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老年干预对接受结直肠癌化疗的虚弱老年患者的影响:一项随机试验(GERICO)。

The effect of geriatric intervention in frail older patients receiving chemotherapy for colorectal cancer: a randomised trial (GERICO).

机构信息

Department of Medicine, Copenhagen University Hospital, Herlev and Gentofte, Copenhagen, Denmark.

CopenAge, Copenhagen Center for Clinical Age Research, University of Copenhagen, Copenhagen, Denmark.

出版信息

Br J Cancer. 2021 Jun;124(12):1949-1958. doi: 10.1038/s41416-021-01367-0. Epub 2021 Apr 7.

Abstract

BACKGROUND

Older patients with colorectal cancer (CRC) experience chemotherapy dose reductions or discontinuation. Comprehensive geriatric assessment (CGA) predicts survival and chemotherapy completion in patients with cancer, but the benefit of geriatric interventions remains unexplored.

METHODS

The GERICO study is a randomised Phase 3 trial including patients ≥70 years receiving adjuvant or first-line palliative chemotherapy for CRC. Vulnerable patients (G8 questionnaire ≤14 points) were randomised 1:1 to CGA-based interventions or standard care, along with guideline-based chemotherapy. The primary outcome was chemotherapy completion without dose reductions or delays. Secondary outcomes were toxicity, survival and quality of life (QoL).

RESULTS

Of 142 patients, 58% received adjuvant and 42% received first-line palliative chemotherapy. Interventions included medication changes (62%), nutritional therapy (51%) and physiotherapy (39%). More interventional patients completed scheduled chemotherapy compared with controls (45% vs. 28%, P = 0.0366). Severe toxicity occurred in 39% of controls and 28% of interventional patients (P = 0.156). QoL improved in interventional patients compared with controls with the decreased burden of illness (P = 0.048) and improved mobility (P = 0.008).

CONCLUSION

Geriatric interventions compared with standard care increased the number of older, vulnerable patients with CRC completing adjuvant chemotherapy, and may improve the burden of illness and mobility.

TRIAL REGISTRATION

ClinicalTrials.gov ID: NCT02748811.

摘要

背景

老年结直肠癌(CRC)患者在化疗过程中会经历剂量减少或停药。综合老年评估(CGA)可预测癌症患者的生存和化疗完成情况,但老年干预措施的益处仍未得到探索。

方法

GERICO 研究是一项随机的 3 期临床试验,纳入≥70 岁接受辅助或一线姑息性化疗的 CRC 患者。脆弱患者(G8 问卷评分≤14 分)以 1:1 随机分配到基于 CGA 的干预组或标准护理组,同时进行基于指南的化疗。主要终点是无剂量减少或延迟的化疗完成情况。次要终点是毒性、生存和生活质量(QoL)。

结果

在 142 例患者中,58%接受辅助化疗,42%接受一线姑息化疗。干预措施包括药物调整(62%)、营养治疗(51%)和物理治疗(39%)。与对照组相比,更多的干预组完成了计划化疗(45% vs. 28%,P=0.0366)。对照组和干预组分别有 39%和 28%的患者发生严重毒性(P=0.156)。与对照组相比,干预组患者的 QoL 得到改善,疾病负担减轻(P=0.048),活动能力提高(P=0.008)。

结论

与标准护理相比,老年干预措施增加了完成辅助化疗的老年、脆弱 CRC 患者数量,并且可能改善疾病负担和活动能力。

试验注册

ClinicalTrials.gov 注册号:NCT02748811。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57c7/8185087/e7641ecaec37/41416_2021_1367_Fig1_HTML.jpg

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