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A Phase II Trial of Neoadjuvant Docetaxel and Capecitabine for Locally Advanced Breast Cancer

¹ Medical Oncology Clinical Research Unit, ² Cancer Therapeutics Branch, ³ Laboratory of Pathology, ⁴ Biostatistics and Data Management, and ⁵ Surgery Branch, National Cancer Institute, Bethesda, Maryland; and ⁶ Diagnostic Radiology Department, National Institutes of Health, Bethesda, Maryland

Purpose: This study evaluated the toxicity and efficacy of docetaxel/capecitabine as neoadjuvant treatment for stage 2/3 breast cancer.

Experimental Design: Subjects with newly diagnosed invasive stage 2 and 3 breast cancer were eligible. The first cohort of patients was treated at dose A with neoadjuvant docetaxel (75 mg/m² i.v. day 1) and capecitabine (1000 mg/m² orally twice daily days 2–15) for four cycles. A second cohort of subjects was treated with a reduced dose, dose B, of docetaxel (60 mg/m² i.v. day 1) and capecitabine (937.5 mg/m² orally twice daily days 2–15).

Results: Thirty patients were enrolled. Eight of 10 patients treated at dose A required dose reductions of either docetaxel or capecitabine secondary to grade 3 or 4 toxicities: mucositis (1), hand-foot syndrome (3), diarrhea (2), perirectal abscess (1), and neutropenia (2). Because of a high rate of dose reductions, the next 20 patients were treated at dose B. The mean cumulative administered dose of docetaxel was 285 and 231 mg/m² at dose A and dose B, respectively. For capecitabine, the mean cumulative dose at dose A and B were similar at 1585 and 1627 mg/m²/day, respectively. The overall clinical response rate was 90% with 31% of patients having a complete response and 59% having a partial response. A pathological complete response in the breast was achieved in 10% of patients after four cycles of docetaxel/capecitabine.

Conclusions: Docetaxel/capecitabine is a highly active regimen in the neoadjuvant setting. Neoadjuvant therapy with 75 mg/m² docetaxel and 1600 mg/m²/day days 2–15 is recommended.

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