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Clinical Trial
. 2004 Oct;15(10):1517-26.
doi: 10.1093/annonc/mdh395.

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 Fountzilas  1 , H P Kalofonos, U Dafni, C Papadimitriou, D Bafaloukos, P Papakostas, A Kalogera-Fountzila, H Gogas, G Aravantinos, L A Moulopoulos, T Economopoulos, D Pectasides, N Maniadakis, V Siafaka, E Briasoulis, C Christodoulou, D Tsavdaridis, P Makrantonakis, E Razis, P Kosmidis, D Skarlos, M A Dimopoulos
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Free article
Clinical Trial

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 Fountzilas et al. Ann Oncol. 2004 Oct.
Free article

Abstract

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/m(2) in a 3-h infusion followed by epirubicin (EPI) 80 mg/m(2) (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.

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