Use this url to cite publication: https://hdl.handle.net/20.500.14172/8992
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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
Type of publication
Straipsnis Web of Science ir Scopus duomenų bazėje / Article in Web of Science and Scopus database (S1)
Type of document
type::text::journal::journal article::research article
Author(s)
Heiss, Markus M. | University of Witten-Herdecke |
Murawa, Pawel | Wielkoposka Cancer Center |
Koralewski, Piotr | Rydygier Memorial Hospital |
Kutarska, Elzbieta | Center of Oncology of Lublin |
Kolesnik, Olena O. | Academy of Medical Science of Ukraine |
Ivanchenko, Vladimir V. | Regional Clinical Oncology Dispensary |
Dudnichenko, Alexander S. | Kharkov Medical Academy of Postgraduate Education |
Aleknavičienė, Birutė | Vilniaus universitetas |
Gore, Martin | Royal Marsden Hospital |
Ganea-Motan, Elena | Spitalul Judetean de Urgenta ‘Sf Ioan cel Nou’ |
Ciuleanu, Tudor | Cancer Institute Ion Chiricuta |
Wimberger, Pauline | University of Duisburg-Essen |
Schmittel, Alexander | University Hospital Berlin |
Schmalfeldt, Barbara | Technical University Munich |
Burges, Alexander | University Hospital Grosshadern |
Bokemeyer, Carsten | University Hospital Eppendorf |
Lindhofer, Horst | TRION Pharma GmbH |
Lahr, Angelika | Fresenius Biotech GmbH |
Parsons, S.L. | Nottingham University Hospitals NHS Trust |
Title
The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: results of a prospective randomized phase II/III trial
Publisher
Hoboken : Wiley
Date Issued
Date Issued | Volume | Issue | Start Page | End Page |
---|---|---|---|---|
2010-09-30 | vol. 127 | iss. 9 | 2209 | 2221 |
Is part of
International journal of cancer
Field of Science
Abstract
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 mug, 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.
Is Referenced by
ISSN (of the container)
0020-7136
1097-0215
WOS
000282539600022
Scopus
2-s2.0-77954676136
PubMED
20473913
eLABa
2676373
Coverage Spatial
Jungtinės Amerikos Valstijos / United States of America (US)
Language
Anglų / English (en)
Bibliographic Details
40
Journal | IF | AIF | AIF (min) | AIF (max) | Cat | AV | Year | Quartile |
---|---|---|---|---|---|---|---|---|
INTERNATIONAL JOURNAL OF CANCER | 4.926 | 4.604 | 4.604 | 4.604 | 1 | 1.07 | 2010 | Q1 |
Journal | IF | AIF | AIF (min) | AIF (max) | Cat | AV | Year | Quartile |
---|---|---|---|---|---|---|---|---|
INTERNATIONAL JOURNAL OF CANCER | 4.926 | 4.604 | 4.604 | 4.604 | 1 | 1.07 | 2010 | Q1 |