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• W2546896467 abstract "Purpose: Cyclophosphamide, epirubicin, and fluorouracil (CEF), compared with classical cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy. has lead to an improvement in relapse-free and overall survival in premenopausal women with node-positive breast cancer. We undertook this analysis to more accurately define the estimate of risk of secondary acute leukemia (sAL) following epirubicin-containing chemotherapy regimens. Patients and Methods: We assessed the conditional probability of sAL among 1,545 women who received adjuvant (n 1,477) or neoadjuvant (n 68) chemotherapy in four National Cancer Institute of Canada Clinical Trials Group trials from 1990 to 1999. The risks associated with epirubicin-containing regimens (CEF or epirubicin and cyclophosphamide [EC]) and other regimens (doxorubicin and cyclophosphamide [AC] or CMF) were determined. Results: A total of 10 cases of sAL were observed (eight acute myelogeneous leukemia, two acute lymphoblastic leukemia): seven among women treated with CEF, two who had received AC, and one following CMF. Using competing risk statistics, the conditional probability of sAL was 1.7% (95% confidence interval [CI], 0.5 to 3.6) among 539 women treated with CEF chemotherapy at a follow-up of 8 years, 0.4% (95% CI, 0% to 1.3%) among the 678 who received CMF, and 1.3% (95% CI, 0% to 4.7%) among the 231 treated with AC. The conditional probability of death from breast cancer at 8 years for the entire group of women treated with epirubicin-containing regimens in all four trials was approximately 34.9%. Conclusion: CEF chemotherapy for breast cancer carries a small increased risk of sAL compared with CMF. These estimates of acute leukemia risk are important in discussing treatment with women, especially patients with a lower risk of death from breast cancer, such as those with nodenegative breast cancer. J Clin Oncol 21:3066-3071. © 2003 by American Society of Clinical Oncology. A DJUVANT CHEMOTHERAPY (AC) decreases the risk of recurrence and death in women with lymph node-positive and node-negative primary breast cancer. The use of anthracycline-based chemotherapy in the adjuvant setting is associated with an improvement in disease-free and overall survival compared with nonanthracycline-containing regimens such as cyclophosphamide, methotrexate, and fluorouracil (CMF). 1 Most trials that have demonstrated an improvement have substituted the anthracycline for methotrexate in CMF and maintained the same dose and schedule of cyclophosphamide and fluorouracil (FU). 2 We have previously shown that cyclophosphamide, epirubicin, and fluorouracil (CEF; cyclophosphamide 75 mg/m 2 orally days 1 to 14, epirubicin 60 mg/m 2 , and FU 500 mg/m 2 intravenously [IV] on days 1 and 8) compared with classical CMF adjuvant chemotherapy (cyclophosphamide 100 mg/m 2 orally days 1 to 14, methotrexate 60 mg/m 2 , and FU 600 mg/m 2 IV on days 1 and 8) results in a 10% absolute improvement in relapse-free survival and a 7% absolute improvement in overall survival after 5 years in premenopausal women with axillary lymph node‐positive primary breast cancer. 3 Our study used slightly reduced doses of cyclophosphamide and FU in order to deliver a relatively high dose and dose-intensity of epirubicin. However, in that study, we observed five cases of acute leukemia among 351 eligible women treated with CEF. CEF is now widely accepted as the standard of care in Canada for women with lymph node‐positive breast cancer, and it is also used for some patients with high-risk node-negative breast cancer. This regimen forms the control arm of the ongoing National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) adjuvant chemotherapy trial in node-positive and high-risk node-negative breast cancer. In light of this, and because the median follow-up of women at the time of analysis in our previous report was relatively short with respect to the potential development of secondary leukemia (59 months), we performed the present analysis to refine the estimate of this complication following epirubicin-based chemotherapy. We reviewed all women treated with chemotherapy on three adjuvant studies and one preoperative chemotherapy trial for locally advanced breast cancer, in order to evaluate a larger number of patients with longer follow-up." @default.
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• W2546896467 date "2003-01-01" @default.
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• W2546896467 title "Risk o f A cute L eukemia F ollowing E pirubicin-Based A djuvant Chemotherapy: A R eport F rom t he N ational C ancer I nstitute o f Canada C linical T rials G roup" @default.
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