Purpose Older adults are vulnerable to chemotherapy toxicity; however, there are limited data to identify those at risk. The goals of this study are to identify risk factors for chemotherapy toxicity in older adults and develop a risk stratification schema for chemotherapy toxicity. Patients and Methods Patients age ≥ 65 years with cancer from seven institutions completed a prechemotherapy assessment that captured sociodemographics, tumor/treatment variables, laboratory test results, and geriatric assessment variables (function, comorbidity, cognition, psychological state, social activity/support, and nutritional status). Patients were followed through the chemotherapy course to capture grade 3 (severe), grade 4 (life-threatening or disabling), and grade 5 (death) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events. Results In total, 500 patients with a mean age of 73 years (range, 65 to 91 years) with stage I to IV lung (29%), GI (27%), gynecologic (17%), breast (11%), genitourinary (10%), or other (6%) cancer joined this prospective study. Grade 3 to 5 toxicity occurred in 53% of the patients (39% grade 3, 12% grade 4, 2% grade 5). A predictive model for grade 3 to 5 toxicity was developed that consisted of geriatric assessment variables, laboratory test values, and patient, tumor, and treatment characteristics. A scoring system in which the median risk score was 7 (range, 0 to 19) and risk stratification schema (risk score: percent incidence of grade 3 to 5 toxicity) identified older adults at low (0 to 5 points; 30%), intermediate (6 to 9 points; 52%), or high risk (10 to 19 points; 83%) of chemotherapy toxicity (P < .001). Conclusion A risk stratification schema can establish the risk of chemotherapy toxicity in older adults. Geriatric assessment variables independently predicted the risk of toxicity.

This study externally validated a chemotherapy toxicity predictive model for older adults with cancer. This predictive model should be considered when discussing the risks and benefits of chemotherapy with older adults.

Purpose Factors captured in a geriatric assessment can predict morbidity and mortality in older adults, but are not routinely measured in cancer clinical trials. This study evaluated the implementation of a geriatric assessment tool in the cooperative group setting. Patients and Methods Patients age ≥ 65 with cancer, who enrolled on cooperative group cancer trials, were eligible to enroll on Cancer and Leukemia Group B (CALGB) 360401. They completed a geriatric assessment tool before initiation of protocol therapy, consisting of valid and reliable geriatric assessment measures which are primarily self-administered and require minimal resources and time by healthcare providers. The assessment measures functional status, comorbidity, cognitive function, psychological state, social support, and nutritional status. The protocol specified criteria for incorporation of the tool in future cooperative group trials was based on the time to completion and percent of patients who could complete their portion without assistance. Patient satisfaction with the tool was captured. Results Of the 93 patients who enrolled in this study, five (5%) met criteria for cognitive impairment and three did not complete the cognitive screen, leaving 85 assessable patients (median age, 72 years). The median time to complete the geriatric assessment tool was 22 minutes, 87% of patients (n = 74) completed their portion without assistance, 92% (n = 78) were satisfied with the questionnaire length, 95% (n = 81) reported no difficult questions, and 96% (n = 82) reported no upsetting questions. One hundred percent of health care professionals completed their portion. Conclusion This brief, primarily self-administered geriatric assessment tool met the protocol specified criteria for inclusion in future cooperative group clinical trials.

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...

Background Frailty has been suggested as a construct for oncologists to consider in treating older cancer patients. Therefore we assessed the potential of creating a Deficit Accumulation Frailty Index (DAFI) from a largely self-administered comprehensive geriatric assessment (CGA). PATIENTS AND METHODS Five hundred patients age 65 and older received a CGA prior to receiving chemotherapy. A DAFI was constructed resulting in a 51 item scale and cut points for robust/non frail (0.0< 0.2), pre-frail (0.2<0.35) and frail (≥0.35) were examined. RESULTS Two Hundred and Fifty patients (50%) were non-frail, 197 (39%) pre-frail, 52 (11%) frail. Older patients (80+), lower education, living alone, and higher stage were associated with pre-frail/frail. Pre-frail/frail patient were more likely to have grade 3+ toxicity, but not to have dose delay or reduction, and were more likely to discontinue drug and be hospitalized. The association with grade 3+ toxicity was attenuated by controlling for a toxicity risk calculator but the other outcomes were not. CONCLUSION A Deficit Accumulation Frailty Index can be constructed from a CGA in older cancer patients and can indicate the frailty status of the population. The frailty status so determined is associated both with outcomes likely due to chemotherapy toxicity as well as those likely due to age related physiologic and functional deficits and thus can be useful in the overall assessment of the patient.

Background Older adults with cancer are vulnerable to functional decline, placing greater onus on caregivers. Few studies have prospectively examined burden in caregivers of older cancer patients. We sought to determine factors associated with high caregiver burden. Methods 100 caregivers of patients age ≥65 with cancer, recruited at a single-institution, completed questionnaires gauging their perception of the patient’s physical, emotional, and social health. The association between these items, cancer-related factors, sociodemographic factors, and caregiver burden [measured by the Caregiver Strain Index (CSI)] was determined through multivariate analysis. Results Patients were a median age of 70 (range 65–91), 70% had advanced disease, and 98% were receiving treatment. Caregivers were mostly female (73%), spouses (68%), and lived with the patient (79%). Median hours of care provided was 10 hours/week. Mean CSI score was 3.1±3.2. Most caregivers (75%) reported some burden, with 15% reporting high caregiver burden (CSI ≥7). In multivariate analysis, employed caregivers (OR 4.5; 95% CI 1.1–18.4, p=0.04) and those who cared for patients requiring more help with instrumental activities of daily living (OARS-IADL score <12 of 14) (OR 12.4; 95% CI 2.4–62.5, p<0.001) were more likely to experience high caregiver burden (CSI ≥7). Conclusions Caregiver burden is common in those who care for older cancer patients. High burden is more likely in employed caregivers and those who care for patients who require increased functional assistance. Further studies are needed to determine unique challenges experienced by caregivers of older adults with cancer and potential interventions to alleviate burden in these caregivers.

Objective In older men with prostate cancer, aging is associated with reduced anxiety and increased depression. The purpose of this study was to examine the association among age, anxiety, and depression in a cohort of older adults receiving chemotherapy. Methods This is a secondary analysis of a prospective longitudinal study investigating chemotherapy toxicity in older adults with cancer. Baseline data (pre‐chemotherapy) included: age, sociodemographics, tumor and treatment factors, functional status, comorbidities, psychological state (measured by the Hospital Anxiety and Depression Scale), and social support. Univariate and multiple regression analyses were conducted to test the relationship between age, anxiety, and depression. Results The average age of the 500 patients (56% females) was 73.1. The majority had late stage disease: 22% Stage III and 61% stage IV. Clinically significant depression was reported in 12.6%. Clinically significant anxiety was reported in 20.9%. In univariate analyses, there was no association between anxiety and age, or depression and age. In multivariable analyses, older age (p=0.05) was associated with decreased anxiety, as well as lack of social support (p<0.01) and increased number of comorbidities (p<0.01). In multivariable analysis, depression was associated with lack of social support (p<0.01), increased number of comorbidities (p<0.01), and advanced stage (p<0.01). Conclusions This study supports previous research that anxiety decreases with age in older adults with cancer. However, depression remained constant with increasing age. Greater resources and attention to identifying and treating the psychological sequelae of cancer in older adults are warranted. Copyright © 2014 John Wiley & Sons, Ltd.

Polypharmacy and potentially inappropriate medication (PIM) use are understudied among older adults with cancer undergoing chemotherapy. The current study’s aims were to evaluate in this population: 1) the prevalence of polypharmacy and PIM use; and 2) the association between these and chemotherapy-related adverse events. Methods This was a secondary analysis of prospectively collected data of adults age ≥65 years with cancer undergoing chemotherapy. Measures included: the number of daily medications (i.e, polypharmacy); PIM use based on 3 indices [Beers, Zhan, and Drugs to Avoid in the Elderly (DAE) criteria], as well as use of 6 “high-risk” medication classes for adverse drug events (i.e., anticoagulants, antiplatelet agents, opioids, insulin, oral hypoglycemics and antiarrhythmics). Using multivariate logistic regression, the relations were evaluated between these criteria and 1) Grade 3-5 chemotherapy-related toxicity; and 2) hospitalization during chemotherapy. Results The patients (N=500; mean age, 73 years, 61% Stage IV disease) took a mean of 5 daily medications (±4; range, 0-23). PIM use among patients was common (up to 29% using Beers criteria). No association was found between the number of daily medications and either toxicity (0-3 medications as reference: 4-9, OR=1.34, 95% CI: 0.92-1.97; ≥10, OR=0.82, 95% CI: 0.45-1.49), or hospitalization (0-3 medications as reference, ≥4, OR=1.34, 95%CI: 0.82-2.18, p=0.24). There was also no association between PIM use and toxicity (p=0.93) or hospitalization (p=0.98). No medication class was associated with either outcome. Conclusions Polypharmacy and PIM use were common but werenot associated with chemotherapy-related toxicity or hospitalization in older adults with cancer.