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Neo-adjuvant Capecitabine Chemotherapy in Women with Newly Diagnosed Locally Advanced Breast Cancer in a Resource-poor Setting (Nigeria): Efficacy and Safety in a Phase II Feasibility Study

The majority of clinical trials of neo-adjuvant therapy for breast cancer have been conducted in resource-rich countries. We chose Nigeria, a resource-poor country, as the major site for a phase II feasibility open-label multicenter clinical trial designed to evaluate the efficacy, safety, and toler...

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Autores principales: Arowolo, Olukayode A, Njiaju, Uchenna O, Ogundiran, Temidayo O, Abidoye, Oyewale, Lawal, Olukayode O, Obajimi, Millicent, Adetiloye, Adebayo V, Im, Hae K, Akinkuolie, Akinbolaji A, Oluwasola, Abideen, Adelusola, Kayode, Kayode, Adesunkanmi A, Agbakwuru, Augustine E, Oduntan, Helen, Babalola, Chinedum P, Fleming, Gini, Olopade, Olusola C, Falusi, Adeyinka Gladys, Durosinmi, Muheez A, Olopade, Olufunmilayo I
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BlackWell Publishing Ltd 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4282544/
https://www.ncbi.nlm.nih.gov/pubmed/23865786
http://dx.doi.org/10.1111/tbj.12149
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author Arowolo, Olukayode A
Njiaju, Uchenna O
Ogundiran, Temidayo O
Abidoye, Oyewale
Lawal, Olukayode O
Obajimi, Millicent
Adetiloye, Adebayo V
Im, Hae K
Akinkuolie, Akinbolaji A
Oluwasola, Abideen
Adelusola, Kayode
Kayode, Adesunkanmi A
Agbakwuru, Augustine E
Oduntan, Helen
Babalola, Chinedum P
Fleming, Gini
Olopade, Olusola C
Falusi, Adeyinka Gladys
Durosinmi, Muheez A
Olopade, Olufunmilayo I
author_facet Arowolo, Olukayode A
Njiaju, Uchenna O
Ogundiran, Temidayo O
Abidoye, Oyewale
Lawal, Olukayode O
Obajimi, Millicent
Adetiloye, Adebayo V
Im, Hae K
Akinkuolie, Akinbolaji A
Oluwasola, Abideen
Adelusola, Kayode
Kayode, Adesunkanmi A
Agbakwuru, Augustine E
Oduntan, Helen
Babalola, Chinedum P
Fleming, Gini
Olopade, Olusola C
Falusi, Adeyinka Gladys
Durosinmi, Muheez A
Olopade, Olufunmilayo I
author_sort Arowolo, Olukayode A
collection PubMed
description The majority of clinical trials of neo-adjuvant therapy for breast cancer have been conducted in resource-rich countries. We chose Nigeria, a resource-poor country, as the major site for a phase II feasibility open-label multicenter clinical trial designed to evaluate the efficacy, safety, and tolerability of neo-adjuvant capecitabine in locally advanced breast cancer (LABC). Planned treatment consisted of 24 weeks of capecitabine at a dose of 1,000 mg/m(2) twice daily (2,000 mg/m(2) total per day). The primary endpoints were overall, partial, complete clinical response rate (OCR, PCR, CCR) and complete pathologic response (cPR). A total of 16 patients were recruited from August 2007 to April 2010. The study was terminated early as a result of slow accrual. After the first three cycles of therapy, PCR were seen in five of 16 patients (31%; 95% CI 11–59%). Of the remaining 11 patients, eight had no response (NR) or stable disease (SD), and three had progressive disease (PD). Seven patients proceeded with further therapy of which had SD. OCR at the end of eight cycles was 44% (95% CI 20–70%). Clinical response and radiologic response by ultrasonomammography were highly concordant (spearman correlation 0.70). The most common adverse effect was Grade 1 hand–foot syndrome, which was seen in 75% of patients. Despite several limitations, we successfully carried out this phase II feasibility study of neo-adjuvant capecitabine for LABC in Nigeria. Capecitabine monotherapy showed good overall response rates with minimal toxicity and further studies are warranted.
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spelling pubmed-42825442015-01-15 Neo-adjuvant Capecitabine Chemotherapy in Women with Newly Diagnosed Locally Advanced Breast Cancer in a Resource-poor Setting (Nigeria): Efficacy and Safety in a Phase II Feasibility Study Arowolo, Olukayode A Njiaju, Uchenna O Ogundiran, Temidayo O Abidoye, Oyewale Lawal, Olukayode O Obajimi, Millicent Adetiloye, Adebayo V Im, Hae K Akinkuolie, Akinbolaji A Oluwasola, Abideen Adelusola, Kayode Kayode, Adesunkanmi A Agbakwuru, Augustine E Oduntan, Helen Babalola, Chinedum P Fleming, Gini Olopade, Olusola C Falusi, Adeyinka Gladys Durosinmi, Muheez A Olopade, Olufunmilayo I Breast J Original Articles The majority of clinical trials of neo-adjuvant therapy for breast cancer have been conducted in resource-rich countries. We chose Nigeria, a resource-poor country, as the major site for a phase II feasibility open-label multicenter clinical trial designed to evaluate the efficacy, safety, and tolerability of neo-adjuvant capecitabine in locally advanced breast cancer (LABC). Planned treatment consisted of 24 weeks of capecitabine at a dose of 1,000 mg/m(2) twice daily (2,000 mg/m(2) total per day). The primary endpoints were overall, partial, complete clinical response rate (OCR, PCR, CCR) and complete pathologic response (cPR). A total of 16 patients were recruited from August 2007 to April 2010. The study was terminated early as a result of slow accrual. After the first three cycles of therapy, PCR were seen in five of 16 patients (31%; 95% CI 11–59%). Of the remaining 11 patients, eight had no response (NR) or stable disease (SD), and three had progressive disease (PD). Seven patients proceeded with further therapy of which had SD. OCR at the end of eight cycles was 44% (95% CI 20–70%). Clinical response and radiologic response by ultrasonomammography were highly concordant (spearman correlation 0.70). The most common adverse effect was Grade 1 hand–foot syndrome, which was seen in 75% of patients. Despite several limitations, we successfully carried out this phase II feasibility study of neo-adjuvant capecitabine for LABC in Nigeria. Capecitabine monotherapy showed good overall response rates with minimal toxicity and further studies are warranted. BlackWell Publishing Ltd 2013-09 2013-07-19 /pmc/articles/PMC4282544/ /pubmed/23865786 http://dx.doi.org/10.1111/tbj.12149 Text en © 2013 The Authors. The Breast Journal published by Wiley Periodicals, Inc. http://creativecommons.org/licenses/by/3.0/ This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Articles
Arowolo, Olukayode A
Njiaju, Uchenna O
Ogundiran, Temidayo O
Abidoye, Oyewale
Lawal, Olukayode O
Obajimi, Millicent
Adetiloye, Adebayo V
Im, Hae K
Akinkuolie, Akinbolaji A
Oluwasola, Abideen
Adelusola, Kayode
Kayode, Adesunkanmi A
Agbakwuru, Augustine E
Oduntan, Helen
Babalola, Chinedum P
Fleming, Gini
Olopade, Olusola C
Falusi, Adeyinka Gladys
Durosinmi, Muheez A
Olopade, Olufunmilayo I
Neo-adjuvant Capecitabine Chemotherapy in Women with Newly Diagnosed Locally Advanced Breast Cancer in a Resource-poor Setting (Nigeria): Efficacy and Safety in a Phase II Feasibility Study
title Neo-adjuvant Capecitabine Chemotherapy in Women with Newly Diagnosed Locally Advanced Breast Cancer in a Resource-poor Setting (Nigeria): Efficacy and Safety in a Phase II Feasibility Study
title_full Neo-adjuvant Capecitabine Chemotherapy in Women with Newly Diagnosed Locally Advanced Breast Cancer in a Resource-poor Setting (Nigeria): Efficacy and Safety in a Phase II Feasibility Study
title_fullStr Neo-adjuvant Capecitabine Chemotherapy in Women with Newly Diagnosed Locally Advanced Breast Cancer in a Resource-poor Setting (Nigeria): Efficacy and Safety in a Phase II Feasibility Study
title_full_unstemmed Neo-adjuvant Capecitabine Chemotherapy in Women with Newly Diagnosed Locally Advanced Breast Cancer in a Resource-poor Setting (Nigeria): Efficacy and Safety in a Phase II Feasibility Study
title_short Neo-adjuvant Capecitabine Chemotherapy in Women with Newly Diagnosed Locally Advanced Breast Cancer in a Resource-poor Setting (Nigeria): Efficacy and Safety in a Phase II Feasibility Study
title_sort neo-adjuvant capecitabine chemotherapy in women with newly diagnosed locally advanced breast cancer in a resource-poor setting (nigeria): efficacy and safety in a phase ii feasibility study
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4282544/
https://www.ncbi.nlm.nih.gov/pubmed/23865786
http://dx.doi.org/10.1111/tbj.12149
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