Phase 2 study of anastrozole in recurrent estrogen (ER)/progesterone (PR) positive endometrial cancer: The PARAGON trial – ANZGOG 0903

Mileshkin, L. et al. (2019) Phase 2 study of anastrozole in recurrent estrogen (ER)/progesterone (PR) positive endometrial cancer: The PARAGON trial – ANZGOG 0903. Gynecologic Oncology, 154(1), pp. 29-37. (doi: 10.1016/j.ygyno.2019.05.007) (PMID:31130288)

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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.

Item Type:Articles
Additional Information:This research was supported by Cancer Australia Grant 632740 (2009–2011), Cancer Australia PdCCRS 1063014 (2014–2016), Cancer Australia Priority-driven Collaborative Cancer Research Scheme Project Grant APP1142697, Cancer Research UK (grants C22375/A12846 and C22375/A13784), and Cancer Institute NSW Research Infrastructure Grant 15/RIG/1-16. UK Co-Sponsors: NHS Greater Glasgow & Clyde and University of Glasgow.
Keywords:Aromatase inhibitor, clinical trial, endometrial cancer, quality of life.
Glasgow Author(s) Enlighten ID:Alexander, Mrs Laura and Paul, Mr James and Carty, Mrs Karen
Authors: Mileshkin, L., Edmondson, R., O'Connell, R. L., Sjoquist, K. M., Andrews, J., Jyothirmayi, R., Beale, P., Bonaventura, T., Goh, J., Hall, M., Clamp, A., Green, J., Lord, R., Amant, F., Alexander, L., Carty, K., Paul, J., Scurry, J., Millan, D., Nottley, S., and Friedlander, M.
College/School:College of Medical Veterinary and Life Sciences > School of Cancer Sciences
Journal Name:Gynecologic Oncology
ISSN (Online):1095-6859
Published Online:23 May 2019
Copyright Holders:Copyright © 2019 Elsevier Inc.
First Published:First published in Gynecologic Oncology 154(1):29-37
Publisher Policy:Reproduced in accordance with the publisher copyright policy

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
164893PARAGON - Phase II study of aromatase inhibitors in women with potentially hormone response recurrent/metastatic gynaecological neoplasmsJames PaulCancer Research UK (CRUK)C22375/A12846CS - Clinical Trials UInit Gartnavel
166881TRANS PARAGON - Translational research in potentially hormone responsive recurrent/metastic gynaecological neoplasms.James PaulCancer Research UK (CRUK)C22375/A13784CS - Clinical Trials UInit Gartnavel