Hunde Daniel, Ekerstad Niklas, Asp Mihaela, Kannisto Päivi, Wedin Madelene, Palmqvist Charlotte, Dahm-Kähler Pernilla, Brandberg Yvonne, Abraham-Nordling Mirna, Åhlund Kristina, Mörlin Vilhelm, Groes-Kofoed Nina, Salehi Sahar
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.
Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
Acta Oncol. 2025 Feb 5;64:208-213. doi: 10.2340/1651-226X.2025.42292.
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.
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.
ClinicalTrials.gov NCT06298877.
我们的研究结果显示，减瘤手术对一部分未知的晚期卵巢癌女性患者无效甚至有害，因此迫切需要改进晚期卵巢癌手术治疗的患者选择。随着人口老龄化，瑞典30%的晚期卵巢癌女性年龄超过75岁。然而，尽管在公共集中医疗环境中对未经过筛选的人群进行治疗，但目前尚无关于患者选择的建议。尽管虚弱评估有可能对不良结局和死亡风险进行分层，但肿瘤学领域对其关注甚少。因此，我们假设虚弱是生存不良的一个预测因素。
在这项瑞典多中心前瞻性队列研究中，暴露因素为虚弱，计划进行根治性手术的连续晚期卵巢癌女性患者符合纳入条件。术前对三种不同的虚弱评估工具进行评估，评估人员对护理人员保密。主要结局是2年总生存率。在固定样本量为450例患者、双侧α为0.05、β为0.20的情况下，假设虚弱患病率为20%，该研究有能力检测出因虚弱导致的2年生存率差异为12.5%。该研究结果预计具有较高的外部效度，将对临床管理和患者选择产生直接影响。研究总时长为5年，入组时间为3年。所有参与中心于2024年9月开始入组。预计2029年公布主要结局数据。
ClinicalTrials.gov NCT06298877
