; p = 0.34	some concerns some concerns some concerns some concerns some concerns some concerns	Efficiancy of supplementation Diarrhea NA NA NA NA
Muecke et al. (2014): Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncology: follow-up analysis of the survival data 6 years after cessation of randomization	10-year disease-free survival intervention arm 80.1% vs. control arm 83.2%; not significant; p = 0.65 10-year overall survival intervention arm 55.3% vs. control arm 42.7%; not significant; p = 0.09	high risk high risk	10-year disease-free survival 10-year overall survival