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

Marco Colleoni, 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

Research output: Contribution to journalArticle


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/m2 plus cyclophosphamide 4 mg/m2 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.

Original languageEnglish
Pages (from-to)1344-1351
Number of pages8
JournalAnnals of Oncology
Issue number8
Publication statusPublished - 2009



  • Adjuvant treatment
  • Dose-intensive chemotherapy
  • Early breast cancer
  • Endocrine responsiveness

ASJC Scopus subject areas

  • Oncology
  • Hematology
  • Medicine(all)

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