Background Malignant ascites (MA) is associated with poor prognosis and limited palliative therapeutic options. Therefore, quality of life (QoL) assessment is of particular importance to demonstrate new treatment value. Following the demonstration of the superiority of catumaxomab and paracentesis over paracentesis on puncture-free survival, this analysis aimed at comparing deterioration in QoL between both the treatment options. Patients and methods In a randomised, multicentre, phase II/III study of patients with MA due to epithelial cell adhesion molecule (EpCAM) positive cancer, the QoL was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items (EORTC QLQ-C30) questionnaire at screening, 1, 3 and 7 months after treatment and in the case of re-puncture on the day of paracentesis. Time to first deterioration in QoL was defined as a decrease in the QoL score of at least five points and compared between the catumaxomab ( n = 160) and control ( n = 85) groups using the log-rank test and Cox proportional hazards models adjusted for baseline score, country and primary tumour type. Results Deterioration in QoL scores appeared more rapidly in the control than in the catumaxomab group (median 19–26 days versus 47–49 days). The difference in time to deterioration in QoL between the groups was statistically significant for all scores ( P < 0.01). The hazard ratios ranged from 0.08 to 0.24 ( P < 0.01). Conclusions Treatment with catumaxomab delayed deterioration in QoL in patients with MA. Compared with paracentesis alone, catumaxomab enabled patients to benefit from better QoL for a prolonged survival period.

Dabigatran was found to be economically dominant over rivaroxaban and apixaban in the UK setting. These economic findings are based on relative clinical efficacy from an indirect treatment comparison and would benefit from any data of direct comparisons of the NOACs in the future.

e13095^ Background: Malignant Ascites (MA) is associated with a poor prognosis and limited palliative treatment options. To demonstrate the value of a new treatment the assessment of quality of life (QoL) is of particular importance. Following the demonstration of catumaxomab’s potential to stabilize QoL and prolong the time to first deterioration of QoL, results from CASIMAS give evidence that the QoL of patients remains unaffected during catumaxomab treatment Methods: In a two-arm, open-label, multicentre phase II/III study 219 patients were randomized to catumaxomab plus premedication of 25 mg prednisolone (111 pts) or to catumaxomab alone (108 pts) QoL was measured using the EQ-5D visual analogue scale (EQ-VAS). The EQ-VAS reports the respondent’s self-rated health on a vertical scale where the endpoints are labelled “Best imaginable health state” (100) and “Worst imaginable health state” (0). This information is used as a quantitative measure of health outcome. Patients were asked to complete EQ-VAS during the treatment period (d 0, 3 and 10) and follow-up (d8, 28). Descriptive analyses were performed according to EQ-5D User Guide (Version 4.0). Additionally ascites related symptoms were measured with a disease specific FACIT patient questionnaire. Results: For the pooled population (catumaxomab plus prednisolone and catumaxomab alone) longitudinal analysis of the EQ-VAS showed no relevant changes in mean score during the treatment period of catumaxomab (d0: 51.5; d3: 50.9; d10: 51.0) and compared to screening (52.7). An increase in mean values was observed in the follow-up period (d8: 53.9, d28: 57.1). Descriptive comparison of both treatment groups revealed no major differences in QoL and ascites related symptoms during the treatment and follow-up period, indicating that prednisolone has no impact on patient`s self-rated health. Conclusions: This analysis shows that QoL as measured by EQ-VAS remains unaltered during the treatment with catumaxomab and improves after the treatment period. The improvement is plausible due to the prolonged-puncture-free survival and is consistent with previous observations of QoL changes during and after intraperitoneal treatment with catumaxomab.

Objective Two novel oral anticoagulants recently have been investigated for the treatment of deep vein thrombosis and/or pulmonary embolism: dabigatran etexilate (dabigatran) and rivaroxaban. The aim of this analysis was to compare their efficacy and safety. Methods Randomized, controlled trials investigating dabigatran or rivaroxaban were identified by a systematic review. Direct meta-analyses and anchored (adjusted) indirect comparisons (AICs) were performed using aggregated results for the following endpoints for the overall treatment duration: first recurrent symptomatic venous thromboembolism (VTE) or VTE-related death, major bleeding events (MBEs), MBEs or clinically relevant bleeding events (CRBEs), and all-cause mortality. Results Four trials were identified; two compared dabigatran with warfarin and two compared rivaroxaban with vitamin K antagonists. The results of the trials, and the direct meta-analyses of the two dabigatran trials and the two rivaroxaban trials, are presented in Table 1. Overall, there was little evidence of heterogeneity in treatment effects among the RE-COVER trials (VTE or VTE-related death, MBEs, MBEs or CRBEs, all-cause mortality: P= 0.82, 0.67, 0.97, 0.97, respectively; I2= 0%). There was some evidence of heterogeneity among the EINSTEIN trials for VTE or VTE-related death (P=0.11; I2=61.9%) and all-cause mortality (P=0.16; I2=50%), but none for MBEs and MBEs/CRBEs with I2= 0% (P= 0.43, 0.47). In the AICs, sensitivity analyses were performed to explore potential trial heterogeneity arising from differences in the type of index VTE and time with an international normalized ratio between 2.0 and 3.0. AIC results suggested that dabigatran was associated with a lower risk of MBEs/CRBEs than rivaroxaban (upper 95% confidence limits for relative risks were less than 1.00). There was no evidence to suggest a difference between dabigatran and rivaroxaban with respect to prevention of recurrent symptomatic VTE or VTE-related death, MBEs, or all-cause mortality. Conclusions Dabigatran may be associated with a lower risk of major or clinically relevant bleeding; there was no evidence to suggest a difference among drugs in prevention of recurrent VTE, MBEs, or overall mortality. Disclosures: Clemens: Boehringer Ingelheim Pharma GmbH & Co. KG: Employment. Off Label Use: Dabigatran etexilate, direct oral thrombin inhibitor, anticoagulant effect; indications for stroke prevention in atrial fibrillation patients in about 90 countries including US; indication for primary VTE prevention in total hip or knee replacement patients in about 100 countries excluding US. Abeysinghe:Boehringer Ingelheim International GmbH: Consultancy. Gonschior:Boehringer Ingelheim GmbH: Employment. Hösel:Boehringer Ingelheim GmbH: Consultancy. Lock:Boehringer Ingelheim International GmbH: Consultancy. Wolowacz:Boehringer Ingelheim International GmbH: Consultancy. Woods:Boehringer Ingelheim International GmbH: Consultancy. Zimovetz:Boehringer Ingelheim International GmbH: Consultancy.