- National Cancer Institute’s Breast Intergroup, INT C9741 and CALGB 9741 trial:
- Was a prospective, randomized trial:
- Designed to study adjuvant chemotherapy treatment regimens in women with axillary node-positive breast cancer:
- It was conducted from September 1997 to March 1999
- Doxorubicin (A), paclitaxel (T), and cyclophosphamide (C) were chosen for this study
- Designed to study adjuvant chemotherapy treatment regimens in women with axillary node-positive breast cancer:
- Was a prospective, randomized trial:
- Using a 2 x 2 factorial design, a total of 2005 patients were randomly assigned to receive 1 of the following regimens:
- Sequential A then C followed by T x 4 cycles every 3 weeks
- Dose-dense, sequential A then C then T x 4 cycles every 2 weeks with filgrastim
- Concurrent AC x 4 cycles followed by T x 4 cycles every 3 weeks
- Dose-dense, concurrent AC x 4 cycles followed by T x 4 cycles every 2 weeks with filgrastim
- Results showed:
- That dose-dense treatment improved the primary endpoints of:
- DFS and OS:
- Four-year DFS was:
- 82% for dose-dense regimens and 75% for other groups:
- Risk ratio, 0.74, P=0.01
- 82% for dose-dense regimens and 75% for other groups:
- Three-year OS:
- Was 92% for dose-dense regimens and 90% in other groups:
- Risk ratio, 0.69, P=0.013
- Was 92% for dose-dense regimens and 90% in other groups:
- There was no difference in either DFS or OS:
- Between the concurrent and sequential schedules
- Four-year DFS was:
- DFS and OS:
- Severe neutropenia:
- Was less common in patients who received:
- The dose-dense regimens
- Was less common in patients who received:
- That dose-dense treatment improved the primary endpoints of:
- As a result of this study:
- Dose-dense and concurrent AC chemotherapy has become one of the standard components of breast cancer therapy
REFERENCES
- Citron ML, Berry DA, Cirrincione C, et al. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol. 2003;21:1431-1439.
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