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BACKGROUND: Older adults are under-represented in cancer clinical trials. However, it remains unclear which types of trials under-enroll aging patients. We aimed to identify associations between trial characteristics and disparate enrollment of older adults onto trials sponsored by the Alliance for Clinical Trials in Oncology (Alliance). METHODS: Actual age ≥ 65 percentage and trial data were extracted from the Alliance closed study list. Each trial, based on its cancer type and years of enrollment, was assigned an expected age ≥ 65 percentage extracted from the Surveillance, Epidemiology, and End Results (SEER) US population-based database. Enrollment disparity difference (EDD), the difference between the expected age ≥ 65 percentage and the actual age ≥ 65 percentage, was calculated for each trial. Linear regression determined trial variables associated with larger EDDs and variables with an overall association p-value < 0.20 were included in a multivariable fixed-effects linear model. RESULTS: The median age of 66,708 patients across 237 trials was 60 years (range 18-102). The average actual age ≥ 65 percentage enrolled per trial was lower than each trial’s expected age ≥ 65 percentage average (39% vs. 58%; EDD 19, 95% CI 17.1-21.3%, p

Background Insufficient social support is associated with increased mortality among older adults. Lung cancer is primarily a disease of older adults and is the leading cause of all cancer deaths. We assessed the association of social support with outcomes among older adults with lung cancer. Materials and methods Adults age 65 and older with lung cancer with a completed geriatric assessment (GA) were assessed. Emotional social support (ES) and tangible (material, instrumental) support (TS) measures and patient characteristics were obtained from the GA. The electronic health record was used to extract clinical variables. Simple linear regression models evaluated the association between social support scales with patient and clinical factors. Results 79 adults were assessed. White race was positively associated with ES score (p=.04), while higher BMI (p=.03), depression (p=.03) and anxiety (p=.02) were associated with worse ES. Higher BMI was associated with higher/better TS score (p=.02) while living alone was associated with lower/worse TS score (p=.03). Completion of platinum-based doublet chemotherapy with immunotherapy as planned was associated with higher ES scores (p=.02) and higher TS scores (p=.02). Disease progression was associated with lower ES scores (p=.03). Conclusion Social support may influence clinical outcomes in older adults with lung cancer. As lung cancer often portends to poor prognosis, social support may be an important prognostic indicator.

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.

Purpose The incidence of treatment-related toxicity for adjuvant chemotherapy in breast cancer is well documented in clinical trials. However, the effect of chemotherapy on functional outcomes in older patients is less well known. We identified a cohort of older women diagnosed with early stage breast cancer to examine the association between exposure to chemotherapy and a claims-based measure of function-related adverse events (FAE). Methods Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare dataset, we identified women aged ≥ 66 diagnosed with stage I or II breast cancer from 2004 to 2011. FAE were defined as one or more claims suggestive of functional impairment within 24 months following chemotherapy including claims for durable medical equipment and skilled care. Women who did not receive chemotherapy were weighted to reflect the covariate distribution of chemotherapy recipients using propensity score weighting for age, stage, baseline healthcare utilization, and comorbidities. Results The cohort included 44,626 patients, 6892 (15%) received chemotherapy. 19% of the population experienced ≥ 1 FAE. After propensity weighting, chemotherapy was associated with a small increased risk of FAEs (HR 1.12, 95% confidence interval: 1.04, 1.20). Results were similar in patients 75 years and older versus younger patients. In the chemotherapy group, the highest risk of FAE occurred in the first 3 months, but persisted through follow-up. Conclusions Exposure to chemotherapy was associated with a small increased risk of FAE which did not vary by age. These data can be used to inform treatment decision making for older patients with breast cancer who are eligible for adjuvant chemotherapy.

Fatigue is a common side effect of radiation therapy and can dramatically affect the quality of life in older cancer patients. We compared a home-based graduated walking intervention with a fixed walking recommendation.recommendation to exercise to determine the effects of these interventions during adjuvant radiotherapy (RT) on older women with breast cancer.A randomized phase 2 trial in women ≥65 years, with stage 0-3 breast cancer. Prior to initiating breast RT, women were randomized to a Home-Based Graduated Walking Program (HBGWP) or a fixed walking recommendation. The primary outcome of fatigue was measured by the Total Disruption Index (TDI) of the Fatigue Symptom Inventory (FSI). Secondary outcomes including a short physical performance battery (SPPB) and questionnaires on exercise, physical function, fatigue (PROMIS Fatigue), and fatigue-related symptoms were collected at 3 time points. The primary goal was to compare the change in TDI between arms at the end of RT. Random coefficients models were used to determine the association between arm, fatigue, and exercise over time. Linear regression models were used to describe the change in outcome variables between visits.Median age of the 54 participants (27 per arm) was 69 years (range 65-84). The baseline characteristics were similar between study arms. The number of minutes walking per week increased in both arms (mean 21 min/wk. baseline to 83 min/wk. end of RT, p 0.01) and physical function improved over time in both arms (median 10.5 at baseline to 12 at end of RT, p 0.01).There was no significant difference in change in TDI between arms (2.7 ± 9.9 vs. 1.8 ± 14.0, p = 0.61)between baseline and end of RT. However, in our linear regression model increasing walking over time was associated with statistically significant lower levels of fatigue (-2.44+/- 1.04, p = 0.04), but not in posthoc subgroup analyses.The HBGWP did not decrease fatigue more than the fixed recommendation to exercise. Both the graduated intervention and fixed recommendation lead to increased walking which was associated with lower fatigue in this study of older adult breast cancer patients.

The relevance and impact of human subject research on clinical practice depends on whether the study population reflects the age distribution and health characteristic profiles of the general population. Older adults with a cancer are disproportionately underrepresented in clinical trials and fewer data are available to assess the risks and benefits of cancer treatments, particularly adverse effects on functional outcomes and quality of life1. Furthermore, there is a lack of understanding of how the underlying biologic processes of aging affect tolerance of cancer treatment and survival outcomes. In 2010, the Cancer and Aging Research Group (CARG) outlined the following gaps in generating high quality research in older adults with cancer: 1) clinical measures most relevant to older adults are rarely incorporated into oncology clinical trials; 2) biological and physiological markers of aging are inconsistently included in oncology research; 3) a need for more studies of vulnerable older adults and/or those aged 75 years or older; and 4) limited research infrastructure to support collaborations between geriatrics and oncology.2 Almost a decade later, CARG has been awarded a five-year R21/R33 grant to develop a sustainable national research infrastructure to create and support significant and innovative projects at the interface of cancer and aging that address the four gaps that were initially identified. As a component of this infrastructure award, interactive Cores were developed to facilitate and support aging-related research in oncology. The purpose of this perspective is to summarize the mission and proposed function, process and procedures for Core 1: Clinical and Biological Measures of Aging; and to provide examples of how the Core will facilitate research in geriatric oncology.

OBJECTIVE Older patients with cancer suffer from chemotherapy-related toxicities more frequently than younger patients. As novel agents are being used more commonly in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL), toxicities of these agents in older patients have not been well studied. Further, impact of these toxicities on outcomes in the elderly is unknown. This study aimed to answer both questions. PATIENTS AND METHODS We reviewed 14 Alliance for Clinical Trials in Oncology trials that enrolled CLL and/or NHL patients between 2004-2014. Toxicity was assessed per the NCI-CTCAE (version 3-5). Probabilities of experiencing grade three or four hematologic and non-hematologic toxicities were modeled as a function of clinical and disease-related factors using logistic regression. RESULTS 1199 patients (409 age ≥ 65; 790 age

Objective Actual weight-based (AWB) chemotherapy dosing is recommended for obese patients in the 2012 ASCO Clinical Practice Guideline. CALGB 49907, which utilized ABW-based adjuvant chemotherapy dosing, was a phase 3 trial in women age ≥ 65 years with early stage breast cancer, providing the opportunity to examine impact of such dosing on toxicities and outcome in older patients with breast cancer. Materials and Methods Adverse event data were available for 615 of 633 enrolled patients. Objectives were to assess grade ≥ 3 hematologic/non-hematologic toxicities by treatment arm, age, study entry BSA/BMI, and relapse-free (RFS) and overall survival (OS) by BSA/BMI. Results The 615 patients were sub-grouped by BSA (quartiles) and standard BMI categories, with BMI underweight/normal weight categories combined. Overall, grade ≥ 3 non-hematologic and hematologic toxicities occurred in 39.8% and 28.3% of patients, respectively. There were no significant differences in grade ≥ 3 toxicities among BSA quartiles. However, more grade ≥ 3 hematologic toxicities occurred in the underweight/normal weight BMI subgroup compared to overweight/obese subgroups (p = 0.048). Type of chemotherapy and age had no impact on toxicity occurrence by BSA/BMI categories. RFS was superior in the 25th–50th BSA percentile patients in univariate analysis (p = 0.042), as was OS in both univariate and multivariate analyses (p = 0.007, p = 0.009, respectively). No differences in RFS or OS were found by BMI categories. Conclusion Obesity was not correlated with adverse relapse or survival outcome, and grade ≥ 3 toxicities were not greater with ABW-based dosing. This supports safety and efficacy of ABW-based dosing as per the 2012 ASCO clinical practice guideline. ClinicalTrials.gov Identifier: NCT00024102 (49907).

A geriatric assessment (GA) assesses functional age of older patients with cancer and is a well-established tool predictive of toxicity and survival. The objective of this study was to investigate the prognostic value of individual GA items.546 patients with cancer ≥ 65 years completed GA from 2009 to 2014 and were followed for survival status for a median of 3.7 years. The GA consisted of function, nutrition, comorbidity, cognition, psychological state, and social activity/support domains. GA items with p 0.05 in univariable analyses for overall survival (OS) were entered into multivariable stepwise selection procedure using a Cox proportional hazards model. A prognostic scale was constructed with significant GA items retained in the final model.Median age was 72 years, 49% had breast cancer, and 42% had stage 3-4 cancer. Three GA items were significant prognostic factors, independent of traditional factors (cancer type, stage, age, and Karnofsky Performance Status): (1) "limitation in walking several blocks", (2) "limitation in shopping", and (3) "≥ 5% unintentional weight loss in 6 months". A three-item prognostic scale was constructed with these items. In comparison with score 0 (no positive items), hazard ratios for OS were 1.85 for score 1, 2.97 for score 2, and 8.67 for score 3. This translated to 2-year estimated survivals of 85%, 67%, 51% and 17% for scores of 0, 1, 2 and 3, respectively.This three-item scale was a strong independent predictor of survival. If externally validated, this could be a streamlined tool with broader applicability.

Although older patients represent the most rapidly growing segment of the oncology population, clinical care is guided by very little data on patient-reported outcomes, particularly satisfaction with healthcare. Using a large cancer center registry, we sought to describe factors associated with satisfaction with care for older and younger oncology patients.Data were collected through the University of North Carolina Health Registry Cancer Survivorship Cohort. Satisfaction was measured with the Patient Satisfaction Questionnaire Short Form. Quality of life (QOL) measures included were the Promis Global short form and the Functional Assessment of Cancer Therapy General (FACT-G).A total of 2385 patients were included. 460 (20%) were aged 70 and above (older group). Older patients reported significantly higher levels of satisfaction in domains of time spent with doctor (scores 3.84 versus 3.73 p=0.03) and financial aspects (scores 4.03 versus 3.44 p0.001) compared to younger patients. In multivariable analysis, higher QOL scores and higher self-reported ECOG performance status were associated with higher satisfaction scores. African American race was associated with lower satisfaction scores in all age groups. QOL was more closely correlated with satisfaction in older patients compared to younger patients.Older patients with cancer report higher levels of satisfaction with care, in part due to lesser financial burden of care. Better QOL is associated with satisfaction with care in older patients. Use of patient-reported outcomes such as patient satisfaction may help improve patient-centered geriatric oncology care.

Objective Sarcopenia is the age-related loss of muscle mass, strength, and function. It is a common finding in older patients and is associated with decreased life expectancy and potentially higher susceptibility to chemotherapy toxicity. This study describes the prevalence of sarcopenia in older adults with early stage colorectal cancer. Materials and Methods Patients ≥ 70 years old who underwent surgical resection for stage I–III colorectal cancer between 2008 and 2013 were identified from the medical record. Sarcopenia was assessed by measuring the total muscle area on computerized tomography (CT) images obtained prior to surgery. Total muscle area was measured at the level of L3 and normalized using each patient’s height to produce a skeletal muscle index (SMI). Sarcopenia was defined using sex- and body mass index (BMI)–specific threshold values of SMI. Results Eighty-seven patients were included, with a median age of 77 years (70–96). Twenty-five men (60% of 42) and 25 women (56% of 45) had sarcopenia. Sarcopenic patients had significantly lower BMI ( p = 0.03) compared to non-sarcopenic patients. There was a positive correlation between BMI and SMI for both men ( r = 0.44) and women ( r = 0.16). Conclusion Sarcopenia is highly prevalent among older patients with early stage colorectal cancer. BMI alone is a poor indicator of lean body mass and improved methods of screening for sarcopenia are necessary. CT scans are a viable option for identifying sarcopenic patients in whom timely interventions may improve survival, quality of life, and functional outcomes.

Geriatric oncology is an emerging discipline focusing on the care of older patients with cancer. Caring for older cancer patients is a challenge. In elders the cancer frequency takes second place to other medical problems, a circumstance most oncologists has not been trained to deal with. This perspective describes how the field emerged, how and why I became interested, why caring for older patients is so rewarding, and the challenges ahead of us.

We appreciate the opportunity to respond to Drs. Safer and Binay Saferregarding ourrecentstudy which utilizedcomputed tomography (CT) imaging to determine the prevalence of sarcopenia in older adults with colorectal cancer. The authors inquired about the usage of single-slice CT imaging to determine total body muscle mass and our functioning definition of sarcopenia.

Objective Emerging results support the value of geriatric assessment (GA) in determining the risk and benefits of cancer treatment in older adults. A brief GA tool consisting of valid and reliable measures has been developed; however, little data exist on the ability to perform the GA in community oncology clinics. The objective of this study was to determine the feasibility of performing the GA in the community. Materials and Methods Patients aged ≥ 65 were eligible. The GA included a health care provider assessment of performance status, cognitive function, a Timed Up and Go test, and a self-administered patient questionnaire that evaluated measures of functional status, comorbidity, psychological state, social support, and nutritional status. Results From 2009 to 2013, 1088 patients were assessed including 339 (31%) from seven community clinics across North Carolina. The median amount of time to complete the patient-report portion of the GA was 19 min in the academic center versus 22 min in the community. The median amount of time to complete the entire GA was 23 min in the academic center and 30 min in community settings. Significantly more patients in the community required assistance completing the questionnaire (24% vs. 14%); however, most patients required no assistance (76%). Conclusion A brief GA can be performed in community oncology clinics. The time to complete the professional assessments and patient self-assessments were similar in both settings. Future studies are planned to determine if such assessments can improve cancer care for older patients.

Treating older patients with metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer is often challenging. This is largely due to the issues providers face in making decisions in the setting of limited efficacy and toxicity data specific to older women in addition to the competing challenges of managing comorbidity and preserving functional status. Here, we discuss currently available treatment regimens and other important issues to consider when treating older patients with metastatic, HER2-positive disease.

National guidelines suggest that women with hormone receptor positive breast cancer be considered for adjuvant endocrine treatment with an aromatase inhibitor (AI). Joint symptoms (arthralgia) are a common AI side-effect. There is a need for effective approaches to arthralgia management that enable survivors to remain on AI therapy while optimizing as pain-free a life as possible. This feasibility study investigates a 6-week self-directed walking program in a sample of elderly female breast cancer survivors on AIs reporting joint pain.Walk With Ease (WWE) goal--minimum 30 min of walking 5 days a week (150 min per week). Eligibility: age65; Stage I-III breast cancer; ≥3 months of AI therapy; self-reported joint pain/stiffness.(1) walking--number of days/week and number of minutes/walk, (2) visual analog scales (VAS) for joint pain, fatigue and stiffness, and (3) arthritis self-efficacy (ASE) to manage joint pain and fatigue.t-tests, correlation coefficients and effect sizes.Sample target of 20 was achieved--mean age 71 (65-87), 85% Caucasian, mean BMI 29. Proportion walking 150 min/week increased from 21% at baseline to 50% at 6 weeks (p0.001). Mean joint pain at baseline (39.7 + 26.9) decreased 10% (p = 0.63), fatigue (37.4+33.3) decreased 19% (p = 0.31), joint stiffness (46.1 + 27.2) decreased 32% (p = 0.07).A self-directed walking program among elderly breast cancer survivors on AI therapy significantly increased total time of walking per week over a 6 week period. Joint pain, stiffness, and fatigue also decreased, although not significantly. Testing within a larger sample is warranted.

The natural history of breast cancer favors a presentation in older patients, and with our aging population the management of breast cancer in geriatric patients has growing importance. Many of these patients will be diagnosed at an early stage. Thoughtful utilization of adjuvant radiation therapy for patients with early stage tumors, tailored within the context of comprehensive geriatric assessment, will optimize clinical outcomes and minimize costs and morbidity.

P11 Paclitaxel and bevacizumab as first-line treatment in elderly women with HER-2 negative locally advanced or metastatic breast cancer: Preliminary results a multicenter phase II trial from Hellenic Oncology Research Group L. Vamvakas, A. Karampeazis, Ch. Nikolaou, A. Ardavanis, E. Saloustros, K. Kalbakis, Z. Zafeiriou, D. Stoltidis, A. Kalykaki, V. Georgoulias, D. Mavroudis. Hellenic Oncology Research Group (HORG), Athens, Greece