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 registrationClinicalTrials.gov ID: NCT02748811. The trial was registered retrospectively; registration date 04/28/2016.
Highlights
Better surgical techniques, chemotherapy and biological therapy have improved survival in patients with colorectal cancer (CRC), most markedly in younger patients
In spite of the high prevalence of CRC and the high incidence of CRC-related mortality, elderly patients are under-presented in clinical trials [38]
When treating elderly patients with comorbidity and poor performance status (PS), oncologists today possess a limited number of treatment options
Summary
Chemotherapy and biological therapy have improved survival in patients with colorectal cancer (CRC), most markedly in younger patients. 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. Mortality has decreased in patients with CRC due to better surgical techniques, chemotherapy and new biological therapy, but in elderly patients, the mortality remains higher than in younger patients [3, 4]. Combination chemotherapy is considered standard therapy for patients with stage III CRC, but the beneficial effect for elderly patients and patients with stage II CC remains controversial [5, 17]
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