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Catumaxomab with an...
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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- Sehouli, Jalid (författare)
- Charite, Germany
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- Pietzner, Klaus (författare)
- Charite, Germany
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- Wimberger, Pauline (författare)
- Technical University of Dresden, Germany
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- Vergote, Ignace (författare)
- University Hospital Leuven, Belgium
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- Rosenberg, Per (författare)
- Östergötlands Läns Landsting,Linköpings universitet,Avdelningen för kliniska vetenskaper,Hälsouniversitetet,Onkologiska kliniken US
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- Schneeweiss, Andreas (författare)
- University of Heidelberg Hospital, Germany
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- Bokemeyer, Carsten (författare)
- University of Medical Centre Hamburg Eppendorf, Germany
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- Salat, Christoph (författare)
- Hematol Oncology Clin, Germany
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- Scambia, Giovanni (författare)
- Catholic University, Italy
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- Berton-Rigaud, Dominique (författare)
- CLCC Rene Gauducheau, France
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- Santoro, Armando (författare)
- Humanitas Cancer Centre, Italy
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- Cervantes, Andres (författare)
- University of Valencia, Spain
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- Tredan, Olivier (författare)
- Centre Leon Berard, France
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- Tournigand, Christophe (författare)
- Hop St Antoine, France
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- Colombo, Nicoletta (författare)
- University of Milano Bicocca, Italy
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- Dudnichenko, Alexander S. (författare)
- Kharkov Medical Academic Postgrad Educ, Ukraine
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- Westermann, Anneke (författare)
- University of Amsterdam, Netherlands
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- Friccius-Quecke, Hilke (författare)
- Neovu Biotech GmbH, Germany
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- Lordick, Florian (författare)
- University of Cancer Centre Leipzig, Germany
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(creator_code:org_t)
- 2014-06-26
- 2014
- Engelska.
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Ingår i: Medical Oncology. - : Humana Press. - 1357-0560 .- 1559-131X. ; 31:8, s. 76-
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Nyckelord
- Catumaxomab; Prednisolone; Premedication; Malignant ascites; Epithelial cancer
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Sehouli, Jalid
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Pietzner, Klaus
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Wimberger, Pauli ...
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Vergote, Ignace
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Rosenberg, Per
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Schneeweiss, And ...
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Bokemeyer, Carst ...
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Salat, Christoph
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Scambia, Giovann ...
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Berton-Rigaud, D ...
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Santoro, Armando
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Cervantes, Andre ...
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Tredan, Olivier
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Tournigand, Chri ...
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Colombo, Nicolet ...
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Dudnichenko, Ale ...
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Westermann, Anne ...
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Friccius-Quecke, ...
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Lordick, Florian
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