Randomized trial of high-dose chemotherapy and autologous hematopoietic stem cell support for high-risk primary breast carcinoma: Follow-up at 12 years

Emer O. Hanrahan, Kristine Broglio, Deborah Frye, Aman U. Buzdar, Richard L. Theriault, Vicente Valero, Daniel J. Booser, Sonja E. Singletary, Eric A. Strom, James L. Gajewski, Richard E. Champlin, Gabriel N. Hortobagyi

Research output: Contribution to journalArticlepeer-review

28 Scopus citations


BACKGROUND. The authors previously reported results from a randomized trial of standard-dose chemotherapy with combined 5-fluorouracil (1000 mg/m 2 per cycle), doxorubicin (50 mg/m2 per cycle), and cyclophosphamide (500 mg/m2 per cycle) (FAC) versus FAC followed by high-dose chemotherapy (HDCT) and autologous stem cell support (ASCS) for patients with high-risk primary breast carcinoma. After a median follow-up of 6.5 years, no significant differences were observed in recurrence-free survival (RFS) or overall survival (OS) between the 2 arms. This report updates the survival analyses. METHODS. Patients with ≥ 10 positive axillary lymph nodes after primary surgery or ≥ 4 positive lymph nodes at surgery after neoadjuvant chemotherapy were eligible. All patients were to receive 8 cycles of FAC. Patients were assigned randomly to receive either no further chemotherapy or 2 cycles of combined high-dose cyclophosphamide (5250 mg/m2 per cycle), etoposide (1200 mg/m2 per cycle), and cisplatin (165 mg/m2 per cycle) with ASCS. Primary endpoints were RFS and OS. RFS and OS were calculated by using the Kaplan-Meier method. The log-rank statistic was used to compare treatment arms. RESULTS. Between 1990 and 1997, 78 patients were registered, and 39 patients were assigned randomly to each arm. The median follow-up for all patients who were alive at last follow-up was 142.5 months (range, 45-169 months). An intention-to-treat analysis showed no significant difference between the 2 arms in terms of RFS (at 10 years: 40% with FAC vs. 26% with FAC plus HDCT; P = .11) or OS (at 10 years: 47% with FAC vs. 42% with FAC plus HDCT; P = .13). CONCLUSIONS. With a median follow-up of nearly 12 years for patients who remained alive, this trial continued to demonstrate no RFS or OS advantage for patients with high-risk primary breast carcinoma treated with HDCT after standard-dose FAC chemotherapy.

Original languageEnglish (US)
Pages (from-to)2327-2336
Number of pages10
Issue number11
StatePublished - Jun 1 2006
Externally publishedYes


  • Autologous stem cell support
  • Axillary lymph nodes
  • Breast cancer
  • High-dose chemotherapy
  • Overall survival
  • Recurrence-free survival

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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