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Annals of Oncology Advance Access originally published online on November 27, 2007
Annals of Oncology 2008 19(5):853-860; doi:10.1093/annonc/mdm539
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© The Author 2007. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

breast cancer

Postoperative dose-dense sequential chemotherapy with epirubicin, paclitaxel and CMF in patients with high-risk breast cancer: safety analysis of the Hellenic Cooperative Oncology Group randomized phase III trial HE 10/00

G. Fountzilas1,*, U. Dafni2, H. Gogas3, H. Linardou4, H. P. Kalofonos5, E. Briasoulis6, D. Pectasides7, E. Samantas8, D. Bafaloukos4, G. P. Stathopoulos9, M. Karina1, C. Papadimitriou10, D. Skarlos9, N. Pisanidis11, P. Papakostas12, C. Markopoulos3, E. Tzorakoeleftherakis5, K. Dimitrakakis10, P. Makrantonakis13, N. Xiros7, A. Polichronis14, I. Varthalitis15, C. Karanikiotis16 and A. M. Dimopoulos10

1 Department of Medical Oncology, Papageorgiou Hospital, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki
2 Laboratory of Biostatistics, University of Athens School of Nursing, Athens
3 Laikon Hospital, University of Athens School of Medicine, Athens
4 Department of Medical Oncology, Metropolitan Hospital, Athens
5 University of Patras Medical School, Patras
6 Department of Medical Oncology, Ioannina University Hospital, Ioannina
7 2nd Department of Internal Medicine-Propaedeutic, University General Hospital Attikon, Athens
8 3rd Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens
9 Department of Medical Oncology, Henry Dunant Hospital, Athens
10 Department of Clinical Therapeutics, Alexandra Hospital, University of Athens School of Medicine, Athens
11 Department of Medical Oncology, IKA Hospital, Thessaloniki
12 Department of Medical Oncology, Hippokration Hospital, Athens
13 Theagenion Cancer Hospital, Thessaloniki
14 6th Social Services Oncological Hospital (IKA), Athens
15 Chania General Hospital, Chania, Crete
16 424 General Military Hospital of Thessaloniki, Thessaloniki, Greece

* Correspondence to: Dr G. Fountzilas, Department of Medical Oncology, Papageorgiou Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece. Tel: +30-2310-693134; Fax: +30-2310-683136; E-mail: fountzil{at}med.auth.gr

Background: A randomized phase III trial in high-risk breast cancer patients was conducted, to further explore the impact of dose-density in the adjuvant treatment for breast cancer. The safety analysis is presented.

Patients and methods: From October 2000 until June 2005, 1121 node-positive patients were randomized to sequential dose-dense epirubicin 110 mg/m2 and paclitaxel (Taxol®, Bristol Myers-Squibb, Princeton, New Jersey, USA) 250 mg/m2 (group A), or concurrent epirubicin 83 mg/m2 and paclitaxel 187 mg/m2 (group B), both followed by three cycles of ‘intensified’ combination chemotherapy with cyclophosphamide, methotrexate and fluorouracil (CMF). Granulocyte colony-stimulating factor was given prophylactically with the dose-dense treatments.

Results: Median dose intensity of epirubicin and paclitaxel was double in group A, as designed, with significantly less cycles administered at full dose (P < 0.001). Median cumulative dose of all drugs and total treatment duration, however, were identical between groups. Severe taxane-related toxic effects were more frequent in group A, while severe thrombocytopenia was low and present only in group A. There were no differences in the rates of other hematological toxic effects, including febrile neutropenia. The rates of secondary malignancies were low.

Conclusion: Both regimens as used in the present study are well tolerated and safe. The rates of severe taxane-related toxic effects and thrombocytopenia, although low overall, are significantly increased with the dose-dense sequential regimen.

Key words: breast cancer, chemotherapy, epirubicin, paclitaxel, randomized phase III trial, taxanes

Received for publication May 18, 2007. Revision received October 22, 2007. Accepted for publication October 23, 2007.


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