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.

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.

Evaluation of two methods of preoperative hair removal and their relationship to postoperative wound infection.

INTRODUCTION: When a surgical operation is to be conducted through a hair bearing part of the body, hair removal is often performed. This study aimed to evaluate the relationship of two methods of preoperative hair removal to postoperative wound infection in a developing country where razor shaving is very popular. METHODOLOGY: Consecutive consenting patients scheduled to have such operations were randomized into two groups. One group had hair removal by shaving with a razor blade while the other had hair removed by depilatory cream. Adequacy of hair removal and presence of skin injuries and/or reactions were noted preoperatively. Details of the procedures were recorded and patients were then assessed for postoperative wound infection. RESULTS: A total of 165 patients were studied. Of the 79 patients who had hair removal by depilatory cream, hair was completely removed in 70 (88.6%) compared to 53 (61.6%) of the 86 patients who had razor hair shaving (p < 0.0001). Skin injuries were noted in 24 (27.9%) of the razor group and 3 (3.8%) of patients who had depilatory cream, (p = 0.001). Thirteen patients (7.9%) had postoperative wound infection including 2 (2.5%) in the depilatory cream group and 11 (12.8%) of the razor group. A significant association was found between preoperative skin injuries and postoperative wound infections. CONCLUSION: Preoperative hair removal with razor shaving predisposes to skin injuries which in turn significantly influence postoperative wound infection rates. Such injuries and resultant wound infection are fewer when depilatory cream is used for hair removal.