February 23, 2010Journal of Clinical Oncology
First-Line Trastuzumab Plus Epirubicin and Cyclophosphamide Therapy in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: Cardiac Safety and Efficacy Data From the Herceptin, Cyclophosphamide, and Epirubicin (HERCULES) Trial
Key result
Trastuzumab plus cyclophosphamide and epirubicin resulted in dose-limiting cardiotoxicity in 5.0% (90 mg/m2) and 1.7% (60 mg/m2) of HER2-positive patients, compared to 0% in HER2-negative controls.
Why the study?
Does trastuzumab plus epirubicin and cyclophosphamide have acceptable cardiac safety compared to epirubicin and cyclophosphamide alone in patients with metastatic breast cancer?
Population
180 patients with metastatic breast cancer and adequate cardiac function
Comparison
Trastuzumab plus cyclophosphamide and either… vs Epirubicin and cyclophosphamide alone
Design
RCT, phase II randomized stage
Authors
Discussion
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Member takes
Implication
Supports trastuzumab-epirubicin-cyclophosphamide in HER2-positive metastatic breast cancer; extends cardiac safety data beyond doxorubicin regimens.
Study Design
Type
RCT (n=180)
Randomization
Randomized
Structured PICO
Does trastuzumab plus epirubicin and cyclophosphamide have acceptable cardiac safety compared to epirubicin and cyclophosphamide alone in patients with metastatic breast cancer?
P
Population
180 patients with metastatic breast cancer and adequate cardiac function, including 120 with HER2-positive disease and 60 with HER2-negative disease.
I
Intervention
Trastuzumab (4 mg/kg intravenous loading dose, then 2 mg/kg every week) plus cyclophosphamide (600 mg/m2) and either epirubicin 60 mg/m2 (HEC-60) or 90 mg/m2 (HEC-90) for six cycles, followed by trastuzumab monotherapy until progression
C
Comparator
Epirubicin (90 mg/m2) and cyclophosphamide (EC-90) alone (administered to the 60 patients with HER2-negative disease)
O
Outcome
Dose-limiting cardiotoxicity (DLC)safety
Main Result
Absolute Event Rate: 5% vs 0%
The combination of trastuzumab, epirubicin, and cyclophosphamide demonstrated a low incidence of dose-limiting cardiotoxicity in patients with HER2-positive metastatic breast cancer, suggesting it is a promising and safer alternative to doxorubicin-based regimens.
Cite This Study
Untch et al. (2010) conducted an RCT in Metastatic breast cancer (n=180). Trastuzumab plus cyclophosphamide and epirubicin vs. Epirubicin (90 mg/m2) and cyclophosphamide alone was evaluated on Dose-limiting cardiotoxicity (DLC). Trastuzumab plus cyclophosphamide and epirubicin resulted in dose-limiting cardiotoxicity in 5.0% (90 mg/m2) and 1.7% (60 mg/m2) of HER2-positive patients, compared to 0% in HER2-negative controls.