In this interview we discuss results of the PlanB trial, which showed that use of the 21-gene recurrence score, Oncotype DX, can identify patients with early breast cancer who likely do not need chemotherapy.
Nadia Harbeck, MD, PhD
This study was designed to evaluate the cardiac safety of the combined treatment of HER2-positive metastatic
breast cancer patients with trastuzumab (Herceptin) plus epirubicin and cyclophosphamide (EC) in
comparison with EC alone in HER2-negative metastatic breast cancer patients. Patients included those with
metastatic breast cancer without any prior anti-HER2 treatment, anthracycline therapy, or any other chemotherapy
for metastatic disease. This was a nonrandomized, prospective, dose-escalating, multicenter, openlabel,
phase II study in Germany. A control group of 23 patients received EC 90/600 mg/m2 3-weekly for six
cycles (EC90 alone). A total of 26 HER2-positive patients were treated with trastuzumab, or H (2 mg/kg weekly
after an initial loading dose of 4 mg/kg), and EC 60/600 mg/m2 3-weekly for six cycles (EC60+H); another 25
HER2-positive patients received H and EC 90/600 mg/m2 3-weekly for six cycles. Asymptomatic reductions in
left ventricular ejection fraction (LVEF) of more than 10% points were detected in 12 patients (48%) treated
with EC60 + H and in 14 patients (56%) treated with EC90 + H vs 6 patients (26%) in the EC90 alone cohort.
LVEF decreases to 60%, vs 26% for EC90 alone. The interim results of this study
suggest the cardiac safety of the combination of H with EC may be greater than that of H with AC (doxorubicin
[Adriamycin]/cyclophosphamide); however, studies in larger numbers of patients are warranted. The combination
regimen revealed promising efficacy.