A Phase II trial of high dose epirubicin in patients with advanced breast carcinoma

✍ Scribed by Kathy D. Miller; Nikhil Munshi; David Loesch; Lawrence H. Einhorn; George W. Sledge Jr.

• Publisher: John Wiley and Sons
• Year: 2000
• Tongue: English
• Weight: 82 KB
• Volume: 88
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/(sici)1097-0142(20000115)88:2<375::aid-cncr19>3.0.co;2-m

✦ Synopsis

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-naı ¨ve 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.