Phase II trial of danazol in advanced, recurrent, or persistent endometrial cancer: a Gynecologic Oncology Group study.
OBJECTIVE
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.
Covens
Allan
A
Division of Gynecology/Oncology, University of Toronto, Toronto, Ontario, M4N 3M5, Canada. al.covens@tsrcc.on.ca
Brunetto
Virginia L
VL
Markman
Maurie
M
Orr
James W
JW
Lentz
Samuel S
SS
Benda
Jo
J
D000368:Aged; D000369:Aged, 80 and over; D003613:Danazol / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D004965:Estrogen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009367:Neoplasm Staging; D011960:Receptors, Estrogen / Q000096:biosynthesis; D011980:Receptors, Progesterone / Q000096:biosynthesis
D004965:Estrogen Antagonists; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D003613:Danazol