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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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Efficacy and Safety of CAP7.1 as Second-Line Treatment for Advanced Biliary Tract Cancers: Data from a Randomised Phase II Study. / Pape, Ulrich-Frank; Kasper, Stefan; Meiler, Johannes; Sinn, Marianne; Vogel, Arndt; Müller, Lothar; Burkhard, Oswald; Caca, Karel; Heeg, Steffen; Büchner-Steudel, Petra; Rodriguez-Laval, Victor; Kühl, Anja A; Arsenic, Ruza; Jansen, Holger; Treasure, Peter; Utku, Nalân.

in: CANCERS, Jahrgang 12, Nr. 11, 27.10.2020.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Pape, U-F, Kasper, S, Meiler, J, Sinn, M, Vogel, A, Müller, L, Burkhard, O, Caca, K, Heeg, S, Büchner-Steudel, P, Rodriguez-Laval, V, Kühl, AA, Arsenic, R, Jansen, H, Treasure, P & Utku, N 2020, 'Efficacy and Safety of CAP7.1 as Second-Line Treatment for Advanced Biliary Tract Cancers: Data from a Randomised Phase II Study', CANCERS, Jg. 12, Nr. 11. https://doi.org/10.3390/cancers12113149

APA

Pape, U-F., Kasper, S., Meiler, J., Sinn, M., Vogel, A., Müller, L., Burkhard, O., Caca, K., Heeg, S., Büchner-Steudel, P., Rodriguez-Laval, V., Kühl, A. A., Arsenic, R., Jansen, H., Treasure, P., & Utku, N. (2020). Efficacy and Safety of CAP7.1 as Second-Line Treatment for Advanced Biliary Tract Cancers: Data from a Randomised Phase II Study. CANCERS, 12(11). https://doi.org/10.3390/cancers12113149

Vancouver

Pape U-F, Kasper S, Meiler J, Sinn M, Vogel A, Müller L et al. Efficacy and Safety of CAP7.1 as Second-Line Treatment for Advanced Biliary Tract Cancers: Data from a Randomised Phase II Study. CANCERS. 2020 Okt 27;12(11). https://doi.org/10.3390/cancers12113149

Bibtex

@article{46c6aa5185ba45dfb4e2e46273a200d0,
title = "Efficacy and Safety of CAP7.1 as Second-Line Treatment for Advanced Biliary Tract Cancers: Data from a Randomised Phase II Study",
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.",
author = "Ulrich-Frank Pape and Stefan Kasper and Johannes Meiler and Marianne Sinn and Arndt Vogel and Lothar M{\"u}ller and Oswald Burkhard and Karel Caca and Steffen Heeg and Petra B{\"u}chner-Steudel and Victor Rodriguez-Laval and K{\"u}hl, {Anja A} and Ruza Arsenic and Holger Jansen and Peter Treasure and Nal{\^a}n Utku",
year = "2020",
month = oct,
day = "27",
doi = "10.3390/cancers12113149",
language = "English",
volume = "12",
journal = "CANCERS",
issn = "2072-6694",
publisher = "Multidisciplinary Digital Publishing Institute (MDPI)",
number = "11",

}

RIS

TY - JOUR

T1 - Efficacy and Safety of CAP7.1 as Second-Line Treatment for Advanced Biliary Tract Cancers: Data from a Randomised Phase II Study

AU - Pape, Ulrich-Frank

AU - Kasper, Stefan

AU - Meiler, Johannes

AU - Sinn, Marianne

AU - Vogel, Arndt

AU - Müller, Lothar

AU - Burkhard, Oswald

AU - Caca, Karel

AU - Heeg, Steffen

AU - Büchner-Steudel, Petra

AU - Rodriguez-Laval, Victor

AU - Kühl, Anja A

AU - Arsenic, Ruza

AU - Jansen, Holger

AU - Treasure, Peter

AU - Utku, Nalân

PY - 2020/10/27

Y1 - 2020/10/27

N2 - 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.

AB - 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.

U2 - 10.3390/cancers12113149

DO - 10.3390/cancers12113149

M3 - SCORING: Journal article

C2 - 33121007

VL - 12

JO - CANCERS

JF - CANCERS

SN - 2072-6694

IS - 11

ER -