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

41 Scopus citations


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
Issue number8
StatePublished - Mar 10 2011


ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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