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
AuthorsBanerjee, S. N.
O'Connell, R. L.
Clamp, Andrew R
Mullassery, V. M.
Goh, J. C.
Grant, P. T.
Edmondson, R. J
AffiliationThe Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, United Kingdom.
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AbstractBackground: Hormonal therapies are commonly prescribed to patients with metastatic granulosa cell tumours (GCT), based on high response rates in small retrospective studies. Aromatase inhibitors (AIs) are reported to have high response rates and an accepted treatment option. We report the results of a phase 2 trial of an AI in recurrent/metastatic GCTs. Methods: 41 patients with recurrent ER/PR + ve GCT received anastrozole 1 mg daily until progression or unacceptable toxicity. The primary endpoint was clinical benefit rate (CBR) at 12 weeks, evaluated by RECIST1.1 criteria. Secondary endpoints included progression-free survival (PFS), CBR duration, quality of life and toxicity. Results: The CBR at 12 weeks in 38 evaluable patients was 78.9%, which included one (2.6%; 95% CI: 0.5-13.5%) partial response and 76.3% stable disease. Two additional patients without measurable disease were stable, based on inhibin. Median PFS was 8.6 m (95% CI 5.5-13.5 m). There were delayed responses observed after 12 weeks with a total of 4 pts. (10.5%; 95% CI 4.2%-24.1%) with a RECIST partial response; 23 (59%) patients were progression-free at 6 months. The adverse effects were predominantly low grade. Conclusions: This is the first prospective trial of hormonal therapy in GCTs. Although there was a high CBR, the objective response rate to anastrozole was much lower than the pooled response rates of >70% to AIs reported in most retrospective series and case reports. PARAGON demonstrates the importance of prospective trials in rare cancers and the need to reconsider the role of AIs as single agents in GCTs.
CitationBanerjee SN, Tang M, O’Connell RL, Sjoquist K, Clamp AR, Millan D, et al. 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. Gynecologic Oncology. 2021 Aug.
- 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
- 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
- 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 (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