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Annals of Oncology Advance Access published online on November 11, 2009
Annals of Oncology, doi:10.1093/annonc/mdp498
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© The Author 2009. 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

Randomized phase III trial comparing docetaxel plus epirubicin versus docetaxel plus capecitabine as first-line treatment in women with advanced breast cancer

D. Mavroudis1,*, P. Papakotoulas2, A. Ardavanis3, K. Syrigos4, S. Kakolyris5, N. Ziras6, C. Kouroussis7, N. Malamos8, A. Polyzos9, C. Christophyllakis10, N. Kentepozidis11, V. Georgoulias1 and on behalf of the Breast Cancer Investigators of the Hellenic Oncology Research Group

1 Department of Medical Oncology, University Hospital of Heraklion, Heraklion, Crete
2 Second Department of Medical Oncology, "Theagenio" Anticancer Hospital of Thessaloniki, Thessaloniki
3 First Department of Medical Oncology, "Agios Savvas" Anticancer Hospital of Athens, Athens
4 Third Department of Medicine, Oncology Unit, "Sotiria" General Hospital of Athens, Athens
5 Department of Medical Oncology, University Hospital of Alexandroupolis, Alexandroupolis
6 First Department of Medical Oncology, "Metaxa" Anticancer Hospital, Pireas
7 First Department of Medical Oncology, "Theagenio" Anticancer Hospital of Thessaloniki, Thessaloniki
8 Oncology Unit, "Elena Iliadi" Hospital, Athens
9 Department of Propedeutic Medicine, Medical Oncology Unit, "Laiko" University Hospital, Athens
10 Department of Oncology, 401 Military Hospital of Athens, Athens
11 First Department of Medical Oncology, IASO General Hospital, Athens, Greece

* Correspondence to: Dr D. Mavroudis, Department of Medical Oncology, University Hospital of Heraklion, 71110 Heraklion, PO Box 1352, Crete, Greece. Tel: +30-2810-392783; Fax:+30-2810-392857; E-mail: georgsec{at}med.uoc.gr

Background: The purpose of this study was to compare docetaxel plus epirubicin versus docetaxel plus capecitabine combinations as front-line treatment in women with advanced breast cancer (ABC).

Patients and Methods: Previously untreated patients with ABC were randomly assigned to receive docetaxel 75 mg/m2 plus epirubicin 75 mg/m2 (DE) on day 1 or docetaxel 75 mg/m2 on day 1 plus capecitabine 950 mg/m2 orally twice daily on days 1–14 (DC) in 21-day cycles. Previous anthracycline-based (neo)-adjuvant chemotherapy was allowed if completed >1 year before enrollment. The primary objective of the study was to compare time to disease progression (TTP).

Results: One hundred and thirty-six women were treated on each arm and median TTP was 10.6 versus 11.0 months (P = 0.7), for DE and DC, respectively. According to RECIST criteria we observed 15 (11%) versus 11 (8%) complete responses and 55 (40%) versus 61 (45%) partial responses (P = 0.8), with DE and DC, respectively. Severe toxicity included grade 3–4 neutropenia (57% versus 46%; P = 0.07), febrile neutropenia (11% versus 8%; P = 0.4), hand–foot syndrome (0% versus 4%; P = 0.02), grade 2–3 anemia (20% versus 7%; P = 0.001) and asthenia (12% versus 6%; P = 0.09) with DE and DC, respectively.

Conclusions: The DE and DC regimens have similar efficacy but different toxicity. Either regimen can be used as front-line treatment of ABC.

capecitabine, chemotherapy, docetaxel, epirubicin, metastatic breast cancer

Received for publication August 21, 2009. Accepted for publication September 15, 2009.


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