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Robertson J.F.R.,University of Nottingham | Lindemann J.P.O.,Astrazeneca | Llombart-Cussac A.,Hospital Arnau de Vilanova | Rolski J.,Centrum Onkologii | And 4 more authors.
Breast Cancer Research and Treatment | Year: 2012

Fulvestrant fIRst-line Study comparing endocrine Treatments is a phase II, randomized, open-label study comparing fulvestrant 500 mg with anastrozole 1 mg as first-line endocrine therapy for postmenopausal women with hormone receptor-positive (HR+) advanced breast cancer. At data cutoff, only 36 % of patients had progressed and the median time to progression (TTP) had not been reached for fulvestrant. Here, we report follow-up data for TTP for fulvestrant 500 mg versus anastrozole 1 mg. Key inclusion criteria were postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive locally advanced or metastatic breast cancer and no prior endocrine therapy. Key exclusion criteria were presence of life-threatening metastases and prior treatment with a non-approved drug. Fulvestrant was administered 500 mg/month plus 500 mg on day 14 of month 1; anastrozole was administered 1 mg/day. TTP was defined by modified Response Evaluation Criteria in Solid Tumors v1.0 before data cut-off for the primary analysis, and investigator opinion after data cut-off. Best overall response to subsequent therapy and serious adverse events are also reported. In total, 205 patients received fulvestrant 500 mg (n = 102) or anastrozole (n = 103). Follow-up analysis was performed when 79.5 % of patients had discontinued study treatment. Median TTP was 23.4 months for fulvestrant versus 13.1 months for anastrozole; a 34 % reduction in risk of progression (hazard ratio 0.66; 95 % confidence interval: 0.47, 0.92; P = 0.01). Best overall response to subsequent therapy and clinical benefit rate for subsequent endocrine therapy was similar between the treatment groups. No new safety concerns for fulvestrant 500 mg were documented. These longer-term, follow-up results confirm efficacy benefit for fulvestrant 500 mg versus anastrozole as first-line endocrine therapy for HR+ advanced breast cancer in terms of TTP, and, importantly, show similar best overall response rates to subsequent endocrine therapy. © Springer Science+Business Media, LLC. 2012. Source


Rello J.,Autonomous University of Barcelona | Afonso E.,Hospital Vall DHebron | Lisboa T.,Hospital de Clinicas | Ricart M.,Hospital de Sant Pau | And 4 more authors.
Clinical Microbiology and Infection | Year: 2013

Implementation of care bundles for prevention of ventilator-associated pneumonia (VAP) and its impact on patient outcomes requires validation with long-term follow-up. A collaborative multi-centre cohort study was conducted in five Spanish adult intensive-care units. A care bundle approach based on five measures was implemented after a 3-month baseline period, and compliance, VAP rates, intensive-care unit length of stay (ICU LOS) and duration of mechanical ventilation were prospectively recorded for 16months. There were 149 patients in the baseline period and 885 after the intervention. Compliance with all measures after intervention was <30% (264/885). In spite of this, VAP incidence decreased from 15.5% (23/149) to 11.7% (104/885), after the intervention (p <0.05). This reduction was significantly associated with hand hygiene (OR=0.35), intra-cuff pressure control (OR=0.21), oral hygiene (OR=0.23) and sedation control (OR=0.51). Use of the care bundle was associated with an incidence risk ratio of VAP of 0.78 (95% CI 0.15-0.99). We documented a reduction of median ICU LOS (from 10 to 6days) and duration of mechanical ventilation (from 8 to 4days) for patients with full bundle compliance (intervention period). Efforts on VAP prevention and outcome improvement should focus on achieving higher compliance in hand and oral hygiene, sedation protocols and intracuff pressure control. © 2012 The Authors. Clinical Microbiology and Infection © 2012 European Society of Clinical Microbiology and Infectious Diseases. Source


MacEira A.M.,Cardiac Imaging Unit | Cosin-Sales J.,Hospital Arnau de Vilanova | Roughton M.,Royal Brompton Hospital | Prasad S.K.,Cardiovascular Magnetic Resonance Unit | Pennell D.J.,Cardiovascular Magnetic Resonance Unit
Journal of Cardiovascular Magnetic Resonance | Year: 2010

Background: Left atrial (LA) size is related to cardiovascular morbidity and mortality. Cardiovascular magnetic resonance (CMR) provides high quality images of the left atrium with high temporal resolution steady state free precession (SSFP) cine sequences. We used SSFP cines to define normal ranges for LA volumes and dimensions relative to gender, age and body surface area (BSA), and examine the relative value of 2D atrial imaging techniques in patients. For definition of normal ranges of LA volume we studied 120 healthy subjects after careful exclusion of cardiovascular abnormality (60 men, 60 women; 20 subjects per age decile from 20 to 80 years). Data were generated from 3-dimensional modeling, including tracking of the atrioventricular ring motion and time-volume curves analysis. For definition of the best 2D images-derived predictors of LA enlargement, we studied 120 patients (60 men, 60 women; age range 20 to 80 years) with a clinical indication for CMR. Results: In the healthy subjects, age was associated with LA 4-chamber transverse and 3-chamber anteroposterior diameters, but not with LA volume. Gender was an independent predictor of most absolute LA dimensions and volume, but following normalization to BSA, some associations became non-significant. CMR normal ranges were modeled and are tabled for clinical use with normalization, where appropriate, for BSA and gender and display of parameter variation with age. The best 2D predictors of LA volume were the 2-chamber area and 3-chamber area (both r = 0.90, p < 0.001). Conclusions: These CMR data show that LA dimensions and volume in healthy, individuals vary significantly by BSA, with lesser effects of age and gender. © 2010 Maceira et al; licensee BioMed Central Ltd. Source


Remon J.,Hospital de Mataro | Moran T.,Autonomous University of Barcelona | Majem M.,Claret Medical | Reguart N.,Hospital Clinic de Barcelona | And 3 more authors.
Cancer Treatment Reviews | Year: 2014

The discovery of mutated oncogenes has opened up a new era for the development of more effective treatments for non-small cell lung cancer patients (NSCLC) harbouring EGFR mutations. However, patients with EGFR-activating mutation ultimately develop acquired resistance (AR). Several studies have identified some of the mechanisms involved in the development of AR to EGFR tyrosine kinase inhibitors (TKI) that can be potential therapeutic strategies, although in up to 30% of cases, the underlying mechanism of AR are still unexplained.In this review we aim to summarize the main mechanisms of AR to EGFR TKI and some clinical strategies that can be used in the daily clinical practice to overcome this resistance and try to prolong the outcomes in this subgroup of patients. © 2013 Elsevier Ltd. Source


Sanchis-Alfonso V.,Hospital Arnau de Vilanova | Montesinos-Berry E.,Agoriaz Orthopedic Center | Monllau J.C.,Hospital Universitari Quiron Dexeus | Merchant A.C.,Stanford University
Arthroscopy - Journal of Arthroscopic and Related Surgery | Year: 2015

Purpose The aim of this study was to assess the outcomes of an isolated lateral retinaculum reconstruction for iatrogenic medial patellar instability (IMPI) in patients with continued pain after failed lateral retinacular release (LRR), including associated psychometric analysis. Methods Pain was assessed using the visual analog scale (VAS) and disability was determined with the Lysholm scale. Psychological variables such as anxiety, depression, catastrophizing, and fear-of-movement beliefs were studied by using self-administered psychometric questionnaires. Results All 17 patients (13 women and 4 men) in this retrospective study had undergone LRR previously for anterior knee pain or lateral patellar instability. Four patients had undergone LRR plus proximal (Insall) realignment, and one had undergone LRR plus a medial tibial tubercle transfer. After their procedures, all had disabling symptoms. All patients underwent reconstructive surgery for IMPI. At a minimum follow-up of 2 years (range, 2 to 8 years), the mean preoperative VAS score was 7.6 (range, 5 to 9) and improved to 1.9 (range, 0 to 8) at the time of final follow-up (P <.001). The mean preoperative Lysholm score was 36.4 (range, 20 to 55), and the knee was described as bad (<65 points) in all cases. Postoperatively, it improved to 86.1 (range, 70 to 94) at final follow-up (P <.001). Before surgery, 4 patients (24%) had the clinical criteria for depression, 10 (59%) had anxiety, 7 (41%) had "catastrophizing" ideas concerning pain, and all (100%) had kinesiophobia (fear of movement). After surgery, none of the patients had depression or anxiety, none had catastrophizing ideation, and only 53% had kinesiophobia. Conclusions Reconstruction of the deep transverse layer of the lateral retinaculum (LR) using a central strip of the iliotibial band for IMPI in patients with continued pain after failed LRR can successfully treat these severely disabled patients. Level of Evidence Level IV, therapeutic case series. © 2015 Arthroscopy Association of North America. Source

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