Docetaxel plus epidoxorubicin as neoadjuvant treatment in patients with large operable or locally advanced carcinoma of the breast : A single-center, Phase II study

✍ Scribed by Andrea de Matteis; Francesco Nuzzo; Giuseppe D'Aiuto; Vincenzo Labonia; Gabriella Landi; Emanuela Rossi; Angelo Antonio Mastro; Gerardo Botti; Ermelinda De Maio; Francesco Perrone

• Publisher: John Wiley and Sons
• Year: 2002
• Tongue: English
• Weight: 76 KB
• Volume: 94
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/cncr.20335

✦ Synopsis

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. Cancer 2002;94:895–901. © 2002 American Cancer Society.

DOI 10.1002/cncr.20335