Results of the first interim analysis of the CARMA study to investigate efficacy and safety profile of catumaxomab in clinical practice.

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e13100^ Background: The trifunctional antibody catumaxomab is approved in the EU for intraperitoneal (i.p.) treatment of malignant ascites in patients (pts) with EpCAM-positive carcinomas. Clinical data for catumaxomab are based on the pivotal trial and several phase I/II trials. So far, the routine use of catumaxomab in clinical practice has not been evaluated systematically. Therefore, a large prospective observational study was started in 2010. The study investigates the administration of catumaxomab in a total of 160 pts with malignant ascites under routine conditions in daily clinical practice. Here we show the results of the first pre-planned interim analysis. Methods: The analysis included 49 pts with malignant ascites due to EpCAM-positive carcinomas treated with i.p. catumaxomab under routine conditions in clinical practice. Participating centres were hospitals and practices of oncologists in Germany. Primary endpoint was puncture-free interval (PFI), secondary endpoints included safety and overall survival (OS). Results: At inclusion into the study pts already had undergone a median number of 9 ascites punctures. Malignant ascites had been diagnosed for the first time 3.3 months before (median). Patients suffered from typical ascites symptoms as follows: swelling (79.6%), pain (44.9%), dyspnea (26.5%), anorexia (26.5%), obstipation (12.2%). 49 pts were treated with catumaxomab, of whom 30 pts received all 4 infusions (61.2%). Median PFI was 108 days (d), the median OS was 102 d. Most frequent adverse events were fever, nausea and diarrhoe. Conclusions: This is the first systematic report on routine use of catumaxomab in clinical practice.. Although The study population mainly comprised patients with advanced tumor diseaset a clinical benefit after catumaxomab therapy could be demonstrated. The treatment showed an acceptable safety profile Theseresults are consistent with the data of the pivotal trial. The data will be evaluated in further analyses including larger patient numbers.