Showing papers by "Horst Lindhofer published in 2014"
TL;DR: OS was significantly improved after catumaxomab treatment in patients with malignant ascites and an RLC > 13% at baseline was a significant prognostic biomarker.
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 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. ©2014 AACR .
19 citations
TL;DR: Patients with HER2/neu expressing tumors progressing after standard therapy are treated to investigate safety, tolerability and preliminary efficacy of ertu, a bispecific, trifunctional antibody targeting HER2, CD3 and the Fcγ-receptors I, IIa, and III forming a tri-cell complex between tumor cell, T cell and accessory cells.
Abstract: 3055 Background: Ertumaxomab (ertu) is a bispecific, trifunctional antibody (ab) targeting HER2/neu, CD3 and the Fcγ-receptors I, IIa, and III forming a tri-cell complex between tumor cell, T cell ...
2 citations