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Annals of Oncology Advance Access originally published online on April 8, 2005
Annals of Oncology 2005 16(6):899-908; doi:10.1093/annonc/mdi181
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© 2005 European Society for Medical Oncology

First-line gemcitabine versus epirubicin in postmenopausal women aged 60 or older with metastatic breast cancer: a multicenter, randomized, phase III study

O. Feher1,*, P. Vodvarka2, J. Jassem3, G. Morack4, S. H. Advani5, K. S. Khoo6, D. C. Doval7, S. Ermisch8, D. Roychowdhury8, M. A. Miller8 and G. von Minckwitz9

1 Hospital do Cancer, São Paulo, Brazil; 2 Faculty Hospital and Policlinic Ostrava-Poruba, Czech Republic; 3 Medical University of Gdansk, Poland; 4 Hospital Berlin-Buch, Germany; 5 Tata Memorial Hospital, India; 6 National Cancer Centre, Singapore; 7 Rajiv Gandhi Cancer Institute, India; 8 Eli Lilly and Company, Indianapolis, IN, USA; 9 Goethe University Women's Hospital, Frankfurt, Germany

* Correspondence to: Dr O. Feher, Hospital do Cancer – A. C. Camargo, Rua Prof. Antonio Prudente, 211 São Paulo – SP – CEP 01509-900, Brazil. Tel: +55-11-32725108; Fax: +55-11-32725138; Email: omfeher{at}terra.com.br

Background:: This randomized, phase III study compared the efficacy and safety of first-line gemcitabine versus epirubicin in the treatment of postmenopausal women with metastatic breast cancer (MBC).

Patients and methods:: Patients aged ≥ 60 years (median 68 years) with clinically measurable MBC received either gemcitabine 1200 mg/m2 or epirubicin 35 mg/m2 on days 1, 8, and 15 of a 28-day cycle.

Results:: Of 410 patients entered, 397 (198 gemcitabine and 199 epirubicin) were randomized and qualified for the time to progressive disease (TTP) and survival analyses. Total cycles administered in 185 gemcitabine and 192 epirubicin patients, respectively, were 699 (mean 3.5, range 0–12) and 917 (mean 4.6, range 0–10). Epirubicin demonstrated statistically significant superiority in TTP (6.1 and 3.4 months, P=0.0001), overall survival (19.1 and 11.8 months, P=0.0004), and independently assessed response rate (40.3% and 16.4% in 186 and 183 evaluable patients, P <0.001). For gemcitabine (n=190) and epirubicin (n=192), respectively, common WHO grade 3/4 toxicities were neutropenia (25.3% and 17.9%) and leukopenia (14.3% and 19.3%). Of the 28 on-study deaths (17 gemcitabine, 11 epirubicin), three were considered possibly or probably related to treatment (gemcitabine).

Conclusions:: Postmenopausal women ≥60 years of age with MBC tolerate chemotherapy well. In this study, epirubicin was superior to gemcitabine in the treatment of MBC in women age ≥60, confirming that anthracyclines remain important drugs for first-line treatment of MBC.

Key words: elderly patients, epirubicin, gemcitabine, metastatic breast cancer


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