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 |
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| Authors: | Oyewale Abidoye MB BS Olukayode O Lawal MB BS FWASC Millicent Obajimi MBBS FWACS Adebayo V Adetiloye MB BS FWASC Hae K Im PhD Akinbolaji A Akinkuolie MB Chb FWASC Abideen Oluwasola MB BS FWACPath Kayode Adelusola Mb Chb FMCPath Adesunkanmi A Kayode MB BS FWASC Augustine E Agbakwuru Mb Chb FWASC Chinedum P Babalola BPharm PhD FAS Gini Fleming MD Olusola C Olopade MBBS FACP Adeyinka Gladys Falusi PhD FAS Muheez A Durosinmi MB BS FMCPath Olufunmilayo I Olopade MB BS FACP |
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| Institution: | 1. Section of Hematology/Oncology, Department of Medicine, The University of Chicago Medical Center, , Chicago, Illinois;2. Department of Surgery, College of Health Sciences, Obafemi Awolowo University, , Ile‐Ife, Osun, Nigeria;3. Department of Radiology, College of Medicine, University of Ibadan, , Ibadan, Oyo, Nigeria;4. Department of Radiology, College of Health Sciences, Obafemi Awolowo University, , Ile‐Ife, Osun, Nigeria;5. Department of Health Studies, The University of Chicago, , Chicago, Illinois;6. Department of Pathology, College of Medicine, University of Ibadan, , Ibadan, Oyo, Nigeria;7. Department of Haematology and Immunology, College of Health Sciences, Obafemi Awolowo University, , Ile‐Ife, Osun, Nigeria;8. Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Ibadan, , Ibadan, Oyo, Nigeria;9. Genetics and Bioethics Unit/Breast Cancer Laboratory, Institute for Advanced Medical Research and Training, College of Medicine, University of Ibadan, , Ibadan, Oyo, Nigeria;10. Center for Global Health, The University of Chicago, , Chicago, Illinois |
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| Abstract: | 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/m2 twice daily (2,000 mg/m2 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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| Keywords: | capecitabine clinical response locally advanced breast cancer Nigeria resource‐poor country |
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