Epirubicin and cyclophosphamide versus epirubicin and docetaxel as first-line therapy for women with metastatic breast cancer: final results of a randomised phase III trial.
BACKGROUND
This randomised phase III trial was carried out to compare the efficacy and safety of epirubicin and cyclophosphamide (EC) with epirubicin and docetaxel (Taxotere) (ED) as first-line chemotherapy for metastatic breast cancer.


METHODS
Patients (n = 240) were randomly assigned to receive either ED (epirubicin 75 mg/m(2) and docetaxel 75 mg/m(2)) or EC (epirubicin 90 mg/m(2) and cyclophosphamide 600 mg/m(2)). The primary end point was objective response rate (ORR). Secondary end points were progression-free survival (PFS), overall survival (OS), and safety.


RESULTS
ORR for patients randomly assigned to receive EC and ED were 42% and 47%, respectively (P = 0.63). Median PFS [10.1 versus 10.3 months; hazard ratio (HR) 0.98; log-rank P = 0.38] and OS (19.9 versus 30.0 months; HR 0.663; log-rank P = 0.21) were comparable in both arms. Although grade 3/4 leucopenia occurred more frequently with ED (81% versus 73%; P = 0.01), there were no significant differences in the incidence of febrile neutropenia and grade 3/4 infections. Grade 3/4 non-haematologic toxicity was infrequent in both arms. Congestive heart failure was observed in one patient in each arm.


CONCLUSIONS
In this randomised trial, no differences in the efficacy study end points were observed between the two treatment arms.
Blohmer
J-U
JU
Department of Gynaecology and Obstetrics, Campus Charité Mitte, Charité University Hospital; Department of Gynaecology and Obstetrics, Sankt Gertrauden-Krankenhaus, Berlin, Germany.
Schmid
P
P
Department of Medical Oncology, Charing Cross Hospital, Imperial College London, London, UK. Electronic address: p.schmid@imperial.ac.uk.
Hilfrich
J
J
Department of Gynaecology and Obstetrics, Henriettenstift, Hannover.
Friese
K
K
Department of Gynaecology and Obstetrics, Ludwig-Maximilians University, München; Department of Gynaecology and Obstetrics, University of Rostock, Rostock.
Kleine-Tebbe
A
A
Department of Gynaecology and Obstetrics, Charité Campus Virchow Klinikum, Charité University Hospital, Berlin.
Koelbl
H
H
Department of Gynaecology and Obstetrics, Martin-Luther University Halle-Wittenberg, Halle.
Sommer
H
H
Department of Gynaecology and Obstetrics, Ludwig-Maximilians University, München.
Morack
G
G
Department of Gynaecology and Obstetrics, Helios Klinikum Berlin-Buch, Berlin.
Wischnewsky
M B
MB
Department of Biomathematics and Intelligent Systems, University of Bremen, Bremen.
Lichtenegger
W
W
Department of Gynaecology and Obstetrics, Campus Charité Mitte, Charité University Hospital; Department of Gynaecology and Obstetrics, Charité Campus Virchow Klinikum, Charité University Hospital, Berlin.
Kuemmel
S
S
Department of Gynaecology and Obstetrics, Campus Charité Mitte, Charité University Hospital; Breast Unit, Cancer Centre Essen, Kliniken Essen-Mitte, Essen, Germany.
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D003520:Cyclophosphamide / Q000008:administration & dosage; D018450:Disease Progression; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D003520:Cyclophosphamide