A Multicenter, Phase II Study of Infliximab Plus Gemcitabine in Pancreatic Cancer Cachexia

Bertram Wiedenmann, MD, Peter Malfertheiner, MD, Helmut Friess, MD, Paul Ritch, MD, James Arseneau, MD, Giovanni Mantovani, MD, Francesco Caprioni, MD, Eric Van Cutsem, MD, PhD, Dirk Richel, MD, Mark DeWitte, VMD, Ming Qi, MD, PhD, Don Robinson, Jr., MSPH, Bob Zhong, PhD, Carla De Boer, PhD, JD Lu, PhD, Uma Prabhakar, PhD, Robert Corringham, MD, and Daniel Von Hoff, MD

Department of Internal Medicine, Charité, Humboldt University, Berlin, Germany; the Clinic for Gastroenterology, Hepatology and Infections Diseases, Otto-von-Guericke-University, Magdeburg, Germany; the Department of General Surgery, University of Heidelberg, Heidelberg, Germany; the Division of Hematology/Oncology, Medical College of Wisconsin, Milwaukee; New York Oncology Hematology PC, Albany, New York; the Department of Medical Oncology, University of Cagliari, Cagliari, Italy; Oncologia Medica, Ospedale San Martino, Genova, Italy; Digestive Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium; Medical Spectrum Twente, Enschede, The Netherlands; Centocor Research and Development Inc., Malvern, Pennsylvania; Translational Genomics Research Institute, Phoenix, Arizona; and Arizona Cancer Center, Tucson, Arizona

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.

J Support Oncol 2008;6:18–25   print e-mail full text 223 kb