This two-arm, randomised, multicentre, open-label, phase IIIb study investigated the safety and efficacy of a 3-h
catumaxomab infusion with/without
prednisolone premedication to reduce
catumaxomab-related adverse events. Patients with malignant
ascites due to epithelial
cancer received four 3-h intraperitoneal
catumaxomab infusions with/without intravenous
prednisolone (25 mg)
premedication before each infusion. The primary safety endpoint was a composite safety score calculated from the incidence and intensity of the most frequent
catumaxomab-related adverse events (
pyrexia,
nausea,
vomiting and
abdominal pain).
Puncture-free survival (PuFS) was a co-primary endpoint. Time to next
puncture (TTPu) and overall survival (OS) were secondary endpoints.
Prednisolone premedication did not result in a significant reduction in the main
catumaxomab-related adverse events. The mean composite safety score was comparable in both arms (
catumaxomab plus
prednisolone, 4.1;
catumaxomab, 3.8; p = 0.383). Median PuFS (30 vs. 37 days) and TTPu (78 vs. 102 days) were shorter in the
catumaxomab plus
prednisolone arm than in the
catumaxomab arm, but the differences were not statistically significant (p = 0.402 and 0.599, respectively). Median OS was longer in the
catumaxomab plus
prednisolone arm than in the
catumaxomab arm (124 vs. 86 days), but the difference was not statistically significant (p = 0.186). The superiority of
catumaxomab plus
prednisolone versus
catumaxomab alone could not be proven for the primary endpoint.
Prednisolone did not result in a significant reduction in the main
catumaxomab-related adverse events. The study confirms the safety and efficacy of
catumaxomab administered as four 3-h
intraperitoneal infusions for the treatment of malignant
ascites.