MUNICH, GermanyEpirubicin-containing regimens
significantly prolong relapse-free and overall survival rates
compared with standard regimens for treating breast cancer,
Michael Untch, MD, reported at a clinical investigators
workshop. The dose-response relationship for
epirubicin, he continued, translated into significant
improvements in outcome, and dose-intensification of epirubicin and
paclitaxel was well tolerated.
Dr. Untch is Chief of the Breast Cancer Service at the University of
Munich, Germany. The workshop was sponsored by the University of
Texas M. D. Anderson Cancer Center and by Pharmacia Oncology.
French Study Reviewed
Dr. Untch reviewed several trials of epirubicin (Ellence)-based
combination therapy including the French Adjuvant Study Group trial
comparing the FEC-100 and FEC-50 regimens in 565 breast cancer
patients with positive axillary nodes. Both of these regimens include
5-fluorouracil at 50 mg/m² and cyclophosphamide (Cytoxan) at 500
mg/m² plus epirubicin at either 100 or 50 mg/m².
Five-year disease-free survival was 65% with FEC-100 vs 52% with
FEC-50 (P = .007). This constitutes a relative risk reduction
of 32%, Dr. Untch noted.
Dr. Untch and colleagues have also studied
epirubicin/cyclophosphamide (EC) in patients with 10 or more positive
nodes. At follow-up of 42 months, the improvement in overall survival
with dose-intensified epirubicin (120 mg/m²) vs standard
epirubicin (90 mg/m²), followed by CMF (cyclophosphamide,
methotrexate, 5-FU), has reached borderline significance (P =
I am positive that with dose-intense EC, we can help these
patients to prevent metastatic disease and improve disease-free and
overall survival, Dr. Untch said.
Phase III Intergroup Study
A phase III intergroup study in patients with 4 to 9 positive nodes
compares epirubicin 150 mg/m² followed by paclitaxel (Taxol) 225
mg/m², and cyclophosphamide 2,500 mg/m², all drugs given
biweekly, to epirubicin 90 mg/m², cyclophosphamide 600 mg/m²
followed by paclitaxel 175 mg/m², triweekly. Current toxicity
data from this trial were presented at this years American
Society of Clinical Oncology meeting and showed that the
epirubicin/paclitaxel regimen is both tolerable and active in these
patients. Next is a trial of epirubicin plus cyclophosphamide,
followed by paclitaxel as neoadjuvant therapy, then followed by
surgery and standard CMF as adjuvant therapy.
Dr. Untch said that epirubicin is also being studied in combination
with trastuzumab (Herceptin) in HER2/neu-positive metastatic
patients. Epirubicin is less cardiotoxic than doxorubicin
(Adriamycin), and the hope is that it can be combined safely with the
monoclonal antibody treatment.