Examestane in advanced or recurrent endometrial carcinoma: a prospective phase II study by the Nordic Society of Gynecologic Oncology (NSGO)
(2014) In BMC Cancer 14.- 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... (More)
- 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. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/4410745
- author
- Lindemann, Kristina
; Malander, Susanne
LU
; Christensen, Rene D. ; Mirza, Mansoor R. ; Kristensen, Gunnar B. ; Aavall-Lundqvist, Elisabeth ; Vergote, Ignace ; Rosenberg, Per ; Boman, Karin and Nordstrom, Britta
- organization
- publishing date
- 2014
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Aromatase inhibitor, Exemestane, Endometrial cancer, Treatment, Phase II, study
- in
- BMC Cancer
- volume
- 14
- article number
- 68
- publisher
- BioMed Central (BMC)
- external identifiers
-
- wos:000332489500003
- scopus:84893190700
- pmid:24498853
- ISSN
- 1471-2407
- DOI
- 10.1186/1471-2407-14-68
- language
- English
- LU publication?
- yes
- id
- 5374ff48-06b9-4dc3-ba3c-9ce55ed47a36 (old id 4410745)
- date added to LUP
- 2016-04-01 13:08:40
- date last changed
- 2022-03-29 05:50:51
@article{5374ff48-06b9-4dc3-ba3c-9ce55ed47a36, 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.}}, author = {{Lindemann, Kristina and Malander, Susanne and Christensen, Rene D. and Mirza, Mansoor R. and Kristensen, Gunnar B. and Aavall-Lundqvist, Elisabeth and Vergote, Ignace and Rosenberg, Per and Boman, Karin and Nordstrom, Britta}}, issn = {{1471-2407}}, keywords = {{Aromatase inhibitor; Exemestane; Endometrial cancer; Treatment; Phase II; study}}, language = {{eng}}, publisher = {{BioMed Central (BMC)}}, series = {{BMC Cancer}}, title = {{Examestane in advanced or recurrent endometrial carcinoma: a prospective phase II study by the Nordic Society of Gynecologic Oncology (NSGO)}}, url = {{https://lup.lub.lu.se/search/files/3187044/4777591}}, doi = {{10.1186/1471-2407-14-68}}, volume = {{14}}, year = {{2014}}, }