A phase II trial of neoadjuvant doxorrubicin plus gemcitabine, followed by weekly paclitaxel in lo- cally advanced breast cancer: An analysis of effectiveness and toxicity

Abstract

Background: Neoadjuvant chemotherapy is a therapeutic strategy for patients with locally advanced breast cancer. To evaluate the toxicity and clinical efficacy of the combination of Gemcitabine plus doxorubicin followed by paclitaxel in neoadjuvancy.

Methods: A phase II trial, in which 19 patients, ages 37 to 65, with pathologically proven breast cancer, were included. They received four cycles of doxorubicin 50mg/m² on day 1 and Gemcitabine 1000 mg/m² on days 1 and 8, every 21 days; followed by four cycles of paclitaxel 80 mg/m² on days 1, 8, and 15, every 28 days. The follow-up was performed with mammography and clinical examination.

Results: The planned regimen was completed in 17 (89.4%) of the 19 patients. Thirty seven percent of the patients presented mucositis grades 3-4 and 15% had diarrhea grades 3-4. Hematologic toxicities grades 3-4 were seen in 31.5% of the cases (6 patients). Complete clinical response was observed in 9 (47%) patients; of whom four showed complete pathological response after surgery.

Conclusion: The response rate (clinical and pathological) in this study was similar to the one observed in the usual regimen of neoadjuvancy using doxorubicin, cyclophosphamide, and paclitaxel. However, the toxicity profile of the combination regimen containing gemcitabine was exceedingly high, causing the interruption of the protocol.