The addition of bevacizumab to the irinotecan-fluorouracil regimen, does not improve progression-free survival in our study population but increases costs per treated patient. These results potentially compromise the cost-effectiveness of the Bevacizumab_CPT-FUFA regimen.

BackgroundPlasma d-dimer (DD) has proven to be a reliable marker of a systemic prothrombotic state and its measurement might be helpful in predicting cardiovascular events and even mortality across a broad variety of diseases. An association between high levels of DD and macrovascular disease, diffuse cutaneous involvement and active disease has been suggested in patients with SSc.ObjectivesTo determine the usefulness of DD measurement as a marker of macrovascular disease and mortality in patients with SSc. To explore its relation with other features and biomarkers of SSc.MethodsDescriptive ambispective observational study. We included, consecutively from 2010 to 2015, SSc patients controlled in a tertiary hospital. We gathered demographic, clinical, and analytical variables, including DD levels measured by turbidimetric immunoassay (ACL TOP 700 CTS, Werfen Spain). Other variables were collected retrospectively from the electronic medical record. We explored the extracranial branches of the carotid artery (ESAOTE MyLab XV70, 7–12 MHz linear probe, software RFQIMT) measuring intima media thickness (IMT) by radiofrequency, and the presence of atheroma plaques, as per the Mannheim consensus, was registered. The ankle-brachial index (ABI) was measured by a Vascular Surgeon. We considered an IMT>900 µ and/or presence of atheroma plaque and/or an ABI <0.9 as macrovascular damage. We prospectively collected mortality until dec-2017. Statistical analysis was performed using SPSS 17.0 software.Results115 patients where included consecutively, of which finally 100 were studied (91 women, 9 men), with a mean age of 60.2 years (SD 15). Mean SSc evolution time was 13.9 years (SD 11.2). LSSc was most frequently diagnosed (50%), followed by DSSc (18%), SSc without scleroderma (17%), overlap syndrome (9%) and pre-SSc (6%). 37% of patients were hypertensive, 45% dyslipidemic, and 7% were diabetic. Overall, 40% had macrovascular damage. The mean values of DD were 437.6 ng/mL (SD 683.5), 60% of the patients having levels of DD (>250 ng/mL). During follow up, there were 16 deaths, 50% due to vascular events. Baseline high levels of plasma DD were associated to macrovascular damage and ischaemic digital ulcers, together with advanced age, arthritis, inflammation biomarkers, HTA, sPAP, lower DLCO% and coexistence of an inflammatory disease (overlap, infection, neoplasia), and showed a tendency to an association with mortality. This association became statistically significant when considering DD plasma levels as a quantitative variable (p<0.001) and remained significant after adjustments (age, coexistence of an inflammatory disease) (p 0,003).ConclusionsDD plasma levels are associated with macrovascular involvement and can be helpful in predicting medium-term mortality in our SSc patients. Levels of plasma DD can be modified by systemic inflammation.Disclosure of InterestNone declared

Background:Psoriatic arthritis (PsA) is associated with insufficent levels of vitamin D (25OHD) and an increased cardiovascular risk. Several studies, have shown an inverse relationship between 25OHD levels and cardiovascular damage.Objectives:To study the relationship between 25OHD and vascular damage, as well as its possible influence on its progression, in patients with PsA.Methods:Pre-post longitudinal study with analytical components. PsA patients with peripheral joint involvement were included. Demographic (sex, age), clinical [follow-up time, DAPSA, current treatment, body mass index (BMI), classic vascular risk factors, vascular events] and analytical variables [atherogenic index, glomerular filtration (GF-MDRD), glycosylated hemoglobin (HbA1c), CRP, ESR, 25OHD] were collected. We considered deficient level of 25OHD <20 ng/ml and insufficient <30 ng/ml. Basal vascular risk was estimated through SCORE tool. Extracranial carotid artery was explored with an Esaote MyLab70XVG ultrasound with linear probe (7-12mHz) and an automated program that measures intima media thickness (IMT) by radiofrequency, and the presence of atheroma plaques was evaluated following Mannheim consensus. Pulse wave velocity (PWV) was measured through Mobil o graph® dispositive. IMT≥900 µ and PWV≥ 10m/s were considered as pathological values. We repeat vascular study 3 years later. Vascular damage progression was defined as the appearance of atheroma plaques during the follow-up and/or an increase in their number. Statistical analysis was performed using SPSS 22.0 program.Results:78 patients were included. Eighteen patients were excluded due to high vascular risk [previous event, diabetes type II or type I with target organ injury and/or GF-MDRD< 60 ml/min]. 57.5% were women with a mean age of 54.2 (SD 10.9) years. The mean follow-up time was 96.8 (SD 163.6) months and mean DAPSA was 10.2 (SD 8.3). 96.2% of patients had received DMARDs and 42.3% biologicals, and 42.3% took calcium and 25OHD supplements. Mean BMI was 27.5 (SD 4.7) kg/m2. 42.3% had tobacco exposure, 29.5% were hypertensive and 32% dyslipidemic. Mean SCORE was 1.6 (SD 1.8) and mean 25OHD was 27.6 (DSD 11.6) ng/ml. 28.2% patients had 25OHD deficit and 60.3 % insufficiency. At the beginning, 32.1 % of patients had atheromatous plaques with a number of plaques around 1.7 (SD 1.2), and 6.7% and 19.7% had a pathological IMT or PWV, respectively. Baseline, we had not observed any association between 25OHD and the presence of atheroma plaques, IMT or PWV. Three years later, we detected progression of vascular damage in 31.2% patients. In these patients, the existence of hypovitaminosis D was associate with the appearance of atheroma plaques (p=0.043). This association desappeared in the multivariate analysis, in which only the CRP influenced the appearance of atherome plaques (OR: 1.4, IC 95% 1.04-1.98, p=0.025).Conclusion:Low 25OHD levels are not related to vascular damage or influence a posible progression of it in our serie. As might be expected, the progression of vascular damage depends on the inflammatory load in these patients.Disclosure of Interests:L Montolio-Chiva: None declared, M Robustillo-Villarino: None declared, Ana V Orenes Vera: None declared, Marta Aguilar-Zamora: None declared, C Vergara-Dangond: None declared, I Vázquez-Gómez: None declared, Eduardo Flores: None declared, A Sendra-García: None declared, À Martínez-Ferrer: None declared, Elia Valls-Pascual Grant/research support from: Roche, Novartis, and AbbVie, Speakers bureau: AbbVie, Lilly, Pfizer, MSD, Novartis, Janssen, Bristol Myers Squibb, UCB Pharma, D Ybáñez-García Speakers bureau: Lilly, Roche, Sanofi, V Núñez-Monje: None declared, I Torner-Hernández: None declared, Juanjo J Alegre-Sancho Consultant of: UCB, Roche, Sanofi, Boehringer, Celltrion, Paid instructor for: GSK, Speakers bureau: MSD, GSK, Lilly, Sanofi, Roche, UCB, Actelion, Pfizer, Abbvie, Novartis

This article compares gravimetry vs. high-performance liquid chromatography (HPLC) as quality control (QC) methods for paclitaxel, docetaxel and oxaliplatin preparations. We aimed at assessing the preparation method reliability in our hospital, evaluating compounding accuracy and estimating the influence of personnel training and standardized homogenization on compounding accuracy. Agreement, correlation, concordance, accuracy and precision between methods were evaluated for each drug. Conforming preparation percentages (CPs) at different tolerance limits (TLs) and compounding accuracy were calculated for each method and drug. Compounding accuracy was compared before and after personnel training and standardized homogenization implantation. SPSS v 20.0 and Ene v 2.0 were used. A total of 222 samples (58 docetaxel, 95 paclitaxel and 69 oxaliplatin) were analyzed. Gravimetry and HPLC are comparable methods. Overall CP was 81% for gravimetry at 10% TL and 85% for HPLC at 15% TL. Compounding accuracy is shown to be good for all methods and drugs. Homogenization optimization and personnel training make measurements more accurate for docetaxel and paclitaxel HPLC, but seem to worsen accuracy for docetaxel gravimetry. Gravimetry has shown to be a good alternative to HPLC for routine QC. Coupling with electronic methods should be considered in the future.

Background:In axial spondyloarthritis (axSpA) the risk of vertebral fracture is increased, not always corresponding with the values of bone mineral density (BMD). One possible explanation is that syndesmophytes interfere with these values. We consider whether the evaluation of trabecular microarchitecture by an accessible methodlike the Trabecular Bone Score (TBS), that does not involve additional irradiation neither seem to be influenced by the presence of syndesmophytes, may be an advantage to estimate the risk of fracture.Objectives:To estimate the prevalence of vertebral fractures in patients with axSpA. To assess the diagnostic accuracy of TBS and BMD for vertebral fracture, and if it is influenced by the presence of syndesmophytes. To analyze the correlation between the absolute values of BMD and TBS in the lumbar spine.Methods:Cross-sectional study. Patients were consecutive recruited. We collected demographic (sex, age), clinical (syndesmophytes, vertebral fracture, BASDAI, BASFI, time of evolution of axSpA, treatment) and analytical variables [vitamin D (1,25-OHD), CRP and ESR]. The BMD was determined using the Lunar Prodigy ProTM densitometer from GE Healthcare, to which the TBS iNsight® software version 2.2 was added to perform the TBS analysis. The presence of fracture was evaluated by radiology. The statistical analysis was performed with the SPSS 22.0 and OpenEpi softwares.Results:84 patients were included, 60 men and 24 women, with a mean age of 59 years (± SD 13). 51.2% had lumbar syndesmophytes. The prevalence of fractures was 13.7%, 95 CI (7.8-22.9). 51.2% were treated with NSAIDs, and 48.8% with biological drugs. The evolution of axSpA was > 10 years in 65.5%. The mean scores of BASDAI and BASFI were 3.7 and 4.3 respectively (± SD 2.2 and 2.3). The mean CRP value was 8.5 mg / L (± SD 8.4), ESR 12.2 mm / h (± SD 11.4) and 1.25-OHD 27.9 ng / dL (± SD 13.6).According to the lumbar and femoral T Score, 9.5% and 15.5% of the patients were in the range of osteoporosis respectively.19% patients had a low TBS value (≤1.23).Regarding the influence of syndesmophytes on TBS and BMD values, we found significant differences in lumbar spine BMD (p = 0.01) but not in total hip and femoral neck BMD (p = 0.2 and 0.3 respectively) nor in the TBS (p = 0.1).Regarding the correlation of TBS and BMD values of the spine, no correlation was observed in patients with syndesmophytes, while a moderate correlation (r = 0.4, p = 0.02) was observed in patients without syndesmophytes.In the univariate analysis, the factors related to the presence of vertebral fracture were age, female sex, absolute BMD values in the lumbar spine and total hip, and TBS values. No relationship was found with the rest of the variables. In the multivariate analysis, only the TBS showed a significant association with the presence of fractures (p =0.02).Regarding the predictive capacity of fractures, TBS showed a higher sensitivity than that of BMD (55.6% versus 18.2% and 30% of BMD in the spine and hip respectively), being the specificity comparable (85.3% versus 91.3% and 85.1% of BMD in column and hip respectively).Conclusion:the prevalence of fractures was 13.7% among the patients studied, 95 CI (7.8-22.9). The presence of syndesmophytes influenced the values of lumbar BMD but not the hip BMD or those of the TBS. We found a correlation between the values of BMD of the spine and TBS only in patients who did not have syndesmophytes. Only TBS values were significantly related to the presence of fractures in the multivariate analysis. TBS showed greater sensitivity with similar specificity than BMD for the detection of vertebral fractures.Disclosure of Interests:Ana V Orenes Vera: None declared, L Montolio-Chiva: None declared, I Vázquez-Gómez: None declared, Eduardo Flores: None declared, Elia Valls-Pascual Grant/research support from: Roche, Novartis, and AbbVie, Speakers bureau: AbbVie, Lilly, Pfizer, MSD, Novartis, Janssen, Bristol Myers Squibb, UCB Pharma, À Martínez-Ferrer: None declared, Desamparados Ybañez: None declared, Luis García-Ferrer: None declared, María Vega-Martínez: None declared, Magdalena Graells-Ferrer: None declared, A Sendra-García: None declared, V Núñez-Monje: None declared, Inmaculada Torner Hernández: None declared, Juanjo J Alegre-Sancho Consultant of: UCB, Roche, Sanofi, Boehringer, Celltrion, Paid instructor for: GSK, Speakers bureau: MSD, GSK, Lilly, Sanofi, Roche, UCB, Actelion, Pfizer, Abbvie, Novartis