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Examestane in advanced or recurrent endometrial carcinoma: a prospective phase II study by the Nordic Society of Gynecologic Oncology (NSGO).

Authors :
Lindemann, Kristina
Malander, Susanne
Christensen, Rene D.
Mirza, Mansoor R.
Kristensen, Gunnar B.
Aavall-Lundqvist, Elisabeth
Vergote, Ignace
Rosenberg, Per
Boman, Karin
Nordstrøm, Britta
Source :
BMC Cancer; 2014, Vol. 14 Issue 1, p1-15, 15p
Publication Year :
2014

Abstract

Background We evaluated the efficacy and safety of the aromatase inhibitor exemestane in patients with advanced, persistent or recurrent endometrial carcinoma. Methods We performed an open-label one-arm, two-stage, phase II study of 25 mg of oral exemestane in 51 patients with advanced (FIGO stage III-IV) or relapsed endometrioid endometrial cancer. Patients were stratified into subsets of estrogen receptor (ER) positive and ER negative patients. Results Recruitment to the ER negative group was stopped prematurely after 12 patients due to slow accrual. In the ER positive patients, we observed an overall response rate of 10%, and a lack of progression after 6 months in 35% of the patients. No responses were registered in the ER negative patients, and all had progressive disease within 6 months. For the total group of patients, the median progression free survival (PFS) was 3.1 months (95% CI: 2.0-4.1). In the ER positive patients the median PFS was 3.8 months (95% CI: 0.7-6.9) and in the ER negative patients it was 2.6 months (95% CI: 2.1-3-1). In the ER positive patients the median overall survival (OS) time was 13.3 months (95% CI: 7.7-18.9), in the ER negative patients the corresponding numbers were 6.1 months (95% CI: 4.1-8.2). Treatment with exemestane was well tolerated. Conclusion Treatment of estrogen positive advanced or recurrent endometrial cancer with exemestane, an aromatase inhibitor, resulted in a response rate of 10% and lack of progression after 6 months in 35% of the patients. Trial registration Trial identification number (Clinical Trials.gov): NCT01965080. Nordic Society of Gynecological Oncology: NSGO-EC-0302. EudraCT number: 2004-001103-35. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
14712407
Volume :
14
Issue :
1
Database :
Complementary Index
Journal :
BMC Cancer
Publication Type :
Academic Journal
Accession number :
94427234
Full Text :
https://doi.org/10.1186/1471-2407-14-68