Abstract
15529 Background: Gastric cancer patients (pts) have a high risk of peritoneal recurrence due to disseminated tumor cells after surgery. The trifunctional antibody catumaxomab (anti-EpCAM × anti-CD3) administered locally into the peritoneal cavity aims at residual tumor cells while activating a complex anti-tumor immune reaction. Methods: A total of 55 gastric cancer pts (T2b/T3/T4, N±, M0) were randomized during surgical D2 procedure to surgery alone or catumaxomab administered as one intraoperative intraperitoneal (ip) and 4 postoperative ip infusions with ascending doses on day 7, 10, 13 and 16. Primary objectives were safety, tolerability and feasibility. Results: All 55 pts (27 surgery alone, 28 catumaxomab) were included in the safety analysis. The target antigen EpCAM was confirmed in 100 % of pts. 78 % (22/28) of the patients treated with catumaxomab received all 5 infusions. 40 % of the treatment-emergent adverse events (TEAEs) occurred directly after the intraoperative administration. TEAEs (CTC-grade ≥3) occurred in 22 patients (control arm: 10 patients). The most frequently TEAEs in the catumaxomab group were anemia, pyrexia, SIRS and abdominal pain. All related serious TEAEs resolved until end of treatment except for nephropathy (one patient), which resolved with minor sequelae. No trend of an accumulation of severe adverse reactions or complications (e.g. wound healing) occurred compared to the surgery only group. Conclusions: Adjuvant treatment of ip administration of catumaxomab is safe and well-tolerable in pts after curative resection, the safety results reflecting catumaxomab´s mode of action (cytokine release related symptoms). This offers a new chance to avoid intraabdominal tumor recurrence. First clinically relevant efficacy data will be obtained after the 1- and 2-year follow-up period. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Fresenius Biotech GmbH Fresenius Biotech GmbH Fresenius Biotech GmbH Fresenius Biotech GmbH
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