Phase III comparison of standard doxorubicin and cyclophosphamide versus weekly doxorubicin and daily oral cyclophosphamide plus granulocyte colony-stimulating factor as neoadjuvant therapy for inflammatory and locally advanced breast cancer: SWOG 0012

Georgiana K. Ellis, William E. Barlow, Julie R. Gralow, Gabriel N. Hortobagyi, Christy A. Russell, Melanie E. Royce, Edith A. Perez, Danika Lew, Robert B Livingston

Research output: Contribution to journalArticle

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Abstract

Purpose: Patients with inflammatory breast cancer (IBC) or locally advanced breast cancer (LABC) were randomly assigned to 21-day doxorubicin and cyclophosphamide administered for five cycles (standard arm) versus weekly doxorubicin and daily oral cyclophosphamide administered with granulocyte colony-stimulating factor support for 15 weeks (continuous arm). All patients had subsequent weekly paclitaxel for 12 weeks before surgery. Patients and Methods: Patients (n = 372) were randomly assigned to the standard arm (n = 186) or the continuous arm (n = 186) stratified by disease type (LABC, n = 256; IBC, n = 116). The primary outcome was microscopic pathologic complete response (pCR) at surgery. Secondary outcomes included disease-free survival, overall survival, and toxicity. Results: More patients in the standard arm had grade 3 to 4 leukopenia and neutropenia, but there were more instances of stomatitis/pharyngitis and hand-foot skin reaction in the continuous arm. Assessed among 356 eligible patients, pCR was not different between the treatment groups stratified by disease type (P = .42). In subset analysis, higher pCR rates were observed in the continuous arm versus the standard arm only for stage IIIB disease (P = .0057) and in IBC (P = .06). Comparison of overall survival and disease-free survival showed no difference between treatment groups (P = .37 and P = .87, respectively). Conclusion: No significant clinical benefit was seen for the investigational arm in this trial overall.

Original languageEnglish (US)
Pages (from-to)1014-1021
Number of pages8
JournalJournal of Clinical Oncology
Volume29
Issue number8
DOIs
StatePublished - Mar 10 2011
Externally publishedYes

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Neoadjuvant Therapy
Granulocyte Colony-Stimulating Factor
Doxorubicin
Cyclophosphamide
Arm
Breast Neoplasms
Inflammatory Breast Neoplasms
Disease-Free Survival
Stomatitis
Survival
Pharyngitis
Leukopenia
Paclitaxel
Neutropenia
Foot
Hand
Skin

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase III comparison of standard doxorubicin and cyclophosphamide versus weekly doxorubicin and daily oral cyclophosphamide plus granulocyte colony-stimulating factor as neoadjuvant therapy for inflammatory and locally advanced breast cancer : SWOG 0012. / Ellis, Georgiana K.; Barlow, William E.; Gralow, Julie R.; Hortobagyi, Gabriel N.; Russell, Christy A.; Royce, Melanie E.; Perez, Edith A.; Lew, Danika; Livingston, Robert B.

In: Journal of Clinical Oncology, Vol. 29, No. 8, 10.03.2011, p. 1014-1021.

Research output: Contribution to journalArticle

Ellis, Georgiana K. ; Barlow, William E. ; Gralow, Julie R. ; Hortobagyi, Gabriel N. ; Russell, Christy A. ; Royce, Melanie E. ; Perez, Edith A. ; Lew, Danika ; Livingston, Robert B. / Phase III comparison of standard doxorubicin and cyclophosphamide versus weekly doxorubicin and daily oral cyclophosphamide plus granulocyte colony-stimulating factor as neoadjuvant therapy for inflammatory and locally advanced breast cancer : SWOG 0012. In: Journal of Clinical Oncology. 2011 ; Vol. 29, No. 8. pp. 1014-1021.
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abstract = "Purpose: Patients with inflammatory breast cancer (IBC) or locally advanced breast cancer (LABC) were randomly assigned to 21-day doxorubicin and cyclophosphamide administered for five cycles (standard arm) versus weekly doxorubicin and daily oral cyclophosphamide administered with granulocyte colony-stimulating factor support for 15 weeks (continuous arm). All patients had subsequent weekly paclitaxel for 12 weeks before surgery. Patients and Methods: Patients (n = 372) were randomly assigned to the standard arm (n = 186) or the continuous arm (n = 186) stratified by disease type (LABC, n = 256; IBC, n = 116). The primary outcome was microscopic pathologic complete response (pCR) at surgery. Secondary outcomes included disease-free survival, overall survival, and toxicity. Results: More patients in the standard arm had grade 3 to 4 leukopenia and neutropenia, but there were more instances of stomatitis/pharyngitis and hand-foot skin reaction in the continuous arm. Assessed among 356 eligible patients, pCR was not different between the treatment groups stratified by disease type (P = .42). In subset analysis, higher pCR rates were observed in the continuous arm versus the standard arm only for stage IIIB disease (P = .0057) and in IBC (P = .06). Comparison of overall survival and disease-free survival showed no difference between treatment groups (P = .37 and P = .87, respectively). Conclusion: No significant clinical benefit was seen for the investigational arm in this trial overall.",
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T1 - Phase III comparison of standard doxorubicin and cyclophosphamide versus weekly doxorubicin and daily oral cyclophosphamide plus granulocyte colony-stimulating factor as neoadjuvant therapy for inflammatory and locally advanced breast cancer

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AU - Ellis, Georgiana K.

AU - Barlow, William E.

AU - Gralow, Julie R.

AU - Hortobagyi, Gabriel N.

AU - Russell, Christy A.

AU - Royce, Melanie E.

AU - Perez, Edith A.

AU - Lew, Danika

AU - Livingston, Robert B

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