Neoadjuvant 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

e11554 Background: The majority of clinical trials of neoadjuvant 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 neoadjuvant capecitabine in locally advanced breast cancer. Methods: Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000mg/m2 twice daily (2000mg/m2 total per day). Each cycle consisted of a 14-day period of therapy followed by a 7-day pause, and patients were evaluated after 3 cycles and taken off study if no response was documented. Responding patients were treated for no more than 8 cycles. The primary endpoints were partial, complete clinical response and pathologic complete response. Results: 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 3 cycles of therapy, partial clinical responses were seen in 5 of 16 patients (31%; 95% CI 11% - 59%). Of the remaining 11 patients, 8 had no response or stable disease, and 3 had progressive disease. Seven pateints proceeded with further therapy, two of them with stable disease but exactly in the border line of 25% increase. By physical examination, only 2 of the 6 patients had a documented complete clinical response, while by ultrasonomammography, partial responses were observed in 5 patients. Thus, overall response rate at the end of 8 cycles were 31.1% both by clinical examination and by ultrasonomammography. Clinical response by physical examination and radiologic response by ultrasonomammography were highly concordant (the spearman correlation between the two ratios was 0.70). The most common adverse effect was Grade 1 Hand and Foot Syndrome in 75% of patients. Conclusions: Despite several limitations, we successfully carried out this phase II feasibility study of neoadjuvant capecitabine for locally advanced breast cancer in Nigeria. Capecitabine monotherapy showed good overall response rates with minimal toxicity and further studies are warranted.

Implementing oncology clinical trials in Nigeria: A model for Capacity building.

“…In recent years, a shift in location of Biopharma industry-sponsored clinical trials to regions such as Eastern European, Latin American, Asian countries and South Africa has occurred largely due to national policies in these emerging markets [9][10][11] An expanded globalization of innovative biomarker-informed oncology clinical trials to include countries in Africa is long overdue. However, despite the significant link to African Americans in the US, there are few clinical trials conducted in Sub-Saharan Africa [12,13,14] (Fig. 1) While lack of infrastructure, resources, medical expertise and incentive to the pharmaceutical industry have been cited as barriers [15], other industries including digital media and financial services, appear to be thriving on the Continent.…”