A multicenter, phase II study of infliximab plus gemcitabine in pancreatic cancer cachexia.
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.
Wiedenmann
Bertram
B
Department of Internal Medicine, Charité, Humboldt University, Berlin, Germany. bertram.wiedenmann@charite.de
Malfertheiner
Peter
P
Friess
Helmut
H
Ritch
Paul
P
Arseneau
James
J
Mantovani
Giovanni
G
Caprioni
Francesco
F
Van Cutsem
Eric
E
Richel
Dirk
D
DeWitte
Mark
M
Qi
Ming
M
Robinson
Don
D
Zhong
Bob
B
De Boer
Carla
C
Lu
J D
JD
Prabhakar
Uma
U
Corringham
Robert
R
Von Hoff
Daniel
D
D000230:Adenocarcinoma / Q000188:drug therapy / Q000556:secondary; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002100:Cachexia / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069285:Infliximab; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008297:Male; D010190:Pancreatic Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D010919:Placebos; D011379:Prognosis; D015996:Survival Rate; D000093542:Gemcitabine
D000911:Antibodies, Monoclonal; D010919:Placebos; D003841:Deoxycytidine; D000069285:Infliximab; D000093542:Gemcitabine