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| |  Catumaxomab Effective in Treating Malignant Ascites Following Ovarian Cancer: Presented at ASCO By Cameron Johnston CHICAGO -- June 1, 2008-- Intraperitoneal injections of catumaxomab in patients with malignant ascites from primary abdominal tumours have demonstrated a substantial and clinically relevant advantage over the usual standard treatment for this condition, according to data from a phase 2/3 study presented at the American Society of Clinical Oncology (ASCO) 44th Annual Meeting. The study involved 258 patients across Britain, Germany, Poland, and Ukraine: 129 with ovarian cancer and 129 with nonovarian cancers. Of these subjects, 170 (85 patients with ovarian cancer and 85 patients with nonovarian cancer) were randomised to receive paracentesis plus 4 intraperitoneal infusions of the trifunctional antibody catumaxomab in doses of 10, 20, 50, and 150 mcg. A further 88 control patients (44 with ovarian cancer and 44 with nonovarian cancer) were randomised to receive paracentesis alone. The primary endpoint of the study was survival until paracentesis, noted lead author Simon Parsons, MD, Department of Surgery, Nottingham University Hospital, Nottingham, England, discussing the study here on May 31. Paracentesis is the procedure by which ascites (peritoneal fluid) is removed. The mean length of time patients could go without requiring additional puncture was 46 days for those who received catumaxomab, and 11 days for those who underwent paracentesis alone, Dr. Parsons noted. Among the patients who had ovarian cancers, the time to renewed puncture was 52 days compared with 11 days for those without ovarian cancer. For patients who had other forms of cancer -- mainly gastric, breast, and pancreatic tumours -- the mean time to paracentesis was 37 days if they received catumaxomab and 14 days if they received paracentesis alone. All of these reached statistical significance at a level of P < .0001. Patients in the control group who eventually had to have paracentesis were allowed to cross over to treatment with catumaxomab, if desired. Interestingly, this group (n = 45) had the best overall survival -- 95 days compared with 54 days, for those who were in the original paracentesis group and did not cross over, and 72 days, for those who began the study in the catumaxomab group. Malignant ascites is a common occurrence in patients with late-stage abdominal cancers. Malignant ascites arises when the lymphatic system becomes blocked and unable to drain fluids from the abdominal cavity. Vascular endothelial growth factor, which is present and stimulates tumour growth, also causes the walls of blood vessels to become porous, so fluid leaks into the abdominal cavity. Typically, the only way to treat this build-up has been through puncturing the peritoneal cavity and draining the fluids. Puncture-free survival times may not seem impressive in this study, but they are important when one considers that once a patient has developed ascites, life expectancy is usually measured in weeks, as this is an end-stage part of the cancer process. For some patients, the only treatment option to date has been repeated paracentesis, which has had only limited utility, even in the most responsive patients. Catumaxomab is known to kill tumour cells within ascites fluid by activating T cells and accessory cells. Funding for this study was provided by Fresenius Biotech GmbH and Trion Research GmbH, both of Munich, Germany. [Presentation title: Intraperitoneal Treatment of Malignant Ascites Due to Epithelial Tumors With Catumaxomab: A Phase II/III Study. Abstract 3000]
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