Geriatric Assessment–Driven Intervention (GAIN) on Chemotherapy-Related Toxic Effects in Older Adults With Cancer

Abstract

Although geriatric assessment-driven intervention improves patient-centered outcomes, its influence on chemotherapy-related toxic effects remains unknown.OBJECTIVE To assess whether specific geriatric assessment-driven intervention (GAIN) can reduce chemotherapy-related toxic effects in older adults with cancer. DESIGN, SETTING, AND PARTICIPANTSA randomized clinical trial enrolled 613 participants from a National Cancer Institute-designated cancer center between 2015 and 2019. Patients were 65 years and older with a solid malignant neoplasm, were starting a new chemotherapy regimen, and completed a geriatric assessment. Patients were followed up until chemotherapy completion or 6 months after initiation, whichever occurred first. Data analysis was done by intention-to-treat principle.INTERVENTIONS Patients were randomized (2:1) to either the GAIN (intervention) or standard of care (SOC) arm. In the GAIN arm, a geriatrics-trained multidisciplinary team composed of an oncologist, nurse practitioner, social worker, physical/occupation therapist, nutritionist, and pharmacist reviewed geriatric assessment results and implemented interventions based on prespecified thresholds built into the geriatric assessment's domains. In the SOC arm, geriatric assessment results were sent to treating oncologists for consideration. MAIN OUTCOMES AND MEASURESThe primary outcome was incidence of grade 3 or higher chemotherapy-related toxic effects (graded using National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0). Secondary outcomes included advance directive completion, emergency department visits, unplanned hospitalizations, average length of stay, unplanned hospital readmissions, chemotherapy dose modifications, and early discontinuation. Overall survival analysis was performed up to 12 months after chemotherapy initiation. RESULTS Among the 605 eligible participants for analysis, median (range) age was 71 (65-91) years, 357 (59.0%) were women, and 432 (71.4%) had stage IV disease. Cancer types included gastrointestinal (202 [33.4%]), breast (136 [22.5%]), lung (97 [16.0%]), genitourinary (91 [15.0%]), gynecologic (54 [8.9%]), and other (25 [4.1%]). Incidence of grade 3 or higher chemotherapy-related toxic effects was 50.5% (95% CI, 45.6% to 55.4%) in the GAIN arm and 60.6% (95% CI, 53.9% to 67.3%) in the SOC arm, resulting in a significant 10.1% reduction (95% CI, −1.5 to −18.2%; P = .02). A significant absolute increase in advance directive completion of 28.4% with GAIN vs 13.3% with SOC (P < .001) was observed. No significant differences were observed in emergency department visits, unplanned hospitalizations, average length of stay, unplanned readmissions, chemotherapy dose modifications or discontinuations, or overall survival. CONCLUSIONS AND RELEVANCEIn this randomized clinical trial, integration of multidisciplinary GAIN significantly reduced grade 3 or higher chemotherapy-related toxic effects in older adults with cancer. Implementation of GAIN into oncology clinical practice should be con...

Economic Evaluation of a Geriatric Oncology Clinic

“…Many of these assumptions were examined in extensive sensitivity analyses and found not to affect our findings. Fourth, we did not explicitly consider a reduction in treatment toxicity or unplanned health care use as benefits of GA. Two recently published RCTs of GA and co-management demonstrated 10-20% reductions in severe toxicity with systemic therapy in the metastatic setting along with reductions in unplanned health care use [6,7]. Incorporating these would have made GA even more cost effective in our study.…”

“…GA is associated with the detection of important conditions that are missed during the typical oncologic evaluation and results in a median of 28% of treatment decisions being modified, with about two-thirds of modifications being reductions in treatment intensity [5]. Based on emerging randomized trial evidence, GA and management are associated with reduced unplanned health care service use during cancer treatment [6][7][8].…”

Strategies to Mitigate Chemotherapy and Radiation Toxicities That Affect Eating

“…Use of the Geriatric Nutrition Risk Index (GNRI) or Mini-Nutritional Assessment (MNA) tools [133][134][135] and patient reported outcomes (PRO) such as the PG-SGA [69][70][71][72][73][136][137][138][139][140] could help to predict risk and trigger more timely interventions to address eating behaviors, malnutrition, cachexia, and sarcopenia in this particularly vulnerable, high-risk population. A recent study showed a proactive team approach which included an oncologist, NP, social worker, PT/OT, pharmacist, and nutritionist resulted in the significant reduction of grade 3 or higher toxicities in older adults [141].…”

Management of Nasopharyngeal Carcinoma in Elderly Patients

“…There are emerging data showing that a combination of geriatric interventions can improve clinical outcomes. The randomised controlled trial by Li et al randomised 613 patients aged 65 years or older planned for new chemotherapy into multidisciplinary geriatric assessment-driven intervention (GAIN) and standardof-care (SOC) arms (97). Patients in the GAIN arm had a lower incidence of grade 3 or higher chemotherapy-related toxic effects compared with the SOC arm (50.5% vs. 60.6%, p = 0.02).…”