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Ann Oncol. 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.

Collaborators (201)

Basser R, Goldhirsch A, Coates AS, Aebi S, Coates AS, Colleoni M, Collins JP, Cortés Funes H, Gelber RD, Goldhirsch A, Green M, Hiltbrunner A, Holmberg SB, Karlsson P, Kössler I, Láng I, Lindtner J, Paganetti F, de Stoppani M, Rudenstam CM, Senn HJ, Stahel R, Thürlimann B, Veronesi A, Hiltbrunner A, Egli G, Rabaglio M, Ruepp B, Maibach R, Gelber RD, Price K, Sun Z, Regan M, Cole B, Gelber S, Giobbie-Hurder A, Aldridge J, Bernhard J, Ribi K, Gerber D, Gusterson B, Viale G, Blacher L, Celano J, Hinkle R, Lippert S, Scott K, Forbes JF, Lindsay D, Preece D, Simes RJ, Collins J, Snyder R, Abdi E, Basser R, Burns WI, Chipman M, Chirgwin J, Ganju V, Green M, McLachlan S, Howell D, Prince M, Schwarer A, Toner G, Underhill C, Craft P, Harris S, Pembrey R, Forbes JF, Stewart J, Ackland S, Bonaventura A, Taylor K, Friedlander M, Brigham B, Lewis C, Goldstein D, Kotasek D, Olver IN, Gill PG, Keefe D, Abraham R, Wyld D, Boyle F, Durrant S, Bell D, Beith J, Boyer M, Coates AS, Sullivan A, Byrne M, van Hazel G, Dewar J, Harvey VJ, Thompson P, Porter D, McCrystal M, Martinelli G, Peccatori F, Veronesi U, Viale G, Luini A, Orecchia R, Cinieri S, Cocorocchio E, Renne G, Mazzarol G, Colleoni M, Agazzi A, Nolé F, Costa A, Zurrida S, Veronesi P, Sacchini V, Galimberti V, de Braud F, Peruzzotti G, Didier F, Goldhirsch A, Ravaioli A, Tassinari D, Oliverio G, Barbanti F, Rinaldi P, Gianni L, Drudi G, Wickham N, Leung T, Yeo W, King W, Kwan W, Suen M, Chak K, Lee L, Fey MF, Aebi S, Dreher E, Schneider H, Buser K, Ludin J, Beck G, Bürgi H, Haenel A, Lüthi JM, Markwalder R, Altermatt HJ, Nandedkar M, Senn HJ, Thürlimann B, Ries G, Töpfer M, Lorenz U, Schiltknecht O, Späti B, Cavalli F, Sessa C, Martinelli G, Ghielmini M, Luscieti P, Bernier J, Pedrinis E, Rusca T, Goldhirsch A, Perey L, Leyvraz S, Anani P, Genton C, Gomez F, De Grandi P, Reymond P, Mirimanoff R, Gillet M, Delaloye JF, Alberto P, Bonnefoi H, Schäfer P, Krauer F, Forni M, Aapro M, Egeli R, Megevand R, Jacot-des-Combes E, Schindler A, Borisch B, Diebold S, Sauter Ch, Metzger U, Engeler V, Haller U, Caduff R, Lindtner J, Erzen D, Majdic E, Stabuc B, Plesnicar A, Golouh R, Lamovec J, Jancar J, Vrhoved I, Kramberger M.

Author information

Department of Medicine, Research Unit in Medical Senology, European Institute of Oncology, Milan, Italy.



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


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.


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).


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.

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