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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...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group
2014
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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. |
format | Online Article Text |
id | pubmed-4453846 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Nature Publishing Group |
record_format | MEDLINE/PubMed |
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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