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A Phase II trial of high dose epirubicin in patients with advanced breast carcinoma
Author(s) -
Miller Kathy D.,
Munshi Nikhil,
Loesch David,
Einhorn Lawrence H.,
Sledge George W.
Publication year - 2000
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/(sici)1097-0142(20000115)88:2<375::aid-cncr19>3.0.co;2-m
Subject(s) - medicine , epirubicin , oncology , breast carcinoma , carcinoma , mammary gland , mammary carcinoma , breast cancer , cancer
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. Cancer 2000;88:375–80. © 2000 American Cancer Society.