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To estimate the incremental cost per life-year gained (LYG) of aflibercept in combination with FOLFIRI as second-line treatment in metastatic colorectal cancer (mCRC) patients previously treated with oxaliplatin.Based on clinical trial VELOUR results, a three-state Markov model (stable disease, progression and death) with 2-week cycle duration was designed. Transition to health state «progression» implied the interruption of second-line treatment and administration of a third-line treatment (post-second line chemotherapy). Cost estimation included disease management cost (pharmaceutical, adverse event management, administration costs, etc.). Both cost and outcomes were discounted (3% annually). Sensitivity analyses (SA) were performed to test model robustness.Administration of aflibercept + FOLFIRI as second-line treatment provided 1.78 LYG (21 life-months gained). With FOLFIRI 1.43 LYG (17 months) were obtained. The cost of the clinical management of aflibercept + FOLFIRI implied an additional investment of Euros 13,564 compared with FOLFIRI for a lifetime horizon, being total costs for aflibercept + FOLFIRI of Euros 38,346, compared to Euros 24,782 with FOLFIRI. In the cost-effectiveness analysis Euros 38,931/LYG was obtained with aflibercept in combination with FOLFIRI versus FOLFIRI.Aflibercept in combination with FOLFIRI increased overall survival versus FOLFIRI, so it is an effective strategy in the treatment of patients with mCRC. Aflibercept in combination with FOLFIRI is an efficient strategy for second-line mCRC treatment from the National Health System perspective.Estimar el coste incremental por año de vida ganado (AVG) de la utilización de aflibercept en combinación con FOLFIRI como tratamiento de 2ª línea en pacientes con cáncer colorrectal metastásico (CCRm) previamente tratados con oxaliplatino. MATERIAL Y MÉTODOS: Basándose en los resultados del ensayo clínico VELOUR, se utilizó un modelo de Markov con 3 estados de salud (enfermedad estable, progresión y muerte) y ciclos de 2 semanas. La transición al estado de salud «progresión» implicaba interrumpir el tratamiento en 2ª línea y administrar una 3ª línea de tratamiento. La estimación de costes incluyó costes del manejo de la enfermedad (farmacológicos, acontecimientos adversos, administración, etc.). Costes y resultados en salud fueron descontados al 3% anualmente. Para probar la robustez del modelo se realizaron análisis de sensibilidad determinístico y probabilístico.La administración de aflibercept + FOLFIRI como 2ª línea de quimioterapia aporta 1,78 AVG (21 meses de vida ganados). Con FOLFIRI se consiguen 1,43 AVG (17 meses). El coste del manejo clínico de aflibercept + FOLFIRI supone una inversión adicional de 13.564 frente a FOLFIRI a lo largo de toda la vida del paciente, siendo el coste total de 38.346 para aflibercept + FOLFIRI y 24.782 para FOLFIRI. Se obtiene un RCEI (ratio coste efectividad incremental) de 38.931 /AVG con aflibercept + FOLFIRI frente a FOLFIRI. CONCLUSIÓN: Aflibercept en combinación con FOLFIRI incrementa la supervivencia global frente a FOLFIRI, lo que supone una estrategia efectiva en el tratamiento de pacientes con CCRm. La relación coste-efectividad incremental de aflibercept en combinación con FOLFIRI supone una estrategia eficiente, coste-efectiva, para el Sistema Nacional de Salud.

Infective endocarditis (IE) is a severe complication in patients with congenital heart disease (CHD). Epidemiology, etiology, and outcome in this group are different to those of patients with acquired heart disease. We reviewed all cases of proven and probable IE (Duke’s criteria) diagnosed in our center during the last two decades. We observed 45 cases of IE in patients with CHD (age range 8 months to 35 years); these represented 5.5 % of all the episodes of IE in our institution during the study period. The most frequent CHD were ventricular septal defect (31 %), tetralogy of Fallot (19 %), and atrioventricular septal defect (11 %). Twenty cases of IE (44 %) were recorded in patients with non-corrected native-valve CHD. Of the 24 patients with prosthetic-valve IE, post-operative acquisition during the first 6 months was confirmed in 11 patients (range 4–110 days). IE was community-acquired in 62 % of cases. Streptococcus spp. were the most frequent etiologic agents (33 %), followed by Staphylococcus spp. (32 %). Surgery was required to treat IE in 47 % of patients (52 % in prosthetic-valve IE and 41 % in native-valve IE, p = ns). In comparison to native-valve IE, prosthetic-valve IE was significantly more nosocomial-acquired (61 vs. 14 %, p = 0.002), presented a higher heart failure rate at diagnosis (39 vs. 9 %, p = 0.035), and developed more breakthrough bacteremia episodes (19 vs. 0 %, p = 0.048). Global mortality was 24 % (75 % in patients with prosthetic-valve IE who required surgery and 0 % in patients with native-valve IE who required surgery, p = 0.001). Multivariate analysis excluding breakthrough bacteremia (100 % mortality in this condition) confirmed that nosocomial IE [odds ratio (OR), 23.7; 95 % confidence interval (CI), 2.3–239.9] and the presence of heart failure at diagnosis of IE (OR, 25.9; 95 % CI, 2.5–269.6) were independent factors associated with mortality. Half of all cases of IE in patients with CHD occurred in patients with non-corrected native-valve CHD and two-thirds were community-acquired. Streptococcus spp. were the most frequent etiological agents. Patients with prosthetic-valve IE present a worse outcome, especially those requiring surgery. Breakthrough bacteremia, nosocomial IE, and heart failure are independent factors of mortality in patients with CHD presenting IE.

Febrile neutropenia (FN) is associated with disruption of planned chemotherapy and increased management costs. However, the economic impact of FN in Spanish clinical practice has not been documented hitherto.A multicenter, retrospective chart review of adults with breast or lung cancer or non-Hodgkin's lymphoma (NHL) who hador = 1 FN episode during chemotherapy. Resource use, direct costs, and FN effect on planned chemotherapy were assessed.238 episodes of FN were analyzed in 194 patients. The mean + or - SD length of FN-related hospitalization was 8.7 + or - 6.9 days (median [p(25)-p(75)] = 7 [5-11] days). At least one transfusion was needed in 77 (32.3%) FN episodes, blood tests were done in 233 (97.9%) and blood cultures in 207 (87.0%). Antibiotics were used in all episodes (100%), other drugs in 186 (78.2%) episodes and the granulocyte colony-stimulating factor (G-CSF) in 161 (67.7%) episodes. The distribution of costs per episode of FN were: hospitalization 79%, antibiotics 10%, G-CSF 5%, complementary tests 4%; other drugs 1%, blood transfusions 1%. The estimated mean (95% CI) cost per FN episode was euro3841 (95% CI: euro3476-4206). FN management was costlier in NHL patients euro4514 (95% CI: euro3805-5223) than in breast or lung cancer patients (euro3519 [95% CI: euro2976-4061] and euro3311 [95% CI: euro2817-3805] respectively) (P0.05 both comparisons). Planned chemotherapy was disrupted in 139 (58.4%) episodes (dose reductions in 75 [34.9%], dose delays in 60 [28.0%] and withdrawal in 33 [14.7%]).FN substantially affects healthcare resource use and costs in breast cancer, lung cancer and, NHL. In this study, hospitalization and antibiotics were the main drivers of cost. A limitation of the analysis was that it did not include the indirect costs associated with FN episodes.

To assess the degree of compliance with standards defined for Total Parenteral Nutrition (TPN) quality control in our hospital in the two-year period 1991-1992.All available information was assessed concerning 52 patients (32 men and 17 women) for whom a TPN course was prescribed in relation with certain pre-set indications. These patients received a total of 1140 TPN units with the TPN lasting an average of 21.9 days (range, 1-73 days). Monitoring was done by the Nutrition and Diet Section. The degree of compliance was assessed with the standards model proposed by the Providence Medical Center, Portland (USA) (PMCP) with 24 parameters (PM): indications, initiation in the first 24 hours, nutritional assessment in the first 24 hours, period of the TPN, metabolic complications (14 PM), septic complications (3 PM), nutritional consequences (2 PM) and TPN losses. All parameters were appraised and admitted, except for urea, which was corrected to standard values of our Laboratory (44 mg/dl), with Transferrin evaluation instead of iron binding capacity (TIBC), taking as compliance standard a figure of190 mg/dl. All analytical calculations were carried out in our Central Laboratory Service.Of all the parameters, the following were discarded, not being calculated on a routine basis: total CO2, serous magnesium, urinary uric nitrogen, nitrogen balance, positive hemocultures, catheters and TPN losses. Levels of compliance varied between 31.9% and 100%, with 8 parameters within the standards (Initiation, 100%; evaluation in first 24 hours, 100%; extent, 100%; creatinine, 100%; total bilirubin, 92.2%; cholesterol, 99.5%; transferrin, 35.9%). Seven parameters fell short (Na, 88.1%; K, 92.9%; Cl, 89.3%; Urea, 54.4%; Glucose, 96.4%; P, 94.1%; Triglycerides, 71.9%).We infer from our study that there is a need to make use of a large part of the indicators described in the literature as indicators for quality guarantee of a TPN program, and the use of new parameters must be assessed in normal monitoring.

e19667 Background: Biphosphonates are currently the cornerstone of treatment of bone metastasis. This is a retrospective observational multicentric study to describe the pattern of use of biphospho...