Abstract
Background: Peritoneal carcinomatosis (PC) of gastrointestinal cancer is an advanced tumor stage with limited prognosis. Presently, there is no standard therapy available. The trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) represents a novel class of antibodies, which is able to activate T lymphocytes against tumor cells. Simultaneously, they are able to stimulate FcγRI/III+ antigen presenting cells (APC) and to induce cellular anti-tumor immunity. The clinical efficacy of intraperitoneal catumaxomab treatment was evaluated in patients with PC in a prospective phase I/II trial by a matched pair analysis. Methods: 22 Patients (8 gastric-ca, 10 colon-ca, 3 pancreatic-ca, 1 CUP) with EpCAM positive peritoneal carcinomatosis were included. Treatment consisted of 4 i. p. applications (10-20-50-200 μg) within 10 days. Abdominal lavages were analysed by immunohistochemical staining. A clinical follow-up was done every 6 weeks, CT-scans were evaluated by RECIST criteria. A matched pair analysis regarding sex, age, surgery, chemotherapy and PC stage. Patients with ileus or ascites were excluded. Results: Analysis of abdominal lavages showed a significant tumor cell destruction (p = 0.04, chi-square). RECIST evaluation was done in 15 patients, which showed complete or partial response in 3/15 patients and stable disease in 8/15 patients. Matched pair analysis showed a mean survival of 15.5 months after diagnosis of PC in the catumaxomab group vs. 9.7 months in patients with any other therapy (p = 0.005, logrank). Conclusion: Intraperitoneal Immunotherapy with the trifunctional antibody catumaxomab is a promising option for treatment of peritoneal carcinomatosis in patients with gastrointestinal cancer, which will be evaluated in further phase II/III trials.
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