The Efficacy and Safety of Gemcitabine Plus Paclitaxel Compared to Doxorubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Journal of Cancer Prevention & Current Research
Neoadjuvant chemotherapy is now considered current practice for patients with locally advanced breast cancer. This two-arm randomized clinical study aims to compare the efficacy and safety of gemcitabine plus paclitaxel with doxorubicin plus cyclophosphamide as neoadjuvant chemotherapy in locally breast cancer. Methods: Eligible women with newly pathologically diagnosed locally advanced breast cancer were randomly assigned to receive 4 cycles of neoadjuvant chemotherapy with doxorubicin (60
... doxorubicin (60 mg/m 2 ) and cyclophosphamide (600 mg/ m 2 ) (AC arm) or gemcitabine (1000 mg/m 2 days 1 and 8) and paclitaxel (175 mg/ m 2 ) (GP arm) every three weeks. Clinical and radiological tumor measurements were performed before and after intervention. Subsequently, all the patients underwent mastectomy after the fourth cycle of neoadjuvant chemotherapy and then crossed over to receive the other treatment arm as adjuvant therapy. Results: Sixty-six patients in both arms (Ac, n=34; and GP, n=32) completed the study. Before intervention, the mean clinical maximum diameter tumor size was 7.9 cm and 7.1 cm in AC and GP arms respectively. After intervention, these values were decreased to 5.1 cm and 4.2 cm respectively. Pathologic complete response rates were 29.5% and 0.0% in the AC and the GP arm, respectively (P = 0.001). However, there was no statistically difference regarding the rate of clinical and radiologic responses in AC arm compared to the GP arm. As well, there was no statistical significant difference regarding treatment-related toxicity. Conclusion: This study suggest that in patients with locally advanced breast cancer, the addition of gemcitabine to paclitaxel in neoadjuvant setting does not provide any superiority in terms of clinical and/or pathological response rate or toxicity profile compared to the AC regimen. Submit Manuscript | http://medcraveonline.com J Cancer Prev Curr Res 2015, 3(5): 000102 We conducted this phase III controlled randomized clinical trial to compare the efficacy of GP with AC on tumor response and evaluate treatment-related side effects.