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

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 (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)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Aromatase inhibitor, Exemestane, Endometrial cancer, Treatment, Phase II, study
in
BMC Cancer
volume
14
publisher
BioMed Central
external identifiers
  • wos:000332489500003
  • scopus:84893190700
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
2014-05-05 07:18:40
date last changed
2017-08-20 03:53:08
@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.},
  articleno    = {68},
  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},
  keyword      = {Aromatase inhibitor,Exemestane,Endometrial cancer,Treatment,Phase II,study},
  language     = {eng},
  publisher    = {BioMed Central},
  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          = {http://dx.doi.org/10.1186/1471-2407-14-68},
  volume       = {14},
  year         = {2014},
}