Abstract
5048 Background: Malignant ascites (MA) in ovarian carcinoma (OC) patients (pts) is associated with a poor prognosis and reduced quality of life due to symptoms from ascites. In 2009, catumaxomab was approved in the EU for the intraperitoneal (IP) treatment of MA. Methods: In this single-arm, open-label, US, multicenter, phase II study, 32 chemotherapy-refractory and heavily pretreated (median of 4.5 prior chemotherapies) OC pts with MA were treated with catumaxomab. Pts received 4 IP infusions (10, 20, 50, and 150 µg) over 3 hours on days 0, 3, 7, and 10. The primary endpoint was the proportion of pts with at least a 4-fold increase in the puncture-free interval (PuFI) relative to their pretreatment interval. Main secondary endpoints were puncture-free survival (PuFS), overall survival (OS), MA symptoms based on patient-assessed FACIT-AI scores, safety, and tolerability. Results: 22.6% pts achieved at least a 4-fold increase in the PFI after catumaxomab treatment, which was below the predefined threshold...
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