Open AccessNeo‐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
Author(s) -
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.
Publication year - 2013
Publication title -
the breast journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.533
H-Index - 72
eISSN - 1524-4741
pISSN - 1075-122X
DOI - 10.1111/tbj.12149
Subject(s) - medicine , capecitabine , tolerability , breast cancer , adverse effect , clinical trial , clinical endpoint , oncology , adjuvant , progressive disease , adjuvant therapy , phases of clinical research , surgery , chemotherapy , cancer , colorectal cancer
The majority of clinical trials of neo‐adjuvant therapy for breast cancer have been conducted in resource‐rich countries. We chose N igeria, 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 N igeria. Capecitabine monotherapy showed good overall response rates with minimal toxicity and further studies are warranted.