TY  - JOUR
AU  - Bergmann, L.
AU  - Maute, L.
AU  - Heil, G.
AU  - Rüssel, J.
AU  - Weidmann, E.
AU  - Köberle, D.
AU  - Fuxius, S.
AU  - Weigang-Köhler, K.
AU  - Aulitzky, W. E.
AU  - Wörmann, B.
AU  - Hartung, G.
AU  - Moritz, B.
AU  - Edler, L.
AU  - Burkholder, I.
AU  - Scheulen, M. E.
AU  - Richly, H.
TI  - A prospective randomised phase-II trial with gemcitabine versus gemcitabine plus sunitinib in advanced pancreatic cancer: a study of the CESAR Central European Society for Anticancer Drug Research-EWIV.
JO  - European journal of cancer
VL  - 51
IS  - 1
SN  - 0959-8049
CY  - Amsterdam [u.a.]
PB  - Elsevier
M1  - DKFZ-2017-02244
SP  - 27 - 36
PY  - 2015
AB  - Pancreatic ductal adenocarcinoma (PDAC) is one of the most common malignant tumours and is still associated with a poor prognosis in advanced disease. To improve the standard therapy with gemcitabine, we initiated a prospective randomised phase-II trial with gemcitabine (GEM) versus gemcitabine plus sunitinib (SUNGEM) based on data of in vitro trials and phase-I data for the combination treatment. The rational of adding sunitinib was its putative antiangiogenic mechanism of action.A total of 106 eligible patients with locally advanced, unresectable or metastatic PDAC without previous system therapy were randomised to receive GEM at a dosage of 1.000mg/m(2) d1, 8, 15 q28 versus a combination of SUNGEM at a dosage of GEM 1.000mg/m(2) d1+8 and sunitinib 50mg p.o. d1-14, q21d. The primary end-point was progression free survival (PFS), secondary end-points were overall survival (OS), toxicity and overall response rate (ORR).The confirmatory analysis of PFS was based on the intend-to-treat (ITT) population (N=106). The median PFS was 13.3 weeks (95
KW  - Antineoplastic Agents (NLM Chemicals)
KW  - Indoles (NLM Chemicals)
KW  - Pyrroles (NLM Chemicals)
KW  - Deoxycytidine (NLM Chemicals)
KW  - gemcitabine (NLM Chemicals)
KW  - sunitinib (NLM Chemicals)
LB  - PUB:(DE-HGF)16
C6  - pmid:25459392
DO  - DOI:10.1016/j.ejca.2014.10.010
UR  - https://inrepo02.dkfz.de/record/126129
ER  -