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/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.

How Effective is the Treatment of Locally Advanced and Metastatic Breast Cancer in Developing Centres?: A Retrospective Review

“…This conforms with findings documented elsewhere in Nigeria where tumors are large (10,17), but contrary to chiedozi's findings where the chemotherapeutic dosing and scheduling were optimal (8,17).…”

A Review on Breast Cancer Care in Africa

“…A phase II trial from Nigeria that included 16 patients who received primary systemic capecitabine for over 24 weeks found that the overall response was 44% after 8 cycles [37]. A study from Egypt reported on gemcitabine and cisplatin in locally advanced or metastatic BC after previous anthracycline therapy.…”

Evaluation of the clinical benefits of adjuvant capecitabine monotherapy in elderly women with breast cancer: A retrospective study

“…Capecitabine has also been used was neoadjuvant chemotherapy for breast cancer. Arowolo et al reported that capecitabine monotherapy achieved good overall response rates with manageable toxicity when administered as neoadjuvant chemotherapy to 16 patients with locally advanced breast cancer (16). In a phase II study by Tolaney et al, 3 patients exhibited a complete clinical response after 4 cycles of capecitabine monotherapy and 8 patients exhibited a partial clinical response among 24 women with operable hormone receptor-positive breast cancer (17).…”