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The Efficacy of Doxorubicin and Docetaxel in a Phase II Trial of Neoadjuvant Treatment of Locally Advanced Breast Cancer

The Efficacy of Doxorubicin and Docetaxel in a Phase II Trial of Neoadjuvant Treatment of Locally Advanced Breast Cancer

Docetaxel (Taxotere) is a semisynthetic taxane that has efficacy in combination regimens with doxorubicin (Adriamycin) in the treatment of metastatic breast cancer. This study was instituted to assess the role of this combination in the neoadjuvant treatment of locally advanced breast cancer (LABC).

Doxorubicin was administered at 50 mg/m² and docetaxel at 75 mg/m². Doxorubicin/docetaxel (AT) was given every 21 days for a total of six cycles to patients with stages IIB (T3, N0), IIIA, and IIIB LABC. Patients were then assessed for clinical response using standard response criteria. They then underwent a modified radical mastectomy (MRM). Specimens from MRMs were examined for pathologic response, which was defined using standard response criteria, with an additional category of minimal residual disease (pMRD) defined as microscopic foci of invasive carcinoma in £ 2 high-powered field.

Sixteen patients have been entered into the study since January 1998, and are evaluable at this time for clinical and pathologic response. Fourteen completed six cycles of AT and proceeded to surgery. One patient has progressed on therapy after three cycles. One patient, included in the clinical response data only, had a clinical and mammographic complete response (CR), refused MRM, and received radiation alone. The patients’ median age was 50 years (range: 31–69 years). Ten patients (63%) were African-American, 4 (25%) were Latina, and 2 (12%) were Caucasian.

At diagnosis, 2 patients (13%) were stage IIIB (T3, N0), 10 (62%) were stage IIIA, and 4 (25%) were stage IIIB. Clinically, 7 patients (44%) had a CR, 6 (38%) had a partial response (PR), 1 (6%) had a minimal response, 1 (6%) had stable disease (SD), and 1 (6%) progressed (PD) on therapy. On pathologic examination, 2 patients (13%) had CR (pCR), 4 (27%) had pMRD, 7 (46%) had pPR, 1 (7%) had pSD, and 1 (7%) had pPD.

CONCLUSION: Doxorubicin/docetaxel is active in the neoadjuvant setting for LABC, with an overall response (CR + PR) of 82%. Forty percent of patients receiving AT had a pCR or pMRD at MRM—a good prognostic factor in this group of patients.

Click here for Dr. Gabriel N. Hortobagyi’s commentary on this abstract.

 
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