Phase III trial of liposomal doxorubicin and cyclophosphamide compared with epirubicin and cyclophosphamide as first-line therapy for metastatic breast cancer.
OBJECTIVE
To ascertain the efficacy and tolerability of non-pegylated liposomal doxorubicin (Myocet) 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/m(2)) or epirubicin (E; 75 mg/m(2)) in combination with cyclophosphamide (C; 600 mg/m(2)), every 3 weeks for up to eight cycles.


METHODS
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.


CONCLUSIONS
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.
Chan
S
S
City Hospital, Nottingham, UK. ytschan@innotts.co.uk
Davidson
N
N
Juozaityte
E
E
Erdkamp
F
F
Pluzanska
A
A
Azarnia
N
N
Lee
L W
LW
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003520:Cyclophosphamide / Q000008:administration & dosage; D018450:Disease Progression; D004317:Doxorubicin / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008081:Liposomes; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016019:Survival Analysis; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000139:chemically induced
D008081:Liposomes; D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D004317:Doxorubicin; D003520:Cyclophosphamide