Phase II trial of danazol in advanced, recurrent, or persistent endometrial cancer: a Gynecologic Oncology Group study

• Published in: Gynecologic oncology 2003-06, Vol.89 (3), p.470-474
• Main Authors: Covens, Allan, Brunetto, Virginia L, Markman, Maurie, Orr, James W, Lentz, Samuel S, Benda, Jo
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Antineoplastic agents; Biological and medical sciences; Chemotherapy; Danazol - adverse effects; Danazol - therapeutic use; Disease-Free Survival; Endometrial Neoplasms - drug therapy; Endometrial Neoplasms - metabolism; Endometrial Neoplasms - pathology; Estrogen Antagonists - adverse effects; Estrogen Antagonists - therapeutic use; Female; Female genital diseases; Gynecology. Andrology. Obstetrics; Humans; Medical sciences; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Neoplasm Staging; Pharmacology. Drug treatments; Receptors, Estrogen - biosynthesis; Receptors, Progesterone - biosynthesis; Tumors
• ISSN: 0090-8258; 1095-6859
• DOI: 10.1016/S0090-8258(03)00149-5

Objectives. To evaluate the activity and toxicity of danazol in advanced, recurrent, or persistent endometrial carcinoma. Methods. Eligible patients with advanced, recurrent, or persistent endometrial carcinoma not amenable to curative therapy were treated with danazol at a dose of 100 mg four times per day until disease progression or toxicity necessitated discontinuation. Eligibility criteria included the presence of measurable disease and no prior chemotherapy. Immunohistochemical analysis of metastatic tumor tissue for estrogen and progesterone receptors was required. Results. Twenty-five patients were enrolled and 3 were excluded. Six patients had tumors staining positive for both estrogen and progesterone receptors. There were no responders among 22 eligible patients. Six patients (27%) demonstrated stable disease as their best response. The median progression-free survival and overall survival were 1.9 and 14.4 months, respectively. A median total dose of 21.7 (range: 1.4 to 67.2) of danazol was administered. Therapy was discontinued in 5 eligible patients due to toxicity. Four of these patients experienced hepatic toxicity. Conclusions. Danazol has minimal activity in advanced, recurrent, or persistent endometrial carcinoma.