Intraperitoneal Application of the Trifunctional Monoclonal Antibody Catumaxomab in Outpatients with Malignant Ascites Related to Various Epithelial Tumors

Abstract

ABSTRACT Aim: Catumaxomab (CATU) is a trifunctional monoclonal antibody approved in the European community for the treatment (Tx) of malignant ascites (MA) related to various carcinomas expressing the epithelial cell adhesion molecule (EpCAM). Recently, the majority of CATU treatments is performed in a hospital. We report on our single-institution experience with an outpatient CATU Tx in patients (pts) with MA due to various EpCAM-positive malignancies. Methods: 29 EpCAM-positive pts were included in this non-interventional analysis: epithelial ovarian cancer (15), metastatic breast cancer (7), endometrial cancer (3), micellanous (4). Patients had failed a median of four prior systemic Tx (range: 1-12) before starting CATU. CATU was administered via an intraperitoneal (IP) catheter system, with four planned increasing doses (i.e., 10, 20, 50, and 150 µg) given at 4-day intervals over a 2 weeks treatment period. Supportive Tx comprised metamizole (1.5 g/d) or paracetamole (2.0 g/d) and granisetrone (3 mg/d). Adverse effects were scored according to the CTCAE 4.0 scale. Puncture-free survival (PuFS) was calculated from start of CATU to the next puncture due malignant ascites, death, or loss to follow-up. Overall survival (OS) was calculated from start of CATU to death from any reason or loss to follow-up. Results: CATU was completely administered in an outpatient setting in all pts.19 pts (65.5%) received all 4 planned applications; another 5 pts (17.2%) received 3 instillations. Outpatient Tx with CATU was generally well tolerated. Secondary hospitalization (fever [1], abdominal pain/subileus [1], infection [1], generally deteriorated condition [5]) was necessary in seven patients (26.9%). Subsequent punctures following CATU were necessary in only five patients (17.2%). Median PuFS was 79.5 days and median OS was 92.5 days. Eleven patients (37.9%) were able to undergo subsequent systemic Tx (1-3 protocols) after IP CATU. 3 patients are still alive and free from subsequent punctures after a maximum of 812 days from start of CATU. Conclusions: Outpatient IP CATU treatment of malignant ascites in selected pts suffering from various EpCAM-positive, mainly gynecologic malignancies is feasible and efficacious. Moreover, CATU allows for subsequent antineoplastic Tx in a substantial proportion of patients. Disclosure: All authors have declared no conflicts of interest.