Determining the effect of frailty on survival in advanced ovarian cancer: study protocol for a prospective multicentre national cohort study (FOLERO)
Background and purpose: There is an urgent need to improve patient-selection to surgical treatment in advanced ovarian cancer as our results showed that cytoreductive surgery was without effect or even detrimental in a yet unknown subgroup of women. With an ageing population, 30% of women with advan...
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Medical Journals Sweden
2025-02-01
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| Series: | Acta Oncologica |
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| Online Access: | https://medicaljournalssweden.se/actaoncologica/article/view/42292 |
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| author | Daniel Hunde Niklas Ekerstad Mihaela Asp Päivi Kannisto Madelene Wedin Charlotte Palmqvist Pernilla Dahm-Kähler Yvonne Brandberg Mirna Abraham-Nordling Kristina Åhlund Vilhelm Mörlin Nina Groes-Kofoed Sahar Salehi |
| author_facet | Daniel Hunde Niklas Ekerstad Mihaela Asp Päivi Kannisto Madelene Wedin Charlotte Palmqvist Pernilla Dahm-Kähler Yvonne Brandberg Mirna Abraham-Nordling Kristina Åhlund Vilhelm Mörlin Nina Groes-Kofoed Sahar Salehi |
| author_sort | Daniel Hunde |
| collection | DOAJ |
| description | Background and purpose: There is an urgent need to improve patient-selection to surgical treatment in advanced ovarian cancer as our results showed that cytoreductive surgery was without effect or even detrimental in a yet unknown subgroup of women. With an ageing population, 30% of women with advanced ovarian cancer in Sweden are >75 years. Nevertheless, there are no recommendations on patient-selection, albeit treating an unselected population in a public and centralized health care setting. Little attention has been placed on frailty assessments in oncology, despite their potential to stratify the risk of adverse outcome and mortality. Consequently, we hypothesize that frailty is a predictor of poor survival.
Patients and methods: In this Swedish multi-centre prospective cohort study, where the exposure is frailty, consecutive women with advanced ovarian cancer scheduled for surgery with curative intent are eligible for inclusion. Three different frailty instruments are evaluated preoperatively, blinded to the caregiver. The primary outcome is 2-year overall survival. With a fixed sample size of 450 patients, a two-sided α of 0.05 and β of 0.20, the study is powered to detect a difference in 2-year survival of 12.5% by frailty, assuming a 20% prevalence of frailty.
The result of the study will have a direct impact on clinical management and patient-selection as the results are expected to have a high external validity.
Total study-time is 5 years, with 3 years of accrual. All participating centres started accrual by September 2024. Presentation of data on primary outcome is expected 2029.
Study registration: ClinicalTrials.gov NCT06298877
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| format | Article |
| id | doaj-art-18091a3891b143798292a4feb02e2656 |
| institution | Kabale University |
| issn | 1651-226X |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Medical Journals Sweden |
| record_format | Article |
| series | Acta Oncologica |
| spelling | doaj-art-18091a3891b143798292a4feb02e26562025-02-05T14:28:04ZengMedical Journals SwedenActa Oncologica1651-226X2025-02-016410.2340/1651-226X.2025.42292Determining the effect of frailty on survival in advanced ovarian cancer: study protocol for a prospective multicentre national cohort study (FOLERO)Daniel Hunde0Niklas Ekerstad1Mihaela Asp2Päivi Kannisto3Madelene Wedin4Charlotte Palmqvist5Pernilla Dahm-Kähler6Yvonne Brandberg7Mirna Abraham-Nordling8Kristina Åhlund9Vilhelm Mörlin10Nina Groes-Kofoed11Sahar Salehi12Department of Women´s and Children´s Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, SwedenDepartment of Health, Medicine and Caring Sciences, Linköping University, Linköping, SwedenDepartment of Clinical Science, Division of Obstetrics and Gynecology Lund University, and Department of Obstetrics and Gynecology, Skåne University Hospital, Lund, SwedenDepartment of Clinical Science, Division of Obstetrics and Gynecology Lund University, and Department of Obstetrics and Gynecology, Skåne University Hospital, Lund, SwedenDepartment of Biomedical and Clinical Sciences Linköping University, and, Department of Obstetrics and Gynecology, Linköping University Hospital, Linköping, SwedenDepartment of Obstetrics and Gynecology , Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, and Department of Gynecology and Obstetrics Sahlgrenska University Hospital, Gothenburg, SwedenDepartment of Obstetrics and Gynecology , Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, and Department of Gynecology and Obstetrics Sahlgrenska University Hospital, Gothenburg, Sweden.Department of Oncology and Pathology, Karolinska Institutet, Stockholm, SwedenDepartment of Molecular Medicine and Surgery, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, SwedenUniversity West, Trollhättan, Sweden and NU Hospital Group, Trollhättan-Uddevalla, SwedenDepartment of Women´s and Children´s Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden.Department of Women´s and Children´s Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, SwedenDepartment of Women´s and Children´s Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, SwedenBackground and purpose: There is an urgent need to improve patient-selection to surgical treatment in advanced ovarian cancer as our results showed that cytoreductive surgery was without effect or even detrimental in a yet unknown subgroup of women. With an ageing population, 30% of women with advanced ovarian cancer in Sweden are >75 years. Nevertheless, there are no recommendations on patient-selection, albeit treating an unselected population in a public and centralized health care setting. Little attention has been placed on frailty assessments in oncology, despite their potential to stratify the risk of adverse outcome and mortality. Consequently, we hypothesize that frailty is a predictor of poor survival. Patients and methods: In this Swedish multi-centre prospective cohort study, where the exposure is frailty, consecutive women with advanced ovarian cancer scheduled for surgery with curative intent are eligible for inclusion. Three different frailty instruments are evaluated preoperatively, blinded to the caregiver. The primary outcome is 2-year overall survival. With a fixed sample size of 450 patients, a two-sided α of 0.05 and β of 0.20, the study is powered to detect a difference in 2-year survival of 12.5% by frailty, assuming a 20% prevalence of frailty. The result of the study will have a direct impact on clinical management and patient-selection as the results are expected to have a high external validity. Total study-time is 5 years, with 3 years of accrual. All participating centres started accrual by September 2024. Presentation of data on primary outcome is expected 2029. Study registration: ClinicalTrials.gov NCT06298877 https://medicaljournalssweden.se/actaoncologica/article/view/42292Frailtyovarian neoplasmcytoreductive surgerysurvival |
| spellingShingle | Daniel Hunde Niklas Ekerstad Mihaela Asp Päivi Kannisto Madelene Wedin Charlotte Palmqvist Pernilla Dahm-Kähler Yvonne Brandberg Mirna Abraham-Nordling Kristina Åhlund Vilhelm Mörlin Nina Groes-Kofoed Sahar Salehi Determining the effect of frailty on survival in advanced ovarian cancer: study protocol for a prospective multicentre national cohort study (FOLERO) Acta Oncologica Frailty ovarian neoplasm cytoreductive surgery survival |
| title | Determining the effect of frailty on survival in advanced ovarian cancer: study protocol for a prospective multicentre national cohort study (FOLERO) |
| title_full | Determining the effect of frailty on survival in advanced ovarian cancer: study protocol for a prospective multicentre national cohort study (FOLERO) |
| title_fullStr | Determining the effect of frailty on survival in advanced ovarian cancer: study protocol for a prospective multicentre national cohort study (FOLERO) |
| title_full_unstemmed | Determining the effect of frailty on survival in advanced ovarian cancer: study protocol for a prospective multicentre national cohort study (FOLERO) |
| title_short | Determining the effect of frailty on survival in advanced ovarian cancer: study protocol for a prospective multicentre national cohort study (FOLERO) |
| title_sort | determining the effect of frailty on survival in advanced ovarian cancer study protocol for a prospective multicentre national cohort study folero |
| topic | Frailty ovarian neoplasm cytoreductive surgery survival |
| url | https://medicaljournalssweden.se/actaoncologica/article/view/42292 |
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