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Annals of Oncology 2004 15(10):1527-1534; doi:10.1093/annonc/mdh393
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© 2004 European Society for Medical Oncology

Original Article

Phase III trial of liposomal doxorubicin and cyclophosphamide compared with epirubicin and cyclophosphamide as first-line therapy for metastatic breast cancer

S. Chan1,*, N. Davidson2, E. Juozaityte3, F. Erdkamp4, A. Pluzanska5, N. Azarnia6 and L. W. Lee6 On behalf of the Myocet Study Group{dagger}

1 City Hospital, Nottingham; 2 North Middlesex Hospital, London, UK; 3 Kaunas Medical Academy, Kaunas, Lithuania; 4 Maasland Hospital, Sittard, the Netherlands; 5 Lodz Chemotherapy Clinic, Lodz, Poland; 6 Elan Pharmaceuticals, Princeton, NJ, USA

* Correspondence to: Dr Stephen Chan, Department of Clinical Oncology, City Hospital, Hucknall Road, Nottingham NG5 1PB, UK. Tel: +44-115-969-1169; Fax: +44-163-683-0070; Email: ytschan{at}innotts.co.uk

Objective: To ascertain the efficacy and tolerability of non-pegylated liposomal doxorubicin (MyocetTM) and epirubicin combined with cyclophosphamide in the first-line treatment of patients with metastatic breast cancer.

Methods: One hundred and sixty anthracycline-naïve metastatic breast cancer patients were randomised to receive Myocet (M; 75 mg/m2) or epirubicin (E; 75 mg/m2) in combination with cyclophosphamide (C; 600 mg/m2), every 3 weeks for up to eight cycles.

Outcome measures: Response (overall response = complete + partial response rates), time to disease progression, overall survival and cardiac function (left ventricular ejection fraction).

Results: Overall response rates were 46% and 39% for MC and EC treatment, respectively (P=0.42). MC was superior to EC with respect to median time to treatment failure (5.7 versus 4.4 months; P=0.01) and median time to disease progression (7.7 versus 5.6 months; P=0.02). Median survival times were 18.3 and 16.0 months for MC and EC, respectively (P=0.504). Unsurprisingly, given an equimolar comparison, neutropenia and stomatitis/mucositis were significantly more common in patients who received MC. However, there was less injection site toxicity with MC. Both treatments showed a low incidence of cardiotoxicity.

Conclusion: Myocet appears to be an acceptable alternative to epirubicin as a first-line treatment for patients with metastatic breast cancer because it combines the dose–effect reliability of doxorubicin with the level of safety provided by epirubicin.

Key words: cyclophosphamide, epirubicin, liposomal doxorubicin, metastatic breast cancer, MyocetTM, phase III study


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