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.
BACKGROUND
To compare survival between patients with advanced breast cancer (ABC) treated with epirubicin/paclitaxel (Taxol) or paclitaxel/carboplatin (Cp) chemotherapy.


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.


CONCLUSIONS
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.
Fountzilas
G
G
Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece. fountzil@med.auth.gr
Kalofonos
H P
HP
Dafni
U
U
Papadimitriou
C
C
Bafaloukos
D
D
Papakostas
P
P
Kalogera-Fountzila
A
A
Gogas
H
H
Aravantinos
G
G
Moulopoulos
L A
LA
Economopoulos
T
T
Pectasides
D
D
Maniadakis
N
N
Siafaka
V
V
Briasoulis
E
E
Christodoulou
C
C
Tsavdaridis
D
D
Makrantonakis
P
P
Razis
E
E
Kosmidis
P
P
Skarlos
D
D
Dimopoulos
M A
MA
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016190:Carboplatin / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D016019:Survival Analysis; D016896:Treatment Outcome
D015251:Epirubicin; D016190:Carboplatin; D017239:Paclitaxel