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@ARTICLE{Httner:301547,
      author       = {F. J. Hüttner and R. Klotz and N. A. Giese and B. Kong and
                      A. Ahmed$^*$ and D. Merz and A. Pöchmann$^*$ and I.
                      Burghaus and T. Hackert and O. Strobel and A. L. Mihaljevic
                      and C. W. Michalski and M. W. Büchler and M. K. Diener},
      title        = {{P}ancreatic resection with perioperative drug repurposing
                      of propranolol and etodolac - the phase {II} randomized
                      controlled {PROSPER} trial.},
      journal      = {Langenbeck's archives of surgery},
      volume       = {410},
      number       = {1},
      issn         = {0023-8236},
      address      = {Heidelberg},
      publisher    = {Springer},
      reportid     = {DKFZ-2025-01068},
      pages        = {168},
      year         = {2025},
      abstract     = {The perioperative period is characterized by psychological
                      stress and inflammatory reactions that can contribute to
                      disease recurrence or metastatic spread. These reactions are
                      mediated particularly by catecholamines and prostaglandins.
                      The PROSPER trial aimed to evaluate whether a perioperative
                      drug repurposing with a non-selective betablocker
                      (propranolol) and a COX-2 inhibitor (etodolac) is feasible
                      and safe in the setting of pancreatic cancer
                      surgery.Patients undergoing partial pancreatoduodenectomy
                      for pancreatic cancer were randomized to perioperative
                      treatment with propranolol and etodolac or placebo. Main
                      safety endpoint was the rate of serious adverse events (SAE)
                      and the main feasibility endpoint was adherence. Overall and
                      disease-free survival (DFS) as well as recurrences were
                      assessed as efficacy parameters and the trial was
                      accompanied by a translational study.The trial was
                      prematurely closed due to slow recruitment. 26 patients were
                      randomized, but 6 never started trial medication. Finally, 9
                      patients received the trial medication and 11 patients
                      placebo. There were 6 SAE in the treatment vs. 14 in the
                      placebo group. Adherence was lower in the treatment group,
                      but without statistically significance. Median DFS was 16.36
                      months $(95\%-CI$ 1.18 - not reached) in verum vs. 11.25
                      $(95\%-CI$ 2.2 - 17.25) in placebo group. The rate of
                      distant recurrences was $11.1\%$ in verum vs. $54.5\%$ in
                      placebo group.There were no safety concerns, but the trial
                      intervention was not feasible given slow recruitment and
                      limited adherence. However, the translational study and
                      preliminary efficacy data revealed some promising findings,
                      warranting further investigation.DRKS00014054.},
      keywords     = {Humans / Male / Female / Middle Aged / Pancreatic
                      Neoplasms: surgery / Pancreatic Neoplasms: mortality /
                      Pancreatic Neoplasms: pathology / Pancreatic Neoplasms: drug
                      therapy / Etodolac: therapeutic use / Drug Repositioning /
                      Aged / Propranolol: therapeutic use /
                      Pancreaticoduodenectomy / Cyclooxygenase 2 Inhibitors:
                      therapeutic use / Adrenergic beta-Antagonists: therapeutic
                      use / Perioperative Care: methods / Betablockade (Other) /
                      COX-2-inhibition (Other) / Inflammation (Other) / Pancreatic
                      cancer (Other) / Perioperative period (Other) / Etodolac
                      (NLM Chemicals) / Propranolol (NLM Chemicals) /
                      Cyclooxygenase 2 Inhibitors (NLM Chemicals) / Adrenergic
                      beta-Antagonists (NLM Chemicals)},
      cin          = {D196},
      ddc          = {610},
      cid          = {I:(DE-He78)D196-20160331},
      pnm          = {314 - Immunologie und Krebs (POF4-314)},
      pid          = {G:(DE-HGF)POF4-314},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:40402347},
      doi          = {10.1007/s00423-025-03735-3},
      url          = {https://inrepo02.dkfz.de/record/301547},
}