Determining the effect of frailty on survival in advanced ovarian cancer: study protocol for a prospective multicentre national cohort study (FOLERO)

Authors

  • Daniel Hunde Department of Women´s and Children´s Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden
  • Niklas Ekerstad Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
  • Mihaela Asp Department of Clinical Science, Division of Obstetrics and Gynecology Lund University, and Department of Obstetrics and Gynecology, Skåne University Hospital, Lund, Sweden
  • Päivi Kannisto Department of Clinical Science, Division of Obstetrics and Gynecology Lund University, and Department of Obstetrics and Gynecology, Skåne University Hospital, Lund, Sweden
  • Madelene Wedin Department of Biomedical and Clinical Sciences Linköping University, and, Department of Obstetrics and Gynecology, Linköping University Hospital, Linköping, Sweden
  • Charlotte Palmqvist Department of Obstetrics and Gynecology , Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, and Department of Gynecology and Obstetrics Sahlgrenska University Hospital, Gothenburg, Sweden
  • Pernilla Dahm-Kähler Department of Obstetrics and Gynecology , Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, and Department of Gynecology and Obstetrics Sahlgrenska University Hospital, Gothenburg, Sweden.
  • Yvonne Brandberg Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden
  • Mirna Abraham-Nordling Department of Molecular Medicine and Surgery, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden
  • Kristina Åhlund University West, Trollhättan, Sweden and NU Hospital Group, Trollhättan-Uddevalla, Sweden
  • Vilhelm Mörlin Department of Women´s and Children´s Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden.
  • Nina Groes-Kofoed Department of Women´s and Children´s Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden
  • Sahar Salehi Department of Women´s and Children´s Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden

DOI:

https://doi.org/10.2340/1651-226X.2025.42292

Keywords:

Frailty, ovarian neoplasm, cytoreductive surgery, survival

Abstract

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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Published

2025-02-05

How to Cite

Hunde, D., Ekerstad, N., Asp, M., Kannisto, P., Wedin, M., Palmqvist, C., … Salehi, S. (2025). Determining the effect of frailty on survival in advanced ovarian cancer: study protocol for a prospective multicentre national cohort study (FOLERO). Acta Oncologica, 64, 208–213. https://doi.org/10.2340/1651-226X.2025.42292

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Vol. 64 (2025): Acta Oncologica

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Short report

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Copyright (c) 2025 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

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