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Pape, Ulrich-Frank [Author]; Kasper, Stefan [Author]; Meiler, Johannes [Author]; Sinn, Marianne [Author]; Vogel, Arndt [Author]; Müller, Lothar [Author]; Burkhard, Oswald [Author]; Caca, Karel [Author]; Heeg, Steffen [Author]; Büchner-Steudel, Petra [Author]; Rodriguez-Laval, Victor [Author]; Kühl, Anja Andrea [Author]; Arsenic, Ruza [Author]; Jansen, Holger [Author]; Treasure, Peter [Author]; Utku, Nalân [Author]

Efficacy and safety of CAP7.1 as second-line treatment for advanced biliary tract cancers: data from a randomised phase II study

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  • Media type: E-Book; Special Print
  • Title: Efficacy and safety of CAP7.1 as second-line treatment for advanced biliary tract cancers: data from a randomised phase II study
  • Contributor: Pape, Ulrich-Frank [Author]; Kasper, Stefan [Author]; Meiler, Johannes [Author]; Sinn, Marianne [Author]; Vogel, Arndt [Author]; Müller, Lothar [Author]; Burkhard, Oswald [Author]; Caca, Karel [Author]; Heeg, Steffen [Author]; Büchner-Steudel, Petra [Author]; Rodriguez-Laval, Victor [Author]; Kühl, Anja Andrea [Author]; Arsenic, Ruza [Author]; Jansen, Holger [Author]; Treasure, Peter [Author]; Utku, Nalân [Author]
  • Published: Basel: MDPI, 2020
  • Published in: Cancers ; 12, 11 (2020), 3149
  • Extent: 1 Online-Ressource (16 Seiten); Illustrationen, Diagramme
  • Language: English
  • DOI: 10.3390/cancers12113149
  • Identifier:
  • Origination:
  • Footnote:
  • Description: Abstract: CAP7.1 is a novel topoisomerase II inhibitor, converted to active etoposide via carboxylesterase 2 (CES2), with signals of efficacy in treatment-refractory solid tumours. In a Phase II trial, 27 patients with advanced biliary tract cancers (BTC) were randomised 1:1 to CAP7.1 plus best supportive care (BSC), or BSC alone, with crossover to CAP7.1 upon disease progression. The primary objective was disease control rate (DCR) following 28-day cycles of CAP7.1 (200/150 mg/m2; iv), or BSC until progression. Secondary objectives included progression-free survival (PFS), time-to-treatment failure (TTF), overall survival (OS) and safety. Fourteen patients received CAP7.1 and 13 BSC. DCR favoured CAP7.1 vs. BSC (50% vs. 20%; treatment difference: 30%, 95%CI −18.44, 69.22, full analysis set [FAS]), with disease progression in 40% vs. 70%, respectively. Significantly longer median PFS was achieved for CAP7.1 vs. BSC: 66 vs. 39 days, respectively (hazard ratio [HR] 0.31; 95%CI 0.11, 0.86; p = 0.009; FAS). Similar trends were observed for TTF and OS. CES2-positive patients had longer median PFS (158 vs. 56 days) and OS (228 vs. 82 days) vs. CES2-negative patients. Adverse events were predictable, dose-dependent and consistent with those previously observed with etoposide. These efficacy and safety findings in second-line BTC warrant further clinical investigation of CAP7.1
  • Access State: Open Access