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.
- 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
- 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
- Paragon (ANZGOG-0903): Phase 2 Study of Anastrozole in Women With Estrogen or Progesterone Receptor-Positive Platinum-Resistant or -Refractory Recurrent Ovarian Cancer.
- Authors: Bonaventura A, OʼConnell RL, Mapagu C, Beale PJ, McNally OM, Mileshkin LR, Grant PT, Hadley AM, Goh JCH, Sjoquist KM, Martyn J, DeFazio A, Scurry J, Friedlander ML, Paragon Investigators.
- Issue date: 2017 Jun
- Neoadjuvant treatment of endometrial cancer using anastrozole: a randomised pilot study.
- Authors: Thangavelu A, Hewitt MJ, Quinton ND, Duffy SR
- Issue date: 2013 Dec
- Aromatase inhibitor therapy for endometrial stromal sarcoma - two-centre experience.
- Authors: Serkies K, Abacjew-Chmyłko A, Wieczorek-Rutkowska M, Pęksa R
- Issue date: 2018