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A Phase I dose-escalation study of third-line regorafenib with trifluridine/tipiracil in metastatic colorectal cancer

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A Phase I dose-escalation study of third-line regorafenib with trifluridine/tipiracil in metastatic colorectal cancer. / Moehler, Markus; Michel, Maurice; Stein, Alexander; Trojan, Joerg; Marquardt, Jens; Tintelnot, Joseph; Waidmann, Oliver; Weinmann, Arndt; Woerns, Marcus-Alexander; Schroeder, Helge; Maenz, Martin; Foerster, Friedrich.

in: FUTURE ONCOL, Jahrgang 17, Nr. 25, 09.2021, S. 3309-3319.

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

Harvard

Moehler, M, Michel, M, Stein, A, Trojan, J, Marquardt, J, Tintelnot, J, Waidmann, O, Weinmann, A, Woerns, M-A, Schroeder, H, Maenz, M & Foerster, F 2021, 'A Phase I dose-escalation study of third-line regorafenib with trifluridine/tipiracil in metastatic colorectal cancer', FUTURE ONCOL, Jg. 17, Nr. 25, S. 3309-3319. https://doi.org/10.2217/fon-2021-0278

APA

Moehler, M., Michel, M., Stein, A., Trojan, J., Marquardt, J., Tintelnot, J., Waidmann, O., Weinmann, A., Woerns, M-A., Schroeder, H., Maenz, M., & Foerster, F. (2021). A Phase I dose-escalation study of third-line regorafenib with trifluridine/tipiracil in metastatic colorectal cancer. FUTURE ONCOL, 17(25), 3309-3319. https://doi.org/10.2217/fon-2021-0278

Vancouver

Moehler M, Michel M, Stein A, Trojan J, Marquardt J, Tintelnot J et al. A Phase I dose-escalation study of third-line regorafenib with trifluridine/tipiracil in metastatic colorectal cancer. FUTURE ONCOL. 2021 Sep;17(25):3309-3319. https://doi.org/10.2217/fon-2021-0278

Bibtex

@article{f7262410b6fe4eb69111b39897a853ea,
title = "A Phase I dose-escalation study of third-line regorafenib with trifluridine/tipiracil in metastatic colorectal cancer",
abstract = "Aim: To determine a recommended Phase II dose of the oral fluoropyrimidine trifluridine/tipiracil (FTD/TPI) combined with the multi-kinase inhibitor regorafenib (REG) in refractory metastatic colorectal cancer patients. Materials & methods: A conventional 3 + 3 dose finding design was used. FTD/TPI was administered on days 1-5 and 8-12 of a 28-day cycle, REG on days 2-22. Two dose levels were used: FTD/TPI 25 mg/m2 b.i.d. + REG 120 mg/d, then escalated to FTD/TPI 35 mg/m2 b.i.d. + REG 120 mg/d. Results: In total, 12 patients were treated at two dose levels. Three dose-limiting toxicities were observed; all were grade 3 hypertension causally attributed to REG. Recommended Phase II dose is FTD/TPI 25 mg/m2 b.i.d. + REG 120 mg/d. Median progression-free survival was 3.81 months (95% CI: 1.51-5.29), median OS 11.1 months (95% CI: 2.3-18.2). Conclusion: The combination of REG and FTD/TPI is feasible and safe. Efficacy signals exceed that of the single agents at acceptable toxicity levels and are clinically meaningful.",
author = "Markus Moehler and Maurice Michel and Alexander Stein and Joerg Trojan and Jens Marquardt and Joseph Tintelnot and Oliver Waidmann and Arndt Weinmann and Marcus-Alexander Woerns and Helge Schroeder and Martin Maenz and Friedrich Foerster",
year = "2021",
month = sep,
doi = "10.2217/fon-2021-0278",
language = "English",
volume = "17",
pages = "3309--3319",
journal = "FUTURE ONCOL",
issn = "1479-6694",
publisher = "Future Medicine Ltd",
number = "25",

}

RIS

TY - JOUR

T1 - A Phase I dose-escalation study of third-line regorafenib with trifluridine/tipiracil in metastatic colorectal cancer

AU - Moehler, Markus

AU - Michel, Maurice

AU - Stein, Alexander

AU - Trojan, Joerg

AU - Marquardt, Jens

AU - Tintelnot, Joseph

AU - Waidmann, Oliver

AU - Weinmann, Arndt

AU - Woerns, Marcus-Alexander

AU - Schroeder, Helge

AU - Maenz, Martin

AU - Foerster, Friedrich

PY - 2021/9

Y1 - 2021/9

N2 - Aim: To determine a recommended Phase II dose of the oral fluoropyrimidine trifluridine/tipiracil (FTD/TPI) combined with the multi-kinase inhibitor regorafenib (REG) in refractory metastatic colorectal cancer patients. Materials & methods: A conventional 3 + 3 dose finding design was used. FTD/TPI was administered on days 1-5 and 8-12 of a 28-day cycle, REG on days 2-22. Two dose levels were used: FTD/TPI 25 mg/m2 b.i.d. + REG 120 mg/d, then escalated to FTD/TPI 35 mg/m2 b.i.d. + REG 120 mg/d. Results: In total, 12 patients were treated at two dose levels. Three dose-limiting toxicities were observed; all were grade 3 hypertension causally attributed to REG. Recommended Phase II dose is FTD/TPI 25 mg/m2 b.i.d. + REG 120 mg/d. Median progression-free survival was 3.81 months (95% CI: 1.51-5.29), median OS 11.1 months (95% CI: 2.3-18.2). Conclusion: The combination of REG and FTD/TPI is feasible and safe. Efficacy signals exceed that of the single agents at acceptable toxicity levels and are clinically meaningful.

AB - Aim: To determine a recommended Phase II dose of the oral fluoropyrimidine trifluridine/tipiracil (FTD/TPI) combined with the multi-kinase inhibitor regorafenib (REG) in refractory metastatic colorectal cancer patients. Materials & methods: A conventional 3 + 3 dose finding design was used. FTD/TPI was administered on days 1-5 and 8-12 of a 28-day cycle, REG on days 2-22. Two dose levels were used: FTD/TPI 25 mg/m2 b.i.d. + REG 120 mg/d, then escalated to FTD/TPI 35 mg/m2 b.i.d. + REG 120 mg/d. Results: In total, 12 patients were treated at two dose levels. Three dose-limiting toxicities were observed; all were grade 3 hypertension causally attributed to REG. Recommended Phase II dose is FTD/TPI 25 mg/m2 b.i.d. + REG 120 mg/d. Median progression-free survival was 3.81 months (95% CI: 1.51-5.29), median OS 11.1 months (95% CI: 2.3-18.2). Conclusion: The combination of REG and FTD/TPI is feasible and safe. Efficacy signals exceed that of the single agents at acceptable toxicity levels and are clinically meaningful.

U2 - 10.2217/fon-2021-0278

DO - 10.2217/fon-2021-0278

M3 - SCORING: Journal article

C2 - 33993741

VL - 17

SP - 3309

EP - 3319

JO - FUTURE ONCOL

JF - FUTURE ONCOL

SN - 1479-6694

IS - 25

ER -