基于家庭的运动康复在衰弱老年癌症手术后改善无病生存率和恢复预期肿瘤治疗：一项随机试验的二次分析。

Home-based exercise prehabilitation to improve disease-free survival and return to intended oncologic treatment after cancer surgery in older adults with frailty: a secondary analysis of a randomized trial.

机构信息

Department of Anesthesiology and Pain Medicine, Faculty of Medicine, University of Ottawa and The Ottawa Hospital, Ottawa, ON, Canada.

Department of Anesthesiology, The Ottawa Hospital, Ottawa, ON, Canada.

出版信息

Can J Anaesth. 2024 Nov;71(11):1525-1534. doi: 10.1007/s12630-024-02835-w. Epub 2024 Sep 5.

DOI:10.1007/s12630-024-02835-w

PMID:39237725

Abstract

BACKGROUND

Improving survivorship for patients with cancer and frailty is a priority. We aimed to estimate whether exercise prehabilitation improves disease-free survival and return to intended oncologic treatment for older adults with frailty undergoing cancer surgery.

METHODS

We conducted a secondary analysis of the oncologic outcomes of a randomized trial of patients ≥ 60 yr of age with frailty undergoing elective cancer surgery. Participants were randomized either to a supported, home-based exercise program plus nutritional guidance or to usual care. Outcomes for this analysis were one-year disease-free survival and return to intended oncologic treatment. We estimated complier average causal effects to account for intervention adherence.

RESULTS

We randomized 204 participants (102 per arm); 182 were included in our modified intention-to-treat population and, of these participants, 171/182 (94%) had complete one-year follow up. In the prehabilitation group, 18/94 (11%) died or experienced cancer recurrence, compared with 19/88 (11%) in the control group (hazard ratio [HR], 1.25; 95% confidence interval [CI], 0.66 to 2.34; P = 0.49). Return to intended oncologic treatment occurred in 24/94 (29%) patients the prehabilitation group vs 20/88 (23%) in the usual care group (HR, 1.53; 95% CI, 0.84 to 2.77; P = 0.16). Complier average causal effects directionally diverged for disease-free survival (HR, 0.91; 95% CI, 0.20 to 4.08; P = 0.90) and increased the point estimate for return to treatment (HR, 2.04; 95% CI, 0.52 to 7.97; P = 0.30), but in both cases the CIs included 1.

CONCLUSIONS

Randomization to home-based exercise prehabilitation did not lead to significantly better disease-free survival or earlier return to intended oncologic treatment in older adults with frailty undergoing cancer surgery. Our results could inform future trials powered for more plausible effect sizes, especially for the return to intended oncologic treatment outcome.

STUDY REGISTRATION

ClinicalTrials.gov ( NCT02934230 ); first submitted 22 August 2016.

摘要

背景

提高癌症和虚弱患者的生存率是当务之急。我们旨在评估对于接受癌症手术的虚弱老年人，进行锻炼预康复是否可以改善无病生存率并恢复预期的肿瘤治疗。

方法

我们对一项针对 60 岁以上患有虚弱症的择期癌症手术患者的肿瘤结局的随机试验进行了二次分析。参与者被随机分配至接受支持性、家庭为基础的锻炼计划加营养指导，或接受常规护理。本分析的结果是一年无病生存率和恢复预期的肿瘤治疗。我们估计了遵从平均因果效应，以说明干预的依从性。

结果

我们随机分配了 204 名参与者（每组 102 名）；182 名参与者纳入了改良意向治疗人群，其中 171/182 名（94%）完成了为期一年的完整随访。在预康复组中，94 名中有 18 名（11%）死亡或出现癌症复发，而对照组 88 名中有 19 名（11%）（风险比 [HR]，1.25；95%置信区间 [CI]，0.66 至 2.34；P=0.49）。预康复组中，24/94（29%）名患者恢复预期的肿瘤治疗，而对照组 20/88（23%）名（HR，1.53；95% CI，0.84 至 2.77；P=0.16）。无病生存率的遵从平均因果效应呈发散趋势（HR，0.91；95% CI，0.20 至 4.08；P=0.90），并增加了治疗恢复的点估计值（HR，2.04；95% CI，0.52 至 7.97；P=0.30），但在两种情况下，CI 均包含 1。