More elderly, frail patients with colorectal cancer were able to complete adjuvant chemotherapy following geriatric intervention.
Geriatric intervention increased the number of older, more vulnerable patients with colorectal cancer (CRC) who completed adjuvant chemotherapy and may improve disease burden and mobility vs the standard of care, according to results of the phase 3 GERICO trial (NCT02748811).1
Results from the study indicated that more patients in the intervention cohort (45%) were able to complete their planned chemotherapy without further dose reductions or delays vs the control group (28%; P = .0366). The difference was most notable in those who received adjuvant chemotherapy (P = .0097), although no significant differences were noted in those who received palliative chemotherapy (P = .751). The beneficial impact of comprehensive geriatric assessment (CGA) was primarily identified in those with a score of 11 or less by the G8 questionnaire (odds ratio, 3.76; 95% CI, 1.19-13.45). GQ a screening tool for predicting survival and treatment-associated complications for which a score of 14 or less suggests full CGA care.
CGA has been recommended to improve treatment outcomes for older patients with cancer.2 As the incidence of cancer increases with the aging population, there has been an increasing interest in CGA.3-5 In light of this, investigators set out to assess whether CGA-based interventions in a vulnerable, elderly population of patients with CRC might be able to increase the number of patients who complete their scheduled chemotherapy.
The study compared the use of CGA-based interventions with standard of care in a population of frail, elderly patients receiving chemotherapy for their disease and featured those who were 70 years of age of older with stage II to IV CRC undergoing adjuvant or first-line palliative/downstaging chemotherapy. Patients needed to have a life expectancy of 3 months or more and an ECOG performance status of 0 to 2. They also needed to undergo assessment utilizing a G8 questionnaire and be classified as vulnerable. Patients who had another co-existing cancer within 5 years or who participated in another pharmaceutical clinical trial were excluded from GERICO.
Patients were randomized 1:1 to receive either CGA-based interventions or standard of care. They were stratified based on performance status and whether they were receiving adjuvant or palliative/downstaging chemotherapy. All patients underwent a standard treatment of 3 to 6 months of either adjuvant or first-line palliative/downstaging chemotherapy until disease progression, surgery, and change in treatment/end of treatment due to severe adverse effects (AEs).
In total, 484 patients were assessed for eligibility from April 2015 to September 2019, of whom 54 did not meet the criteria and 121 did not receive treatment with chemotherapy. Of the 153 patients who were included in the study, 11 were later excluded, 4 did not start chemotherapy, and 3 were hospitalized due to toxicity and discontinued treatment prior to CGA intervention.
Additional data from the study indicated that 92% of patients in the experimental group required interventions, including 88% of those in the adjuvant cohort and 100% of those in the palliative cohort. The most common interventions reported by investigators included changes in medication (62%), nutritional therapy (51%), and exercise (39%). Nutritional therapy and exercise were most needed within the palliative cohort vs the adjuvant cohort (64% vs 43% and 50% vs 38%, respectively).
In total, 72% of those in the intervention group performed below the cut off in at least 1 physical screening, and thus needed physiotherapy. Additionally, 75% of patients in the intervention group experienced weight loss of more than 5% and were at risk of malnutrition prior tochemotherapy. Thirty-six patients (51%) had accepted a referral to a dietitian. In the control group, 63% of patients were at risk for malnutrition and 11% were referred to a dietitian. Further, significant weight loss (2.5% or more during treatment) was observed in 15% of patients in the experimental arm and 24% in the control arm (P = .0206).
Starting chemotherapy doses were reduced in 60% of patients across all arms. However, secondary dose reductions were less common in the experimental cohort (28%) vs the control cohort (45%; P = .037). In terms of safety, 28% of patients in the experimental arm experienced grade 3 or higher toxicity vs 39% in the control group (P = .156). The most common grade 3 or higher AEs included infections (n = 11), cardiotoxicity (n = 10), and fatigue (n = 8). Both groups experienced similar hospitalization rates.