Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2009 Aug;20(8):1344-51.
doi: 10.1093/annonc/mdp024. Epub 2009 May 25.

The effect of endocrine responsiveness on high-risk breast cancer treated with dose-intensive chemotherapy: results of International Breast Cancer Study Group Trial 15-95 after prolonged follow-up

M Colleoni  1 , Z Sun, G Martinelli, R L Basser, A S Coates, R D Gelber, M D Green, F Peccatori, S Cinieri, S Aebi, G Viale, K N Price, A Goldhirsch; International Breast Cancer Study Group
Collaborators, Affiliations
Randomized Controlled Trial

The effect of endocrine responsiveness on high-risk breast cancer treated with dose-intensive chemotherapy: results of International Breast Cancer Study Group Trial 15-95 after prolonged follow-up

M Colleoni et al. Ann Oncol. 2009 Aug.

Abstract

Background: The role of adjuvant dose-intensive chemotherapy and its efficacy according to baseline features has not yet been established.

Patients and methods: Three hundred and forty-four patients were randomized to receive seven courses of standard-dose chemotherapy (SD-CT) or three cycles of dose-intensive epirubicin and cyclophosphamide (epirubicin 200 mg/m(2) plus cyclophosphamide 4 mg/m(2) with filgrastim and progenitor cell support). All patients were assigned tamoxifen at the completion of chemotherapy. The primary end point was disease-free survival (DFS). This paper updates the results and explores patterns of recurrence according to predicting baseline features.

Results: At 8.3-years median follow-up, patients assigned DI-EC had a significantly better DFS compared with those assigned SD-CT [8-year DFS percent 47% and 37%, respectively, hazard ratio (HR) 0.76; 95% confidence interval 0.58-1.00; P = 0.05]. Only patients with estrogen receptor (ER)-positive disease benefited from the DI-EC (HR 0.61; 95% confidence interval 0.39, 0.95; P = 0.03).

Conclusions: After prolonged follow-up, DI-EC significantly improved DFS, but the effect was observed only in patients with ER-positive disease, leading to the hypothesis that efficacy of DI-EC may relate to its endocrine effects. Further studies designed to confirm the importance of endocrine responsiveness in patients treated with dose-intensive chemotherapy are encouraged.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Disease-free survival (DFS) (A) and overall survival (B) comparing patients assigned to dose-intensive epirubicin and cyclophosphamide × 3 (DI-EC) with patients assigned to standard-dose chemotherapy (SD-CT). The median follow-up was 8.3 years.
Figure 2.
Figure 2.
Cumulative incidence of competing causes of failure according to treatment.
Figure 3.
Figure 3.
Disease-free survival (DFS) for estrogen receptor (ER)-positive (A) and ER-negative cohorts (B) comparing patients assigned to dose-intensive epirubicin and cyclophosphamide × 3 (DI-EC) with patients assigned to standard-dose chemotherapy (SD-CT).
Figure 4.
Figure 4.
Subpopulation treatment effect pattern plots (STEPPs) for overlapping age subgroups. The 5-year disease-free survival (DFS) percentages are plotted for cohorts defined by estrogen receptor status (positive, left; negative, right) among all patients (A and B) and patients with ≥10 positive nodes (C and D).
See this image and copyright information in PMC

References

    1. Roche H, Viens P, Biron P, et al. High-dose chemotherapy for breast cancer: the French PEGASE experience. Cancer Control. 2003;10:42–47. - PubMed
    1. Nitz U, Mohrmann S, Fischer J, et al. Comparison of rapidly cycled tandem high dose chemotherapy plus peripheral-blood stem-cell support versus dose-dense conventional chemotherapy for adjuvant treatment of high-risk breast cancer: results of a multicentre phase III trial. Lancet. 2005;366:1935–1944. - PubMed
    1. Zander AR, Kroeger N, Schmoor C, et al. High-dose chemotherapy with autologous hematopoietic stem-cell support compared with standard-dose chemotherapy in breast cancer patients with 10 or more positive lymph nodes: first results of a randomized trial. J Clin Oncol. 2004;22:2273–2283. - PubMed
    1. Rodenhuis S, Bontenbal M, Beex LV, et al. High-dose chemotherapy with hematopoietic stem-cell rescue for high risk breast cancer. N Engl J Med. 2003;349:7–16. - PubMed
    1. Leonard R, Lind M, Twelves C, et al. Conventional adjuvant chemotherapy versus single-cycle, autograft-supported, high-dose, late-intensification chemotherapy in high-risk breast cancer patients: a randomized trial. J Natl Cancer Inst. 2004;96:1076–1083. - PubMed

Publication types

MeSH terms