Table 2: The summary of Experimental Designs of the four studies
Study
Patient Criteria
Number of Patients: 69
Treatment Plan
Cardiac Monitoring
minutes, once a week,
for 52 weeks.
Martin, et al
Age Range: 37-78 (Median: 57)
Liposomal Doxorubicin:
2
Illness: HER-2 Overexpressing
50mg/m once every 4
echocardiography or
Metastatic Breast Cancer
weeks, for 6 cycles.
MUGA scan (Multi Gated
Other Criteria: Adequate cardiac
Trastuzumab: Initial
Acquisition Scan). Cardiac
function, Baseline LVEF ≥ 50%.
loading dose of 4mg/kg
Toxicity Criteria: absolute
Patients with prior chemo therapy
on day 1, followed by 2
LVEF decrease from
were not allowed. Prior adjuvant
mg/kg Intravenous
baseline ≥15% or a
therapy was allowed if completed
Infusion, once a week,
decrease <10% with an
6 months before testing.
for 24 weeks.
absolute baseline value
Number of Patients: 48
Chia, et al
Stickeler, et
al
LVEF was measured using
≤45%
Age Range: 29-73 (Median: 57)
Liposomal Doxorubicin:
LVEF was measured using
Illness: HER-2 Overexpressing
50mg/m2 intravenously,
serial MUGA scans.
Metastatic Breast Cancer
over 1 hour once every 4 Cardiac toxicity criteria: A
Other Criteria: Baseline LVEF ≥
weeks, for 6 cycles.
patient with symptomatic
55%, Prior use of Trastuzumab
Trastuzumab: Initial
cardiotoxicity (Ex:
was not allowed. Life expectancy
loading dose of 4mg/kg
orthopnea, S3 gallop,
> 6 Months
on day 1, followed by 2
tachycardia), or a ≥ 15%
Number of Patients:30
mg/kg Intravenous
decline from baseline in
Infusion, once a week,
LVEF regardless of final
for 24 weeks.
(absolute) value
Liposomal Doxorubicin:
LVEF was measured using
Age Range: 37-68 (Median: 63)
2
Illness: HER-2 Overexpres sing
40mg/m intravenously,
Simpson’s method
Metastatic Breast Cancer
once every 4 weeks, for
(Echocardiography).
Other Criteria: No prior history of
9 cycles.
Cardiac Toxicity was
cardiac defects, Baseline LVEF ≥
Trastuzumab: 2 mg/kg
defined by the incidence of
50%, No prior heavy
Intravenous Infusion,
a cardiac symptom (Ex:
chemotherapy
once a week, until end
Tachycardia), or a decrease
Number of Patients: 16
of Liposomal
in LVEF <44% or ≥ 10
Doxorubicin treatment
units below the normal
value of 50%
3.4.1. Study Outcome: Safety of the Treatment