Abstract
Purpose: To compare adjuvant dose-intensive epirubicin and cyclophosphamide chemotherapy administered with filgrastim and progenitor cell support (DI-EC) with standard-dose anthracycline-based chemotherapy (SD-CT) for patients with early-stage breast cancer and a high risk of relapse, defined as stage II disease with 10 or more positive axillary nodes; or an estrogen receptor-negative or stage III tumor with five or more positive axillary nodes. Patients and Methods: Three hundred forty-four patients were randomized after surgery to receive seven cycles of SD-CT over 22 weeks, or three cycles of DI-EC (epirubicin 200 mg/m2 plus cyclophosphamide 4 gm/m2 with filgrastim and progenitor cell support) over 6 weeks. All patients were assigned tamoxifen at the completion of chemotherapy. The primary end point was disease-free survival (DFS). Results: After a median follow-up of 5.8 years (range, 3 to 8.4 years), 188 DFS events had occurred (DI-EC, 86 events; SD-CT, 102 events). The 5-year DFS was 52% for DI-EC and 43% for SD-CT, with hazard ratio of DI-EC compared with SD-CT of 0.77 (95% CI, 0.58 to 1.02; P = .07). The 5-year overall survival was 70% for DI-EC and 61 % for SD-CT, with a hazard ratio of 0.79 (95% CI, 0.56 to 1.11; P = .17). There were eight cases (5%) of anthracycline-induced cardiomyopathy (two fatal) among those who received DI-EC. Women with hormone receptor-positive tumors benefited significantly from DI-EC. Conclusion: There was a trend in favor of DI-EC with respect to disease-free survival. A larger trial or meta-analysis will be required to reveal the true effect of dose-intensive therapy.
| Original language | English |
|---|---|
| Pages (from-to) | 370-378 |
| Number of pages | 9 |
| Journal | Journal of Clinical Oncology |
| Volume | 24 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Jan 20 2006 |
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ASJC Scopus subject areas
- Cancer Research
- Oncology
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Multicycle dose-intensive chemotherapy for women with high-risk primary breast cancer : Results of International Breast Cancer Study Group trial 15-95. / Basser, Russell L.; O'Neil, Anne; Martinelli, Giovanni; Green, Michael D.; Peccatori, Fedro; Cinieri, Severio; Caotes, Alan S.; Gelber, Richard D.; Aebi, Stefan; Castiglione-Gertsch, Monica; Viale, Guiseppe; Price, Karen N.; Goldhirsch, Aron.
In: Journal of Clinical Oncology, Vol. 24, No. 3, 20.01.2006, p. 370-378.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Multicycle dose-intensive chemotherapy for women with high-risk primary breast cancer
T2 - Results of International Breast Cancer Study Group trial 15-95
AU - Basser, Russell L.
AU - O'Neil, Anne
AU - Martinelli, Giovanni
AU - Green, Michael D.
AU - Peccatori, Fedro
AU - Cinieri, Severio
AU - Caotes, Alan S.
AU - Gelber, Richard D.
AU - Aebi, Stefan
AU - Castiglione-Gertsch, Monica
AU - Viale, Guiseppe
AU - Price, Karen N.
AU - Goldhirsch, Aron
PY - 2006/1/20
Y1 - 2006/1/20
N2 - Purpose: To compare adjuvant dose-intensive epirubicin and cyclophosphamide chemotherapy administered with filgrastim and progenitor cell support (DI-EC) with standard-dose anthracycline-based chemotherapy (SD-CT) for patients with early-stage breast cancer and a high risk of relapse, defined as stage II disease with 10 or more positive axillary nodes; or an estrogen receptor-negative or stage III tumor with five or more positive axillary nodes. Patients and Methods: Three hundred forty-four patients were randomized after surgery to receive seven cycles of SD-CT over 22 weeks, or three cycles of DI-EC (epirubicin 200 mg/m2 plus cyclophosphamide 4 gm/m2 with filgrastim and progenitor cell support) over 6 weeks. All patients were assigned tamoxifen at the completion of chemotherapy. The primary end point was disease-free survival (DFS). Results: After a median follow-up of 5.8 years (range, 3 to 8.4 years), 188 DFS events had occurred (DI-EC, 86 events; SD-CT, 102 events). The 5-year DFS was 52% for DI-EC and 43% for SD-CT, with hazard ratio of DI-EC compared with SD-CT of 0.77 (95% CI, 0.58 to 1.02; P = .07). The 5-year overall survival was 70% for DI-EC and 61 % for SD-CT, with a hazard ratio of 0.79 (95% CI, 0.56 to 1.11; P = .17). There were eight cases (5%) of anthracycline-induced cardiomyopathy (two fatal) among those who received DI-EC. Women with hormone receptor-positive tumors benefited significantly from DI-EC. Conclusion: There was a trend in favor of DI-EC with respect to disease-free survival. A larger trial or meta-analysis will be required to reveal the true effect of dose-intensive therapy.
AB - Purpose: To compare adjuvant dose-intensive epirubicin and cyclophosphamide chemotherapy administered with filgrastim and progenitor cell support (DI-EC) with standard-dose anthracycline-based chemotherapy (SD-CT) for patients with early-stage breast cancer and a high risk of relapse, defined as stage II disease with 10 or more positive axillary nodes; or an estrogen receptor-negative or stage III tumor with five or more positive axillary nodes. Patients and Methods: Three hundred forty-four patients were randomized after surgery to receive seven cycles of SD-CT over 22 weeks, or three cycles of DI-EC (epirubicin 200 mg/m2 plus cyclophosphamide 4 gm/m2 with filgrastim and progenitor cell support) over 6 weeks. All patients were assigned tamoxifen at the completion of chemotherapy. The primary end point was disease-free survival (DFS). Results: After a median follow-up of 5.8 years (range, 3 to 8.4 years), 188 DFS events had occurred (DI-EC, 86 events; SD-CT, 102 events). The 5-year DFS was 52% for DI-EC and 43% for SD-CT, with hazard ratio of DI-EC compared with SD-CT of 0.77 (95% CI, 0.58 to 1.02; P = .07). The 5-year overall survival was 70% for DI-EC and 61 % for SD-CT, with a hazard ratio of 0.79 (95% CI, 0.56 to 1.11; P = .17). There were eight cases (5%) of anthracycline-induced cardiomyopathy (two fatal) among those who received DI-EC. Women with hormone receptor-positive tumors benefited significantly from DI-EC. Conclusion: There was a trend in favor of DI-EC with respect to disease-free survival. A larger trial or meta-analysis will be required to reveal the true effect of dose-intensive therapy.
UR - http://www.scopus.com/inward/record.url?scp=33644840156&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33644840156&partnerID=8YFLogxK
U2 - 10.1200/JCO.2005.03.5196
DO - 10.1200/JCO.2005.03.5196
M3 - Article
C2 - 16421418
AN - SCOPUS:33644840156
VL - 24
SP - 370
EP - 378
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 3
ER -