The effect of geriatric intervention in frail elderly patients receiving chemotherapy for colorectal cancer: a randomized trial (GERICO)

Abstract

BackgroundBetter surgical techniques, chemotherapy and biological therapy have improved survival in patients with colorectal cancer (CRC), most markedly in younger patients. About half of patients over 70 years receive dose reductions or early treatment discontinuation of the planned adjuvant or first-line treatment due to side effects. The Comprehensive Geriatric Assessment (CGA) is a multidisciplinary evaluation of an elderly individual’s health status. This assessment in older patients with cancer can predict survival, chemotherapy toxicity and morbidity.MethodsThis randomized phase II trial (GERICO) is designed to investigate whether comprehensive geriatric assessment and intervention before and during treatment with chemotherapy in frail elderly patients with stages II–IV CRC will increase the number of patients completing chemotherapy. All patients ≥70 years in whom chemotherapy for CRC is planned to start at Herlev and Gentofte Hospital are screened for frailty using the G8 questionnaire at the first visit to the outpatient clinic. The G8 questionnaire is a multi-domain screening tool to identify frail or vulnerable patients at risk of increased toxicity and morbidity. Frail patients are offered inclusion and are then randomized to two groups (the intervention group and the control group). Patients in the intervention group receive a full geriatric assessment of comorbidity, medication, psycho-cognitive function, physical, functional and nutrition status, and interventions are undertaken on identified health issues. Simultaneously, they are treated for their cancer according to international guidelines. Patients in the control group receive the same chemotherapy regimens and standard of care. Primary outcome is number of patients completing scheduled chemotherapy at starting dose. Secondary outcomes are dose reductions, treatment delays, toxicity, time to recurrence, survival, cancer-related mortality and quality of life.DiscussionThis ongoing trial is one of the first to evaluate the effect of geriatric intervention in frail elderly patients with CRC. The trial will provide new and valuable knowledge about whether it is beneficial for the elderly patient undergoing chemotherapy to be treated simultaneously by a geriatrician.Trial registration ClinicalTrials.gov ID: NCT02748811. The trial was registered retrospectively; registration date 04/28/2016.

Should we invest in biological age predictors to treat colorectal cancer in older adults?

“…Recently, a randomized phase II trial was launched with the aim to increase the proportion of frail late-stage CRC patients who complete chemotherapy. Prior to, and in the course of treatment of these patients with stages IIeIV CRC, geriatric assessments and interventions are performed to decrease or postpone frailty [34]. As secondary outcomes, this study considers dose reductions, treatment delays, toxicity, time to recurrence, survival, cancer-related mortality and quality of life in relation to the geriatric assessment of frailty and interventions [34].…”

Post‐Acute Care among Older Adults with Stage I to III Colorectal Cancer

“…At a minimum, patients may benefit from a comprehensive conversation about the functional impact of cancer treatment . Moreover, interventions that address the functional, physical, and cognitive changes after CRC treatment for older adults are also important . Cancer rehabilitation and support services can facilitate these interventions and may be best utilized when combined with a systematic assessment of overall health, such as a comprehensive geriatric assessment .…”

“…23 Moreover, interventions that address the functional, physical, and cognitive changes after CRC treatment for older adults are also important. 24 Cancer rehabilitation and support services can facilitate these interventions and may be best utilized when combined with a systematic assessment of overall health, such as a comprehensive geriatric assessment. 25 Growing evidence indicates that acute care services are actually underutilized in older patients with cancer and a functional deficit.…”

Characteristics of older people in an inpatient haematology unit: A descriptive study

“…Two RCT protocols have been published recently that will investigate the impact of geriatrician‐led CGA‐based interventions in patients aged ≥70 years identified as needing a GA based on screening with the G8 tool. In one study, participants will be restricted to those with stages II–IV colorectal cancer , while the other study will include patients with cancer of the breast, colorectal, lung, prostate, bladder, ovary or lymphoma .…”