Concurrent administration of Epirubicin plus Paclitaxel did not significantly increase the risk of cardiac events compared to sequential administration, as cardiotoxicity correlated primarily with the cumulative dose of Epirubicin.
RCT (n=136)
Open-label
Randomized
Yes
Does concurrent administration of Epirubicin and Paclitaxel compared to sequential administration affect cardiac safety in advanced breast cancer patients?
Concurrent administration of Epirubicin and Paclitaxel leads to greater LVEF decline and more CHF episodes compared to sequential administration, correlating with cumulative Epirubicin dose.
Absolute Event Rate: 23.6% vs 14.1%
p-value: p=0.13
The aim of the study was to evaluate cardiac safety of two different schedules of Epirubicin and Paclitaxel in advanced breast cancer patients enrolled into a multicenter randomized phase III trial. Patients received Epirubicin 90 mg m(-2) plus Paclitaxel 200 mg m(-2) (3-h infusion) on day 1 every 3 weeks for eight courses (arm A), or Epirubicin 120 mg m(-2) on day 1 every 3 weeks for four courses followed by four courses of Paclitaxel 250 mg m(-2) on day 1 every 3 weeks (arm B). Left ventricular ejection fraction was evaluated by bidimesional echocardiography at baseline, after four and eight courses of chemotherapy and every 4 months during follow-up. Baseline median left ventricular ejection fraction was 60% in arm A and 65% in arm B; after four courses, figures were 57 and 60%, respectively. After eight courses, the median left ventricular ejection fraction in arm A declined to 50% while no further reduction was detected in arm B by adding four courses of high-dose Paclitaxel. Seven episodes of congestive heart failure were observed during treatment in arm A. Present monitoring demonstrated that the risk of congestive heart failure or impairment in the cardiac function correlated only with the cumulative dose of Epirubicin; no impact on cardiotoxicity can be attributed to high-dose Paclitaxel.
Baldini et al. (Tue,) conducted a rct in Metastatic breast cancer (n=136). Epirubicin plus Paclitaxel vs. Epirubicin 120 mg/m2 for 4 courses followed by Paclitaxel 250 mg/m2 for 4 courses was evaluated on Incidence of cardiac events (20% decline in LVEF from baseline or congestive heart failure) (p=0.13). Concurrent administration of Epirubicin plus Paclitaxel did not significantly increase the risk of cardiac events compared to sequential administration, as cardiotoxicity correlated primarily with the cumulative dose of Epirubicin.
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