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Preoperative FLAC/Granulocyte-Colony-Stimulating Factor Chemotherapy for Stage II Breast Cancer: A Prospective Randomized Trial

From the Surgery (DND), Medicine (KC, AB, JZ), and Radiation Oncology (RA) Branches, the Laboratory of Pathology (MM), and the Biostatistics and Data Management Section (SMS), Center for Cancer Research of the National Cancer Institute, Bethesda, Maryland; the Departments of Radiology (CC) and Rehabilitation Medicine (UC), Clinical Center, National Institutes of Health, Bethesda, Maryland; and the Department of Surgery (CS), Walter Reed Army Medical Center, Washington, DC.

Correspondence: Address correspondence and reprint requests to: David N. Danforth, Jr, MD, Surgery Branch, National Cancer Institute, Bldg. 10, Rm. 2B38, Bethesda, MD 20815; Fax: 301-496-0011; E-mail: david_danforth{at}nih.gov

Background: Preoperative chemotherapy for stage II breast cancer may reduce locoregional tumors and provides initial treatment for systemic micrometastases. We conducted a prospective, randomized trial to evaluate the ability of intensive preoperative chemotherapy to enhance the outcome of this approach.

Methods: Patients with clinical stage II breast cancer (T2N0, T1N1, and T2N1) were prospectively randomized to receive either preoperative or postoperative chemotherapy with five 21-day cycles of fluorouracil, leucovorin calcium, doxorubicin, and cyclophosphamide (FLAC)/granulocyte-colony-stimulating factor. Local therapy consisted of modified radical mastectomy or segmentectomy/axillary dissection/breast radiotherapy, according to patient preference.

Results: Fifty-three women were randomized (26 preoperative chemotherapy and 27 postoperative chemotherapy). The objective clinical response rate of the primary tumor to preoperative chemotherapy was 80%, and the pathologic complete response rate was 20%. Preoperative chemotherapy reduced the overall incidence and number of axillary lymph node metastases. There was no difference in the use of breast-conserving local therapy between the two treatment arms. There were 20 local/regional or distant recurrences (9 preoperative and 11 postoperative). There was no difference in the overall or disease-free survival between the preoperative and postoperative chemotherapy arms.

Conclusions: Preoperative FLAC/granulocyte-colony-stimulating factor chemotherapy was effective against local/regional tumors in stage II breast cancer but was otherwise comparable to postoperative chemotherapy.

Key Words: Breast cancer • Preoperative chemotherapy • Neoadjuvant • Breast conservation • Axillary lymph nodes

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