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Phase I and II Study of Gemcitabine and Vinorelbine in Heavily Pretreated Patients with Metastatic Breast Cancer and Review of the Literature

Background: Many phase II trials investigated the combination of Gemcitabine (G) and Vinorelbine (V) in the treatment of metastatic breast cancer (MBC) with variable outcomes. This study was conducted to explore whether this combination was effective and tolerable in MBC patients who were heavily pr...

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Autores principales: Abdayem, Pamela, Ghosn, Marwan, Valero, Vicente, Walters, Ronald, Arun, Banu, Murray, James L., Theriault, Richard, Frye, Debbie, Ibrahim, Nuhad K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Ivyspring International Publisher 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3982182/
https://www.ncbi.nlm.nih.gov/pubmed/24723978
http://dx.doi.org/10.7150/jca.8304
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author Abdayem, Pamela
Ghosn, Marwan
Valero, Vicente
Walters, Ronald
Arun, Banu
Murray, James L.
Theriault, Richard
Frye, Debbie
Ibrahim, Nuhad K.
author_facet Abdayem, Pamela
Ghosn, Marwan
Valero, Vicente
Walters, Ronald
Arun, Banu
Murray, James L.
Theriault, Richard
Frye, Debbie
Ibrahim, Nuhad K.
author_sort Abdayem, Pamela
collection PubMed
description Background: Many phase II trials investigated the combination of Gemcitabine (G) and Vinorelbine (V) in the treatment of metastatic breast cancer (MBC) with variable outcomes. This study was conducted to explore whether this combination was effective and tolerable in MBC patients who were heavily pretreated with anthracyclines and taxanes. Methods: A phase I study was conducted first to establish the maximum tolerated dose (MTD) of the G and V combination in MBC patients. Then, a phase II study evaluated the response rates, the median time to progression (TTP), the overall survival (OS) as well as the toxicities resulting from this combination at the MTD. Results: Nine patients were enrolled in the phase I study. The MTD was identified as 700mg/m(2) of G on days 1 and 8 in combination with 15 mg/m(2) of V on days 2 and 9, every 21 days. Twenty-one of 25 patients involved in the phase II study were evaluable for response. No complete or partial responses were achieved; 6 patients (24.0%) had stable disease and 15 (60.0%) progressed. The median TTP was 2 months and the median OS 10 months. Grade 3/4 Neutropenia was the major hematologic toxicity, occurring in 52% of the cycles. The most common non-hematologic grade 3/4 toxicities were fatigue (18%), myalgias (17%) and arthralgias (13%). Conclusion: In heavily pretreated patients with MBC, the combination of G and V at the doses stated above was ineffective as it did not induce partial or complete responses. Other chemotherapy agents or combinations should be evaluated in future studies.
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spelling pubmed-39821822014-04-10 Phase I and II Study of Gemcitabine and Vinorelbine in Heavily Pretreated Patients with Metastatic Breast Cancer and Review of the Literature Abdayem, Pamela Ghosn, Marwan Valero, Vicente Walters, Ronald Arun, Banu Murray, James L. Theriault, Richard Frye, Debbie Ibrahim, Nuhad K. J Cancer Research Paper Background: Many phase II trials investigated the combination of Gemcitabine (G) and Vinorelbine (V) in the treatment of metastatic breast cancer (MBC) with variable outcomes. This study was conducted to explore whether this combination was effective and tolerable in MBC patients who were heavily pretreated with anthracyclines and taxanes. Methods: A phase I study was conducted first to establish the maximum tolerated dose (MTD) of the G and V combination in MBC patients. Then, a phase II study evaluated the response rates, the median time to progression (TTP), the overall survival (OS) as well as the toxicities resulting from this combination at the MTD. Results: Nine patients were enrolled in the phase I study. The MTD was identified as 700mg/m(2) of G on days 1 and 8 in combination with 15 mg/m(2) of V on days 2 and 9, every 21 days. Twenty-one of 25 patients involved in the phase II study were evaluable for response. No complete or partial responses were achieved; 6 patients (24.0%) had stable disease and 15 (60.0%) progressed. The median TTP was 2 months and the median OS 10 months. Grade 3/4 Neutropenia was the major hematologic toxicity, occurring in 52% of the cycles. The most common non-hematologic grade 3/4 toxicities were fatigue (18%), myalgias (17%) and arthralgias (13%). Conclusion: In heavily pretreated patients with MBC, the combination of G and V at the doses stated above was ineffective as it did not induce partial or complete responses. Other chemotherapy agents or combinations should be evaluated in future studies. Ivyspring International Publisher 2014-03-29 /pmc/articles/PMC3982182/ /pubmed/24723978 http://dx.doi.org/10.7150/jca.8304 Text en © Ivyspring International Publisher. This is an open-access article distributed under the terms of the Creative Commons License (http://creativecommons.org/licenses/by-nc-nd/3.0/). Reproduction is permitted for personal, noncommercial use, provided that the article is in whole, unmodified, and properly cited.
spellingShingle Research Paper
Abdayem, Pamela
Ghosn, Marwan
Valero, Vicente
Walters, Ronald
Arun, Banu
Murray, James L.
Theriault, Richard
Frye, Debbie
Ibrahim, Nuhad K.
Phase I and II Study of Gemcitabine and Vinorelbine in Heavily Pretreated Patients with Metastatic Breast Cancer and Review of the Literature
title Phase I and II Study of Gemcitabine and Vinorelbine in Heavily Pretreated Patients with Metastatic Breast Cancer and Review of the Literature
title_full Phase I and II Study of Gemcitabine and Vinorelbine in Heavily Pretreated Patients with Metastatic Breast Cancer and Review of the Literature
title_fullStr Phase I and II Study of Gemcitabine and Vinorelbine in Heavily Pretreated Patients with Metastatic Breast Cancer and Review of the Literature
title_full_unstemmed Phase I and II Study of Gemcitabine and Vinorelbine in Heavily Pretreated Patients with Metastatic Breast Cancer and Review of the Literature
title_short Phase I and II Study of Gemcitabine and Vinorelbine in Heavily Pretreated Patients with Metastatic Breast Cancer and Review of the Literature
title_sort phase i and ii study of gemcitabine and vinorelbine in heavily pretreated patients with metastatic breast cancer and review of the literature
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3982182/
https://www.ncbi.nlm.nih.gov/pubmed/24723978
http://dx.doi.org/10.7150/jca.8304
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