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@ARTICLE{Bergmann:126129,
      author       = {L. Bergmann and L. Maute and G. Heil and J. Rüssel and E.
                      Weidmann and D. Köberle and S. Fuxius and K.
                      Weigang-Köhler and W. E. Aulitzky and B. Wörmann and G.
                      Hartung and B. Moritz and L. Edler$^*$ and I. Burkholder and
                      M. E. Scheulen and H. Richly},
      title        = {{A} prospective randomised phase-{II} trial with
                      gemcitabine versus gemcitabine plus sunitinib in advanced
                      pancreatic cancer: a study of the {CESAR} {C}entral
                      {E}uropean {S}ociety for {A}nticancer {D}rug
                      {R}esearch-{EWIV}.},
      journal      = {European journal of cancer},
      volume       = {51},
      number       = {1},
      issn         = {0959-8049},
      address      = {Amsterdam [u.a.]},
      publisher    = {Elsevier},
      reportid     = {DKFZ-2017-02244},
      pages        = {27 - 36},
      year         = {2015},
      abstract     = {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 $(95\%$ 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.},
      keywords     = {Antineoplastic Agents (NLM Chemicals) / Indoles (NLM
                      Chemicals) / Pyrroles (NLM Chemicals) / Deoxycytidine (NLM
                      Chemicals) / gemcitabine (NLM Chemicals) / sunitinib (NLM
                      Chemicals)},
      cin          = {C060},
      ddc          = {610},
      cid          = {I:(DE-He78)C060-20160331},
      pnm          = {313 - Cancer risk factors and prevention (POF3-313)},
      pid          = {G:(DE-HGF)POF3-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:25459392},
      doi          = {10.1016/j.ejca.2014.10.010},
      url          = {https://inrepo02.dkfz.de/record/126129},
}