- Title
- Phase 2 study of anastrozole in recurrent estrogen (ER)/progesterone (PR) positive endometrial cancer: the PARAGON trial – ANZGOG 0903
- Creator
- Mileshkin, Linda; Edmondson, Richard; O'Connell, Rachel L.; Sjoquist, Katrin M.; Andrews, John; Jyothirmayi, Rema; Beale, Philip; Bonaventura, Tony; Goh, Jeffrey; Hall, Marcia; Clamp, Andrew; Green, John; Lord, Rosemary; Amant, Frédéric; Alexander, Laura; Carty, Karen; Paul, James; Scurry, James; Millan, David; Nottley, Steven; Friedlander, Michael
- Relation
- Gynecologic Oncology Vol. 154, Issue 1, p. 29-37
- Publisher Link
- http://dx.doi.org/10.1016/j.ygyno.2019.05.007
- Publisher
- Academic Press
- Resource Type
- journal article
- Date
- 2019
- Description
- 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.
- Subject
- endometrial cancer; quality of life; aromatase inhibitor; clinical trial; SDG 3; Sustainable Development Goals
- Identifier
- http://hdl.handle.net/1959.13/1459108
- Identifier
- uon:45582
- Identifier
- ISSN:0090-8258
- Language
- eng
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