Outcomes that matter to patients: The Geriatric Oncology Surgical Assessment and Functional rEcovery after Surgery (GOSAFE) study—Analysis of 471 patients.

Abstract

11511 Background: Older cancer patients value functional outcomes as much as survival but surgical studies lack functional recovery (FR) data. The international, multicenter GOSAFE study (ClinicalTrials.gov NCT03299270) aims to evaluate patients’ quality of life (QoL)and FR after cancer surgery and to assess predictors of FR. Methods: GOSAFE prospectively collects functional and clinical data before and after major elective cancer surgery on senior adults (≥70 years). Surgical outcomes are recorded (30 days, 90 days, and 180 dayspost-operatively) with QoL(EQ-5D-3L) and FR (Activities of Daily Living (ADL) + Timed Up and Go (TUG) + MiniCog), 28centers are prospectively enrolling patients; accrual ends February 2019. Results: 643 patients underwent major cancer surgery with curative(94%) or palliative (6%) intent (February 2017-September 2018). Median age was 78(range 70-94); 51.6% males, ASA III-IV 52%. Patients dependent (ADL < 5) were 8%. Frailty was detected by G8 > 14 in 32% and fTRST≥2 in 36% of patients. 639 (99%) lived at home, 32% lived alone, and 88% were able to go out. Major comorbidities (CCI > 6) were detected in 36% and 22% had cognitive impairment according to MiniCog (5% self-reported). 26% had > 3 kg weight loss, 30% were hospitalized in the last 90 days, 45% had ≥3 medications (6% none). For 471 patients, a 90-day comprehensive evaluation was available. Postoperative morbidity was 42% (30 day) and 63.3% (90 day), but Clavien-Dindo III-IV complications were only 11.2% and 17.6%. 90-day mortality was 7.4% (5% 30-day). QoL improved 90 days after surgery (mean EQ-5D index from 0.76 to 0.80). Patients with EQ-5D VAS score > 60 raised from 73.9% at baseline to 82.8% at 90 days. 29% had complete FR (ADL score > 4, MiniCog > 2, TUG < 20). Decreased functional capacity was seen in 23.4% of patients alive at 90-days. Conclusions: GOSAFE is the largest prospective study on older cancer patients undergoing major surgery. Interim analysis reports decreased functional capacity in a quarter of patients. The study will allow clinicians to associate clinical outcomes with individual factors of the preoperative assessment and create a user-friendly tool to predict outcomes that matter to patients.