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000126129 0247_ $$2ISSN$$a1879-2995
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000126129 037__ $$aDKFZ-2017-02244
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000126129 1001_ $$aBergmann, L.$$b0
000126129 245__ $$aA 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.
000126129 260__ $$aAmsterdam [u.a.]$$bElsevier$$c2015
000126129 3367_ $$2DRIVER$$aarticle
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000126129 520__ $$aPancreatic 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% confidence interval (95%-CI): 10.4-18.1 weeks) for GEM and 11.6 weeks for SUNGEM (95%-CI: 7.0-18.0 weeks; p=0.78 one-sided log-rank). The ORR was 6.1% (95%-CI: 0.7-20.2%) for GEM and for 7.1% (95%-CI: 0.9-23.5%) for SUNGEM (p=0.87). The median time to progression (TTP) was 14.0 weeks (95%-CI: 12.4-22.3 weeks) for GEM and 18.0 weeks (95%-CI: 11.3-19.3 weeks) for SUNGEM (p=0.60; two-sided log-rank). The median OS was 36.7 weeks (95%-CI: 20.6-49.0 weeks) for the GEM arm and 30.4 weeks (95%-CI: 18.1-37.6 weeks) for the SUNGEM (p=0.78, one-sided log-rank). In regard to toxicities, suspected SAEs were reported in 53.7% in the GEM arm and 71.2% in the SUNGEM arm. Grade 3 and 4 neutropenia was statistically significantly higher in the SUNGEM arm with 48.1% versus 27.8% in the GEM arm (p=0.045, two sided log-rank).The combination SUNGEM was not sufficient superior in locally advanced or metastatic PDAC compared to GEM alone in regard to efficacy but was associated with more toxicity.
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000126129 650_7 $$2NLM Chemicals$$aAntineoplastic Agents
000126129 650_7 $$2NLM Chemicals$$aIndoles
000126129 650_7 $$2NLM Chemicals$$aPyrroles
000126129 650_7 $$00W860991D6$$2NLM Chemicals$$aDeoxycytidine
000126129 650_7 $$0B76N6SBZ8R$$2NLM Chemicals$$agemcitabine
000126129 650_7 $$0V99T50803M$$2NLM Chemicals$$asunitinib
000126129 7001_ $$aMaute, L.$$b1
000126129 7001_ $$aHeil, G.$$b2
000126129 7001_ $$aRüssel, J.$$b3
000126129 7001_ $$aWeidmann, E.$$b4
000126129 7001_ $$aKöberle, D.$$b5
000126129 7001_ $$aFuxius, S.$$b6
000126129 7001_ $$aWeigang-Köhler, K.$$b7
000126129 7001_ $$aAulitzky, W. E.$$b8
000126129 7001_ $$aWörmann, B.$$b9
000126129 7001_ $$aHartung, G.$$b10
000126129 7001_ $$aMoritz, B.$$b11
000126129 7001_ $$0P:(DE-He78)621efe295db6fdfa7f9f95011a5ea943$$aEdler, L.$$b12$$udkfz
000126129 7001_ $$aBurkholder, I.$$b13
000126129 7001_ $$aScheulen, M. E.$$b14
000126129 7001_ $$aRichly, H.$$b15
000126129 773__ $$0PERI:(DE-600)1468190-0$$a10.1016/j.ejca.2014.10.010$$gVol. 51, no. 1, p. 27 - 36$$n1$$p27 - 36$$tEuropean journal of cancer$$v51$$x0959-8049$$y2015
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