Monica Tang1, Rachel L O'Connell2, Frederic Amant3, Philip Beale4, Orla McNally5, Katrin M Sjoquist2, Peter Grant6, Alison Davis7, Peter Sykes8, Linda Mileshkin9, Tania Moujaber10, Catherine J Kennedy11, Anna deFazio11, King Tan12, Yoland Antill13, Jeffrey Goh14, Tony Bonaventura15, James Scurry16, Michael Friedlander17. 1. NHMRC Clinical Trials Centre, The University of Sydney, Levels 4-6 Medical Foundation Building, 92-94 Parramatta Rd, Camperdown, NSW 2050, Australia. Electronic address: monica.tang@unsw.edu.au. 2. NHMRC Clinical Trials Centre, The University of Sydney, Levels 4-6 Medical Foundation Building, 92-94 Parramatta Rd, Camperdown, NSW 2050, Australia. 3. Department of Oncology, University of Leuven, Oude Markt 13, 3000 Leuven, Belgium; Centre for Gynaecologic Oncology, Netherlands Cancer Institute and Amsterdam Medical Centres, Plesmanlaan 121, 1066, CX, Amsterdam, Netherlands. 4. Concord Repatriation General Hospital, Hospital Rd, Concord, NSW 2139, Australia. 5. Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, VIC 3000, Australia; Royal Women's Hospital, 20 Flemington Rd, Parkville, VIC 3052, Australia; University of Melbourne, Parkville, VIC 3010, Australia. 6. University of Melbourne, Parkville, VIC 3010, Australia; Mercy Hospital for Women, 163 Studley Rd, Heidelberg, VIC 3084, Australia. 7. The Canberra Hospital, Yamba Dr, Woden, ACT 2606, Australia; Australian National University, Canberra, ACT 0200, Australia. 8. University of Otago Christchurch, Christchurch Women's Hospital, 2 Riccarton Ave, Christchurch Central, Christchurch 8011, New Zealand. 9. Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, VIC 3000, Australia; Royal Women's Hospital, 20 Flemington Rd, Parkville, VIC 3052, Australia; University of Melbourne, Parkville, VIC 3010, Australia; Mercy Hospital for Women, 163 Studley Rd, Heidelberg, VIC 3084, Australia. 10. The Westmead Institute for Medical Research, The University of Sydney, 176 Hawkesbury Rd, Westmead, NSW 2145, Australia. 11. The Westmead Institute for Medical Research, The University of Sydney, 176 Hawkesbury Rd, Westmead, NSW 2145, Australia; Department of Gynaecological Oncology, Westmead Hospital, Hawkesbury Rd, Westmead, NSW 2145, Australia. 12. NSW Health Pathology, The Institute for Clinical Pathology and Medical Research (ICPMR), Westmead Hospital, Darcy Rd, Westmead, NSW 2145, Australia. 13. Frankston Hospital, Hastings Rd, Frankston, VIC 3199, Australia. 14. Royal Brisbane and Women's Hospital, Bowen Bridge Rd and Butterfield St, Herston, QLD 4029, Australia; University of Queensland, St Lucia, QLD 4072, Australia. 15. Calvary Mater Newcastle, Edith St and Platt St, Waratah, NSW 2298, Australia. 16. Pathology New South Wales, Hunter New England, Lookout Rd, New Lambton Heights, NSW 2305, Australia; Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia. 17. Prince of Wales Clinical School, UNSW Sydney, NSW 2052, Australia; Royal Hospital for Women, Barker St, Randwick, NSW 2031, Australia.
Abstract
OBJECTIVE: Treatment options are limited for patients with recurrent/metastatic low-grade ovarian cancers (LGOCs) and serous borderline ovarian tumors (SBOTs) as response rates to chemotherapy are low. A subset of patients appears to derive clinical benefit from antiestrogens, but most studies have been retrospective and clinical benefit rates (CBR) remain uncertain. The primary aim of PARAGON was to prospectively investigate the CBR of anastrozole, an aromatase inhibitor, in patients with estrogen receptor (ER) and/or progesterone receptor (PR) positive LGOC and SBOT. METHODS: Post-menopausal women with ER-positive and/or PR-positive recurrent/metastatic LGOCs and SBOTs and evaluable disease by RECIST v1.1 or GCIG CA125 criteria were treated with anastrozole 1 mg daily until progression or unacceptable toxicity. RESULTS: Thirty-six patients were enrolled. Clinical benefit at 3 months (primary endpoint) was observed in 23 patients (64%, 95% CI 48%-78%) and was similar at 6 months (61%, 95% CI 43%-75%). The median duration of clinical benefit was 9.5 months (95% CI 8.3-25.8). Best study response was partial response by RECIST in 5 patients (14%), stable disease in 18 patients (50%) with progressive disease in 13 patients (36%). Median PFS was 11.1 months (95% CI 3.2-11.9). Anastrozole was well-tolerated. Patients with evidence of clinical benefit at 3 months reported less pain, fatigue, and improved physical and role functioning as early as 1 month of commencing treatment. CONCLUSIONS: Anastrozole was associated with a CBR of 61% of patients with recurrent ER-positive and/or PR-positive LGOC or SBOT for at least 6 months with acceptable toxicity.
OBJECTIVE: Treatment options are limited for patients with recurrent/metastatic low-grade ovarian cancers (LGOCs) and serous borderline ovarian tumors (SBOTs) as response rates to chemotherapy are low. A subset of patients appears to derive clinical benefit from antiestrogens, but most studies have been retrospective and clinical benefit rates (CBR) remain uncertain. The primary aim of PARAGON was to prospectively investigate the CBR of anastrozole, an aromatase inhibitor, in patients with estrogen receptor (ER) and/or progesterone receptor (PR) positive LGOC and SBOT. METHODS: Post-menopausal women with ER-positive and/or PR-positive recurrent/metastatic LGOCs and SBOTs and evaluable disease by RECIST v1.1 or GCIG CA125 criteria were treated with anastrozole 1 mg daily until progression or unacceptable toxicity. RESULTS: Thirty-six patients were enrolled. Clinical benefit at 3 months (primary endpoint) was observed in 23 patients (64%, 95% CI 48%-78%) and was similar at 6 months (61%, 95% CI 43%-75%). The median duration of clinical benefit was 9.5 months (95% CI 8.3-25.8). Best study response was partial response by RECIST in 5 patients (14%), stable disease in 18 patients (50%) with progressive disease in 13 patients (36%). Median PFS was 11.1 months (95% CI 3.2-11.9). Anastrozole was well-tolerated. Patients with evidence of clinical benefit at 3 months reported less pain, fatigue, and improved physical and role functioning as early as 1 month of commencing treatment. CONCLUSIONS:Anastrozole was associated with a CBR of 61% of patients with recurrent ER-positive and/or PR-positive LGOC or SBOT for at least 6 months with acceptable toxicity.
Authors: David M Gershenson; Austin Miller; William E Brady; James Paul; Karen Carty; William Rodgers; David Millan; Robert L Coleman; Kathleen N Moore; Susana Banerjee; Kate Connolly; Angeles Alvarez Secord; David M O'Malley; Oliver Dorigo; Stephanie Gaillard; Hani Gabra; Brian Slomovitz; Parviz Hanjani; John Farley; Michael Churchman; Ailith Ewing; Robert L Hollis; C Simon Herrington; Helen Q Huang; Lari Wenzel; Charlie Gourley Journal: Lancet Date: 2022-02-05 Impact factor: 202.731
Authors: Gerardo Colon-Otero; Valentina Zanfagnin; Xiaonan Hou; Nathan R Foster; Erik J Asmus; Andrea Wahner Hendrickson; Aminah Jatoi; Matthew S Block; Carrie L Langstraat; Gretchen E Glaser; Tri A Dinh; Matthew W Robertson; John K Camoriano; Kristina A Butler; John A Copland; S John Weroha Journal: ESMO Open Date: 2020-10