Linda Mileshkin1, Richard Edmondson2, Rachel L O'Connell3, Katrin M Sjoquist3, John Andrews3, Rema Jyothirmayi4, Philip Beale5, Tony Bonaventura6, Jeffrey Goh7, Marcia Hall8, Andrew Clamp9, John Green10, Rosemary Lord10, Frédéric Amant11, Laura Alexander12, Karen Carty12, James Paul12, James Scurry6, David Millan13, Steven Nottley13, Michael Friedlander14. 1. Peter MacCallum Cancer Centre, The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia. Electronic address: Linda.Mileshkin@petermac.org. 2. Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, St Mary's Hospital, Manchester, UK; Department of Obstetrics and Gynaecology, Manchester Academic Health Science Centre, St Mary's Hospital, Central Manchester NHS Foundation Trust, Manchester Academic Health Science Centre, Level 5, Research, Oxford Road, Manchester, UK. 3. NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia. 4. Maidstone Hospital, Kent, UK. 5. Chris O'Brien Lifehouse, Sydney, NSW, Australia. 6. Pathology New South Wales, Hunter New England and Faculty of Health and Medicine, University of Newcastle, Newcastle, NSW, Australia. 7. Royal Brisbane and Women's Hospital, Brisbane, Australia. 8. Mount Vernon Cancer Centre, Middlesex, UK. 9. The Christie NHS Foundation Trust, Manchester, UK. 10. The Clatterbridge Cancer Centre, Liverpool and Wirral, UK. 11. Division of Gynecologic Oncology, University Hospitals Gasthuisberg, Leuven, Belgium. 12. Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, UK. 13. Queen Elizabeth University Hospital, Glasgow, Scotland, UK. 14. Royal Hospital for Women, Prince of Wales Hospital and Prince of Wales Clinical School, University of New South Wales, Sydney, Australia.
Abstract
BACKGROUND: The clinical benefit rate with aromatase inhibitors and the impact of treatment on quality of life (QOL) in endometrial cancer is unclear. We report the results of a phase 2 trial of anastrozole in endometrial cancer. METHODS: Investigator initiated single-arm, open label trial of anastrozole, 1 mg/d in patients with ER and/or PR positive hormonal therapy naive metastatic endometrial cancer. Patients were treated until progressive disease (PD) or unacceptable toxicity. The primary end-point was clinical benefit (response + stable disease) at 3 months. Secondary endpoints include progression-free survival (PFS), quality of life (QOL) and toxicity. RESULTS: Clinical benefit rate in 82 evaluable patients at 3 months was 44% (95% CI: 34-55%) with a best response by RECIST of partial response in 6 pts. (7%; 95% CI: 3-15%). The median PFS was 3.2 months (95% CI: 2.8-5.4). Median duration of clinical benefit was 5.6 months (95% CI: 3.0-13.7). Treatment was well tolerated. Patients who had clinical benefit at 3 months reported clinically significant improvements in several QOL domains compared to those with PD; this was evident by 2 months including improvements in: emotional functioning (39 vs 6%: p = 0.002), cognitive functioning (45 vs 19%: p = 0.021), fatigue (47 vs 19%: p = 0.015) and global health status (42 vs 9%: p = 0.003). CONCLUSION: Although the objective response rate to anastrozole was relatively low, clinical benefit was observed in 44% of patients with ER/PR positive metastatic endometrial cancer and associated with an improvement in QOL.
BACKGROUND: The clinical benefit rate with aromatase inhibitors and the impact of treatment on quality of life (QOL) in endometrial cancer is unclear. We report the results of a phase 2 trial of anastrozole in endometrial cancer. METHODS: Investigator initiated single-arm, open label trial of anastrozole, 1 mg/d in patients with ER and/or PR positive hormonal therapy naive metastatic endometrial cancer. Patients were treated until progressive disease (PD) or unacceptable toxicity. The primary end-point was clinical benefit (response + stable disease) at 3 months. Secondary endpoints include progression-free survival (PFS), quality of life (QOL) and toxicity. RESULTS: Clinical benefit rate in 82 evaluable patients at 3 months was 44% (95% CI: 34-55%) with a best response by RECIST of partial response in 6 pts. (7%; 95% CI: 3-15%). The median PFS was 3.2 months (95% CI: 2.8-5.4). Median duration of clinical benefit was 5.6 months (95% CI: 3.0-13.7). Treatment was well tolerated. Patients who had clinical benefit at 3 months reported clinically significant improvements in several QOL domains compared to those with PD; this was evident by 2 months including improvements in: emotional functioning (39 vs 6%: p = 0.002), cognitive functioning (45 vs 19%: p = 0.021), fatigue (47 vs 19%: p = 0.015) and global health status (42 vs 9%: p = 0.003). CONCLUSION: Although the objective response rate to anastrozole was relatively low, clinical benefit was observed in 44% of patients with ER/PR positive metastatic endometrial cancer and associated with an improvement in QOL.
Authors: Nicole Concin; Carien L Creutzberg; Ignace Vergote; David Cibula; Mansoor Raza Mirza; Simone Marnitz; Jonathan A Ledermann; Tjalling Bosse; Cyrus Chargari; Anna Fagotti; Christina Fotopoulou; Antonio González-Martín; Sigurd F Lax; Domenica Lorusso; Christian Marth; Philippe Morice; Remi A Nout; Dearbhaile E O'Donnell; Denis Querleu; Maria Rosaria Raspollini; Jalid Sehouli; Alina E Sturdza; Alexandra Taylor; Anneke M Westermann; Pauline Wimberger; Nicoletta Colombo; François Planchamp; Xavier Matias-Guiu Journal: Virchows Arch Date: 2021-02 Impact factor: 4.064
Authors: Heidi Rütten; Cornelia Verhoef; Willem Jan van Weelden; Anke Smits; Joëlle Dhanis; Nelleke Ottevanger; Johanna M A Pijnenborg Journal: Cancers (Basel) Date: 2021-12-14 Impact factor: 6.639