Nguyen Julie My Van, Vicus Danielle, Hogen Liat, Zigras Tiffany, Paré Guillaume, Chong Michael, Benitez Yetiani Roldan, Devereaux P J, Ofori Sandra, Borges Flavia K, Di Sante Emily, Miletic Denise, Panus Olivia, Vincent Jessica, Ramasundarahettige Chinthanie, Nene Sofia, Patel Ameen, Marcucci Maura
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, McMaster University, Hamilton, Ontario, Canada.
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Toronto, Toronto, Ontario, Canada.
PLoS One. 2025 Jul 28;20(7):e0325651. doi: 10.1371/journal.pone.0325651. eCollection 2025.
There is considerable variability in how older adults with cancer tolerate and recover from surgery and systemic treatments. A greater understanding of individual trajectories is crucial in guiding personalized treatment decisions. Frailty may explain these inter-individual differences. Despite emerging evidence on the association between perioperative frailty assessment and outcomes after noncardiac surgery, there is limited data in gynecologic oncology. A perioperative cardiovascular risk assessment, recommended by scientific guidelines, is widely adopted in noncardiac surgery, often as the only standardized perioperative risk stratification approach. While based on robust evidence on the association with cardiovascular complications and overall mortality, it might be insufficient to predict other essential surgical, oncologic and patient-important outcomes.
The FARGO study is a multi-centre prospective cohort study targeting 280 patients aged 55 or older undergoing surgery, with or without chemotherapy, for a suspected or confirmed gynecologic malignancy. The primary objective is to evaluate the predictive value of the Frailty Phenotype measured preoperatively, compared with the currently used perioperative risk assessment (cardiovascular risk assessment based on the Revised Cardiac Risk Index, age, and occurrence of myocardial injury after non-cardiac surgery) in predicting the composite outcome of all-cause death or new disability at six months after surgery. Secondary objectives include comparing the predictive value of the Frailty Phenotype with that of the Clinical Frailty Scale; evaluating the performance of a preoperative frailty assessments on other postoperative complications, chemotherapy tolerance, and 1-year recurrence-free survival; exploring the added predictive value of a dynamic perioperative frailty assessment repeated 28 days after surgery; assessing the acceptability of frailty assessments by physicians and patients; and establishing a biobank to investigate frailty biomarkers.
The findings could have important implications for risk stratification, planning and tailoring surgical and oncologic care for older adults with gynecologic malignancies. Our study emphasizes patient-centered outcomes and stakeholders' perspectives. Trial registration: Clinicaltrials.gov Identifier: NCT05738252.
患有癌症的老年人在耐受手术及全身治疗并从中恢复的过程中存在相当大的差异。更深入地了解个体病程对于指导个性化治疗决策至关重要。虚弱可能解释了这些个体差异。尽管围手术期虚弱评估与非心脏手术后结局之间的关联已有新证据，但妇科肿瘤学方面的数据有限。科学指南推荐的围手术期心血管风险评估在非心脏手术中被广泛采用，通常作为唯一的标准化围手术期风险分层方法。虽然有强有力的证据表明其与心血管并发症和总体死亡率相关，但它可能不足以预测其他重要的手术、肿瘤学及对患者重要的结局。
FARGO研究是一项多中心前瞻性队列研究，目标是280名55岁及以上因疑似或确诊的妇科恶性肿瘤接受手术（无论是否接受化疗）的患者。主要目标是评估术前测量的虚弱表型与当前使用的围手术期风险评估（基于修订心脏风险指数、年龄及非心脏手术后心肌损伤发生情况的心血管风险评估）相比，在预测术后六个月全因死亡或新残疾这一复合结局方面的预测价值。次要目标包括比较虚弱表型与临床虚弱量表的预测价值；评估术前虚弱评估对其他术后并发症、化疗耐受性及1年无复发生存率的预测性能；探索术后28天重复进行的动态围手术期虚弱评估的附加预测价值；评估医生和患者对虚弱评估的可接受性；以及建立生物样本库以研究虚弱生物标志物。
这些发现可能对妇科恶性肿瘤老年患者的风险分层、手术和肿瘤治疗的规划及个体化具有重要意义。我们的研究强调以患者为中心的结局及利益相关者的观点。试验注册：Clinicaltrials.gov标识符：NCT05738252。
