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Annals of Oncology Advance Access published online on September 7, 2005
Annals of Oncology, doi:10.1093/annonc/mdi366
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© 2005 European Society for Medical Oncology
Received April 7, 2005
Revised June 28, 2005
Accepted July 4, 2005

Original article

Postoperative dose-dense sequential chemotherapy with epirubicin, followed by CMF with or without paclitaxel, in patients with high-risk operable breast cancer: a randomized phase III study conducted by the Hellenic Cooperative Oncology Group

G. Fountzilas 1*, D. Skarlos 2, U. Dafni 3, H. Gogas 4, E. Briasoulis 5, D. Pectasides 6, C. Papadimitriou 7, C. Markopoulos 4, A. Polychronis 8, H. P. Kalofonos 9, V. Siafaka 5, P. Kosmidis 10, E. Timotheadou 1, D. Tsavdaridis 11, D. Bafaloukos 12, P. Papakostas 13, E. Razis 10, P. Makrantonakis 14, G. Aravantinos 15, C. Christodoulou 2, and A.-M. Dimopoulos 7

1 Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece
2 Henry Dunant Hospital, Athens, Greece
3 Laboratory of Biostatistics, University of Athens School of Nursing, Athens, Greece
4 Laikon Hospital, Athens, Greece
5 University of Ioannina School of Medicine, Ioannina, Greece
6 University Hospital Attikon, Athens, Greece
7 Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece
8 6th Social Services Oncological Hospital (IKA), Athens, Greece
9 University of Patras School of Medicine, Patras, Greece
10 Hygeia Hospital, Athens, Greece
11 IKA Hospital, Thessaloniki, Greece
12 Metropolitan Hospital, Athens, Greece
13 Ippokration Hospital, Athens, Greece
14 Theagen on Cancer Hospital, Thessaloniki, Greece
15 Agii Anargiri Cancer Hospital, Athens, Greece

* To whom correspondence should be addressed.
G. Fountzilas, E-mail: fountzil{at}med.auth.gr


  Abstract

Purpose: The aim of this study was to explore the effect of dose-dense sequential chemotherapy with or without paclitaxel primarily on disease-free survival (DFS) and secondarily on overall survival (OS) in patients with high-risk operable breast cancer.

Patients and methods: From June 1997 until November 2000, 604 patients with T1-3N1M0 or T3N0M0 tumors were randomized to three cycles of epirubicin 110 mg/m2 followed by three cycles of paclitaxel 250 mg/m2 followed by three cycles of ‘intensified’ CMF (cyclophosphamide 840 mg/m2, methotrexate 47 mg/m2 and fluorouracil 840 mg/m2) (group A), or to four cycles of epirubicin followed by four cycles of CMF, as in group A (group B). All cycles were given every 2 weeks with granulocyte colony-stimulating factor support.

Results: A total of 595 patients were eligible. Median follow-up was 61.7 months for group A and 62 months for group B. The 3-year DFS was 80% in group A and 77% in group B. Survival rates were 93% and 90%, respectively. The effect of treatment on the hazard of death was different according to hormonal receptor status. More specifically, in patients with negative receptor status the hazard of death was significantly higher for group B (hazard ratio 2.42). Both regimens were well tolerated and severe acute side-effects were infrequent. No cases of severe cardiotoxicity or acute leukemia were recorded.

Conclusions: The present study failed to demonstrate a significant difference in DFS or OS between the two treatment groups. However, our study has shown clearly that high-dose paclitaxel can be safely incorporated to dose-dense sequential chemotherapy.

Keywords: breast cancer; dose-dense chemotherapy; E-CMF; paclitaxel; randomized.
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