'Neo-FAC' (5-fluorouracil, doxorubicin, and cyclophosphamide) for poor- prognosis stage IV breast cancer: A Southwest Oncology Group phase II study

Georgiana K. Ellis, Stephanie Green, Robert B. Livingston, Michael J. Kraut, H. Irving Pierce, Jorge C. Paradelo, Sarah A. Taylor, Silvana Martino

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1 Scopus citations


The authors report a phase II pilot investigation in the Southwest Oncology Group examining a combination of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC) incorporating modulated 5-FU in patients with poor- prognosis stage IV breast cancer. Patients with poor-prognosis stage IV breast cancer were treated with this 'neo-FAC' as front-line therapy. The regimen consisted of 5-fluorouracil by continuous ambulatory infusion pump at 200 mg/m2/day for 42 days, repeated at 56-day intervals; doxorubicin at 20 mg/m2/week intravenously to a maximum cumulative total dose (including adjuvant therapy, if any) of 500 mg/m2; cyclophosphamide 60 mg/m2/day taken orally; methotrexate 15 mg/m2/week intravenously beginning 1 week after termination of doxorubicin; and oral prednisone decreasing from 60 mg/day on a tapering schedule for a total of 7 weeks of treatment. Treatment was continued until progression, unacceptable toxicity, or patient refusal. Twenty-four patients were accrued to this study. Of these, two were ineligible, and the remaining 22 were evaluable for response. Ten patients experienced grade 3 toxicity, and six had grade 4. There were no treatment- associated deaths. Best responses were a complete response in one patient (5%) and partial responses in 6, for an overall response rate of 32% (7/22 evaluable patients). Overall survival in five pilot studies in the Southwest Oncology Group in this poor-prognosis population are relatively superimposable. The present regimen, with its relatively poor outcome and the expense and inconvenience of administering chemotherapy by ambulatory infusion pump, will not be pursued further.

Original languageEnglish (US)
Pages (from-to)446-449
Number of pages4
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Issue number5
StatePublished - Oct 1999
Externally publishedYes


  • 'Neo-FAC'
  • Advanced breast cancer
  • Breast cancer
  • Modulated 5-FU

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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