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

Abstract

Summary The EORTC Breast Cancer Cooperative Group carried out a randomized trial to compare doxorubicin with epirubicin as secondline chemotherapy in patients with metastatic breast cancer. Two hundred and fifty-nine patients with at least one site of metastatic disease entered this trial, of whom 232 patients were eligible. Treatment consisted of doxorubicin 75 mg m-2 or epirubicin 90 mg m-2 i.v. every 3 weeks. The overall response rates for doxorubicin and epirubicin were 36% and 28% respectively (P = 0.173). The median time to progression was 23 weeks for doxorubicin and 19 weeks for epirubicin (P = 0.063) and the median duration of response was 40 weeks for doxorubicin and 32 weeks for epirubicin (P = 0.059). The median survival was 47 weeks for doxorubicin and 44 weeks for epirubicin (P = 0.196). Leucocyte count on retreatment day (P = 0.011) and platelet nadir (P = 0.031) were significantly lower in the doxorubicin-treated group. Also mucositis (P < 0.001), diarrhoea (P = 0.005) and haemorrhage (P = 0.048) were significantly worse in the doxorubicin arm. Nine patients on doxorubicin and two patients on epirubicin experienced congestive heart failure (CHF). At the dose levels used in this study, no statistical differences in response rate and survival were found between the two treatment arms. Treatment with doxorubicin tended to result in a slightly longer duration of response and time to progression but doxorubicin was more toxic than epirubicin.

Optimizing the treatment of metastatic breast cancer

“…Several single-agent chemotherapeutic options have been shown to be effective as first-or second-line therapy, with taxanes and anthracyclines being among the most effective [13][14][15][16][17][18][19]. After treatment with an anthracycline or taxane, administration of capecitabine, gemcitabine, and vinorelbine have been found to result in OR rates of 20-25% (Table 2) [20][21][22].…”

“…After treatment with an anthracycline or taxane, administration of capecitabine, gemcitabine, and vinorelbine have been found to result in OR rates of 20-25% (Table 2) [20][21][22]. The decision of which single-agent treatment to use in the first-, second-, third-, or fourth-line setting depends on several factors, including patient characteristics, previous treatments, and the expected toxicity of the treatments [15,16,18,19].…”

Recent Advances in the Systemic Management of Metastatic Breast Cancer

“…One study demonstrated similar efficacy between 75 mg/m 2 DOX and 90 mg/m 2 EPI. 41 Another trial with analogous design demonstrated similar efficacy with 60 mg/m 2 DOX and 90 mg/m 2 EPI. 42 A third trial compared 60 mg/m 2 of DOX with 85 mg/m 2 of EPI.…”

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 .…”