The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: Results of a prospective randomized phase II/III trial.
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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.
in: INT J CANCER, Jahrgang 127, Nr. 9, 9, 2010, S. 2209-2221.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: Results of a prospective randomized phase II/III trial.
AU - Heiss, Markus M
AU - Murawa, Pawel
AU - Koralewski, Piotr
AU - Kutarska, Elzbieta
AU - Kolesnik, Olena O
AU - Ivanchenko, Vladimir V
AU - Dudnichenko, Alexander S
AU - Aleknaviciene, Birute
AU - Razbadauskas, Arturas
AU - Gore, Martin
AU - Ganea-Motan, Elena
AU - Ciuleanu, Tudor
AU - Wimberger, Pauline
AU - Schmittel, Alexander
AU - Schmalfeldt, Barbara
AU - Burges, Alexander
AU - Bokemeyer, Carsten
AU - Lindhofer, Horst
AU - Lahr, Angelika
AU - Parsons, Simon L
PY - 2010
Y1 - 2010
N2 - 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.
AB - 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.
M3 - SCORING: Zeitschriftenaufsatz
VL - 127
SP - 2209
EP - 2221
JO - INT J CANCER
JF - INT J CANCER
SN - 0020-7136
IS - 9
M1 - 9
ER -
