Showing papers by "Markus M. Heiss published in 2010"
TL;DR: Catumaxomab showed a clear clinical benefit in patients with malignant ascites secondary to epithelial cancers, especially gastric cancer, with an acceptable safety profile.
Abstract: Malignant ascites is a common manifestation of advanced cancers, and treatment options are limited. The trifunctional antibody catumaxomab (anti-epithelial cell-adhesion molecule x anti-CD3) represents a targeted immunotherapy for the intraperitoneal (i.p.) treatment of malignant ascites secondary to epithelial cancers. In this phase II/III trial (EudraCT 2004-000723-15; NCT00836654), cancer patients (n = 258) with recurrent symptomatic malignant ascites resistant to conventional chemotherapy were randomized to paracentesis plus catumaxomab (catumaxomab) or paracentesis alone (control) and stratified by cancer type (129 ovarian and 129 nonovarian). Catumaxomab was administered as an i.p. infusion on Days 0, 3, 7 and 10 at doses of 10, 20, 50 and 150 μg, respectively. The primary efficacy endpoint was puncture-free survival. Secondary efficacy parameters included time to next paracentesis, ascites signs and symptoms and overall survival (OS). Puncture-free survival was significantly longer in the catumaxomab group (median 46 days) than the control group (median 11 days) (hazard ratio = 0.254: p < 0.0001) as was median time to next paracentesis (77 versus 13 days; p < 0.0001). In addition, catumaxomab patients had fewer signs and symptoms of ascites than control patients. OS showed a positive trend for the catumaxomab group and, in a prospectively planned analysis, was significantly prolonged in patients with gastric cancer (n = 66; 71 versus 44 days; p = 0.0313). Although adverse events associated with catumaxomab were frequent, they were manageable, generally reversible and mainly related to its immunologic mode of action. Catumaxomab showed a clear clinical benefit in patients with malignant ascites secondary to epithelial cancers, especially gastric cancer, with an acceptable safety profile.
474 citations
TL;DR: Based on the high and effective local concentrations, low systemic exposure and acceptable safety profile, the i.p. application scheme of catumaxomab for the treatment of malignant ascites is appropriate.
Abstract: AIMS
Catumaxomab is the first EMEA approved trifunctional anti-EpCAM×anti-CD3 antibody for the treatment of cancer patients with malignant ascites. A phase II pharmacokinetic study was conducted to determine local and systemic antibody concentrations and anti-drug antibody (ADA) development.
85 citations
TL;DR: Catumaxomab is discussed to be an outstanding option for local control and therapy of peritoneal carcinomatosis, which could be an optimal modular therapy in addition to systemic chemotherapy and surgical tumor resection.
Abstract: Peritoneal carcinomatosis remains an unsolved medical problem in modern oncologic treatment. Excruciating symptoms such as malignant ascites, ileus, nausea, vomiting, dyspnoea and pain deteriorate the quality of life for affected patients. There is still no effective standard treatment for peritoneal carcinomatosis. The trifunctional antibody catumaxomab (antiepithelial cell adhesion molecule x anti-CD3) is able to direct T lymphocytes and Fcg-receptor-positive accessory cells to epithelial cell adhesion molecule-positive tumor cells. Intraperitoneal catumaxomab therapy was shown to be the first effective therapy against accumulation of malignant ascites in patients with peritoneal carcinomatosis of epithelial cancer, reducing the need of paracentesis and prolonging puncture-free survival. This paper reviews the mode of action of catumaxomab and analyzes different fields of local immunotherapy in patients with peritoneal carcinomatosis. A summary of completed and ongoing studies is included. Catumaxomab is discussed to be an outstanding option for local control and therapy of peritoneal carcinomatosis, which could be an optimal modular therapy in addition to systemic chemotherapy and surgical tumor resection.
20 citations
TL;DR: The trifunctional antibody catumaxomab is approved for treatment of MA and is described as a “game-changer” in the treatment ofignant ascites.
Abstract: 2521 Background: Malignant ascites (MA) is a symptom of late-stage tumor disease and associated with a poor prognosis. The trifunctional antibody catumaxomab is approved for treatment of MA. Method...
2 citations