Universität zu Köln

Heiss, Markus M., Stroehlein, Michael A., Bokemeyer, Carsten, Arnold, Dirk ORCID: 0000-0002-5325-8182, Parsons, Simon L., Seimetz, Diane, Lindhofer, Horst, Schulze, Elisabeth and Hennig, Michael ORCID: 0000-0001-5318-4788 (2014). The Role of Relative Lymphocyte Count as a Biomarker for the Effect of Catumaxomab on Survival in Malignant Ascites Patients: Results from a Phase II/III Study. Clin. Cancer Res., 20 (12). S. 3348 - 3358. PHILADELPHIA: AMER ASSOC CANCER RESEARCH. ISSN 1557-3265

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Abstract

Purpose: We report the role of relative lymphocyte count (RLC) as a potential biomarker with prognostic impact for catumaxomab efficacy and overall survival (OS) based on a post hoc analysis of the pivotal phase II/III study of intraperitoneal catumaxomab treatment of malignant ascites. Experimental Design: The impact of treatment and RLC on OS was evaluated using multivariate Cox models. Kaplan-Meier and log-rank tests were used for group comparisons. Survival analyses were performed on the safety population [patients with paracentesis plus >= 1 dose of catumaxomab (n = 157) and paracentesis alone (n 88)]. Determination of the optimal cutoff value for RLC was based on five optimality criteria. Results: OS was significantly longer with catumaxomab versus paracentesis alone (P = 0.0219). The 6-month OS rate with catumaxomab was 28.9% versus 6.7% with paracentesis alone. RLC had a positive impact on OS and was an independent prognostic factor (P < 0.0001). In patients with RLC > 13% (n = 159: catumaxomab, 100 and control, 59), catumaxomab was associated with a favorable effect on OS versus paracentesis alone (P = 0.0072), with a median/mean OS benefit of 41/131 days and an increased 6-month survival rate of 37.0% versus 5.2%, respectively. In patients with RLC <= 13% at screening (n 74: catumaxomab, 50 and control, 24), the median (mean) OS difference between the catumaxomab and the control group was 3 (16) days, respectively (P = 0.2561). Conclusions: OS was significantly improved after catumaxomab treatment in patients with malignant ascites. An RLC > 13% at baseline was a significant prognostic biomarker. Clin Cancer Res; 20(12); 3348-57. (C) 2014 AACR.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Heiss, Markus M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stroehlein, Michael A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bokemeyer, Carsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Arnold, Dirk UNSPECIFIED orcid.org/0000-0002-5325-8182 UNSPECIFIED Parsons, Simon L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Seimetz, Diane UNSPECIFIED UNSPECIFIED UNSPECIFIED Lindhofer, Horst UNSPECIFIED UNSPECIFIED UNSPECIFIED Schulze, Elisabeth UNSPECIFIED UNSPECIFIED UNSPECIFIED Hennig, Michael UNSPECIFIED orcid.org/0000-0001-5318-4788 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-435751
DOI:	10.1158/1078-0432.CCR-13-2351
Journal or Publication Title:	Clin. Cancer Res.
Volume:	20
Number:	12
Page Range:	S. 3348 - 3358
Date:	2014
Publisher:	AMER ASSOC CANCER RESEARCH
Place of Publication:	PHILADELPHIA
ISSN:	1557-3265
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language TRIFUNCTIONAL ANTIBODY CATUMAXOMAB; EPITHELIAL OVARIAN-CANCER; BISPECIFIC ANTIBODY; PERITONEAL CARCINOMATOSIS; ANTITUMOR IMMUNITY; GASTRIC-CANCER; IMMUNOTHERAPY; NEUTROPHIL; CELLS; RATIO Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/43575