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FOLFOX plus ziv-aflibercept or placebo in first-line metastatic esophagogastric adenocarcinoma: A double-blind, randomized, multicenter phase 2 trial.
Cleary, JM, Horick, NK, McCleary, NJ, Abrams, TA, Yurgelun, MB, Azzoli, CG, Rubinson, DA, Brooks, GA, Chan, JA, Blaszkowsky, LS, et al
Cancer. 2019;(13):2213-2221
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Abstract
BACKGROUND Antiangiogenic therapy is a proven therapeutic modality for refractory gastric and gastroesophageal junction adenocarcinoma. This trial assessed whether the addition of a high affinity angiogenesis inhibitor, ziv-aflibercept, could improve the efficacy of first-line mFOLFOX6 (oxaliplatin, leucovorin, and bolus plus infusional 5- fluorouracil) in metastatic esophagogastric adenocarcinoma. METHODS Patients with treatment-naive metastatic esophagogastric adenocarcinoma were randomly assigned (in a 2:1 ratio) in a multicenter, placebo-controlled, double-blind trial to receive first-line mFOLFOX6 with or without ziv-aflibercept (4 mg/kg) every 2 weeks. The primary endpoint was 6-month progression-free survival (PFS). RESULTS Sixty-four patients were randomized to receive mFOLFOX6 and ziv-aflibercept (43 patients) or mFOLFOX6 and a placebo (21 patients). There was no difference in the PFS, overall survival, or response rate. Patients treated with mFOLFOX6/ziv-aflibercept tended to be more likely to discontinue study treatment for reasons other than progressive disease (P = .06). The relative dose intensity of oxaliplatin and 5-fluorouracil was lower in the mFOLFOX6/ziv-aflibercept arm during the first 12 and 24 weeks of the trial. There were 2 treatment-related deaths due to cerebral hemorrhage and bowel perforation in the mFOLFOX6/ziv-aflibercept cohort. CONCLUSIONS Ziv-aflibercept did not increase the anti-tumor activity of first-line mFOLFOX6 in metastatic esophagogastric cancer, potentially because of decreased dose intensity of FOLFOX. Further evaluation of ziv-aflibercept in unselected, chemotherapy-naive patients with metastatic esophagogastric adenocarcinoma is not warranted.
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Continuous Glucose Monitoring in Older Adults With Type 1 and Type 2 Diabetes Using Multiple Daily Injections of Insulin: Results From the DIAMOND Trial.
Ruedy, KJ, Parkin, CG, Riddlesworth, TD, Graham, C, ,
Journal of diabetes science and technology. 2017;(6):1138-1146
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Abstract
OBJECTIVE The objective was to determine the effectiveness of real-time continuous glucose monitoring (CGM) in adults ≥ 60 years of age with type 1 (T1D) or type 2 (T2D) diabetes using multiple daily insulin injections (MDI). METHODS A multicenter, randomized trial was conducted in the United States and Canada in which 116 individuals ≥60 years (mean 67 ± 5 years) with T1D (n = 34) or T2D (n = 82) using MDI therapy were randomly assigned to either CGM (Dexcom™ G4 Platinum CGM System® with software 505; n = 63) or continued management with self-monitoring blood glucose (SMBG; n = 53). Median diabetes duration was 21 (14, 30) years and mean baseline HbA1c was 8.5 ± 0.6%. The primary outcome, HbA1c at 24 weeks, was obtained for 114 (98%) participants. RESULTS HbA1c reduction from baseline to 24 weeks was greater in the CGM group than Control group (-0.9 ± 0.7% versus -0.5 ± 0.7%, adjusted difference in mean change was -0.4 ± 0.1%, P < .001). CGM-measured time >250 mg/dL ( P = .006) and glycemic variability ( P = .02) were lower in the CGM group. Among the 61 in the CGM group completing the trial, 97% used CGM ≥ 6 days/week in month 6. There were no severe hypoglycemic or diabetic ketoacidosis events in either group. CONCLUSION In adults ≥ 60 years of age with T1D and T2D using MDI, CGM use was high and associated with improved HbA1c and reduced glycemic variability. Therefore, CGM should be considered for older adults with diabetes using MDI.
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Does intermittent pneumatic compression reduce the risk of post stroke deep vein thrombosis? The CLOTS 3 trial: study protocol for a randomized controlled trial.
Dennis, M, Sandercock, P, Reid, J, Graham, C, Forbes, J, ,
Trials. 2012;:26
Abstract
BACKGROUND Approximately 80,000 patients each year are admitted to U.K. hospitals with an acute stroke and are immobile. At least 10% will develop a proximal deep vein thrombosis in the first month and 1.5% a pulmonary embolus. Although hydration, antiplatelet treatment and early mobilisation may reduce the risk of deep vein thrombosis, there are currently no preventive strategies which have been clearly shown to be both effective and safe. Anticoagulation increases the risks of bleeding and compression stockings are ineffective. Systematic reviews of small randomized trials of intermittent pneumatic compression have shown that this reduces the risk of deep vein thrombosis in patients undergoing surgery, but that there are few data concerning its use after stroke. The CLOTS trial 3 aims to determine whether, compared with best medical care, best medical care plus intermittent pneumatic compression in immobile stroke patients reduces the risk of proximal deep vein thrombosis. METHODS/DESIGN CLOTS Trial 3 is a parallel group multicentre trial; with centralized randomisation (minimisation) to ensure allocation concealment. Over 80 centres in the U.K. will recruit 2800 immobile stroke patients within the first 3 days of their hospital admission. Patients will be allocated to best medical care or best medical care plus intermittent pneumatic compression. Ultrasonographers will perform a Compression Duplex Ultrasound Scan to detect deep vein thrombosis in each treatment group at about 7-10 days and 25-30 days. The primary outcome cluster includes symptomatic or asymptomatic deep vein thrombosis in the popliteal or femoral veins detected on either scan. Patients are then followed up by postal or telephone questionnaire at 6 months from randomisation to detect later symptomatic deep vein thrombosis and pulmonary emboli and to establish their functional outcome (Oxford handicap scale) and quality of life (EQ5D-3 L). The ultrasonographers performing the scans are blinded to treatment allocation, whereas the patients and caregivers are not. The trial has 90% power to detect a 4% absolute difference in risk of the primary outcome and includes a health economic analysis. DISCUSSION The trial started recruitment in Dec 2008 and will complete recruitment during 2012. It will report results in 2013. TRIAL REGISTRATION NUMBER ISRCTN ISRCTN93529999.
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Age- and sex-dependent effects of long-term zinc supplementation on essential trace element status and lipid metabolism in European subjects: the Zenith Study.
Hininger-Favier, I, Andriollo-Sanchez, M, Arnaud, J, Meunier, N, Bord, S, Graham, C, Polito, A, Maiani, G, O'Connor, JM, Coudray, C, et al
The British journal of nutrition. 2007;(3):569-78
Abstract
Given the key role of Zn in many physiological functions, optimal Zn status could be a predictive parameter of successful ageing. However, the benefit of Zn supplementation is still a matter of debate since Zn supplementation has been reported to be associated with the alteration of Cu status and lipid metabolism. As part of the Zenith Project, the present study aimed to investigate, in free-living healthy European middle-aged and older subjects, the effect of Zn supplementation on the biochemical status of Zn, Fe and Cu and on lipid profile. Volunteers aged 55-70 (n 188) and 70-85 (n 199) years old participated in a double-blinded, randomised study and received a daily placebo, or Zn as 15 or 30 mg for 6 months. Zn supplementation did not significantly modify erythrocyte Zn levels or erythrocyte Cu,Zn-superoxide dismutase activity. But Zn supplementation at 15 or 30 mg/d for 6 months increased significantly serum Zn levels and Zn urinary excretion with no major adverse effects on Fe and Cu status or on lipid metabolism. However, Zn supplementation at 30 mg/d showed some age- and sex-dependent alterations in Fe status or lipid profile. Therefore, with respect to the key role of an optimal Zn status in successful ageing, Zn supplementation at 15 mg/d, when necessary, could be safely proposed regarding lipids and the risk of interaction with Fe and Cu.