Docetaxel plus epidoxorubicin as neoadjuvant treatment in patients with large operable or locally advanced carcinoma of the breast: a single-center, phase II study
Andrea de Matteis, Francesco Nuzzo, Giuseppe D'Aiuto, Vincenzo Labonia, Gabriella Landi, Emanuela Rossi, Angelo Antonio Mastro, Gerardo Botti, Ermelinda De Maio, Francesco Perrone, Andrea de Matteis, Francesco Nuzzo, Giuseppe D'Aiuto, Vincenzo Labonia, Gabriella Landi, Emanuela Rossi, Angelo Antonio Mastro, Gerardo Botti, Ermelinda De Maio, Francesco Perrone
Abstract
Background: The objective of this study was to test the activity and toxicity of epirubicin plus docetaxel as primary chemotherapy for women with large, operable (T2; > 3 cm) or locally advanced (Stage III) breast carcinoma, including patients with inflammatory breast carcinoma.
Methods: In this single-center, open-label, single-stage, Phase II trial, epirubicin (75 mg/m(2); intravenous bolus) followed by docetaxel (80 mg/m(2); 1-hour intravenous infusion) was administered on Day 1 of each cycle for four cycles.
Results: Nine of 30 patients (30%) had inflammatory breast carcinoma. Twenty-three patients (76.7%; 95% confidence interval, 57.7-90.1) had a clinical objective response that was complete in 6 patients (20%). Twenty-seven patients (90%) underwent surgery that was conservative in 5 patients (16.7%). Pathologic response evaluation revealed four complete responses (13.3%; 95% confidence interval, 3.8-30.7). Grade 4 neutropenia was recorded in 80.0% of patients, and febrile neutropenia was recorded in one-third of patients. Anemia and thrombocytopenia were never severe. Other side effects were diarrhea (26.6%), oral mucositis (43.3%), and emesis (26.6%).
Conclusions: Neoadjuvant chemotherapy with epirubicin plus docetaxel was a feasible treatment and was active in an unfavorable series of patients with locally advanced breast carcinoma, including patients with inflammatory breast carcinoma.
Copyright 2002 American Cancer Society.DOI 10.1002/cncr.20335
Source: PubMed