- Title
- 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)
- Creator
- Edmondson, R. J.; O'Connell, R. L.; Benson, C.; Hamilton, A.; Sjoquist, K.; Alexander, L.; Kelly, C.; Carty, K.; Divers, L.; Bradshaw, N.; Friedlander, M.; Banerjee, S.; Mileshkin, L.; Sykes, P.; Beale, P.; Fisher, A.; Bonaventura, A.; Millan, D.; Nottley, S.
- Relation
- Gynecologic Oncology Vol. 163, Issue 3, p. 524-530
- Publisher Link
- http://dx.doi.org/10.1016/j.ygyno.2021.09.010
- Publisher
- Academic Press
- Resource Type
- journal article
- Date
- 2021
- Description
- Background: Aromatase inhibitors have been used empirically to treat a subset of patients with hormone receptor positive uterine leiomyosarcomas(LMS) and carcinosarcomas (UCS) mainly supported by retrospective data. We evaluated the activity of anastrozole in two rare cohorts; patients with recurrent/metastatic LMS and UCS enrolled in PARAGON, a basket trial of anastrozole in estrogen receptor (ER+)/progesterone receptor positive (PR+) gynecological cancers. Method: An investigator-initiated, single-arm, prospective open-label trial of anastrozole 1 mg/day in patients with ER &/or PR + ve LMS or UCS with measurable disease, treated until progression 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: 39 eligible patients were enrolled, 32 with LMS and 7 with UCS. For the LMS cohort CBR at 3 months was 35% (95% CI: 21–53%) with a median duration of clinical benefit of 5.8 months. Best response was a partial response in one patient. Two patients remained on treatment for more than one year. The median progression-free survival was 2.8 months (95% CI: 2.6–4.9). For the UCS cohort CBR at 3 months was 43% (95% CI: 16–75%) with a median duration of clinical benefit of 5.6 months. Stable disease was seen in 3 patients but no objective responses were seen. The median progression-free survival was 2.7 months (95% CI, 1.1–8.2). Safety was acceptable with 5/39 evaluable patients showing grade 3 toxicities. Conclusion: Whilst objective response rates with anastrozole are low, the clinical benefit rate and good tolerance suggests that aromatase inhibitor therapy may have a role in a subset of patients with metastatic LMS and UCS.
- Subject
- aromatase inhibitor; uterine leiomyosarcoma; uterine carcinosarcoma; SDG 3; Sustainable Development Goals
- Identifier
- http://hdl.handle.net/1959.13/1467729
- Identifier
- uon:47888
- Identifier
- ISSN:0090-8258
- Language
- eng
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