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Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study)

INTRODUCTION: Previous small-molecule antiangiogenics have compromised chemotherapy dose intensity in breast cancer. We present a phase I trial of a novel selective agent, nintedanib, plus standard chemotherapy in early breast cancer. METHODS: Her-2-negative breast cancer patients with tumours large...

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Autores principales: Quintela-Fandino, M, Urruticoechea, A, Guerra, J, Gil, M, Gonzalez-Martin, A, Marquez, R, Hernandez-Agudo, E, Rodriguez-Martin, C, Gil-Martin, M, Bratos, R, Escudero, M J, Vlassak, S, Hilberg, F, Colomer, R
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4453846/
https://www.ncbi.nlm.nih.gov/pubmed/25058346
http://dx.doi.org/10.1038/bjc.2014.397
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author Quintela-Fandino, M
Urruticoechea, A
Guerra, J
Gil, M
Gonzalez-Martin, A
Marquez, R
Hernandez-Agudo, E
Rodriguez-Martin, C
Gil-Martin, M
Bratos, R
Escudero, M J
Vlassak, S
Hilberg, F
Colomer, R
author_facet Quintela-Fandino, M
Urruticoechea, A
Guerra, J
Gil, M
Gonzalez-Martin, A
Marquez, R
Hernandez-Agudo, E
Rodriguez-Martin, C
Gil-Martin, M
Bratos, R
Escudero, M J
Vlassak, S
Hilberg, F
Colomer, R
author_sort Quintela-Fandino, M
collection PubMed
description INTRODUCTION: Previous small-molecule antiangiogenics have compromised chemotherapy dose intensity in breast cancer. We present a phase I trial of a novel selective agent, nintedanib, plus standard chemotherapy in early breast cancer. METHODS: Her-2-negative breast cancer patients with tumours larger than 2 cm were eligible for dose-escalation trial (classic 3+3 method). RESULTS: The recommended phase II dose (RP2D) was 150 mg BID of nintedanib combined with standard dose of weekly paclitaxel followed by adriamycin plus cyclophosphamide. The dose-limiting toxicity was transaminase elevation. At the RP2D, the dose intensity was ∼100%. The pathologic complete response was 50%. CONCLUSIONS: The combination allows the delivery of full-dose intensity, while efficacy seems promising.
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spelling pubmed-44538462015-09-09 Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study) Quintela-Fandino, M Urruticoechea, A Guerra, J Gil, M Gonzalez-Martin, A Marquez, R Hernandez-Agudo, E Rodriguez-Martin, C Gil-Martin, M Bratos, R Escudero, M J Vlassak, S Hilberg, F Colomer, R Br J Cancer Short Communication INTRODUCTION: Previous small-molecule antiangiogenics have compromised chemotherapy dose intensity in breast cancer. We present a phase I trial of a novel selective agent, nintedanib, plus standard chemotherapy in early breast cancer. METHODS: Her-2-negative breast cancer patients with tumours larger than 2 cm were eligible for dose-escalation trial (classic 3+3 method). RESULTS: The recommended phase II dose (RP2D) was 150 mg BID of nintedanib combined with standard dose of weekly paclitaxel followed by adriamycin plus cyclophosphamide. The dose-limiting toxicity was transaminase elevation. At the RP2D, the dose intensity was ∼100%. The pathologic complete response was 50%. CONCLUSIONS: The combination allows the delivery of full-dose intensity, while efficacy seems promising. Nature Publishing Group 2014-09-09 2014-07-24 /pmc/articles/PMC4453846/ /pubmed/25058346 http://dx.doi.org/10.1038/bjc.2014.397 Text en Copyright © 2014 Cancer Research UK http://creativecommons.org/licenses/by-nc-sa/3.0/ From twelve months after its original publication, this work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/
spellingShingle Short Communication
Quintela-Fandino, M
Urruticoechea, A
Guerra, J
Gil, M
Gonzalez-Martin, A
Marquez, R
Hernandez-Agudo, E
Rodriguez-Martin, C
Gil-Martin, M
Bratos, R
Escudero, M J
Vlassak, S
Hilberg, F
Colomer, R
Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study)
title Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study)
title_full Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study)
title_fullStr Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study)
title_full_unstemmed Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study)
title_short Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study)
title_sort phase i clinical trial of nintedanib plus paclitaxel in early her-2-negative breast cancer (cnio-br-01-2010/geicam-2010-10 study)
topic Short Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4453846/
https://www.ncbi.nlm.nih.gov/pubmed/25058346
http://dx.doi.org/10.1038/bjc.2014.397
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