Phase 2 study of anastrozole in recurrent estrogen (ER)/progesterone (PR) positive endometrial cancer: the PARAGON trial - ANZGOG 0903
Clamp, Andrew R
AffiliationPeter MacCallum Cancer Centre, The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia
MetadataShow full item record
AbstractBACKGROUND: 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.
CitationMileshkin 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.
- Phase 2 study of anastrozole in patients with estrogen receptor/progesterone receptor positive recurrent low-grade endometrial stromal sarcomas: The PARAGON trial (ANZGOG 0903).
- Authors: Friedlander M, Benson C, O'Connell RL, Reed N, Clamp A, Lord R, Millan D, Nottley S, Amant F, Steer C, Anand A, Mileshkin L, Beale P, Banerjee S, Bradshaw N, Kelly C, Carty K, Divers L, Alexander L, Edmondson R
- Issue date: 2021 Apr
- PARAGON: A Phase II study of anastrozole in patients with estrogen receptor-positive recurrent/metastatic low-grade ovarian cancers and serous borderline ovarian tumors.
- Authors: Tang M, O'Connell RL, Amant F, Beale P, McNally O, Sjoquist KM, Grant P, Davis A, Sykes P, Mileshkin L, Moujaber T, Kennedy CJ, deFazio A, Tan K, Antill Y, Goh J, Bonaventura T, Scurry J, Friedlander M
- Issue date: 2019 Sep
- Phase 2 study of anastrozole in rare cohorts of patients with estrogen receptor/progesterone receptor positive leiomyosarcomas and carcinosarcomas of the uterine corpus: The PARAGON trial (ANZGOG 0903).
- Authors: Edmondson RJ, O'Connell RL, Banerjee S, Mileshkin L, Sykes P, Beale P, Fisher A, Bonaventura A, Millan D, Nottley S, Benson C, Hamilton A, Sjoquist K, Alexander L, Kelly C, Carty K, Divers L, Bradshaw N, Friedlander M, PARAGON investigators
- Issue date: 2021 Dec
- PARAGON (ANZGOG-0903): a phase 2 study of anastrozole in asymptomatic patients with estrogen and progesterone receptor-positive recurrent ovarian cancer and CA125 progression.
- Authors: Kok PS, Beale P, O'Connell RL, Grant P, Bonaventura T, Scurry J, Antill Y, Goh J, Sjoquist K, DeFazio A, Mapagu C, Amant F, Friedlander M, PARAGON Investigators
- Issue date: 2019 Sep
- A phase 2 study of anastrozole in patients with oestrogen receptor and/progesterone receptor positive recurrent/metastatic granulosa cell tumours/sex-cord stromal tumours of the ovary: The PARAGON/ANZGOG 0903 trial.
- Authors: Banerjee SN, Tang M, O'Connell RL, Sjoquist K, Clamp AR, Millan D, Nottley S, Lord R, Mullassery VM, Hall M, Gourley C, Bonaventura T, Goh JC, Sykes P, Grant PT, McNally O, Alexander L, Kelly C, Carty K, Divers L, Bradshaw N, Edmondson RJ, Friedlander M, PARAGON investigators
- Issue date: 2021 Oct