The evidence supporting this protocol is provided by a phase III multicentre randomised trial involving 705 patients comparing epirubicin and paclitaxel (EP) with epirubicin and cyclophosphamide (EC) for first-line treatment for metastatic breast cancer.r
Between 1996 and 1999, 353 patients were randomised to receive EP (epirubicin 75 mg/m2 IV and paclitaxel 200 mg/m2 IV every 21 days for 6 cycles) and 352 patients were randomised to receive EC (epirubicin 75 mg/m2 IV and cyclophosphamide 600 mg/m2 IV every 21 days for 6 cycles).r
The primary end point was progression-free survival (PFS) and secondary outcomes were overall survival (OS), objective response rate (ORR), and toxicity.r
Efficacy
71% of patients in both arms received 6 cycles of treatment. The objective response rates were 65% for the EP group and 55% for the EC group (p=0.015). Median progression-free survival time was 7.0 months for the EP group and 7.1 months for the EC group (HR=1.07; 95% CI, 0.92 to 1.24; p=0.41), and median overall survival time was 13 months for the EP group and 14 months for the EC group (HR=1.02; 95% CI, 0.87 to 1.19; p=0.8).r
Kaplan-Meier curves of (A) progression-free survival and (B) overall survivalr
(A)
© Journal of Clinical Oncology 2005
|
(B)
© Journal of Clinical Oncology 2005
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Toxicity
48% of EP-treated patients and 38% of EC-treated patients had at least one grade 3 or 4 toxicity. Mucositis, neurotoxicity and alopecia were observed more frequently in patients receiving EP.r
Toxicity r
Grade 3/4 |
EP %
(n=326-334*) |
EC %
(n=327-331*) |
p-value |
Alopecia |
71 |
62 |
0.02 |
Infection |
13 |
11 |
0.09 |
Nausea/vomiting |
10 |
13 |
0.60 |
Pain |
14 |
11 |
0.02 |
Mucositis |
6 |
2 |
0.0006 |
Neurotoxicity |
5 |
1 |
<0.0001 |
*values show a range because of missing values for some toxicities