Phase 2 study of anastrozole in recurrent estrogen (ER)/progesterone (PR) positive endometrial cancer: the PARAGON trial - ANZGOG 0903
Authors
Mileshkin, LEdmondson, R
O'Connell, R
Sjoquist, K
Andrews, J
Jyothirmayi, R
Beale, P
Bonaventura, T
Goh, J
Hall, M
Clamp, Andrew R
Green, J
Lord, R
Amant, F
Alexander, L
Carty, K
Paul, J
Scurry, J
Millan, D
Nottley, S
Friedlander, M
Affiliation
Peter MacCallum Cancer Centre, The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, AustraliaIssue Date
2019
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BACKGROUND: The clinical benefit rate with aromatase inhibitors and the impact of treatment on quality of life (QOL) in endometrial cancer is unclear. We report the results of a phase 2 trial of anastrozole in endometrial cancer. METHODS: Investigator initiated single-arm, open label trial of anastrozole, 1?mg/d in patients with ER and/or PR positive hormonal therapy naive metastatic endometrial cancer. Patients were treated until progressive disease (PD) or unacceptable toxicity. The primary end-point was clinical benefit (response?+?stable disease) at 3?months. Secondary endpoints include progression-free survival (PFS), quality of life (QOL) and toxicity. RESULTS: Clinical benefit rate in 82 evaluable patients at 3?months was 44% (95% CI: 34-55%) with a best response by RECIST of partial response in 6 pts. (7%; 95% CI: 3-15%). The median PFS was 3.2?months (95% CI: 2.8-5.4). Median duration of clinical benefit was 5.6?months (95% CI: 3.0-13.7). Treatment was well tolerated. Patients who had clinical benefit at 3?months reported clinically significant improvements in several QOL domains compared to those with PD; this was evident by 2?months including improvements in: emotional functioning (39 vs 6%: p?=?0.002), cognitive functioning (45 vs 19%: p?=?0.021), fatigue (47 vs 19%: p?=?0.015) and global health status (42 vs 9%: p?=?0.003). CONCLUSION: Although the objective response rate to anastrozole was relatively low, clinical benefit was observed in 44% of patients with ER/PR positive metastatic endometrial cancer and associated with an improvement in QOL.Citation
Mileshkin L, Edmondson R, O'Connell RL, Sjoquist KM, Andrews J, Jyothirmayi R, et al. Phase 2 study of anastrozole in recurrent estrogen (ER)/progesterone (PR) positive endometrial cancer: the PARAGON trial - ANZGOG 0903. Gynecol Oncol. 2019.Journal
Gynecologic OncologyDOI
10.1016/j.ygyno.2019.05.007PubMed ID
31130288Additional Links
https://dx.doi.org/10.1016/j.ygyno.2019.05.007Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1016/j.ygyno.2019.05.007
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