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The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: Results of a prospective randomized phase II/III trial

Heiss, Markus M. ; Murawa, Pawel ; Koralewski, Piotr ; Kutarska, Elzbieta ; Kolesnik, Olena O. ; Ivanchenko, Vladimir V. ; Dudnichenko, Alexander S. ; Aleknaviciene, Birute ; Razbadauskas, Arturas ; Gore, Martin ; Ganea‐Motan, Elena ; Ciuleanu, Tudor ; Wimberger, Pauline ; Schmittel, Alexander ; Schmalfeldt, Barbara ; Burges, Alexander ; Bokemeyer, Carsten ; Lindhofer, Horst ; Lahr, Angelika ; Parsons, Simon L.

International journal of cancer, 2010-11, Vol.127 (9), p.2209-2221 [Periódico revisado por pares]

Hoboken: Wiley Subscription Services, Inc., A Wiley Company

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  • Título:
    The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: Results of a prospective randomized phase II/III trial
  • Autor: Heiss, Markus M. ; Murawa, Pawel ; Koralewski, Piotr ; Kutarska, Elzbieta ; Kolesnik, Olena O. ; Ivanchenko, Vladimir V. ; Dudnichenko, Alexander S. ; Aleknaviciene, Birute ; Razbadauskas, Arturas ; Gore, Martin ; Ganea‐Motan, Elena ; Ciuleanu, Tudor ; Wimberger, Pauline ; Schmittel, Alexander ; Schmalfeldt, Barbara ; Burges, Alexander ; Bokemeyer, Carsten ; Lindhofer, Horst ; Lahr, Angelika ; Parsons, Simon L.
  • Assuntos: Adult ; Aged ; Aged, 80 and over ; Antibodies, Bispecific - therapeutic use ; Ascites - complications ; Ascites - drug therapy ; Cancer Therapy ; catumaxomab ; clinical trial ; Combined Modality Therapy ; Drug Administration Schedule ; epithelial cancer ; Humans ; malignant ascites ; Middle Aged ; Neoplasms, Glandular and Epithelial - complications ; Neoplasms, Glandular and Epithelial - drug therapy ; Paracentesis ; trifunctional antibody
  • É parte de: International journal of cancer, 2010-11, Vol.127 (9), p.2209-2221
  • Notas: Fax: +49‐221‐8907‐8561
    All the authors participated in the study and reviewed and approved the manuscript. Markus Heiss was the coordinating investigator for Germany, Simon Parsons was the coordinating investigator for the other countries and Angelika Lahr was the Global Clinical Project Director.
    Conflict of interest: Markus Heiss has served as a consultant for Fresenius Biotech GmbH and TRION Pharma GmbH. Simon Parsons has served as a consultant and advisory board member for Fresenius Biotech GmbH and received funding for a research fellow. Carsten Bokemeyer has served as a consultant and advisory board member for Fresenius Biotech GmbH. Pauline Wimberger received honoraria for presentations, research funding for other clinical trials with catumaxomab and other remuneration from Fresenius Biotech GmbH. Horst Lindhofer is the inventor and patent holder for catumaxomab and the chief executive officer of TRION Pharma GmbH. Angelika Lahr is an employee of Fresenius Biotech GmbH.
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  • Descrição: Malignant ascites is a common manifestation of advanced cancers, and treatment options are limited. The trifunctional antibody catumaxomab (anti‐epithelial cell‐adhesion molecule x anti‐CD3) represents a targeted immunotherapy for the intraperitoneal (i.p.) treatment of malignant ascites secondary to epithelial cancers. In this phase II/III trial (EudraCT 2004‐000723‐15; NCT00836654), cancer patients (n = 258) with recurrent symptomatic malignant ascites resistant to conventional chemotherapy were randomized to paracentesis plus catumaxomab (catumaxomab) or paracentesis alone (control) and stratified by cancer type (129 ovarian and 129 nonovarian). Catumaxomab was administered as an i.p. infusion on Days 0, 3, 7 and 10 at doses of 10, 20, 50 and 150 μg, respectively. The primary efficacy endpoint was puncture‐free survival. Secondary efficacy parameters included time to next paracentesis, ascites signs and symptoms and overall survival (OS). Puncture‐free survival was significantly longer in the catumaxomab group (median 46 days) than the control group (median 11 days) (hazard ratio = 0.254: p < 0.0001) as was median time to next paracentesis (77 versus 13 days; p < 0.0001). In addition, catumaxomab patients had fewer signs and symptoms of ascites than control patients. OS showed a positive trend for the catumaxomab group and, in a prospectively planned analysis, was significantly prolonged in patients with gastric cancer (n = 66; 71 versus 44 days; p = 0.0313). Although adverse events associated with catumaxomab were frequent, they were manageable, generally reversible and mainly related to its immunologic mode of action. Catumaxomab showed a clear clinical benefit in patients with malignant ascites secondary to epithelial cancers, especially gastric cancer, with an acceptable safety profile.
  • Editor: Hoboken: Wiley Subscription Services, Inc., A Wiley Company
  • Idioma: Inglês;Russo
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  • Realização: ABCD-USP USP   Logos de Redes Sociais: Freepik

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