A phase II trial of high dose epirubicin in patients with advanced breast carcinoma.
BACKGROUND
Anthracyclines are among the most active drugs in the treatment of breast carcinoma and exhibit a steep dose-response curve in vitro. This trial was performed to determine the efficacy and toxicity of epirubicin in the treatment of patients with advanced breast carcinoma when administered as a single agent in maximal doses.


METHODS
Patients with chemotherapy-naïve American Joint Committee on Cancer/International Union Against Cancer Stage IIIB or IV breast carcinoma received epirubicin, 180 mg/m(2), intravenously every 3 weeks for a maximum of 8 cycles of therapy. Hematopoietic growth factors and cardioprotective agents were not used routinely.


RESULTS
Twenty-seven patients were entered in the study. Although NCI/CTC criteria Grade 4 neutropenia occurred in 96% of patients, epirubicin was administered at 83.1% of the planned dose intensity. The median fall in left ventricular ejection fraction was 10%; clinical cardiac toxicity was observed in 3 patients. Objective responses were observed in 21 patients, including 6 complete responses.


CONCLUSIONS
High dose epirubicin was found to result in substantial hematologic toxicity but was highly active in the treatment of patients with advanced breast carcinoma.
Miller
D K
DK
Division of Hematology and Oncology, Indiana University School of Medicine, Indianapolis, Indiana.
Munshi
N
N
Loesch
D
D
Einhorn
L E
LE
Sledge
G W
GW
D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000187:drug effects
D000903:Antibiotics, Antineoplastic; D015251:Epirubicin