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Catumaxomab with and without prednisolone premedication for the treatment of malignant ascites due to epithelial cancer: results of the randomised phase IIIb CASIMAS study

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Catumaxomab with and without prednisolone premedication for the treatment of malignant ascites due to epithelial cancer: results of the randomised phase IIIb CASIMAS study. / Sehouli, Jalid; Pietzner, Klaus; Wimberger, Pauline; Vergote, Ignace; Rosenberg, Per; Schneeweiss, Andreas; Bokemeyer, Carsten; Salat, Christoph; Scambia, Giovanni; Berton-Rigaud, Dominique; Santoro, Armando; Cervantes, Andrés; Trédan, Olivier; Tournigand, Christophe; Colombo, Nicoletta; Dudnichenko, Alexander S; Westermann, Anneke; Friccius-Quecke, Hilke; Lordick, Florian.

in: MED ONCOL, Jahrgang 31, Nr. 8, 01.08.2014, S. 76.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Sehouli, J, Pietzner, K, Wimberger, P, Vergote, I, Rosenberg, P, Schneeweiss, A, Bokemeyer, C, Salat, C, Scambia, G, Berton-Rigaud, D, Santoro, A, Cervantes, A, Trédan, O, Tournigand, C, Colombo, N, Dudnichenko, AS, Westermann, A, Friccius-Quecke, H & Lordick, F 2014, 'Catumaxomab with and without prednisolone premedication for the treatment of malignant ascites due to epithelial cancer: results of the randomised phase IIIb CASIMAS study', MED ONCOL, Jg. 31, Nr. 8, S. 76. https://doi.org/10.1007/s12032-014-0076-7

APA

Sehouli, J., Pietzner, K., Wimberger, P., Vergote, I., Rosenberg, P., Schneeweiss, A., Bokemeyer, C., Salat, C., Scambia, G., Berton-Rigaud, D., Santoro, A., Cervantes, A., Trédan, O., Tournigand, C., Colombo, N., Dudnichenko, A. S., Westermann, A., Friccius-Quecke, H., & Lordick, F. (2014). Catumaxomab with and without prednisolone premedication for the treatment of malignant ascites due to epithelial cancer: results of the randomised phase IIIb CASIMAS study. MED ONCOL, 31(8), 76. https://doi.org/10.1007/s12032-014-0076-7

Vancouver

Sehouli J, Pietzner K, Wimberger P, Vergote I, Rosenberg P, Schneeweiss A et al. Catumaxomab with and without prednisolone premedication for the treatment of malignant ascites due to epithelial cancer: results of the randomised phase IIIb CASIMAS study. MED ONCOL. 2014 Aug 1;31(8):76. https://doi.org/10.1007/s12032-014-0076-7

Bibtex

@article{75bc3ece10f84631ad8256fe731ad1c0,
title = "Catumaxomab with and without prednisolone premedication for the treatment of malignant ascites due to epithelial cancer: results of the randomised phase IIIb CASIMAS study",
abstract = "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.",
author = "Jalid Sehouli and Klaus Pietzner and Pauline Wimberger and Ignace Vergote and Per Rosenberg and Andreas Schneeweiss and Carsten Bokemeyer and Christoph Salat and Giovanni Scambia and Dominique Berton-Rigaud and Armando Santoro and Andr{\'e}s Cervantes and Olivier Tr{\'e}dan and Christophe Tournigand and Nicoletta Colombo and Dudnichenko, {Alexander S} and Anneke Westermann and Hilke Friccius-Quecke and Florian Lordick",
year = "2014",
month = aug,
day = "1",
doi = "10.1007/s12032-014-0076-7",
language = "English",
volume = "31",
pages = "76",
journal = "MED ONCOL",
issn = "1357-0560",
publisher = "Humana Press",
number = "8",

}

RIS

TY - JOUR

T1 - Catumaxomab with and without prednisolone premedication for the treatment of malignant ascites due to epithelial cancer: results of the randomised phase IIIb CASIMAS study

AU - Sehouli, Jalid

AU - Pietzner, Klaus

AU - Wimberger, Pauline

AU - Vergote, Ignace

AU - Rosenberg, Per

AU - Schneeweiss, Andreas

AU - Bokemeyer, Carsten

AU - Salat, Christoph

AU - Scambia, Giovanni

AU - Berton-Rigaud, Dominique

AU - Santoro, Armando

AU - Cervantes, Andrés

AU - Trédan, Olivier

AU - Tournigand, Christophe

AU - Colombo, Nicoletta

AU - Dudnichenko, Alexander S

AU - Westermann, Anneke

AU - Friccius-Quecke, Hilke

AU - Lordick, Florian

PY - 2014/8/1

Y1 - 2014/8/1

N2 - 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.

AB - 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.

U2 - 10.1007/s12032-014-0076-7

DO - 10.1007/s12032-014-0076-7

M3 - SCORING: Journal article

C2 - 24965536

VL - 31

SP - 76

JO - MED ONCOL

JF - MED ONCOL

SN - 1357-0560

IS - 8

ER -