Role of geriatric intervention in the treatment of older patients with cancer: rationale and design of a phase III multicenter trial

Abstract

BackgroundIn the general geriatric population, programs linking geriatric evaluation with interventions are effective for improving functional status and survival of the patients. Whether or not these interventions improve health related quality of life (HRQoL) or overall survival (OS) in older patients with cancer is not yet clear. Indeed, randomized data on the effect of such interventions on survival and HRQoL are rare and conflicting. We describe the rationale and design of a phase III multicenter trial aimed at assessing the efficacy of geriatric intervention in the management of elderly patients with cancer.Methods/designApproximately 1200 patients, 70 years and older, considered in need of a geriatric intervention based on the G8 screening tool will be randomized into two intervention arms. The ‘Usual-care’ arm involves standard oncological care based on pre-defined oncological protocols. In addition to the standard oncological care, the ‘Case-management’ arm involves a multidimensional geriatric assessment and interventions tailored for the patient. Efficacy will be assessed using a co-primary endpoint encompassing OS and HRQoL.DiscussionThis trial has been designed to assess whether focused geriatric case management can either improve OS or HRQoL in elderly cancer patients considered in need of geriatric assessment.Trial registrationClinicaltrials.gov ID: NCT02704832.

Prevalence of comorbidities in elderly cancer patients

“…But no randomised controlled trial has been completed for this intervention in the oncology setting. There are currently several randomised trials ongoing that are examining the benefits of implementing geriatric management for older adults with cancer [31,32].…”

The Prognostic Impact of Comorbidities in Patients with De-Novo Diffuse Large B-Cell Lymphoma Treated with R-CHOP Immunochemotherapy in Curative Intent

“…Attenuated treatment regimens like R-miniCHOP or ofatumumab-miniCHOP have already shown to provide good efficacy and safety in lymphoma patients above 80 years [42,43]. Additionally, standardized comorbidity evaluations might serve as an easy-to-use and inexpensive tool for elaborating patient prognosis and individualizing treatment decisions [44]. Integration of different domains of geriatric assessment will serve to tailor the treatment algorithms in this large group of patients irrespective of currently established age cutoffs [45].…”

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 .…”