Phase II study of esorubicin (4'-deoxydoxorubicin) in advanced epithelial carcinoma of the ovary: a Gynecologic Oncology Group study.

Twenty-six patients with advanced, measurable epithelial carcinoma of the ovary were treated with 76 courses of esorubicin at doses ranging from 20-30 mg/m2 every 3 weeks. All patients are evaluable for toxicity and response. All patients had received prior therapy including radiation therapy in 9, non-anthracycline chemotherapy in 25, and surgery in 25. All patients were GOG performance status 0, 1 or 2. Two partial responses were seen. Severe (grade 3 or 4) leukopenia, thrombocytopenia, and anemia were seen in 13, 1 and 4 patients, respectively. Moderate gastrointestinal toxicity was also noted. Alopecia and mucositis were rare. Phlebitis was not seen. Neither clinical congestive cardiomyopathy nor decrement in left ventricular ejection fraction was observed. We conclude that using this dose and schedule of esorubicin as second-line chemotherapy in ovarian epithelial neoplasms lacks significant activity and is associated with moderate toxicity.