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Background: In the last years different studies have reported an increase of amyotrophic lateral sclerosis (ALS) incidence, highlighting the role of the environment in this disease. This prompted us to review ALS cases diagnosed at our hospital in the last decade and to compare them with a previous ALS series reported in our region 30 years ago. Methods: We reviewed those ALS cases diagnosed at our centre between 2004 and 2013. Subsequently, we compared them with the previous series regarding clinical and epidemiological features. Results: A total of 53 patients (30 males, 23 females) were included. The annual incidence was 1.7 cases per 100,000 inhabitants (2.2 and 1.2 per 100,000 in males and females, respectively), which was significantly higher than in the previous series (1 case per 100,000 inhabitants). Otherwise, the clinical and epidemiological features were similar in both series. The median age at symptom onset was 67 years, with a median diagnosis delay of 6 months. About two thirds of the patients presented with systemic ALS, whereas the remaining had a bulbar onset. Weakness, dysphagia, and dysarthria were the most common clinical symptoms at diagnosis. The median survival from symptom onset was 22 months. Conclusion: After 3 decades, the annual incidence of ALS has almost doubled in our region. We did not find significant differences regarding other clinical or epidemiological features.

Objetivo: La duracion de la administracion intravenosa (i.v.) con hierro carboximaltosa (Ferinject®) es menor que con otros hierros inyectables (hierro dextrano [Cosmofer®] y hierro sacarosa [Feriv®, Hierro sacarosa Normon® y Venofer®]). Por este motivo, se decidio estimar el coste del tratamiento de la deficiencia de hierro con la administracion i.v. de hierro carboximaltosa en comparacion con hierro dextrano y hierro sacarosa. Metodo: Se llevo a cabo un analisis de costes, desde la perspectiva del Sistema Nacional de Salud (SNS), considerando el coste de adquisicion y el de administracion de los hierros intravenosos; y otro analisis desde la perspectiva de la sociedad, incluyendo los gastos de transporte y la perdida de jornadas laborales de los pacientes. Todos los costes se obtuvieron de fuentes espanolas. La utilizacion de recursos se estimo a partir de una revision de la literatura y con la informacion aportada por un panel de expertos clinicos espanoles. Se efectuaron analisis de costes deterministicos para diferentes variables (deficit acumulado de hierro, tasa de perfusiones/inyecciones i.v., costes hospitalarios de la administracion) y probabilisticos (simulacion de Monte Carlo). Resultados: En el caso basico, desde la perspectiva del SNS, el empleo de hierro carboximaltosa generaria un ahorro por tratamiento de 183 € en compa racion con hierro dextrano y de 131–164 € en comparacion con hierro sacarosa. Los analisis de sensibilidad deterministicos confirmaron la estabilidad del caso basico en la mayoria de los supuestos, con ahorros que oscilaron entre 20 y 294 e por tratamiento. Los analisis de Monte Carlo confirmaron el resultado, con ahorros con hierro carboximaltosa (media de −153,38 € ± 137,16 €) en el 89,7% y 94,9% de las 1.000 simulaciones realizadas, desde la perspectiva del SNS y de la sociedad, respectivamente. Conclusiones: En comparacion con los demas hierros inyectables actualmente comercializados en Espana, el tratamiento del deficit de hierro con hierro carboximaltosa (Ferinject®) puede generar ahorros para los hospitales del Sistema Nacional de Salud a consecuencia de su menor coste de administracion.

Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; BACKGROUND Taxanes are among the most active drugs for the treatment of metastatic breast cancer, and, as a consequence, they have also been studied in the adjuvant setting. METHODS After breast cancer surgery, women with lymph node-positive disease were randomly assigned to treatment with fluorouracil, epirubicin, and cyclophosphamide (FEC) or with FEC followed by weekly paclitaxel (FEC-P). The primary endpoint of study-5-year disease-free survival (DFS)-was assessed by Kaplan-Meier analysis. Secondary endpoints included overall survival and analysis of the prognostic and predictive value of clinical and molecular (hormone receptors by immunohistochemistry and HER2 by fluorescence in situ hybridization) markers. Associations and interactions were assessed with a multivariable Cox proportional hazards model for DFS for the following covariates: age, menopausal status, tumor size, lymph node status, type of chemotherapy, tumor size, positive lymph nodes, HER2 status, and hormone receptor status. All statistical tests were two-sided. RESULTS Among the 1246 eligible patients, estimated rates of DFS at 5 years were 78.5% in the FEC-P arm and 72.1% in the FEC arm (difference = 6.4%, 95% confidence interval [CI] = 1.6% to 11.2%; P = .006). FEC-P treatment was associated with a 23% reduction in the risk of relapse compared with FEC treatment (146 relapses in the 614 patients in the FEC-P arm vs 193 relapses in the 632 patients in the FEC arm, hazard ratio [HR] = 0.77, 95% CI = 0.62 to 0.95; P = .022) and a 22% reduction in the risk of death (73 and 95 deaths, respectively, HR = 0.78, 95% CI = 0.57 to 1.06; P = .110). Among the 928 patients for whom tumor samples were centrally analyzed, type of chemotherapy (FEC vs FEC-P) (P = .017), number of involved axillary lymph nodes (P < .001), tumor size (P = .020), hormone receptor status (P = .004), and HER2 status (P = .006) were all associated with DFS. We found no statistically significant interaction between HER2 status and paclitaxel treatment or between hormone receptor status and paclitaxel treatment. CONCLUSIONS Among patients with operable breast cancer, FEC-P treatment statistically significantly reduced the risk of relapse compared with FEC as adjuvant therapy. Yes

The COSTABRAX study evaluated the cost-effectiveness of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) versus polyethylated castor oil-based standard paclitaxel (sb-paclitaxel) in the treatment of patients with previously treated metastatic breast cancer in Spain.Efficacy data were obtained from the CA012 trial (nab-paclitaxel administered every 3 weeks [q3w] and sb-paclitaxel q3w) and indirect comparison (sb-paclitaxel administered weekly), and were modeled to a time horizon of 5 years using a Markov model. The analysis was performed from the National Health Service perspective. Use of resources and key assumptions of the model were validated by a panel of 22 local oncologists.Compared with sb-paclitaxel q3w, nab-paclitaxel q3w was cost effective, with a cost per life year gained of €11,088 and a cost per quality-adjusted life year of €17,808. Compared with sb-paclitaxel administered weekly, it showed savings of €711 per patient.The COSTABRAX study showed that nab-paclitaxel q3w is a cost-effective alternative compared with sb-paclitaxel q3w and a cost-saving alternative to sb-paclitaxel administered weekly in Spain.

This is one of the first reports of weekly docetaxel (Taxotere) in the neoadjuvant treatment of stage II and III breast cancer. We evaluated docetaxel's efficacy and safety and analyzed correlations between response and the expression of c-erbB2, ER status, and Ki-67 labeling index.Patients with previously untreated, stage II and III breast cancer were entered into the study. Docetaxel (40 mg/m(2)) was given i.v. once weekly for the first 6 weeks of an 8-week cycle for 2 cycles.A total of 56 patients were evaluated by intention-to-treat analysis for efficacy and safety. The overall clinical response rate was 68% (complete and partial response, 29 and 39%, respectively). Nine patients (16%) achieved a pathological complete response. There was no correlation between response to docetaxel and the expression of molecular markers, however, the majority of the pathological complete responses were observed in patients with c-erbB2-negative tumors. Nonhematological toxicity was more common than hematological toxicity, with alopecia and asthenia the most frequently reported adverse events (89 and 77% of patients, respectively). Severe hematological toxicity was rare.Weekly docetaxel appears to be very effective in the neoadjuvant setting. A high pathological response rate was achieved with tolerable toxicity.

To assess the effectiveness and safety of an implanted portal with a central venous brachial implanted catheter, P.A.S. Port TM(P–P), and the accuracy of its Cath Finder TM tracking system (C–F), (Pharmacia Deltec) vs. radiology, a phase II multicentric study was designed. The catheter was implanted in 53 oncologic patients treated with chemotherapy and the performance of the catheter was evaluated for 3 months. No problems arose during the implantation in 77% of the cases and in all cases radiologic location of the catheter tip coincided with the C–F. We can conclude that P–P is easy to implant and to maintain in the arm and that it is well tolerated by the patients. C–F is an accurate and reliable system for locating the catheter tip. The use of both systems is an attractive alternative to the standard ones. © Wiley-Liss, Inc.