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

Allan Covens, Virginia L. Brunetto, Maurie Markman, James W. Orr, Samuel S. Lentz, J Bénda, Jo Benda, Gynecologic Oncology Group
Gynecologic Oncology · 2003 · vol. 89(3) , pp. 470–474 · doi:10.1016/s0090-8258(03)00149-5 · PMID:12798713 · W2053246551
Non-randomised trial OA: closed CC0 ⤵ 3 in-corpus citations
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A Gynecologic Oncology Group phase II trial found danazol to have minimal activity in advanced, recurrent, or persistent endometrial carcinoma, with no responders among 22 eligible patients.

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Abstract

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.

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MeSH descriptors

Danazol Endometrial Neoplasms Estrogen Antagonists Neoplasm Recurrence, Local Aged Aged, 80 and over Danazol Danazol Disease-Free Survival Endometrial Neoplasms Endometrial Neoplasms Endometrial Neoplasms Estrogen Antagonists Estrogen Antagonists Female Humans Middle Aged Neoplasm Recurrence, Local Neoplasm Staging Receptors, Estrogen

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