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.
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/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.
authors.affiliation: Department of Surgery, College of Health Sciences, Obafemi Awolowo University, Ile-Ife, Osun, Nigeria.
authors.forename: Olukayode A
authors.initials: OA
authors.lastname: Arowolo
authors.forename: Uchenna O
authors.initials: UO
authors.lastname: Njiaju
authors.forename: Temidayo O
authors.initials: TO
authors.lastname: Ogundiran
authors.forename: Oyewale
authors.initials: O
authors.lastname: Abidoye
authors.forename: Olukayode O
authors.initials: OO
authors.lastname: Lawal
authors.forename: Millicent
authors.initials: M
authors.lastname: Obajimi
authors.forename: Adebayo V
authors.initials: AV
authors.lastname: Adetiloye
authors.forename: Hae K
authors.initials: HK
authors.lastname: Im
authors.forename: Akinbolaji A
authors.initials: AA
authors.lastname: Akinkuolie
authors.forename: Abideen
authors.initials: A
authors.lastname: Oluwasola
authors.forename: Kayode
authors.initials: K
authors.lastname: Adelusola
authors.forename: Adesunkanmi A
authors.initials: AA
authors.lastname: Kayode
authors.forename: Augustine E
authors.initials: AE
authors.lastname: Agbakwuru
authors.forename: Helen
authors.initials: H
authors.lastname: Oduntan
authors.forename: Chinedum P
authors.initials: CP
authors.lastname: Babalola
authors.forename: Gini
authors.initials: G
authors.lastname: Fleming
authors.forename: Olusola C
authors.initials: OC
authors.lastname: Olopade
authors.forename: Adeyinka Gladys
authors.initials: AG
authors.lastname: Falusi
authors.forename: Muheez A
authors.initials: MA
authors.lastname: Durosinmi
authors.forename: Olufunmilayo I
authors.initials: OI
authors.lastname: Olopade
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009549:Nigeria
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil
keywords: Nigeria; capecitabine; clinical response; locally advanced breast cancer; resource-poor country