Table 2

Summary of cardiac safety with trastuzumab in early breast cancer

TRIAL
ARM
Baseline LEVF(%)
CHF(%)
Cardiac death
Cardiac follow-up

HERA
NIL
>= 55
0
1
MUGA scan or echocardiogram at 3–4 wks prior to randomization, and 3, 6, 12, 18, 24, 30, 36, and 60 mos from randomization

H 1 YEAR

0.6
0

NSABP-31
AC followed P
>= 50
0.8
1
MUGA scan or echocardiogram 3 wks after last AC dose, 6, 9, and 18 mos from randomization, and 3 mos after last trastuzumab dose

AC followed PH

4.1
0

NCCTGN9831
AC followed P
>= 50
0.3
1
MUGA scan 3 wks after last AC dose, 6 and 9 mos from randomization, and 3 mos after the last trastuzumab dose

AC followed P and H

2.5
1


AC followed PH

3.5
0

BCIRG006
AC followed D
>= 50
0.3
0
After last AC dose, after second docetaxel dose, after end of chemotherapy, and at 3, 12 and 36 mos from randomization. At baseline, at 6 wks, 4.5 mos,13.5 mos, and 37.5 mos from randomization

AC followed DH

1.6
0


DCarbo followed H

0.4
0

FIN HER
NO H
>= 50
3
0
MUGA scan or echocardiogram before chemotherapy, after CEF, and 12 and 36 mos after completion of chemotherapy

H

0
0


AC, doxorubicin plus cyclophosphamide; BCIRG, Breast Cancer International ;NCCTG, North Central Cancer Treatment Group; NSABP, National Surgical Adjuvant Breast and Bowel Project; P, paclitaxel. MUGA, multigated acquisition;Research Group; Carbo, carboplatin;CHF, congestive heart failure; cum, cumulative incidence; D, docetaxel; H, trastuzumab; HERA, Herceptin® Adjuvant; LVEF, left ventricular ejection fraction;

Viani et al. BMC Cancer 2007 7:153   doi:10.1186/1471-2407-7-153