Preoperative FLAC/granulocyte-colony-stimulating factor chemotherapy for stage II breast cancer: A prospective randomized trial

David N. Danforth*, Kenneth Cowan, Rosemary Altemus, Maria Merino, Catherine Chow, Arlene Berman, Usha Chaudhry, Craig Shriver, Seth M. Steinberg, Jo Anne Zujewski

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

29 Scopus citations


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.

Original languageEnglish
Pages (from-to)635-644
Number of pages10
JournalAnnals of Surgical Oncology
Issue number6
StatePublished - 2003
Externally publishedYes


  • Axillary lymph nodes
  • Breast cancer
  • Breast conservation
  • Neoadjuvant
  • Preoperative chemotherapy


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