Title: A multicenter, phase II study of infliximab plus gemcitabine in pancreatic cancer cachexia
Authors: Wiedenmann, Bertram ×
Malfertheiner, Peter
Friess, Helmut
Ritch, Paul
Arseneau, James
Mantovani, Giovanni
Caprioni, Francesco
Van Cutsem, Eric
Richel, Dirk
DeWitte, Mark
Qi, Ming
Robinson, Don
Zhong, Bob
De Boer, Carla
Prabhakar, Uma
Corringham, Robert
Von Hoff, Daniel #
Issue Date: Jan-2008
Series Title: The journal of supportive oncology vol:6 issue:1 pages:18-25
Abstract: To evaluate the safety and efficacy of infliximab administered with gemcitabine to treat cancer cachexia and to explore a functional measure of clinical benefit, investigators involved in this multicenter, phase II, placebo-controlled study randomized 89 patients with stage II-IV pancreatic cancer and cachexia to receive either placebo or 3 mg/ kg or 5 mg/kg of infliximab at weeks 0, 2, and 4 and then every 4 weeks to week 24; patients also received 1,000 mg/m2 of gemcitabine weekly from weeks 0-6 and then for 3 of every 4 weeks until their disease progressed. The primary endpoint was change in lean body mass (LBM) at 8 weeks from baseline; major secondary endpoints included overall survival, progression-free survival, Karnofsky performance status, and 6-minute walk test distance. In addition, quality of life was measured. The mean change in LBM at 8 weeks was +0.4 kg for patients receiving placebo, +0.3 kg for those receiving 3 mg/kg of infliximab, and +1.7 kg for those receiving 5 mg/kg of infliximab. No statistically significant differences in LBM or secondary endpoints were observed among the groups. Safety findings were similar in all groups. Adding infliximab to gemcitabine to treat cachexia in advanced pancreatic cancer patients was not associated with statistically significant differences in safety or efficacy when compared with placebo.
ISSN: 1544-6794
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Translational Research in GastroIntestinal Disorders
Clinical Digestive Oncology (+)
× corresponding author
# (joint) last author

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