1596P - Maintenance of Quality of Life in Patients with Malignant Ascites During Treatment with the Trifunctional Antibody Catumaxomab: Results from the Phase III B Casimas Trial

Abstract

ABSTRACT Background Malignant Ascites (MA) is associated with a poor prognosis and a major deterioration in quality of life (QoL). To demonstrate the value of a new treatment the assessment of QoL is of particular importance. Results from the pivotal study demonstrated catumaxomab's potential to stabilize QoL and prolong the time to first deterioration of QoL in these patients. Observations from the two-arm, open-label, multicentre CASIMAS trial now give evidence that QoL remains unaffected during catumaxomab treatment Methods In our trial, 219 patients were randomized to receive catumaxomab plus premedication of 25 mg prednisolone (CP, 111 pts) or catumaxomab alone (C, 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 the 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). In addition, ascites-related symptoms were measured with a disease specific patient questionnaire (Functional Assessment of Chronic Illness Therapy, FACIT). Results Longitudinal analysis of the EQ-VAS for the pooled population (CP and C) showed no relevant changes in mean score during the treatment period with catumaxomab (d0: 51.5; d3: 50.9; d10: 51.0) and compared to screening (52.7). During the follow-up period (d8: 53.9, d28: 57.1), an increase in mean values was observed. 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 Quality of Life as measured by EQ-VAS remains unchanged during 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. Disclosure F. Lordick: consultant for Fresenius Biotech GmbH, J. Sehouli: consultant for Fresenius Biotech GmbH and financial support for clinical studies, I.B. Vergote: consultant for Fresenius Biotech GmbH, P. Rosenberg: financial support for clinical studies from Fresenius Biotech GmbH, A. Schneeweiss: financial support for clinical studies from Fresenius Biotech GmbH, A. Block: financial support for clinical studies from Fresenius Biotech GmbH, C. Salat: financial support for clinical studies from Fresenius Biotech GmbH, G. Scambia: financial support for clinical studies from Fresenius Biotech GmbH, D. Berton-Rigaud: financial support for clinical studies from Fresenius Biotech GmbH, P. Wimberger: consultant for Fresenius Biotech GmbH