Phase 2 study of anastrozole in patients with estrogen receptor/progesterone receptor positive recurrent low-grade endometrial stromal sarcomas: The PARAGON trial (ANZGOG 0903)
O'Connell, R. L.
Clamp, Andrew R
AffiliationRoyal Hospital for Women/Prince of Wales Hospital and Prince of Wales Clinical School, University of New South Wales, Sydney, Australia
MetadataShow full item record
AbstractBackground: Aromatase inhibitors are standard of care for low-grade endometrial stromal sarcomas (LGESS), based on very high response rates reported in retrospective studies. We evaluated the activity of anastrozole in recurrent/metastatic LGESS patients enrolled in PARAGON, a basket trial of anastrozole in estrogen receptor (ER±)/progesterone receptor (PR+) gynecological cancers. Method: An investigator-initiated, single-arm, prospective open-label trial of anastrozole 1 mg/day in patients with ER ± PR + ve LGESS with measurable disease, treated until progressive disease or unacceptable toxicity. Primary endpoint was clinical benefit (complete/partial response + stable disease) rate (CBR) at 3 months. Secondary endpoints include progression-free survival (PFS), quality of life and toxicity. Results: 15 eligible patients were enrolled. CBR at 3 months was 73% (95% CI: 48-89.1%); unchanged at 6 months. Best response was 26.7%, including complete response in one (6.7%; 95% CI 1.2-29.8%), partial response in three (20%, 95% CI 7.1-45.2%) and stable disease in seven (46.7%). Four patients ceased treatment by 3 months due to progression. Median PFS was not reached (25th percentile: 2.9 months (95% CI: 1.2-NR)). PFS was 73.3%, 73.3% and 66% at 6, 12, and 18 months, respectively. Six patients remained on treatment for an average of 44.2 months (range 34.5-63.6) up until data cut. Toxicity was as expected, with 3 patients stopping due to adverse effects. Conclusion: The 26.7% objective response rate with anastrozole is lower than reported in retrospective series, but the CBR was high and durable. The results underscore the importance of prospective trials in rare cancers.
CitationFriedlander M, Benson C, O'Connell RL, Reed N, Clamp A, Lord R, et al. Phase 2 study of anastrozole in patients with estrogen receptor/progesterone receptor positive recurrent low-grade endometrial stromal sarcomas: The PARAGON trial (ANZGOG 0903). Gynecol Oncol. 2021;161(1):160-5.
- 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 Aug 16
- Phase 2 study of anastrozole in recurrent estrogen (ER)/progesterone (PR) positive endometrial cancer: The PARAGON trial - ANZGOG 0903.
- Authors: Mileshkin L, Edmondson R, O'Connell RL, Sjoquist KM, 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, Friedlander M, PARAGON study group.
- Issue date: 2019 Jul
- 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: 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): 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