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A phase II trial of anastrozole in advanced recurrent or persistent endometrial carcinoma: a Gynecologic Oncology
P G Rose1, V L Brunetto, L VanLe
1Department of Obstetrics and Gynecology, University Hospital of Cleveland, Ohio, 44106, USA.
Background:
Some endometrial cancers are hormonally dependent. A principal source of circulating estrogen is conversion of adrenal androstenedione by aromatase. Anastrozole (Arimidex) is an oral nonsteroidal aromatase inhibitor which is active in recurrent breast cancer. This Phase II study was undertaken to evaluate anastrozole in recurrent endometrial carcinoma.
Methods:
Patients with advanced or recurrent endometrial cancer not curable with either surgery or radiation therapy and with measurable disease, a GOG (Zubrod) performance status of < or = 2, no more than one prior hormonal therapy regimen, and no prior chemotherapy were eligible. Anastrozole was administered at a dose of 1 mg/day orally for at least 28 days.
Results:
Twenty-three patients were entered on this trial. On central pathology review, 9 of them had grade 2 and 14 had grade 3 tumors. One to 24 courses (median: 1) of therapy were administered. Two partial responses were noted (9%; 90% confidence interval 3 to 23%). Two additional patients had short-term stable disease. With the exception of 1 case of venous thrombosis, the toxicity profile was mild. Median durations of progression-free survival and overall survival are 1 and 6 months, respectively.
Conclusions:
Anastrozole has minimal activity in an unselected population of patients with recurrent endometrial cancer.
Insights
Anastrozole showed minimal activity in patients with recurrent endometrial cancer. The drug, an aromatase inhibitor, resulted in few responses and short survival durations in this Phase II trial.
Area of Science:
- Oncology
- Endocrinology
- Pharmacology
Background:
- Endometrial cancers can be hormonally dependent.
- Aromatase converts androstenedione to estrogen, a key factor in some endometrial cancers.
- Anastrozole is a nonsteroidal aromatase inhibitor effective in breast cancer.
Purpose of the Study:
- To evaluate the efficacy of anastrozole in patients with recurrent endometrial carcinoma.
- To assess the activity of anastrozole in advanced or recurrent endometrial cancer.
Main Methods:
- Phase II clinical trial.
- Eligible patients had advanced/recurrent endometrial cancer, measurable disease, and limited prior therapy.
- Anastrozole was administered orally at 1 mg/day.
Main Results:
- Two partial responses (9%) were observed in 23 patients.
- Two additional patients had short-term stable disease.
- Median progression-free and overall survival were 1 and 6 months, respectively; toxicity was mild.
Conclusions:
- Anastrozole demonstrated minimal activity in an unselected group of patients with recurrent endometrial cancer.
- Further investigation may be needed for specific patient subgroups.