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Guerrero A.,Instituto Valenciano Of Oncologia | Servitja S.,Hospital Del Mar | Rodriguez-Lescure A.,Hospital General Universitario Of Elche | Calvo L.,Complejo Hospitalario Universitario Juan Canalejo | And 6 more authors.
Anti-Cancer Drugs | Year: 2011

The objective of this phase I/II study was to establish the recommended dose of biweekly vinorelbine and oxaliplatin in patients with metastatic breast cancer and to evaluate the efficacy and safety profile of this schedule as first-line treatment. Four different dose levels of vinorelbine and oxaliplatin were selected for the phase I study: (i) 25 and 80 mg/m2; (ii) 25 and 90 mg/m2; (iii) 25 and 100 mg/m2; and (iv) 30 and 90 mg/m2; respectively. At least three patients were treated at each dose level. Overall, 12 patients were included in the phase I trial. No dose-limiting toxicities occurred at any dose level. Therefore, the fourth dose level (30 mg/m of vinorelbine and 90 mg/m2 of oxaliplatin) every 2 weeks was selected for the phase II trial. In this part, 44 patients were included and 61% completed the eight 2-week cycles of study treatment. On an intention-to-treat basis, overall response rate was 59%, and median progression-free survival and overall survival were 9.2 months (95% confidence interval: 7.6-10.9) and 18.6 months (95% confidence interval: 14.4-22.9), respectively. The main severe toxicities were neutropenia (46%) and fatigue (14%). We conclude that the biweekly combination of vinorelbine and oxaliplatin at doses of 30 mg/m and 90 mg/m2, respectively, is highly active and well tolerated as first-line treatment for patients with metastatic breast cancer. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Fernandez-Berges D.,Investigation Unit Don Benito Villanueva | Bertomeu-Gonzalez V.,Hospital Universitario La Paz | Sanchez P.L.,Hospitales Universitarios Salamanca y Valladolid | Cruz-Fernandez J.M.,Hospital Virgen de Macarena | And 6 more authors.
International Journal of Cardiology | Year: 2011

Background: Risk stratification of patients with unstable angina or non-ST-segment elevation myocardial infarction (UA/NSTEMI) is problematic given the heterogeneous presentation of the condition. This study was undertaken to compare, in UA/NSTEMI patients, the prognostic value of two clinical risk scores (RS) (i.e. Thrombolysis in Myocardial Infarction (TIMI) and physician's risk assessment (PRA)) and to assess whether serum biomarkers can increase the prognostic accuracy of these RS. Methods: We prospectively assessed 610 consecutive UA/NSTEMI patients, 217 (36%) UA and 393 (64%) NSTEMI. In all patients RS, high sensitivity C-reactive protein, CD40 ligand, IL6, IL10, IL18, E-selectin, P-selectin, white blood cell count, neopterin, myeloperoxidase, fibrinogen and NT proBNP were assessed at study entry. The primary study endpoint was death and non-fatal MI at 30 and 360 days of follow-up. Results: At 1 year, 54 patients (8.9%) had reached the primary study endpoint (26 suffered a cardiac death (4.3%) and 34 (5.6%) a non-fatal MI). For both RS, the study endpoint occurred more commonly in patients at a "higher risk" compared to those classified as being at a "lower risk". Moreover, TIMI and PRA RS had similar discriminatory accuracy. TIMI RS, however, was a better predictor of events than PRA at both 30- and 360-day follow-up. The inflammatory biomarkers assessed in the study did not improve significantly the predictive value of RS. Conclusions: Our study suggests both that TIMI RS is a better marker of risk than PRA RS and inflammatory biomarkers do not increase the predictive value of these clinical risk scores. © 2009 Elsevier Ireland Ltd. All rights reserved.

Vazquez-Alonso E.,Hospital Universitario Virgen Of Las Nieves | Fabregas N.,University of Barcelona | Rama-Maceiras P.,Complejo Hospitalario Universitario Juan Canalejo | Ingelmo Ingelmo I.,Hospital Universitario Ramon y Cajal | And 3 more authors.
Revista Espanola de Anestesiologia y Reanimacion | Year: 2015

Objectives: To determine the protocols used by Spanish anaesthesiologists for thromboprophylaxis and anticoagulant or antiplatelet drugs management in neurosurgical or neurocritical care patients. Material and methods: An online survey with 22 questions, with one or multiple options, launched by the Neuroscience Subcommittee of the Spanish Anaesthesia Society and available between June and October 2012. Results: Of the 73 hospitals included in the National Hospitals Catalogue, a valid response to the online questionnaire was received by 41 anaesthesiologists from 37 sites (response rate 50.7%). Only one response per site was used. A specific protocol was available in 27% of these centres. Mechanical thromboprophylaxis is used, intraoperatively or postoperatively, in 80%, and pharmacological treatment is used by 75% of respondents. Enoxaparin was the most frequent heparin used in craniotomy patients (78%). Craniotomies were performed maintaining acetylsalicylic acid treatment in patients with coronary stents and double anti-platelet treatment in a half of the centres. Conclusions: Mechanical thromboprophylaxis is used more frequently than the pharmacological approach in neurosurgical or neurocritical populations in Spanish hospitals. Management of patients under previous anticoagulant treatment was highly heterogeneous among hospitals included in this survey. Previous antiplatelet treatment is modified depending on primary or secondary prescription. © 2014 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor.

Marin M.J.D.C.,Hospital Universitario Ramon y Cajal | Rotes A.S.,Autonomous University of Barcelona | Ogando A.R.,Hospital Gregorio Maranon | Soto A.M.,Hospital Universitario 12 Of Octubre | And 6 more authors.
American Journal of Respiratory and Critical Care Medicine | Year: 2014

Rationale: There is a lack of knowledge regarding the epidemiology, clinical characterization, and survival in pediatric pulmonary hypertension.Objectives: To describe the epidemiology, outcomes, and risk factors for mortality in pediatric pulmonary hypertension in Spain.Conclusions: In moderate to severe pediatric pulmonary hypertension, the prognosis is better in pulmonary arterial hypertension than in other Nice categories. In pediatric pulmonary hypertension age at diagnosis younger than 2 years is a risk factor for mortality, in addition to the previously established risk factors.Methods: We analyzed data from the Spanish Registry for Pediatric Pulmonary Hypertension. From January 2009 to June 2012, a total of 225 patients diagnosed with pulmonary hypertension in 1998 or after were collected from 21 referral and nonreferral centers. We included all Nice etiologies, estimated incidence and prevalence of pulmonary hypertension in the Spanish pediatric population, and analyzed risk factors for mortality (Nice etiologic group, clinical and hemodynamic variables). Patients were classified as follows: group I, pulmonary arterial hypertension (n = 142; 61%); group II, left heart disease (n = 31; 14%); group III, respiratory disease (n = 41; 18%); group IV, thromboembolic pulmonary hypertension (n = 2; 1%); or group V, mostly inherited metabolic diseases (n = 10; 4.5%). Of the patients studied, 31% had multifactorial pulmonary hypertension.Measurements and Main Results: Mean age at diagnosis was 4.364.9 years (50%,2 yr). Survival rates at 1 and 3 years were 80 and 74% for the whole cohort, and 89 and 85% for patients with pulmonary arterial hypertension. Independent risk factors for mortality included an etiologic group other than pulmonary arterial hypertension (P<0.001), age at diagnosis younger than 2 years old (P<0.001), advanced functional class at diagnosis (P<0.001), and high right atrial pressure at diagnosis (P = 0.002). Copyright © 2014 by the American Thoracic Society.

Martinez-Balibrea E.,Institute Catala dOncologia | Martinez-Balibrea E.,Fundacio Institutdinvestigacio En Ciencies Of La Salut Germans Trias I Pujol C Ctra Of Can Ruti | Abad A.,Institute Catala dOncologia | Abad A.,Fundacio Institutdinvestigacio En Ciencies Of La Salut Germans Trias I Pujol C Ctra Of Can Ruti | And 15 more authors.
British Journal of Cancer | Year: 2010

Background: The impact of thymidylate synthase (TYMS) and UDP-glucoronosyltransferase 1A (UGT1A) germline polymorphisms on the outcome of colorectal cancer (CRC) patients treated with irinotecan plus 5-fluorouracil (irinotecan/5FU) is still controversial. Our objective was to define a genetic-based algorithm to select patients to be treated with irinotecan/5FU. Methods: Genotyping of TYMS (5′TRP and 3′UTR), UGT1A1 28, UGT1A9 22 and UGT1A7 3 was performed in 149 metastatic CRC patients treated with irinotecan/5FU as first-line chemotherapy enrolled in a randomised phase 3 study. Their association with response, toxicity and survival was investigated by univariate and multivariate statistical analysis. Results: TYMS 3TRP/3TRP genotype was the only independent predictor of tumour response (OR5.87, 95% confidence interval (CI)1.68-20.45; P=0.005). UGT1A1 28/28 was predictive for haematologic toxicity (OR=6.27, 95% CI1.09-36.12; P=0.04), specifically for neutropenia alone (OR=6.40, 95% CI=1.11-37.03; P=0.038) or together with diarrhoea (OR18.87, 95% CI2.14-166.67; P=0.008). UGT1A9 1/1 was associated with non-haematologic toxicity (OR=2.70, 95% CI1.07-6.82; P=0.035). Haplotype VII (all non-favourable alleles) was associated with non-haematologic toxicity (OR=2.11, 95% CI1.12-3.98; P=0.02).Conclusion:TYMS and UGT1A polymorphisms influence on tumour response and toxicities derived from irinotecan/5FU treatment in CRC patients. A genetic-based algorithm to optimise treatment individualisation is proposed. © 2010 Cancer Research UK All rights reserved.

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