A randomized comparison of single-agent doxorubicin and epirubicin as first-line cytotoxic therapy in advanced breast cancer.

Abstract

One hundred forty-one patients with advanced breast cancer who had not received prior chemotherapy were randomly assigned to receive doxorubicin 60 mg/m2 or epirubicin 90 mg/m2 every 3 weeks. These doses were selected to produce equivalent toxicities. All patients were assessed for toxicity, and 138 patients were assessable for response. After a median of five treatment cycles, 47% (32 of 68) of doxorubicin-treated patients achieved a partial or complete response. Response duration and survival were 10 and 12 months for doxorubicin and 8 and 10 months for epirubicin, respectively. Noncardiac toxicities were similar for both drugs. Of 41 patients receiving doxorubicin who had serial left ventricular ejection fraction assessments, seven sustained a fall of 10% or more, and one patient developed congestive cardiac failure at a cumulative doxorubicin dose of 489 mg/m2. Of 39 patients receiving epirubicin who had serial cardiac assessments, five sustained left ventricular ejection fraction falls of 10% or more and two patients developed congestive cardiac failure at cumulative doses of 178 mg/m2 and 833 mg/m2. These data indicate that an epirubicin dose of 90 mg/m2 produces toxicity equivalent to doxorubicin 60 mg/m2 but does not improve response rates, response duration, or survival in advanced breast cancer.

Doxorubicin vs epirubicin, report of a second-line randomized phase II/III study in advanced breast cancer

“…Doxorubicin treatment resulted in more bone marrow depression, mucositis and diarrhoea. In the study of Perez et al (1991), bone marrow toxicity of doxorubicin 60 mg m-2 and epirubicin 90 mg m-were almost superimposable, and the same results were found for gastrointestinal toxicity. Response percentages in this study were indentical, and the authors concluded that the higher dose of epirubicin had no advantages over the lower dose of doxorubicin.…”

“…Toxicity, however, was generally more pronounced in the doxorubicintreated patients. The four other studies compared the two drugs on an expected equimyelotoxic basis with doses of epirubicin ranging from 1.4 to 1.5 times the dose of doxorubicin (Jain et al, 1985;Taguchi et al, 1986;Hortobagyi et al, 1989;Perez et al, 1991). Similarly none of these studies showed significant differences in response rates, duration of response or survival between the two treatment arms.…”

High-sensitivity cardiac troponin I detection for 2 types of drug-induced cardiotoxicity in patients with breast cancer

“…Generally, because of cardiotoxicity, 900 mg/m 2 is recommended as the upper limit for the lifetime total dose of epirubicin [26][27][28], although there are reports of cardiac insufficiency occurring at 178 and 540 mg/m 2 [27,29]. The results of this study were also thought to have been influenced by the use of anthracyclines, which suggests the need for regular cardiac function tests, even when the total dose of anthracyclines is \900 mg/m 2 .…”

Systemic Treatment Approaches in her2-Negative Advanced Breast Cancer—Guidance on the Guidelines

“…Response rates in anthracycline-naïve patients are reported to be in the 25%-50% range [58][59][60][61] . Prior anthracycline exposure, including evaluation of total cumulative dose and other cardiac risk factors (for example, coronary artery disease, prior myocardial infarction, prior mediastinal radiotherapy) necessitate a baseline review of cardiac ejection fraction and monitoring thereafter 62 .…”