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): The PARAGON trial (ANZGOG 0903)
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| 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): The PARAGON trial (ANZGOG 0903) |
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| Authors: | Edmondson, R J, O'Connell, R L, 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 |
| Contributors: | The University of Newcastle. College of Health, Medicine & Wellbeing, School of Medicine and Public Health |
| Source: | PARAGON investigators 2021, '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)', Gynecologic Oncology, vol. 163, no. 3, pp. 524-530. https://doi.org/10.1016/j.ygyno.2021.09.010 |
| Publisher Information: | Elsevier BV, 2021. |
| Publication Year: | 2021 |
| Subject Terms: | Adult, Leiomyosarcoma, 0301 basic medicine, Carcinosarcoma/drug therapy, Receptors, Progesterone/metabolism, Sustainable Development Goals, Anastrozole, uterine carcinosarcoma, uterine leiomyosarcoma, 03 medical and health sciences, 0302 clinical medicine, Carcinosarcoma, Uterine Neoplasms/drug therapy, Uterine leiomyosarcoma, Receptors, 80 and over, Humans, Prospective Studies, Neoplasm Metastasis, SDG 3, Aged, Aged, 80 and over, Manchester Cancer Research Centre, Uterine carcinosarcoma, Aromatase Inhibitors, Leiomyosarcoma/drug therapy, Anastrozole/adverse effects, Aromatase inhibitor, Middle Aged, ResearchInstitutes_Networks_Beacons/mcrc, name=Manchester Cancer Research Centre, 3. Good health, Receptors, Estrogen, aromatase inhibitor, Uterine Neoplasms, Quality of Life, Progesterone/metabolism, Female, Aromatase Inhibitors/adverse effects, Estrogen/metabolism, Receptors, Estrogen/metabolism, Receptors, Progesterone |
| Description: | 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.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.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.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. |
| Document Type: | Article |
| Language: | English |
| ISSN: | 0090-8258 |
| DOI: | 10.1016/j.ygyno.2021.09.010 |
| Access URL: | https://pubmed.ncbi.nlm.nih.gov/34625284 https://research.manchester.ac.uk/en/publications/a4447fca-4b40-4043-bd44-5f411c01edde https://doi.org/10.1016/j.ygyno.2021.09.010 https://chesterrep.openrepository.com/handle/10034/626171 https://www.sciencedirect.com/science/article/pii/S0090825821013792 https://pubmed.ncbi.nlm.nih.gov/34625284/ https://www.gynecologiconcology-online.net/article/S0090-8258(21)01379-2/fulltext |
| Rights: | Elsevier TDM |
| Accession Number: | edsair.doi.dedup.....cba7b35a6e1ebaef5e1a84e8b74a3377 |
| Database: | OpenAIRE |
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Nájsť tento článok vo Web of Science | Abstract: | 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.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.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.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. |
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| ISSN: | 00908258 |
| DOI: | 10.1016/j.ygyno.2021.09.010 |