Re-challenge with catumaxomab in patients with malignant ascites: results from the SECIMAS study

Klaus Pietzner, Ignace Vergote, Armando Santoro, Radoslav Chekerov, Frederik Marmé, Per Rosenberg, Holger Martinius, Hilke Friccius-Quecke, Jalid Sehouli

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Malignant ascites is a common phenomenon in cancer patients. It poses a great challenge to the clinician, because of limited treatment options and strong impairment of the quality of life of the often palliative patients. The SECIMAS study investigated the feasibility of a re-challenge with four catumaxomab intraperitoneal infusions in patients who had already received a first cycle of four infusions in the phase III CASIMAS study, which compared catumaxomab with and without prednisolone premedication. The primary endpoint was the proportion of patients who received at least three catumaxomab infusions. Secondary endpoints included a composite safety score (CSS) summarising the worst grades for the main catumaxomab-related adverse events (pyrexia, nausea, vomiting and abdominal pain), safety, efficacy and the occurrence of anti-drug antibodies (ADAs). Eight of nine screened patients received a second catumaxomab cycle. Compliance with a catumaxomab re-challenge was high: all eight patients (100%) received all four infusions. The median CSS was 3.0 versus 3.4 in CASIMAS. The tolerability profile of the second catumaxomab cycle was comparable to that of the first cycle. Median puncture-free survival (48 days) and overall survival (407 days) were longer than in CASIMAS (35 and 103 days, respectively), although median time to next puncture was shorter (60 vs. 97 days). Of six patients sampled, all were ADA positive at screening and remained ADA positive until the end of the study. The presence of ADAs did not affect catumaxomab's safety or efficacy. The CSS and tolerability profile for catumaxomab in SECIMAS were comparable to those in CASIMAS. The majority of patients benefitted from a second cycle of catumaxomab. A re-challenge seems to be feasible and safe for selected patients with recurrent malignant ascites due to carcinoma after a first cycle of catumaxomab.

Original languageEnglish
Pages (from-to)308
Number of pages1
JournalMedical Oncology
Volume31
Issue number12
DOIs
Publication statusPublished - Dec 1 2014

Fingerprint

Ascites
Anti-Idiotypic Antibodies
Safety
Punctures
Pharmaceutical Preparations
catumaxomab
Parenteral Infusions
Survival
Premedication
Feasibility Studies
Prednisolone
Nausea
Abdominal Pain
Vomiting
Fever
Quality of Life
Carcinoma

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Re-challenge with catumaxomab in patients with malignant ascites : results from the SECIMAS study. / Pietzner, Klaus; Vergote, Ignace; Santoro, Armando; Chekerov, Radoslav; Marmé, Frederik; Rosenberg, Per; Martinius, Holger; Friccius-Quecke, Hilke; Sehouli, Jalid.

In: Medical Oncology, Vol. 31, No. 12, 01.12.2014, p. 308.

Research output: Contribution to journalArticle

Pietzner, K, Vergote, I, Santoro, A, Chekerov, R, Marmé, F, Rosenberg, P, Martinius, H, Friccius-Quecke, H & Sehouli, J 2014, 'Re-challenge with catumaxomab in patients with malignant ascites: results from the SECIMAS study', Medical Oncology, vol. 31, no. 12, pp. 308. https://doi.org/10.1007/s12032-014-0308-x
Pietzner, Klaus ; Vergote, Ignace ; Santoro, Armando ; Chekerov, Radoslav ; Marmé, Frederik ; Rosenberg, Per ; Martinius, Holger ; Friccius-Quecke, Hilke ; Sehouli, Jalid. / Re-challenge with catumaxomab in patients with malignant ascites : results from the SECIMAS study. In: Medical Oncology. 2014 ; Vol. 31, No. 12. pp. 308.
@article{7a26cb2400c24fa9bbe54087a3149a96,
title = "Re-challenge with catumaxomab in patients with malignant ascites: results from the SECIMAS study",
abstract = "Malignant ascites is a common phenomenon in cancer patients. It poses a great challenge to the clinician, because of limited treatment options and strong impairment of the quality of life of the often palliative patients. The SECIMAS study investigated the feasibility of a re-challenge with four catumaxomab intraperitoneal infusions in patients who had already received a first cycle of four infusions in the phase III CASIMAS study, which compared catumaxomab with and without prednisolone premedication. The primary endpoint was the proportion of patients who received at least three catumaxomab infusions. Secondary endpoints included a composite safety score (CSS) summarising the worst grades for the main catumaxomab-related adverse events (pyrexia, nausea, vomiting and abdominal pain), safety, efficacy and the occurrence of anti-drug antibodies (ADAs). Eight of nine screened patients received a second catumaxomab cycle. Compliance with a catumaxomab re-challenge was high: all eight patients (100{\%}) received all four infusions. The median CSS was 3.0 versus 3.4 in CASIMAS. The tolerability profile of the second catumaxomab cycle was comparable to that of the first cycle. Median puncture-free survival (48 days) and overall survival (407 days) were longer than in CASIMAS (35 and 103 days, respectively), although median time to next puncture was shorter (60 vs. 97 days). Of six patients sampled, all were ADA positive at screening and remained ADA positive until the end of the study. The presence of ADAs did not affect catumaxomab's safety or efficacy. The CSS and tolerability profile for catumaxomab in SECIMAS were comparable to those in CASIMAS. The majority of patients benefitted from a second cycle of catumaxomab. A re-challenge seems to be feasible and safe for selected patients with recurrent malignant ascites due to carcinoma after a first cycle of catumaxomab.",
author = "Klaus Pietzner and Ignace Vergote and Armando Santoro and Radoslav Chekerov and Frederik Marm{\'e} and Per Rosenberg and Holger Martinius and Hilke Friccius-Quecke and Jalid Sehouli",
year = "2014",
month = "12",
day = "1",
doi = "10.1007/s12032-014-0308-x",
language = "English",
volume = "31",
pages = "308",
journal = "Medical Oncology",
issn = "1357-0560",
publisher = "Humana Press Inc.",
number = "12",

}

TY - JOUR

T1 - Re-challenge with catumaxomab in patients with malignant ascites

T2 - results from the SECIMAS study

AU - Pietzner, Klaus

AU - Vergote, Ignace

AU - Santoro, Armando

AU - Chekerov, Radoslav

AU - Marmé, Frederik

AU - Rosenberg, Per

AU - Martinius, Holger

AU - Friccius-Quecke, Hilke

AU - Sehouli, Jalid

PY - 2014/12/1

Y1 - 2014/12/1

N2 - Malignant ascites is a common phenomenon in cancer patients. It poses a great challenge to the clinician, because of limited treatment options and strong impairment of the quality of life of the often palliative patients. The SECIMAS study investigated the feasibility of a re-challenge with four catumaxomab intraperitoneal infusions in patients who had already received a first cycle of four infusions in the phase III CASIMAS study, which compared catumaxomab with and without prednisolone premedication. The primary endpoint was the proportion of patients who received at least three catumaxomab infusions. Secondary endpoints included a composite safety score (CSS) summarising the worst grades for the main catumaxomab-related adverse events (pyrexia, nausea, vomiting and abdominal pain), safety, efficacy and the occurrence of anti-drug antibodies (ADAs). Eight of nine screened patients received a second catumaxomab cycle. Compliance with a catumaxomab re-challenge was high: all eight patients (100%) received all four infusions. The median CSS was 3.0 versus 3.4 in CASIMAS. The tolerability profile of the second catumaxomab cycle was comparable to that of the first cycle. Median puncture-free survival (48 days) and overall survival (407 days) were longer than in CASIMAS (35 and 103 days, respectively), although median time to next puncture was shorter (60 vs. 97 days). Of six patients sampled, all were ADA positive at screening and remained ADA positive until the end of the study. The presence of ADAs did not affect catumaxomab's safety or efficacy. The CSS and tolerability profile for catumaxomab in SECIMAS were comparable to those in CASIMAS. The majority of patients benefitted from a second cycle of catumaxomab. A re-challenge seems to be feasible and safe for selected patients with recurrent malignant ascites due to carcinoma after a first cycle of catumaxomab.

AB - Malignant ascites is a common phenomenon in cancer patients. It poses a great challenge to the clinician, because of limited treatment options and strong impairment of the quality of life of the often palliative patients. The SECIMAS study investigated the feasibility of a re-challenge with four catumaxomab intraperitoneal infusions in patients who had already received a first cycle of four infusions in the phase III CASIMAS study, which compared catumaxomab with and without prednisolone premedication. The primary endpoint was the proportion of patients who received at least three catumaxomab infusions. Secondary endpoints included a composite safety score (CSS) summarising the worst grades for the main catumaxomab-related adverse events (pyrexia, nausea, vomiting and abdominal pain), safety, efficacy and the occurrence of anti-drug antibodies (ADAs). Eight of nine screened patients received a second catumaxomab cycle. Compliance with a catumaxomab re-challenge was high: all eight patients (100%) received all four infusions. The median CSS was 3.0 versus 3.4 in CASIMAS. The tolerability profile of the second catumaxomab cycle was comparable to that of the first cycle. Median puncture-free survival (48 days) and overall survival (407 days) were longer than in CASIMAS (35 and 103 days, respectively), although median time to next puncture was shorter (60 vs. 97 days). Of six patients sampled, all were ADA positive at screening and remained ADA positive until the end of the study. The presence of ADAs did not affect catumaxomab's safety or efficacy. The CSS and tolerability profile for catumaxomab in SECIMAS were comparable to those in CASIMAS. The majority of patients benefitted from a second cycle of catumaxomab. A re-challenge seems to be feasible and safe for selected patients with recurrent malignant ascites due to carcinoma after a first cycle of catumaxomab.

UR - http://www.scopus.com/inward/record.url?scp=84946232204&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84946232204&partnerID=8YFLogxK

U2 - 10.1007/s12032-014-0308-x

DO - 10.1007/s12032-014-0308-x

M3 - Article

C2 - 25367854

AN - SCOPUS:84919916463

VL - 31

SP - 308

JO - Medical Oncology

JF - Medical Oncology

SN - 1357-0560

IS - 12

ER -