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Objectives The goal of this study was to evaluate the relationship between social support (SS) and grade 3–5 chemotherapy-related toxicities among older adults with cancer. Methods This is a secondary analysis of a prospective longitudinal study of patients aged 65+ with solid cancer which led to the development of a predictive model for grade 3–5 chemotherapy-related toxicity (the Cancer and Aging Research Group [CARG] Chemotherapy Toxicity Risk Score). SS was measured by a modified version of Medical-Outcome Study-Social Support Survey and grade 3–5 hematological and non-hematological toxicities were captured and graded using CTCAE version 3.0. Patients were categorized into those with poor (SS score ≤ 75) and good SS (score of 76–100). Multivariate polychotomous logistic regression was used to examine the associations between SS and chemotherapy-related toxicity with adjustment for the CARG Toxicity Risk Score. Results Compared to patients with good SS, those with poor SS were less likely to have grade 3–5 toxicity, especially for non-hematological toxicity (adjusted OR = 0.52, p = .02). Patients who did not have someone to take them to the doctor “most” or “all of the time” were less likely to have grade 3–5 non-hematological toxicity compared to patients who had someone to take them to the doctor most or all of the time (adjusted OR = 0.32, p = .02). Conclusion Our study showed that patients with poor SS, especially those with less availability of someone to take them to doctors were less likely to have a documented grade 3–5 non-hematological toxicity.

Introduction Cognitive impairment (CI) increases chemotherapy toxicity risk with need to understand this association utilizing publicly available short screening tools. We evaluated this utilizing a lower threshold on a short screening tool in older adults with cancer. Materials and methods We analyzed data from the Cancer and Aging Research Group (CARG) Chemotherapy Toxicity Risk tool (CARG score) development and validation cohorts (n = 703), which recruited adults age ≥ 65 with cancer from academic centers. Cognition was evaluated with the Blessed Orientation-Memory-Concentration test (BOMC). Patients with BOMC score ≥ 11 were excluded. Utilizing cut-points for older adults, we considered moderate BOMC scores (5-10) as potential CI. Logistic regression was used for analysis. Results Patient baseline characteristics included: mean age 73; 85% white; 63% college or higher education; 250 (36%) potential CI; 385 (55%) severe toxicity. Patients with potential CI were more likely non-white (p ≤ 0.01) and to have high school or lower education (p ≤ 0.01) and high CARG score (p = 0.04). Potential CI was associated with increased severe toxicity risk (OR = 1.54, p ≤ 0.01). After adjusting for CARG score, this association became nonsignificant (OR = 1.35; p = 0.08). Among patients with lower education (n = 258; 36.7%), potential CI remained associated with severe toxicity, even after adjusting for CARG score (OR = 1.87, p = 0.03). Conclusions Our findings suggest potential cognitive impairment, defined by BOMC score 5–10, in older adults with cancer and lower education is associated with increased severe toxicity risk. Future studies are needed to validate these findings. Healthcare providers should consider cognitive testing before treatment for these vulnerable patients.

Background Improved assessment strategies are needed to individualize treatment for adults of all ages receiving palliative chemotherapy for non-small cell lung cancer (NSCLC). Our aim was to evaluate the utility of the Fried Frailty Index (FFI) and a cancer-specific geriatric assessment (GA) to predict chemotherapy toxicity and overall survival (OS). Methods We conducted a multi-site pilot study of 50 patients with newly diagnosed advanced NSCLC, age ≥ 18 years. All participants received carboplatin AUC 6, paclitaxel 200 mg/m2 every 3 weeks. FFI and the GA were administered prior to chemotherapy. A GA toxicity risk score was calculated. Grade 3–5 toxicity was assessed during 1st two cycles of chemotherapy. OS was measured from chemotherapy initiation. Logistic regression and Cox proportional hazards models were fit to estimate the association between baseline characteristics and toxicity and OS respectively. Results Among 50 participants, 48 received chemotherapy and were evaluable. The mean age was 68.5 y (range 42–86), 79% male, 85% KPS ≥80. The median OS was 8 months. Many (27%) met FFI criteria for frailty with ≥3 impairments. Impairments detected by the GA were common. In multivariable analyses both FFI ≥ 3 and GA toxicity risk score > 7 were independently associated with higher odds of toxicity (Odds ratio [OR] 7.0; 95% confidence interval [CI] 1.1–44.6 and OR 4.3; 95% CI 1.0–17.7, respectively) in first cycle chemotherapy. Neither score was associated with OS. Conclusions Frailty predicts chemotherapy toxicity during first cycle. Frailty assessment may inform toxicity risk regardless of chronologic age.

Chimeric antigen receptor (CAR) T-cell therapy has emerged as a promising treatment for relapsed or refractory large B-cell lymphoma (LBCL) with the Food and Drug Administration (FDA) approvals of axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tis-cel). Although the incidence of LBCL is highest among patients age ≥ 65, clinical trials supporting approval of these 2 products primarily enrolled younger patients. Safety data for axi-cel and tis-cel in older patients is limited.In this analysis, we queried the FDA Adverse Events Reporting System (FAERS) database for cases associated with axi-cel or tis-cel from the FDA approval dates for the LBCL indication for each product through December 31, 2019, and compared adverse events (AEs) reported for cases involving patients aged65 and ≥ 65.A total of 804 cases were retrieved, with 333 (41%) involving patients age ≥ 65. Cytokine release syndrome (CRS) was the most common AE reported in both age groups. Cases involving older patients had a significantly higher proportion of neurological AEs, including CAR T-cell-related encephalopathy syndrome (8% vs. 4%, p = 0.03). Some individual clinical features of CRS were significantly more common among younger age group cases, including pyrexia (33% vs. 23%, p 0.01), tachycardia (10% vs. 5%, p 0.01), and thrombocytopenia (4% vs. 2%, p = 0.03).In this age-based analysis of FAERS reports for patients treated with axi-cel or tis-cel, we identified differences in patterns of AEs experienced. This large-scale post-marketing study complements clinical trial safety data and may help inform clinicians' decision making when treating adult patients with CAR-T cell therapy.

This study sought to define the role of first-line platinum-based doublet chemotherapy in older patients with non-small cell lung cancer (NSCLC).We analyzed three first-line NSCLC trials: CALGB 9730, CALGB 30203, and CALGB 30801, which tested carboplatin and paclitaxel; carboplatin and gemcitabine; and carboplatin with either pemetrexed or gemcitabine, respectively. Overall survival was the primary endpoint. Age-based comparisons with a cutpoint of 65 years were performed with Cox proportional hazards models with adjustments for sex, tumor histology, cancer stage, chemotherapy, and smoking history and after stratifying by performance score. Secondary endpoints were grade 3-5 adverse events, chemotherapy cycles completed, and whether toxicity prompted chemotherapy discontinuation.730 patients were included; 337 (46%) were 65+ years of age. No statistically significant difference in survival was observed for older (≥65) versus younger patients (HR = 1.096; 95% CI = (0.94, 1.28); p = 0.25). A trend emerged with increased odds of a grade 3-5 adverse event for patients ≥65 years versus65 years (OR = 1.52; 95% CI = (0.99, 2.31); p = 0.05). The proportion of completed chemotherapy cycles was marginally lower in older patients (difference = -5%; 95% CI = (-9, 0.2); p = 0.06) for those ≥65 years versus65 years, but no statistically significant difference occurred in the rate of chemotherapy discontinuation for toxicity (OR = 1.4; 95% CI = (0.85, 2.19); p = 0.21) for patients ≥65 years versus65 years. A cutpoint of 70 years yielded similar results.These findings support carboplatin doublet-based chemotherapy in select older patients with advanced NSCLC.

BACKGROUND: Chemotherapy preference refers to a patient’s interest in receiving chemotherapy. This study examined whether chemotherapy preference was associated with toxicity, efficacy, quality of life (QoL), and functional outcomes during and after completion of adjuvant chemotherapy in older women with breast cancer. METHODS: This study is a secondary analysis of CALGB 49907, a randomized trial that compared standard adjuvant chemotherapy versus capecitabine in patients age 65 years or older with breast cancer. A subset of 145 patients completed a questionnaire to describe chemotherapy preference pre-treatment. The association of this pre-treatment preference with the patient’s perception of self-health, predicted and actual QoL, patient- and professional-reported toxicity, mental health, self-rated function, and survival was studied during and after treatment. RESULTS: The median age of patients was 71 years and 47% had a high preference for chemotherapy. On baseline demographics, the low preference group had a higher proportion of white patients (95% vs. 78%, p=0.004). Before treatment, low chemotherapy preference was associated with greater nausea/vomiting (p=0.008). Mid-treatment, low preference was associated with lower QoL, worse social, emotional and physical function (all p≤0.02) and worse nausea/vomiting, cancer symptoms and financial worries (all p

Age-based reduction of chemotherapy dose with the first cycle (primary dose reduction, PDR) is not routinely guideline recommended. Few studies, however, have evaluated how frequently PDR is utilized in the treatment of older patients with cancer and which factors may be associated with this decision.We conducted a secondary analysis of a multi-institutional prospective cohort study of patients age ≥65 years treated with chemotherapy. The dose and regimen were at the discretion of the treating oncologist. The prevalence of PDR and its association with treatment intent (palliative vs. curative), tumor type, patient characteristics (sociodemographics and geriatric assessment variables), and chemotherapy-associated toxicity were evaluated.Among 500 patients (mean age 73, range 65-91 years), 179 patients received curative intent chemotherapy and 321 patients received palliative intent chemotherapy, with PDR being more common in the latter sub-group (15% vs. 25%, p = 0.005). Increasing age was independently associated with PDR in both sub-groups. Comorbidity (prior cancer or liver/kidney disease) was independently associated with PDR in the palliative sub-group alone while Karnofsky Performance Status (KPS) was not associated with PDR in either subgroup. There was no significant difference in the rates of grades 3-5 toxicity, dose reductions, or delays with PDR. Patients in the palliative sub-group treated with PDR had higher rates of hospitalization compared to those treated with standard doses.PDR is more common in the palliative setting, but is also utilized among patients treated with curative intent. Factors associated with PDR include age and comorbid conditions, but not KPS.

Lung cancer is the leading cause of cancer associated mortality in the US. Majority of patients with lung cancer are diagnosed with advanced stage cancer and median age at diagnosis is 70 years. The prevalence of comorbidity increases with age and older patients with lung cancer have a particularly high burden, given the common association with smoking. Based on recent data from the US, the vast majority of adults 65 years or older have significant and often multiple comorbid conditions: hypertension (73%), chronic obstructive pulmonary disease (57%), ischemic heart disease (53%), diabetes (32%), congestive cardiac failure (31%), chronic kidney disease (30%), and depression (21%). Since the prognosis in older adults with advanced non-small cell lung cancer (NSCLC) is particularly poor, it is essential to capture the “host” factors that rendermanagement of this disease challenging. Many elderly do not receive treatment for advanced NSCLC. This is largely attributed to poor performance status (PS), a high comorbid disease burden, or a combination thereof. The thoracic medical oncologist typically relies on Eastern Cooperative Oncology Group (ECOG) PS for decision making regarding chemotherapy. The relative contribution of underlying comorbid disease and cancer in defining PS is undetermined. Recent ASCO guidelines allude to the importance of comorbidity (described as multiple chronic

Cancer is a disease occurring disproportionately in older adults. However, the evidence base regarding how best to care for these patients remains limited due to their underrepresentation in cancer clinical trials. Pragmatic clinical trials represent a promising approach for enhancing the evidence base in geriatric oncology by allowing investigators to enroll older, frailer patients onto cancer clinical trials. These trials are more accessible, less resource intensive, and place minimal additional burden on participating patients. Additionally, these trials can be designed to measure endpoints directly relevant to older adults, such as quality of life, functional independence and treatment tolerability which are often not addressed in standard clinical trials. Therefore, pragmatic clinical trials allow researchers to include patients for whom the treatment will ultimately be applied and to utilize meaningful endpoints. Examples of pragmatic studies include both large, simple trials and cluster randomized trials. These study designs allow investigators to conduct clinical trials within the context of everyday practice. Further, researchers can devise these studies to place minimal burden on the patient, the treating clinicians and the participating institutions. In order to be successful, pragmatic trials must efficiently utilize the electronic medical record for data capture while also maximizing patient recruitment, enrollment and retention. Additionally, by strategically utilizing pragmatic clinical trials to test therapies and interventions that have previously shown efficacy in younger, fitter patients, these trials represent a potential mechanism to improve the evidence base in geriatric oncology and enhance care for older adults with cancer.

Objectives There is a gap in knowledge regarding the rates of utilization of palliative care services (PCS) and acute care services (ACS) among older patients with advanced cancer close to end of life. We analyzed the utilization of these services among older adults (65years and older) and compared them to those in younger adults (40–64years) with advanced cancer. Materials and Methods A retrospective chart review of 567 veterans who died with advanced cancer between 2002 and 2009 and utilized PCS and ACS prior to death was conducted after IRB approval. To assess PCS utilization, we studied the mean duration between day of hospice referral and time of death (DOR) and the mean length of stay with hospice (LoS). The frequency of emergency room visits (ERVLM), hospital admissions (HALM), and ICU admissions (ICULM) in the last month of life was used as a measure for ACS. The differences among older and younger patients were compared using two sample t-tests. Results Older adults had earlier referral to PCS [mean DOR : 47.3 versus 34.5days, p=0.015 ], longer stay with hospice [mean LoS : 32.5 versus 20.2days, p=0.007 ], fewer hospital [ HALM: 0.7 versus 0.9, p=0.043 ], and ICU admissions [ ICULM: 0.1 versus 0.2, p=0.030 ] per patient. The proportion of patients utilizing ER visits [53.5 % versus 59.5%, p=0.173] and hospital admissions [58.6% versus 65.1%, p=0.13] in the last month of life was similar in both age groups with fewer older adults utilizing ICU care [13.2% versus 19.5%, p=0.047]. Conclusion Older patients with cancer are likely to be referred to PCS earlier than younger patients and spend a longer duration with PCS prior to death. However, there continues to be significant utilization of ACS in all patients with advanced cancer. Better understanding of the goals of care in older adults with cancer and education of oncology providers regarding the need to utilize and integrate palliative care services earlier in the course of disease is imperative.

Adjuvant treatment decisions are challenging since benefit for the individual patient cannot be measured immediately, and the decision process is actually a risk calculation. In 2007, the International Society of Geriatric Oncology (SIOG) established evidence-based recommendations for the management of breast cancer in elderly individuals and updated this guideline in 2012. Whole breast radiotherapy after breast conserving surgery, with a boost to the tumor bed, should be considered in all elderly patients since it decreases risk of local relapse. There is no subgroup of fit older patients in whom post-BCS WBRT can be systematically omitted but benefit in terms of overall survival can be very limited in low risk or frail patients. Hypofractionated radiation schedules offer similar local-regional control and adverse effects as standard fractionation regimens. The evidence for partial breast irradiation in older patients is not sufficiently robust to recommend it as standard therapy. Concerning adjuvant hormonal therapy, there is no age-dependent efficacy of tamoxifen or aromatase inhibitors. Efficacy is slightly greater with aromatase inhibitors; however, elderly patients are more vulnerable to toxicity and safety is important in choice of agent. Omission of endocrine therapy is an option for patients with a very low-risk tumour (pT1aN0) or life-threatening comorbidities. The decision to treat with adjuvant chemotherapy should not be age-based. Older patients with node-positive, hormone-negative disease potentially derive the largest benefit. Four cycles of an anthracycline-containing regimen are usually preferred over CMF. Standard AC and CMF chemotherapy are better than single-agent capecitabine. Taxanes are associated with increased toxicity compared with younger women, but can be added to anthracyclines in high-risk healthy elderly patients, or replace anthracyclines to reduce the cardiac risk. Patients with HER2-positive breast cancer, without cardiac disease, should be offered trastuzumab in combination with chemotherapy. Tumor extent, general health status assessed by geriatric evaluation, tumor biology, and patient preference are critically important parameters to include for optimal adjuvant treatment decisions. Disclosure of interest: None declared