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| | | ![]() Novel Trifunctional Antibody Offers Potential Treatment for Inoperable Peritoneal Carcinomatosis: Presented at ASCO By Cameron Johnston ATLANTA, G.A. -- June 8, 2006 -- A small phase 1 trial has demonstrated that the trifunctional antibody known as catumaxomab could be used to treat peritoneal carcinomatosis. More than 4,500 patients so far have been treated with this novel agent in Europe and it could represent a promising concept for treating carcinomatosis secondary to gastrointestinal malignancies as well as for other cancerous conditions. Peritoneal carcinomatosis is a disease without a treatment, according to Dr. Michael Strohlein, surgeon, department of abdominal surgery, Merheim Medical Center, Koln, Germany. The disease affects the entire lining of the peritoneal sac and rather than appearing as a solid tumor that can be excised, it may be spread throughout the entire abdomen. The prognosis for people who develop this form of cancer is very poor, he said, as the disease cannot be treated by either radiation, chemotherapy, and usually not by surgery. In a study presented this week at the American Society of Clinical Oncology 2006 Annual Meeting (ASCO), the novel antibody, catumaxomab, was injected into the abdominal cavities of 22 patients who had had gastrointestinal cancer. The drug was delivered in 4 doses spread out over 10 days. Patients received 10 mcg for a first infusion, and this was increased to as high as 400 mcg for the fourth infusion. The maximum tolerated dose was established to be 10 mcg as a first infusion and 200 mcg as a fourth infusion. "What we found was that median survival was 12.0 months after the diagnosis of peritoneal carcinomatosis, and 7.0 months after treatment with catumaxomab," Dr. Strohlein said. The findings were surprising since the disease is considered untreatable. Typically, if it were detected in the course of surgery, a doctor would not complete the procedure and, instead, would refer the patient for palliative care. Survival is usually measured in the order of weeks, he said. "Knowing the natural history of carcinomatosis, you would expect some kind of exponential tumor growth," he said. According to Dr. Strohlein, 1 patient has now had a complete response, while another is alive 19 months after catumaxomab treatment. Two other patients have survived for 13 and 14 months after catumaxomab therapy, with either a partial response, or stable disease. These survival results will continue to improve, he said, since there are patients who are still alive. Trifunctional antibodies differ from other targeted biologic therapies in that they act by binding to the EpCAM glycoprotein on the surface of tumor cells, as well as to the CD3 T-cells, and via the Fc receptor accessory cells. In this way, the antibody accelerates the recognition and destruction of tumor cells through different immune processes. To date, catumaxomab has also been tested in patients with malignant ascites caused by ovarian cancer, and in patients with non-small-cell lung cancer. The study was funded by Trion PharmaGmbH, and by Fresenius Biotech, both of Munich, Germany.
[Presentation title: Efficacy of Intraperitoneal Treatment With the Trifunctional Antibody Catumaxomab in Patients With GI-Tract Cancer and Peritoneal Carcinomatosis: A Matched-Pair Analysis. Poster 2544]
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