1683P - Catumaxomab versus catumaxomab plus prednisolone in patients with malignant ascites due to epithelial cancer: results from the CASIMAS study

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Supportive Care
Presenter Jalid Sehouli
Authors J. Sehouli1, P. Wimberger2, I.B. Vergote3, P. Rosenberg4, A. Schneeweiss5, C. Bokemeyer6, C. Salat7, G. Scambia8, D. Berton-Rigaud9, F. Lordick10
  • 1Charite Medical University, 13353 - Berlin/DE
  • 2University Of Duisburg-essen, AGO and Department of Gynecology and Obstetrics, Essen/DE
  • 3Obstetrics & Gynaecology, University Hospital Gasthuisberg, BE-3000 - Leuven/BE
  • 4Onkologiska Kliniken Universitetssjukhuset, University Hospital Linköping, Linköping/SE
  • 5Heidelberg, National Center for Tumor Diseases, Heidelberg/DE
  • 6Dept. Hemato/oncology, UKE II. Medizinische Klinik und PoliklinikMedizinische Klinik II., 20246 - Hamburg-Eppendorf/DE
  • 7Munich, Hematology Oncology Clinic, Munich/DE
  • 8Department Of Gynecologic Oncology, Catholic University, Rome/IT
  • 9Oncology, Centre René Gaducheau, Nantes/FR
  • 10University Cancer Center Leipzig, Staedtisches Klinikum Braunschweig, DE-38114 - Braunschweig/DE

Abstract

Purpose

This phase III b study compared catumaxomab with prednisolone (CP) to catumaxomab without prednisolone (C) as 3-hour intraperitoneal (i.p.) infusion in patients with malignant ascites from epithelial cancers.

Patients and methods

We randomised 219 patients to receive catumaxomab plus 25 mg prednisolone as premedication (111 pts) or catumaxomab alone (108 pts). Primary endpoint of the study was the composite safety score (CSS) summarizing the worst CTCAE grades for the main TEAEs (pyrexia, nausea, vomiting, and abdominal pain). A potential impact of prednisolone on efficacy was assessed by the co-primary endpoint puncture-free survival (PuFS). Further parameters included overall survival (OS) and time to next therapeutic puncture (TTPu).

Results

The primary objective, to demonstrate superiority for safety of the CP arm was not met as the mean CSS was comparable for the two groups (CP: 4.1; C: 3.8 for; p= 0.383). The median PuFS was slightly lower in CP (30 days) compared to C (37 days). However the hazard ratio (HR) for PuFS (HR: 1.130, p = 0.402) as well as the 75% quartiles (CP: 155 days, C: 92 days) were in favour of CP compared to C. The median TTPu was similar in both groups (CP: 78 days; C: 102 days, p= 0.599). The majority of patients (123 pts) had no therapeutic paracentesis prior to death (CP: 54.8%; C; 61.7%, p = 0.297). Median OS was longer for CP (CP: 124 days; C: 86 days, p= 0.186), but lacking statistical significance.

Conclusions

The administration of 25mg prednisolone as premedication prior to catumaxomab infusion did not change the safety profile and did not negatively impact the efficacy of catumaxomab. The efficacy results of the CASIMAS study are in concordance with the data of the pivotal study and thus confirm the robustness of the treatment effect of catumaxomab in malignant ascites. The composite safety score after 3-hour infusion time was comparable to that seen in the pivotal study using 6 hours.

Disclosure

J. Sehouli: consultant for Fresenius Biotech GmbH.

P. Wimberger: consultant for Fresenius Biotech GmbH.

I.B. Vergote: consultant for Fresenius Biotech GmbH.

P. Rosenberg: financial support for clinical studies from Fresenius Biotech GmbH.

A. Schneeweiss: financial support for clinical studies from Fresenius Biotech GmbH.

C. Bokemeyer: consultant for Fresenius Biotech GmbH.

C. Salat: financial support for clinical studies from Fresenius Biotech GmbH.

G. Scambia: financial support for clinical studies from Fresenius Biotech GmbH.

D. Berton-Rigaud: financial support for clinical studies from Fresenius Biotech GmbH.

F. Lordick: consultant for Fresenius Biotech GmbH