Montroni Isacco, Rostoft Siri, Spinelli Antonino, Van Leeuwen Barbara L, Ercolani Giorgio, Saur Nicole M, Jaklitsch Michael T, Somasundar Ponnandai S, de Liguori Carino Nicola, Ghignone Federico, Foca Flavia, Zingaretti Chiara, Audisio Riccardo A, Ugolini Giampaolo
U.O. Chirurgia Generale, Ospedale "per gli Infermi", Faenza, AUSL Romagna, Italy.
Department of Geriatric Medicine, Oslo University Hospital, University of Oslo, Norway.
J Geriatr Oncol. 2020 Mar;11(2):244-255. doi: 10.1016/j.jgo.2019.06.017. Epub 2019 Sep 3.
Older patients with cancer value functional outcomes as much as survival, but surgical studies lack functional recovery (FR) data. The value of a standardized frailty assessment has been confirmed, yet it's infrequently utilized due to time restrictions into everyday practice. The multicenter GOSAFE study was designed to (1) evaluate the trajectory of patients' quality of life (QoL) after cancer surgery (2) assess baseline frailty indicators in unselected patients (3) clarify the most relevant tools in predicting FR and clinical outcomes. This is a report of the study design and baseline patient evaluations.
MATERIALS & METHODS: GOSAFE prospectively collected a baseline multidimensional evaluation before major elective surgery in patients (≥70 years) from 26 international units. Short-/mid-/long-term surgical outcomes were recorded with QoL and FR data.
1003 patients were enrolled in a 26-month span. Complete baseline data were available for 977(97.4%). Median age was 78 years (range 70-94); 52.8% males. 968(99%) lived at home, 51.6% without caregiver. 54.4% had ≥ 3 medications, 5.9% none. Patients were dependent (ADL < 5) in 7.9% of the cases. Frailty was either detected by G8 ≤ 14(68.4%), fTRST ≥ 2(37.4%), TUG > 20 s (5.2%) or ASAIII-IV (48.8%). Major comorbidities (CACI > 6) were detected in 36%; 20.9% of patients had cognitive impairment according to Mini-Cog.
The GOSAFE showed that frailty is frequent in older patients undergoing cancer surgery. QoL and FR, for the first time, are going to be primary outcomes of a real-life observational study. The crucial role of frailty assessment is going to be addressed in the ability to predict postoperative outcomes and to correlate with QoL and FR.
老年癌症患者对功能结局和生存同样重视，但外科研究缺乏功能恢复（FR）数据。标准化衰弱评估的价值已得到证实，但由于日常实践中的时间限制，其使用并不频繁。多中心GOSAFE研究旨在：（1）评估癌症手术后患者的生活质量（QoL）轨迹；（2）评估未选择患者的基线衰弱指标；（3）明确预测FR和临床结局的最相关工具。这是一份关于研究设计和患者基线评估的报告。
GOSAFE前瞻性收集了来自26个国际单位的患者（≥70岁）在择期大手术前的基线多维评估数据。记录了短期/中期/长期手术结局以及QoL和FR数据。
在26个月的时间跨度内共纳入1003例患者。977例（97.4%）有完整的基线数据。中位年龄为78岁（范围70 - 94岁）；男性占52.8%。968例（99%）居家生活，51.6%无照料者。54.4%的患者服用≥3种药物，5.9%未服药。7.9%的病例患者存在依赖（日常生活活动能力<5）。通过G8≤14（68.4%）、fTRST≥2（37.4%）、定时起立行走测试>20秒（5.2%）或美国麻醉医师协会身体状况分级III - IV级（48.8%）检测到衰弱。36%检测到主要合并症（累积共病指数>6）；根据简易认知评估，20.9%的患者存在认知障碍。
GOSAFE研究表明，接受癌症手术的老年患者中衰弱情况常见。QoL和FR首次成为一项现实生活观察性研究的主要结局。衰弱评估在预测术后结局以及与QoL和FR的相关性方面的关键作用将得到探讨。
