Multicycle dose-intensive chemotherapy for women with high-risk primary breast cancer: Results of International Breast Cancer Study Group trial 15-95

Russell L. Basser, Anne O'Neil, Giovanni Martinelli, Michael D. Green, Fedro Peccatori, Severio Cinieri, Alan S. Caotes, Richard D. Gelber, Stefan Aebi, Monica Castiglione-Gertsch, Guiseppe Viale, Karen N. Price, Aron Goldhirsch

Research output: Contribution to journalArticle

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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 languageEnglish
Pages (from-to)370-378
Number of pages9
JournalJournal of Clinical Oncology
Volume24
Issue number3
DOIs
Publication statusPublished - Jan 20 2006

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Anthracyclines
Breast Neoplasms
Drug Therapy
Disease-Free Survival
Epirubicin
Cyclophosphamide
Stem Cells
Tamoxifen
Cardiomyopathies
Estrogen Receptors
Meta-Analysis
Neoplasms
Hormones
Recurrence
Survival

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 journalArticle

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. / Multicycle dose-intensive chemotherapy for women with high-risk primary breast cancer : Results of International Breast Cancer Study Group trial 15-95. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 3. pp. 370-378.
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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.",
author = "Basser, {Russell L.} and Anne O'Neil and Giovanni Martinelli and Green, {Michael D.} and Fedro Peccatori and Severio Cinieri and Caotes, {Alan S.} and Gelber, {Richard D.} and Stefan Aebi and Monica Castiglione-Gertsch and Guiseppe Viale and Price, {Karen N.} and Aron Goldhirsch",
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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.

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