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

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

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 (US)
Pages (from-to)635-644
Number of pages10
JournalAnnals of Surgical Oncology
Volume10
Issue number6
DOIs
StatePublished - Dec 1 2003

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Granulocyte Colony-Stimulating Factor
Breast Neoplasms
Drug Therapy
Breast
Arm
Modified Radical Mastectomy
Neoplasms
Neoplasm Micrometastasis
Segmental Mastectomy
Leucovorin
Patient Preference
Therapeutics
Fluorouracil
Doxorubicin
Cyclophosphamide
Disease-Free Survival
Dissection
Radiotherapy
Lymph Nodes
Neoplasm Metastasis

Keywords

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

ASJC Scopus subject areas

  • Surgery
  • Oncology

Cite this

Preoperative FLAC/granulocyte-colony-stimulating factor chemotherapy for stage II breast cancer : A prospective randomized trial. / Danforth, David N.; Cowan, Kenneth; Altemus, Rosemary; Merino, Maria; Chow, Catherine; Berman, Arlene; Chaudhry, Usha; Shriver, Craig; Steinberg, Seth M.; Zujewski, Jo Anne.

In: Annals of Surgical Oncology, Vol. 10, No. 6, 01.12.2003, p. 635-644.

Research output: Contribution to journalArticle

Danforth, DN, Cowan, K, Altemus, R, Merino, M, Chow, C, Berman, A, Chaudhry, U, Shriver, C, Steinberg, SM & Zujewski, JA 2003, 'Preoperative FLAC/granulocyte-colony-stimulating factor chemotherapy for stage II breast cancer: A prospective randomized trial', Annals of Surgical Oncology, vol. 10, no. 6, pp. 635-644. https://doi.org/10.1245/ASO.2003.12.008
Danforth, David N. ; Cowan, Kenneth ; Altemus, Rosemary ; Merino, Maria ; Chow, Catherine ; Berman, Arlene ; Chaudhry, Usha ; Shriver, Craig ; Steinberg, Seth M. ; Zujewski, Jo Anne. / Preoperative FLAC/granulocyte-colony-stimulating factor chemotherapy for stage II breast cancer : A prospective randomized trial. In: Annals of Surgical Oncology. 2003 ; Vol. 10, No. 6. pp. 635-644.
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T2 - A prospective randomized trial

AU - Danforth, David N.

AU - Cowan, Kenneth

AU - Altemus, Rosemary

AU - Merino, Maria

AU - Chow, Catherine

AU - Berman, Arlene

AU - Chaudhry, Usha

AU - Shriver, Craig

AU - Steinberg, Seth M.

AU - Zujewski, Jo Anne

PY - 2003/12/1

Y1 - 2003/12/1

N2 - 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.

AB - 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.

KW - Axillary lymph nodes

KW - Breast cancer

KW - Breast conservation

KW - Neoadjuvant

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