Evaluation of Clinicopathological and Molecular Parameters on Disease Recurrence of Papillary Thyroid Cancer Patient: A Retrospective Observational Study

The American Joint Committee on Cancer has revised the Tumor-Node-Metastasis (TNM) staging system for papillary thyroid cancer (PTC) patients. We examined the impact of this new classification (TNM-8) on patient stratification and estimated the prognostic value of clinicopathological features for the disease-free interval (DFI) in a cohort of 1148 PTC patients. Kaplan-Meier analyses showed that all clinicopathological parameters analyzed, except age and multifocality, were associated significantly with DFI. Cox regression identified tall cell PTC variant and stage as independent risk factors for DFI. When the stage was replaced with age, tumor size, and lymph node (LN) metastases in the set of covariates, the lateral LN metastases stood out as the strongest independent predictor of DFI, followed by tall cell variant and age. A noteworthy result emerging from these analyzes is that regression models had lower Akaike and Bayesian information criterions if variables were categorized based on the TNM-7. In addition, we examined data from a different PTC patient cohort, acquired from The Cancer Genome Atlas database, to verify whether the DFI prediction could be enhanced by further clinicopathological and molecular parameters. However, none of these was found to be a significant predictor of DFI in the Cox model

Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter Study

Background: Erythropoiesis-stimulating agents (ESAs) are biological molecules approved for the treatment of anemia associated with chronic renal failure. Biosimilars were licensed for use in Europe in 2007. Aim: This study aimed to compare the safety profile of biosimilars with respect to the reference product in a nephrology setting. Methods: A prospective study was conducted in four Italian regions between 1 October 2013 and 30 June 2015. The study population included patients aged 65 18 years undergoing hemodialysis and treated with epoetins as per the clinical practice of the participating centers. The two comparison cohorts included patients treated with either an originator or a biosimilar epoetin alfa. Each patient was followed up until occurrence of any safety outcome of interest (grouped into three major categories), switch to a different ESA product, transplant or peritoneal dialysis, death, or end of the study period, whichever came first. Results: Overall, 867 subjects were included in the study (originator: N = 423; biosimilar: N = 444). Biosimilar users were older than originator users (median age of 76 vs 64 years, respectively), more frequently affected by arrhythmia (29.3 vs 22.5%), and less frequently candidates for transplantation (3.8 vs 18.2%). Cox-regression analysis showed no increase in risk of safety outcomes in biosimilar users, even after adjusting for confounding factors: 1.0 (95% confidence interval [CI] 0.7\u20131.3) for any outcomes; 1.1 (95% CI 0.7\u20131.8) for problems related to dialysis device; 0.9 (95% CI 0.6\u20131.5) for cardio- and cerebro-vascular conditions; 0.9 (95% CI 0.6\u20131.5) for infections. Conclusion: This study confirms the comparable safety profiles of originator and biosimilar epoetin alfa drugs when used in patients receiving dialysis

Low vitamin K1 intake in haemodialysis patients

Background & aims: Vitamin K acts as a coenzyme in the g-carboxylation of vitamin K-dependent proteins,including coagulation factors, osteocalcin, matrix Gla protein (MGP), and the growth arrest-specific6 (GAS6) protein. Osteocalcin is a key factor for bone matrix formation. MGP is a local inhibitor of softtissue calcification. GAS6 activity prevents the apoptosis of vascular smooth muscle cells. Few data onvitamin K intake in chronic kidney disease patients and no data in patients on a Mediterranean diet areavailable. In the present study, we evaluate the dietary intake of vitamin K1 in a cohort of patientsundergoing haemodialysis.Methods: In this multi-centre controlled observational study, data were collected from 91 patients aged>18 years on dialysis treatment for at least 12 months and from 85 age-matched control subjects withnormal renal function. Participants completed a food journal of seven consecutive days for the estimationof dietary intakes of macro- and micro-nutrients (minerals and vitamins).Results: Compared to controls, dialysis patients had a significant lower total energy intake, along with alower dietary intake of proteins, fats, carbohydrates, fibres, and of all the examined minerals (Ca, P, Fe,Na, K, Zn, Cu, and Mg). With the exception of vitamin B12, vitamins intake followed a similar pattern,with a lower intake in vitamin A, B1, B2, C, D, E, folates, K1 and PP. These finding were confirmed alsowhen normalized for total energy intake or for body weight.In respect to the adequate intakes recommended in the literature, the prevalence of a deficient vitamin Kintake was very high (70e90%) and roughly double than in controls. Multivariate logistic model identifiedvitamin A and iron intake as predictors of vitamin K deficiency