澳大利亚癌症患者开始全身抗癌治疗时的综合老年评估和治疗效果（INTEGERATE）：一项多中心、开放标签、随机对照试验。

Integrated Geriatric Assessment and Treatment Effectiveness (INTEGERATE) in older people with cancer starting systemic anticancer treatment in Australia: a multicentre, open-label, randomised controlled trial.

机构信息

Eastern Health Clinical School, Monash University, Box Hill, VIC, Australia; Cancer Services, Eastern Health, Box Hill, VIC, Australia; Aged Medicine Program, Eastern Health, Box Hill, VIC, Australia.

School of Psychology, University of Sydney, Sydney, NSW, Australia.

出版信息

Lancet Healthy Longev. 2022 Sep;3(9):e617-e627. doi: 10.1016/S2666-7568(22)00169-6. Epub 2022 Aug 22.

DOI:10.1016/S2666-7568(22)00169-6

PMID:36102776

Abstract

BACKGROUND

The effectiveness of comprehensive geriatric assessment (CGA) in improving health outcomes in cancer settings is unclear. We evaluated whether CGA can improve health-related quality of life (HRQOL) in older people with cancer who are starting systemic anticancer treatment.

METHODS

INTEGERATE is a multicentre, open-label, pragmatic, parallel-group, randomised controlled trial that was done at three hospitals in Australia. Participants aged 70 years and older with solid cancer or diffuse large B-cell lymphoma planned for chemotherapy, targeted therapy, or immunotherapy, were randomly assigned (1:1; using a central computer-generated minimisation algorithm with a random element, balancing treatment intent, cancer type, age, sex, and performance status) to receive CGA integrated into oncology care (integrated oncogeriatric care) or usual care only. Group assignment was not concealed from the participants and clinicians. The primary outcome was HRQOL over 24 weeks, assessed at baseline, week 12, week 18, and week 24, using the Elderly Functional Index (ELFI; score range 0-100). Analyses were by intention to treat. The trial is registered with ANZCTR.org.au, ACTRN12614000399695, and is completed.

FINDINGS

Between Aug 18, 2014, and Sept 5, 2018, 154 participants were randomly assigned to integrated oncogeriatric care (n=76) or usual care (n=78). 13 participants died by week 12 and 130 (92%) of the remaining 141 participants completed two or more ELFI assessments. Participants assigned to integrated oncogeriatric care reported better adjusted ELFI change scores over 24 weeks compared with those in the usual care group (overall main effect of group: t=2·1, df=213, p=0·039; effect size=0·38), with maximal between-group differences at week 18 (mean difference in change 9·8 [95% CI 2·4-17·2]; p=0·010, corrected p=0·030, effect size=0·48). The integrated oncogeriatric care group also had significantly fewer unplanned hospital admissions at 24 weeks (multivariable-adjusted incidence rate ratio 0·60 [95% CI 0·42-0·87]; p=0·0066). No statistically significant between-group difference was observed in overall survival.

INTERPRETATION

CGA led to better quality of life and health-care delivery in older people receiving systemic anticancer treatment. Routine CGA-based interventions should be considered in at-risk older people starting systemic anticancer treatment.

FUNDING

National Health and Medical Research Council (Australia), Monash University, and Eastern Health.

摘要

背景

综合老年评估（CGA）在改善癌症环境中健康结果的有效性尚不清楚。我们评估了 CGA 是否可以改善开始接受系统抗癌治疗的老年癌症患者的健康相关生活质量（HRQOL）。

方法

INTEGERATE 是一项多中心、开放标签、实用、平行组、随机对照试验，在澳大利亚的三家医院进行。计划接受化疗、靶向治疗或免疫治疗的 70 岁及以上患有实体瘤或弥漫性大 B 细胞淋巴瘤的参与者，按 1:1 比例（使用中央计算机生成的最小化算法，带有随机元素，平衡治疗意向、癌症类型、年龄、性别和表现状态）随机分配接受 CGA 整合到肿瘤学护理中（综合老年肿瘤学护理）或仅接受常规护理。组分配对参与者和临床医生不保密。主要结局是 24 周时的 HRQOL，使用老年功能指数（ELFI；评分范围 0-100）在基线、第 12 周、第 18 周和第 24 周进行评估。分析按意向治疗进行。该试验在 ANZCTR.org.au 进行注册，ACTRN12614000399695，现已完成。

结果

2014 年 8 月 18 日至 2018 年 9 月 5 日期间，154 名参与者被随机分配至综合老年肿瘤学护理组（n=76）或常规护理组（n=78）。13 名参与者在第 12 周死亡，141 名剩余参与者中有 130 名（92%）完成了两次或两次以上的 ELFI 评估。与常规护理组相比，接受综合老年肿瘤学护理的参与者报告 ELFI 调整后的变化评分在 24 周时更好（总体组间主要影响：t=2.1，df=213，p=0.039；效应量=0.38），最大组间差异在第 18 周（变化差值为 9.8[95%CI 2.4-17.2]；p=0.010，校正后 p=0.030，效应量=0.48）。在 24 周时，综合老年肿瘤学护理组的非计划性住院治疗也明显减少（多变量调整后的发病率比 0.60[95%CI 0.42-0.87]；p=0.0066）。两组之间的总生存率无统计学显著差异。