0000000000303173
AUTHOR
M.w. Büchler
The management of locally advanced pancreatic cancer: European Society of Digestive Oncology (ESDO) expert discussion and recommendations from the 14th ESMO/World Congress on Gastrointestinal Cancer, Barcelona
T. Seufferlein1, J. L. Van Laethem2, E. Van Cutsem3*, J. D. Berlin4, M. Buchler5, A. Cervantes6, K. Haustermans3, M. Hidalgo7, E. M. O’Reilly8, C. Verslype3, W. Schmiegel9 & P. Rougier10 Department of Internal Medicine I, University of Ulm, Ulm, Germany; Department of Gastroenterology, Hopitaux Universitaires Bordet-Erasme, Brussels; Digestive Oncology and Radiation Oncology, University Hospitals and KU Leuven, Leuven, Belgium; Department of Medicine, Vanderbilt University, Nashville, USA; Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany; Department of Hematology and Medical Oncology, INCLIVA, University of Valencia, Valencia; Gastro…
The management of metastatic pancreatic cancer: expert discussion and recommendations from the 14th ESMO/World Congress on Gastrointestinal Cancer, Barcelona, 2012
TH-302 + Gemcitabine (G + T) vs Gemcitabine (G) in Patients with Previously Untreated advanced Pancreatic Cancer (PAC)
ABSTRACT Background TH-302 is a hypoxia targeted prodrug with a hypoxia-triggered 2-nitroimidazole component designed to release the DNA alkylator, bromo-isophosphoramide mustard (Br-IPM), when reduced in severe hypoxia. A randomized Phase 2B study (NCT01144455) was conducted to assess the benefit of G + T to standard dose G as first-line therapy of PAC. Materials and methods An open-label multi-center study of two dose levels of TH-302 (240 mg/m2 or 340 mg/m2) in combination with G versus G alone (randomized 1:1:1). G (1000 mg/m2) and T were administered IV over 30-60 minutes on Days 1, 8 and 15 of a 28-day cycle. Patients on the G could crossover after progression and be randomized to a G…