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Annals of Oncology 2004 15(10):1517-1526; doi:10.1093/annonc/mdh395
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© 2004 European Society for Medical Oncology

Original Article

Paclitaxel and epirubicin versus paclitaxel and carboplatin as first-line chemotherapy in patients with advanced breast cancer: a phase III study conducted by the Hellenic Cooperative Oncology Group

G. Fountzilas1,*, H. P. Kalofonos2, U. Dafni3, C. Papadimitriou4, D. Bafaloukos5, P. Papakostas6, A. Kalogera-Fountzila1, H. Gogas7, G. Aravantinos8, L. A. Moulopoulos4, T. Economopoulos9, D. Pectasides9, N. Maniadakis2, V. Siafaka10, E. Briasoulis10, C. Christodoulou11, D. Tsavdaridis12, P. Makrantonakis13, E. Razis14, P. Kosmidis14, D. Skarlos11 and M. A. Dimopoulos4

1 Aristotle University of Thessaloniki School of Medicine, Thessaloniki; 2 University of Patras School of Medicine, Patras; 3 Laboratory of Biostatistics, University of Athens School of Nursing, Athens; 4 Department of Clinical Therapeutics, University of Athens School of Medicine, Athens; 5 ‘Metropolitan’ Hospital, Athens; 6 ‘Ippokration’ Hospital, Athens; 7 ‘Laikon’ Hospital, Athens; 8 ‘Agii Anargiri’ Cancer Hospital, Athens; 9 University Hospital ‘Attikon’, Athens; 10 University of Ioannina School of Medicine, Ioannina; 11 ‘Henry Dunant’ Hospital, Athens; 12 ‘IKA’ Hospital, Thessaloniki; 13 ‘Theagenion’ Cancer Hospital, Thessaloniki; 14 ‘Hygeia’ Hospital, Athens, Greece

* Correspondence to: Dr G. Fountzilas, 1st Department of Internal Medicine, Section of Medical Oncology, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Macedonia, Greece. Tel/Fax: +30-2310-994617; Email: fountzil{at}med.auth.gr

Background: To compare survival between patients with advanced breast cancer (ABC) treated with epirubicin/paclitaxel (Taxol) or paclitaxel/carboplatin (Cp) chemotherapy.

Patients and methods: From January 1999 to April 2002, 327 eligible patients with ABC were randomized to receive either paclitaxel 175 mg/m2 in a 3-h infusion followed by epirubicin (EPI) 80 mg/m2 (group A) or paclitaxel, as in group A, followed by Cp at an AUC of 6 mg x min/ml (group B) every 3 weeks for six cycles.

Results: After a median follow-up of 23.5 months, median survival was not significantly different between the two groups (22.4 months versus 27.8 months, P=0.25), whereas median time to treatment failure was significantly longer in patients treated with paclitaxel/Cp (8.1 months in group A versus 10.8 months in group B, P=0.04). Both regimens were well tolerated. In total, 39 patients (24%) in group A and 46 (29%) in group B suffered at least one severe side-effect. Quality-of-life assessment and cost analysis did not reveal any significant differences between the two groups.

Conclusion: Our study suggests that the paclitaxel/Cp combination is an effective therapeutic alternative for patients with ABC in which anthracycline administration has the potential of being harmful.

Key words: anthracyclines, breast cancer, carboplatin, chemotherapy, paclitaxel


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