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Alegria-Barrero E.,Cardiovascular Biomedical Research Unit | Chan P.H.,Cardiovascular Biomedical Research Unit | Paulo M.,Cardiovascular Biomedical Research Unit | Duncan A.,Cardiovascular Biomedical Research Unit | And 6 more authors.
Circulation Journal

MitraClip® therapy is a percutaneous edge-to-edge plication of the mitral leaflets, mimicking the Alfieri surgical technique. MitraClip® implantation is a safe procedure, and survival outcomes in high-surgical-risk patients are superior to historical controls. Despite these results, questions remain concerning long-term efficacy and durability. The MitraClip® device has been studied in a safety and feasibility trial in the USA, a randomized pivotal trial against surgical mitral valve repair. Moreover, MitraClip® now has over 2 years of CE-mark approval and a rapidly expanding clinical experience in Europe, primarily in patients at high risk for surgery. A dedicated multidisciplinary team is necessary, as well as thoughtful patient selection, familiarity with the technical aspects of the procedure, including transesophageal ultrasound imaging and post-procedure monitoring. Currently available clinical data and procedural steps are herein reviewed. Because the MitraClip® procedure is still relatively new, continued investigation is required to further better define the patient populations that will benefit most. Source

Lopez-Pousa A.,Santa Creu i Sant Pau Hospital | Rifa J.,Son Dureta Hospital | casas de tejerina A.,Virgen del Rocio Hospital | Gonzalez-Larriba J.L.,Clinico San Carlos Hospital | And 2 more authors.
European Journal of Cancer Care

Chemotherapy-induced neutropenia, the major dose-limiting toxicity of chemotherapy, is directly associated with concomitant morbidity, mortality and health-care costs. The use of prophylactic granulocyte colony-stimulating factors may reduce the incidence and duration of chemotherapy-induced neutropenia, and is recommended in high-risk patients. The objective of this study was to develop a model to predict first-cycle chemotherapy-induced neutropenia (defined as neutropenia grade ≥3, with or without body temperature ≥38°C) in patients with solid tumours. A total of 1194 patients [56% women; mean age 58 ± 12 years; 94% Eastern Cooperative Oncology Group (ECOG) status ≤1] with solid tumours were included in a multi-centre non-interventional prospective cohort study. A predictive logistic regression model was developed. Several factors were found to influence chemotherapy-induced neutropenia. Higher ECOG status values increased toxicity (ECOG 2 vs. 0, P = 0.003; odds ratio 3.12), whereas baseline lymphocyte (P = 0.011; odds ratio 0.67) and neutrophil counts (P = 0.026; odds ratio 0.90) were inversely related to neutropenia occurrence. Sex and treatment intention also significantly influenced chemotherapy-induced neutropenia (P = 0.012). The sensitivity and specificity of the model were 63% and 67% respectively, and the positive and negative predictive values were 17% and 94% respectively. Once validated, this model should be a useful tool for clinical decision making. © 2010 The Authors. Journal compilation © 2010 Blackwell Publishing Ltd. Source

Grande E.,Ramon y Cajal University Hospital | Capdevila J.,Autonomous University of Barcelona | Castellano D.,12 Of Octubre University Hospital | Teule A.,Catalan Institute of Oncology LHospitalet | And 15 more authors.
Annals of Oncology

Background: The management of advanced neuroendocrine tumors (NETs) has recently changed. We assessed the activity of pazopanib after failure of other systemic treatments in advanced NETs. Methods: This was a multicenter, open-label, phase II study evaluating pazopanib as a single agent in advanced NETs (PAZONET study). The clinical benefit rate (CBR) at 6 months was the primary end point. Translational correlation of radiological response and progression-free survival (PFS) with circulating and tissue biomarkers was also evaluated. Results: A total of 44 patients were enrolled. Twenty-five patients (59.5%) were progression-free at 6 months (4 partial responses, 21 stable diseases) with a median PFS of 9.5 months [95% confidence interval (CI) 4.8-14.1]. The CBR varied according to prior therapy received, with 73%, 60% and 25% in patients treated with prior multitarget inhibitors, prior mTOR inhibitors and both agents, respectively. A nonsignificant increase in PFS was observed in patients presenting lower baseline circulating tumor cell (CTC) counts (9.1 versus 5.8 months; P = 0.22) and in those with decreased levels of soluble-vascular endothelial growth factor receptor-2 (sVEGFR-2) (12.6 versus 9.1 months; P = 0.067). A trend toward reduced survival was documented in patients with VEGFR3 rs307821 and rs307826 missense polymorphisms [hazard ratio (HR): 12.3; 95% CI 1.09-139.2; P = 0.042 and HR: 6.9; 95% CI 0.96-49.9; P = 0.055, respectively]. Conclusions: Pazopanib showed clinical activity in patients with advanced NETs regardless of previous treatments. Additionally, CTCs, soluble-s VEFGR-2 and VEGFR3 gene polymorphisms constitute potential biomarkers for selecting patients for pazopanib (NCT01280201). Clinical trial number: NCT01280201. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Source

Bueno-Muino C.,Infanta Cristina Hospital | Garcia-Saenz J.A.,Clinico San Carlos Hospital
Cancer and Chemotherapy Reviews

Intravenous administration has been the standard formulation to deliver trastuzumab in HER2-positive breast cancer patients. The essential concerns with intravenous delivery are that a patent intravenous line is required and the infusion time. A new potential subcutaneous delivery method for trastuzumab has been recently developed, which is rapidly administered, potentially improving convenience for patients and clinical staff, enhancing medical resources, and reducing administration costs. In the neo/adjuvant setting, the phase III HannaH study showed the non-inferiority of subcutaneous trastuzumab when compared with the intravenous formulation. Based on comparable pharmacokinetics, efficacy, and safety, the subcutaneous formulation and regimen provide an alternative treatment to the registered intravenous formulation for stage I to IIIC HER2-positive breast cancer. The safety profile of subcutaneous trastuzumab was comparable and consistent with the known safety profile of trastuzumab. The phase III SafeHer study will further evaluate the safety and tolerability of subcutaneous trastuzumab in a broader HER2-positive breast cancer patient population. In addition, the study called PrefHer showed that patients preferred fixed-dose subcutaneous delivery of trastuzumab via a single-use injection device over standard intravenous administration for the treatment of HER2-positive early breast cancer. In conclusion, patient efficacy, safety, and preference suggest that a fixed dose of 600 mg subcutaneous trastuzumab every three weeks is a validated, well tolerated, and preferred option of patients for the treatment of HER2-positive breast cancer. © Permanyer Publications 2016. Source

Ancin I.,Biomedical Research Foundation | Santos J.L.,Virgen de la Luz Hospital | Teijeira C.,Clinico San Carlos Hospital | Sanchez-Morla E.M.,Virgen de la Luz Hospital | And 11 more authors.
Acta Psychiatrica Scandinavica

Objective: Nowadays, it is accepted that to identify the biological basis of psychiatric illnesses it would be useful to deconstruct them into the most basic manifestations, such as cognitive deficits. The aim of this study was to set attention deficit as a stable vulnerability marker of bipolar disorder. Method: Sustained attention was evaluated by the Continuous Performance Test (DS-CPT) in 143 euthymic bipolar patients and 105 controls. To estimate the influence of clinical profile in attention, patients completed a semi-structured interview. Results: Bipolar patients showed a deficit in attention during euthymic periods. This disturbance correlated with years of evolution, age of onset and age of first hospitalisation; and was not influenced by other clinical data. Conclusion: Sustained attention may be considered as an endophenotype of the illness. © 2010 John Wiley & Sons A/S. Source

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