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000301547 0247_ $$2ISSN$$a0174-4542
000301547 0247_ $$2ISSN$$a0367-0023
000301547 0247_ $$2ISSN$$a1432-1491
000301547 0247_ $$2ISSN$$a1435-2451
000301547 037__ $$aDKFZ-2025-01068
000301547 041__ $$aEnglish
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000301547 1001_ $$aHüttner, Felix J$$b0
000301547 245__ $$aPancreatic resection with perioperative drug repurposing of propranolol and etodolac - the phase II randomized controlled PROSPER trial.
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000301547 520__ $$aThe 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.
000301547 536__ $$0G:(DE-HGF)POF4-314$$a314 - Immunologie und Krebs (POF4-314)$$cPOF4-314$$fPOF IV$$x0
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000301547 650_7 $$2Other$$aBetablockade
000301547 650_7 $$2Other$$aCOX-2-inhibition
000301547 650_7 $$2Other$$aInflammation
000301547 650_7 $$2Other$$aPancreatic cancer
000301547 650_7 $$2Other$$aPerioperative period
000301547 650_7 $$02M36281008$$2NLM Chemicals$$aEtodolac
000301547 650_7 $$09Y8NXQ24VQ$$2NLM Chemicals$$aPropranolol
000301547 650_7 $$2NLM Chemicals$$aCyclooxygenase 2 Inhibitors
000301547 650_7 $$2NLM Chemicals$$aAdrenergic beta-Antagonists
000301547 650_2 $$2MeSH$$aHumans
000301547 650_2 $$2MeSH$$aMale
000301547 650_2 $$2MeSH$$aFemale
000301547 650_2 $$2MeSH$$aMiddle Aged
000301547 650_2 $$2MeSH$$aPancreatic Neoplasms: surgery
000301547 650_2 $$2MeSH$$aPancreatic Neoplasms: mortality
000301547 650_2 $$2MeSH$$aPancreatic Neoplasms: pathology
000301547 650_2 $$2MeSH$$aPancreatic Neoplasms: drug therapy
000301547 650_2 $$2MeSH$$aEtodolac: therapeutic use
000301547 650_2 $$2MeSH$$aDrug Repositioning
000301547 650_2 $$2MeSH$$aAged
000301547 650_2 $$2MeSH$$aPropranolol: therapeutic use
000301547 650_2 $$2MeSH$$aPancreaticoduodenectomy
000301547 650_2 $$2MeSH$$aCyclooxygenase 2 Inhibitors: therapeutic use
000301547 650_2 $$2MeSH$$aAdrenergic beta-Antagonists: therapeutic use
000301547 650_2 $$2MeSH$$aPerioperative Care: methods
000301547 7001_ $$aKlotz, Rosa$$b1
000301547 7001_ $$aGiese, Nathalia A$$b2
000301547 7001_ $$aKong, Bo$$b3
000301547 7001_ $$0P:(DE-He78)bac8c2c56238485ecf0475ff14438430$$aAhmed, Azaz$$b4$$udkfz
000301547 7001_ $$aMerz, Daniela$$b5
000301547 7001_ $$0P:(DE-He78)3ca80d09e9dd0c1e6adb522a70caf051$$aPöchmann, Alexandra$$b6$$udkfz
000301547 7001_ $$aBurghaus, Ina$$b7
000301547 7001_ $$aHackert, Thilo$$b8
000301547 7001_ $$aStrobel, Oliver$$b9
000301547 7001_ $$aMihaljevic, André L$$b10
000301547 7001_ $$aMichalski, Christoph W$$b11
000301547 7001_ $$aBüchler, Markus W$$b12
000301547 7001_ $$aDiener, Markus K$$b13
000301547 773__ $$0PERI:(DE-600)1459390-7$$a10.1007/s00423-025-03735-3$$gVol. 410, no. 1, p. 168$$n1$$p168$$tLangenbeck's archives of surgery$$v410$$x0023-8236$$y2025
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