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Open Access Research article

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

Kristina Lindemann1, Susanne Malander2, Rene D Christensen3, Mansoor R Mirza4, Gunnar B Kristensen15*, Elisabeth Aavall-Lundqvist6, Ignace Vergote7, Per Rosenberg8, Karin Boman9 and Britta Nordstrøm10

Author Affiliations

1 Department of Gynecologic Oncology, Norwegian Radium Hospital, Oslo University Hospital, Nydalen 0424, PB 4953, Oslo, Norway

2 Department of gynecologic oncology, Lund University Hospital, Lund, Sweden

3 Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Odense, Denmark

4 Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

5 Department of Gynecologic Oncology and Institute for Medical Informatics, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway

6 Department of Oncology, Karolinska University Hospital, Stockholm, Sweden

7 Department of Gynecologic Oncology and Leuven Cancer Institute, University Hospital Leuven, Leuven, European Union

8 Department of Gynecologic Oncology, University Hospital, Linkjoeping, Sweden

9 Department of Oncology, University Hospital, Umeaa, Sweden

10 Department of Oncology, Karolinska University Hospital, Stockholm, Sweden

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BMC Cancer 2014, 14:68  doi:10.1186/1471-2407-14-68

Published: 5 February 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.

Keywords:
Aromatase inhibitor; Exemestane; Endometrial cancer; Treatment; Phase II study