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Despite recent advances in cancer, racial disparities in treatment outcomes persist, and their mechanisms are still not fully understood. The objective of this study was to examine racial differences in frailty and geriatric assessment impairments in an unselected cohort of older adults with newly diagnosed gastrointestinal (GI) malignancies.This study used data from the Cancer and Aging Resilience Evaluation Registry, a prospective cohort study that enrolled older adults (≥60 years) with GI malignancies who were presenting for their initial consultation. Participants who had a geriatric assessment completed before chemotherapy initiation and self-reported as either White or Black were included. Frailty was defined with a frailty index based on the deficit accumulation method. The differences in the prevalence and adjusted odds ratios for frailty and geriatric assessment impairments between Black and White participants were examined.Of the 710 eligible patients who were seen, 553 consented with sufficient data for analyses. The mean age at enrollment was 70 ± 7.1 years, 58% were male, and 23% were Black. Primary cancer diagnoses included colorectal cancer (32%), pancreatic cancer (27%), and hepatobiliary cancer (18%). Black participants were more likely to be frail (50.0% vs 32.7%; P.001) and report limitations in activities of daily living (27.3% vs 14.1%; P = .001), instrumental activities of daily living (64.8% vs 47.3%; P = .002), and walking 1 block (62.5% vs 48.2%; P = .004). These associations persisted even after adjustments for age, sex, education, cancer type, cancer stage, and comorbidity.Black participants were frailer and reported more limitations in function in comparison with White participants. These findings may partially explain disparities in cancer outcomes and warrant further examination.

Little is known regarding the predictive value of the Cancer and Aging Research Group (CARG) score, a validated chemotherapy toxicity prediction tool for older adults with cancer, for survival outcomes.This was a prospective observational study of patients ≥65 years old receiving first-line chemotherapy for advanced noncolorectal gastrointestinal cancer for which combination chemotherapy is the standard of care. Overall survival (OS), time to treatment failure (TTF), which was defined as the time from the start of first-line chemotherapy to the discontinuation of first-line chemotherapy for any reason, and toxicity were compared in 4 groups of patients: 1) non-high-risk (nHR) CARG score (10) and standard-intensity therapy (ST), 2) nHR score and reduced-intensity therapy (RT), 3) high-risk (HR) CARG score (≥10) and ST, and 4) HR score and RT.Fifty patients (median age, 71 years) were enrolled. The median OS in months was 19.7 in nHR/ST (n = 19) group, 12.7 in nHR/RT (n = 9) group, 4.5 in HR/ST (n = 12) group, and 3.9 in HR/RT (n = 10) group (log-rank test, P = .005). The median TTF in months was 9.1 in nHR/ST group, 2.5 in nHR/RT group, 2.3 in HR/ST group, and 3.0 in HR/RT group (log-rank test, P = .04). The CARG-score category was prognostic of OS (HR, 3.04; 95% confidence interval [CI], 1.59-5.83, P = .001) and TTF (HR, 2.60; 95% CI, 1.31-5.20, P = .007). The incidence of grade 3-5 toxicity was 68% in nHR/ST group, 33% in nHR/RT group, 92% in HR/ST group, and 70% in HR/RT group (Fisher exact test, P = .048).Risk-adapted chemotherapy based on the CARG-score may improve treatment outcomes.

It is not known whether chemotherapy-related symptom experiences differ between Black and White women with early breast cancer (Stage I–III) receiving current chemotherapy regimens and, in turn, influences dose delay, dose reduction, early treatment discontinuation, or hospitalization. Patients self-reported their race and provided symptom reports for 17 major side effects throughout chemotherapy. Toxicity and adverse events were analyzed separately for anthracycline and non-anthracycline regimens. Fisher’s exact tests and two-sample t-tests compared baseline patient characteristics. Modified Poisson regression estimated relative risks of moderate, severe, or very severe (MSVS) symptom severity, and chemotherapy-related adverse events.Please check and confirm that the authors and their respective affiliations have been correctly identified and amend if necessary.no changes In 294 patients accrued between 2014 and 2020, mean age was 58 (SD13) and 23% were Black. For anthracycline-based regimens, the only significant difference in MSVS symptoms was in lymphedema (41% Black vs 20% White, p = .04) after controlling for axillary surgery. For non-anthracycline regimens, the only significant difference was MSVS peripheral neuropathy (41% Blacks vs. 23% White) after controlling for taxane type (p = .05) and diabetes (p = .05). For all other symptoms, severity scores were similar. Dose reduction differed significantly for non-anthracycline regimens (49% Black vs. 25% White, p = .01), but not for anthracycline regimens or in dose delay, early treatment discontinuation, or hospitalization for either regimen. Except for lymphedema and peripheral neuropathy, Black and White patients reported similar symptom severity during adjuvant chemotherapy. Dose reductions in Black patients were more common for non-anthracycline regimens. In this sample, there were minimal differences in patient-reported symptoms and other adverse outcomes in Black versus White patients.

Myosteatosis (intramuscular adiposity) is predictive of chemotherapy toxicity in women undergoing adjuvant chemotherapy for breast cancer (BC). We evaluated a novel, user-friendly and cost-effective technique utilizing a Picture Archiving and Communication Systems (PACS) tool that is readily available in the electronic medical record (EMR), using skeletal muscle density (SMD) to detect myosteatosis and then compared PACS results with those derived from widely used body composition software (SliceOMatic, QC, Canada). Using retrospective data from a sample of women with early BC (Stage I-III) who had CT scan and received chemotherapy. Pearson correlation coefficients were used to compare SliceOMatic with PACS results. Associations of PACS results with chemotherapy-related adverse events were evaluated using multivariable (MV) log-binomial models adjusted for age, race, BMI, anthracycline-based therapy, and number of comorbidities. In 338 patients, mean age was 51, 32% were non-white, and 40% had obesity (BMI ≥ 30 kg/m2). Correlation of SMD using SliceOMatic whole muscle measurements with PACS psoas muscle was 0.76 (p

Cancer-related cognitive impairment (CRCI) has been largely unstudied in patients with multiple myeloma (MM). This study describes patient-reported cognition over time and patient factors associated with adverse cognitive outcomes in MM.Participants enrolled in a registry in which they completed a geriatric assessment at study entry, and 36 months after entry. Cognitive function was assessed using the EORTC QLQ-C30 Cognitive Function subscale, with CRCI defined as scores75. Generalized estimating equation (GEE) models were used to fit longitudinal models to investigate differences by group and differences in changes over time by group, with adjustment for time since diagnosis.One hundred and four adults with MM had mean age of 67 years and 30% identified as Black. Patient-reported CRCI was present in 18% of participants at enrollment, 21% at 3 months, and 30% at 6 months. Worse cognitive function was reported in those with impairments in physical function (P = .002), IADLs (P = .02), and performance status (P = .04), as well as in those who were prefrail/frail (P = .02) and depressed (P = .049). Greater cognitive decline over time was observed in patients without CRCI at enrollment (P.0001) and those with lower levels of education (P = .04).This is one of the first studies to describe longitudinal changes in patient-reported cognition in patients with MM. Several potentially intervenable factors, including physical function impairment and depression, were associated with worse cognition at study entry, but only baseline CRCI status and education level were predictive of future decline.

BACKGROUND This study investigates obesity and comorbidity in Black and White women with early breast cancer (stages I-III) and their potential impact on treatment decisions for patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) tumors. METHODS In this retrospective chart review, comparisons of frequencies for Black and White patients were calculated with the Fisher exact test. Log binomial regression was used to estimate prevalence ratios (PRs) with 95% confidence intervals for total and individual comorbidities, and multivariable modeling was used to estimate PRs adjusted for age and body mass index (BMI). RESULTS In a sample of 548 patients, 26% were Black, and 74% were White. Sixty-two percent of Black patients and 32% of White patients were obese (BMI ≥ 30 kg/m2 ; P < .0001). Seventy-five percent of Black patients and 87% of White patients had HR+ tumors (P = .001). Significant intergroup differences were seen for 2 or more total comorbidities (62% of Blacks vs 47% of Whites; P = .001), 2 or more obesity-related comorbidities (33% vs 10%; P < .0001), hypertension (60% vs 32%; P < .0001), diabetes mellitus (23% vs 6%; P < .0001), hypercholesterolemia or hyperlipidemia (28% vs 18%; P = .02), and hypothyroidism (4% vs 11%; P = .012). In women with HR+/HER2- tumors, there were no intergroup differences in treatment decisions regarding the type of surgery, chemotherapy regimen, radiation, or endocrine treatment despite significant differences in the prevalence of obesity and comorbidities. CONCLUSIONS This study documents significant disparities between Black and White women with early breast cancer with regard to high rates of obesity, overall comorbidities, and obesity-related comorbidities, and it highlights the prevalence of competing risks that may complicate outcomes in breast cancer.

BACKGROUND To the authors' knowledge, it is unknown whether patient-reported symptom severity and symptom interference with daily activities differ between younger (aged

Background Depression and anxiety are common in patients with breast cancer and associated with worse quality of life and treatment outcomes. Yet, these symptoms are often underrecognized and undermanaged in oncology practice. The objective of this study was to describe depression and anxiety severity and associated patient factors during adjuvant or neoadjuvant chemotherapy in women with early breast cancer using repeated single-item reports. Materials and Methods Depression and anxiety were measured from consecutive patients and their clinicians during chemotherapy infusion visits. Associations between psychiatric symptoms and patient characteristics were assessed using Fisher's exact tests for categorical variables and t tests for continuous variables. The joint relationship of covariates significant in unadjusted analyses was evaluated using log-binomial regression. Cohen's kappa was used to assess agreement between patient- and clinician-reported symptoms. Results In a sample of 256 patients, 26% reported at least moderately severe depression, and 41% reported at least moderately severe anxiety during chemotherapy, representing a near doubling in the prevalence of these symptoms compared with before chemotherapy. Patient-provider agreement was fair (depression: κ = 0.31; anxiety: κ = 0.28). More severe psychiatric symptoms were associated with being unmarried, having worse function, endorsing social activity limitations, using psychotropic medications, and having a mental health provider. In multivariable analysis, social activity limitations were associated with more severe depression (relative risk [RR], 2.17; 95% confidence interval [CI], 1.36–3.45) and anxiety (RR, 1.48; 95% CI, 1.05–2.09). Conclusion Oncologists frequently underestimate patients’ depression and anxiety and should consider incorporating patient-reported outcomes to enhance monitoring of mental health symptoms. Implications for Practice In this sample of 256 patients with breast cancer, depression and anxiety, measured using single-item toxicity reports completed by patients and providers, were very common during adjuvant or neoadjuvant chemotherapy. Patient-reported depression and anxiety of at least moderate severity were associated with multiple objective indicators of psychiatric need. Unfortunately, providers underrecognized the severity of their patients’ mental health symptoms. The use of patient-reported, single-item toxicity reports can be incorporated into routine oncology practice and provide clinically meaningful information regarding patients’ psychological health.

There is great variability in life-expectancy, physical, cognitive, and functional domains in cancer patients of similar chronologic age. Nowhere is this more apparent than among middle-aged and older patients. However, even in younger patients of similar age, extensive exposure to environmental stressors can cause great variability in health status. A biomarker that would reflect biologic age and any and all health deficits in a cancer patient at a distinct point in time might help predict long term outcomes related to treatment, especially toxicity and overall survival. p16INK4a (hereafter referred to as p16) expression represents an ideal biomarker that reflects both cellular senescence and biologic aging. In murine models, p16 expression reflects biologic aging in almost all organs. Preliminary findings in patients with cancer support p16 measurement as a marker of physiologic aging and predictor of toxicity in patients treated with chemotherapy. This review describes the role of p16 in cell senescence, the methodology of p16 measurement in humans, preliminary studies of p16 in humans, and the potential clinical utility of p16 in guiding treatment for cancer patients.

Body composition metrics as predictors of adverse events are a growing area of interest in oncology research. One barrier to the use of these metrics in clinical practice is the lack of standardized cut points for identifying patients with at-risk body composition profiles. We examined the association of chemotherapy adverse events with several body composition measures, using alternative cut points from published studies. This is a retrospective study of women diagnosed with early breast cancer (EBC). Axial computerized tomography (CT) images from lumbar L3 segments were analyzed for the following body composition measures: myosteatosis (low Skeletal Muscle Density/SMD), sarcopenia (low Skeletal Muscle Index/SMI), and high Visceral Adipose Tissue (VAT). Adverse events during chemotherapy were dose reduction, early treatment discontinuation, and hospitalization. Log-binomial modeling was used to evaluate associations between body composition measures at different cut points with adverse events, adjusting for age, race, Body Mass Index/BMI, and comorbidities. Relative risks were reported as the measure of association. In a sample of 338 women, mean age was 51, 14% were age 65 or older, 32% were non-white, 40% had obesity (/BMI ≥ 30 kg/m2), and mean number of comorbidities was 1.56. In multivariable analysis (MV), all three SMD cut points for myosteatosis had significant associations with total number of adverse events, as well as different cut points having significant associations with either dose reduction, early treatment discontinuation or hospitalization. SMI and VAT were not significant in the MV analysis; however, in some models, age and total comorbidities were significant for adverse events. Among CT-derived measures of body composition, myosteatosis determined at any of three SMD cut points was associated with total and individual adverse events during chemotherapy for early breast cancer.

Introduction: Sarcopenia and muscle composition are associated with treatment-related toxicities and adverse events in women with EBC (Shachar 2017). We investigated the relationship of muscle mass with other measures of body composition as well as comorbidities, physical function, fatigue, and quality of life. Methods: Women age 21 or older were enrolled in intervention studies (NCT02167932, NCT02328313) investigating home-based walking during chemotherapy for early breast cancer (stage I-III). Prior to the start of chemotherapy, patients completed the Short Physical Performance Battery (SPPB) and the Timed Up and Go (TUG) test. When available from staging, transverse views of computed tomography (CT) through L3 lumbar segments were analyzed using Slice-O-Matic software (Tomovision Quebec, Canada) to ascertain skeletal muscle area (SMA= -29 to +150 Hounsfield Units), skeletal muscle density (SMD= average attenuation of skeletal muscle in HU), skeletal muscle index (SMI= SMA/height2), and skeletal muscle gauge (SMG= SMI x SMD). BSA and BMI were calculated using standard formulas. Descriptive statistics (mean and standard deviation (SD)) were estimated and simple linear regression models were used to evaluate associations of body composition, function and quality of life and continuous muscle measures. Pearson correlation coefficients were estimated to assess the relationship between muscle metrics. Results: In 99 patients, mean age was 56 (SD 13), BMI was 30 (SD 7), 47% were obese (≥30 kg/m2), and 54% had stage III breast cancer. Mean SMI was 45.3 (SD. 8.5), 26% were sarcopenic (SMI 1512 Arbitrary Units]. For each additional comorbidity, mean SMD decreased by 1.91 (p=.003), mean BSA increased by 0.035 (p=.02), and mean BMI increased by 1.31 (p=.005). Lower SMD and SMG were seen for patients with TUG >14 seconds (-5.70, p=.04 and -325.4, p=.02, respectively). The mean SMD increased by 1.22 (p=.02) for each additional point on the SPPB scale. For the correlation between BMI and muscle matrices, there was a strong positive correlation for SMI (+0.648 p Citation Format: Gabriel F. P. Aleixo, Allison M Deal, Grant R Williams, Hyman B Muss, Kirsten A Nyrop, Ji Hye Park, Hyeon Yu, Shlomit S Shachar. Muscle measures, body composition, and function in patients with early breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P3-08-73.

Introduction: Visceral adipose tissue (VAT) is correlated with lower overall survival and higher chemotherapy toxicity in women with breast cancer (Del Fabbro 2012, Feliciano 2019). In a sample of women scheduled for chemotherapy for early breast cancer (EBC) (stage I-III), we evaluate whether VAT or superficial adipose tissue (SAT) are associated with comorbidities, function, and clinically-used body metrics, Body Mass Index (BMI) and Body Surface Area (BSA).Methods: Women age 21 or older were enrolled in intervention studies (NCT02167932, NCT02328313) to encourage home-based walking during chemotherapy for EBC. Prior to chemotherapy initiation, patients had abdominal computerized tomography (CT) scans and completed Timed Up and Go (TUG) and Short Physical Performance Battery (SPPB) tests. Axial CT images were evaluated at the L3 level using Slice-O-Matic software (Tomovision Quebec, Canada). Superficial adipose tissue(SAT) was calculated from extra-muscular tissue with densities ranging from -190 to -30 Hounsfield Units (HU). Visceral adipose tissue (VAT) was calculated from non-subcutaneous tissue with densities from -150 to -50 HU, with values in cm2. BSA and BMI were calculated using standard formulas. Descriptive statistics(mean and standard deviation (SD)) were estimated and simple linear regression models were used to evaluate associations of comorbidities, function, and clinically-used body metrics and continuous adiposity measures. Pearson correlation coefficients were estimated to assess the relationship between adiposity measures.Results: In a sample of 99 women, mean age was56 (SD 13.1), BMI was 30 (SD 7), 47% were obese (≥30 kg/m2), and mean number of comorbidities was1.3 (SD 1.5).The mean VAT was 113.9 (SD 71.2), 50% had high VAT (>100 cm2), and the mean SAT was 294.2 (SD 71.2). For each additional comorbidity, mean VAT increased by 16.68, and SAT increased by 21.6. Both arthritis and high blood pressure were associated with higher VAT (+67.2 p14 seconds +57.87 (p=.004). For each additional point on the SPPB scale, the mean VAT decreased by 12.14(p=.002). For each additional comorbidity, BSA increased 0.035(p=.004) and BMI increased 1.31(p=.003). Strong positive correlations with VAT were seen for BSA (.697 p Citation Format: Gabriel F. P. Aleixo, Allison M Deal, Shlomit S Shachar, Hyman B Muss, Kirsten A Nyrop, Ji Hye Park, Hyeon Yu, Grant R Williams. Adiposity, comorbidities, and function in patients with early breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P3-08-48.

Background Hospitalized older adults have significant geriatric deficits that may lead to poor outcomes. We conducted a randomized trial to investigate the effectiveness of providing clinicians with a real-time geriatric assessment (GA) report in nonelectively hospitalized older patients with cancer. Subjects, Materials, and Methods We developed a web-based software platform for administering a modified GA (Cancer 2005;104:1998–2005) to older (>70 years) nonelectively hospitalized patients with pathologically confirmed malignancy. Patients were randomized to have their GA report provided to their treating clinicians (Intervention arm) or not provided (Control arm). Results Our study included 135 patients, median age 76 years, 52% female, 75% white, 21% black, 79% greater than high school education, 59% married, and 17% living alone. All patients had at least one GA-identified deficit, including physical function deficits (90%), cognitive impairment (22%), >5 comorbidities (28%), polypharmacy (>9 medications; 38%), weight loss ≥10% in the past 6 months (40%), anxiety (32%), or depression (30%). There was no difference between the Intervention (6%) and Control arms (9%) in the proportion of patients who were referred by their clinical team for an intervention to address a deficit (p = .53). Conclusion Many older nonelectively hospitalized patients with cancer have geriatric deficits that are amenable to evidence-based interventions. Real-time GA reports provided to the care team prior to discharge did not influence provider referral for such interventions. There is a need for systems-level interventions to address deficits in this vulnerable patient population. Implications for Practice Geriatric deficits are common in hospitalized older adults with cancer and lead to poor outcomes. Addressing modifiable deficits represents an appealing way to improve outcomes. Widespread geriatrician consultation is impractical owing to resource and personnel constraints. This work tested whether prompt delivery of a mostly self-administered, web-based geriatric assessment report to clinicians improved referral rates for evidence-informed interventions. It confirmed frequent geriatric deficits and high readmission rates in this population but found that real-time geriatric assessment reporting did not influence provider referral for evidence-informed interventions on geriatric assessment identified deficits. These findings highlight the need for systems-level intervention to improve outcomes in this vulnerable patient population.

Background In this study, we explore recruitment, retention, and potential quality of life (QoL) and function benefits from a self-directed, home-based walking intervention in women during active treatment for metastatic breast cancer (MBC). Methods In this single-arm pilot study, women with stage IV BC wore an activity tracker (FitbitTM) to measure steps per week throughout the intervention study. Participants were asked to walk 150 min per week at a comfortable and safe pace. Patient-reported outcome measures (PRO) were collected at baseline and follow-up. Results Target recruitment of 60 patients was achieved. In 52 patients who completed all baseline measures, mean age was 55 (SD 11.1), 23% were pre-menopausal, and 19% non-White. Forty patients (77%) were retained at 3 months and 29 (56%) at 6 months. Baseline walking was the strongest predictor of retention at 3 months (P = .02). For 24 patients (46%) with analyzable Fitbit data at 3 months, mean steps/week rose from 19,175 to 31,306. Higher number of steps correlated with larger improvements FACT-G General well-being (FACT-G, rho = 0.55, P = .01), FACT-G Physical well-being (rho = 0.48, P = .03), and PROMIS Mental Health (rho = 0.55, P = .01). Conclusion Recruitment into a walking intervention is feasible (a priory target of N = 60) in women during treatment for MBC, but retention at 3 months follow-up fell short (77% versus a priori 80%), yet there were potential benefits in general and physical well-being and mental health. ClinicalTrials.gov Identifier NCT02682836.

BackgroundThe plasma cell disorders (PCDs), multiple myeloma (MM), and light-chain amyloidosis (AL) are disproportionately diseases of older adults, whose care may be complicated by frailty associated with advancing age. We sought to evaluate the prevalence of functional deficits and symptoms in a cohort of persons with PCDs and associations of demographic, disease-related, functional, and psychosocial measures with quality of life (QoL).Patients and MethodsAdults with PCDs were recruited into an observational registry in 2018-2020. Patients completed a functional assessment and European Organization for Research and Treatment of Cancer QoL questionnaire (QLQ-C30). Associations of covariates of interest with QoL were evaluated via univariate linear regression.ResultsAmong 121 adults, the mean age was 68.6. Diagnoses were 74% MM, 14% AL, 7% both MM and AL, and 5% other PCDs. The median time from diagnosis was 34.9 months. Median lines of therapy were 2, with 11% having received ≥4th-line therapy.Patients with functional deficits had lower mean QoL scores: dependence in IADLs (66.3 vs. 79.9, P = .001) and recent falls (56.7 vs. 76.8, P = .001). Patients ≤6 months from diagnosis had lower QoL (66.7) than those ≥2 years from diagnosis (77.3, P = .03). However, patients on later lines of therapy (≥4th-line) had lower QoL (62.2) than those on 1st-line treatment (76.0, P = .04).ConclusionsPatients with physical impairments and more advanced PCDs had lower QoL than those without deficits or earlier in their disease course. Early identification of physical impairments may facilitate interventions that mitigate these deficits and thereby improve QoL for patients with PCDs.

Background Women with obesity are at higher risk for high-grade and/or advanced-stage breast cancer in comparison with women without obesity. Many women with a high body mass index (BMI) at breast cancer diagnosis experience further weight gain during and after treatment. This study investigated Black and White patient perspectives on conversations with their oncologists about weight and weight management. Methods Focus groups using a virtual platform (Zoom) were conducted with women after primary treatment for stage I to III breast cancer who were 21 years or older and had a BMI ≥ 30 kg/m2 : 2 with Black women (n = 12) and 2 with White women (n = 14). Results Participants asked that their oncologists be "transparent" about weight gain as a potential side effect of their cancer treatment and how excess weight might affect their prognosis and survival. They asked to be "seen as an individual" to facilitate both person-centered and culturally appropriate conversations about behavioral changes needed for weight management. Participants urged clinicians to take the lead in initiating conversations about weight to underscore its importance in cancer care and survivorship. They welcomed actionable recommendations about nutrition and exercise from either the oncology clinician or a specialist. Participants offered specific suggestions on how clinicians could initiate weight-related conversations, beginning with questions eliciting patients' perspectives on their weight and lifestyle. Conclusions Many women with early-stage breast cancer and obesity have concerns about weight and weight gain and urge their oncologists to use an active and personalized approach in recommending and supporting efforts at weight management. Lay summary Focus group discussions with Black and White women with early-stage breast cancer and obesity have elicited patient perspectives on conversations with their oncologists about weight and weight management. Many patients have concerns about weight and weight gain and urge their oncologists to use an active and personalized approach in recommending and supporting efforts at weight management.

Weight gain after breast cancer (BC) diagnosis is a well-known phenomenon; however, it is not a universal phenomenon and identification of patients at highest risk for weight gain is needed. This study investigates weight trajectories in early BC patients at 2 years post-primary treatment, examining potential contributing factors such as age, race, and receipt of chemotherapy, anti-HER-2 therapy, and endocrine treatment (ET).A single institution cohort of newly diagnosed women age 21 and older with early breast cancer patients (Stage 0-3) were identified by retrospective chart review (diagnosis year 1995 to 2016). Log-binomial regression models for net weight changes at 2 years post-primary treatment including patient demographic, clinical, and treatment characteristics.The final sample of 625 patients included 29% who were non-White and 37% who were pre-menopausal at diagnosis. Body mass index (BMI) at diagnosis was calculated and found to be normal in 33% (BMI 18 to 25), overweight in 27% (BMI 25 to 30), and obese in 40% (BMI 30 and higher). At 2 years, compared to weight at diagnosis, 31% had lost 2 kg, 34% had stable weight ± 2 kg, and 35% had gained 2 kg. Factors associated with 2 kg weight gain were menopausal status (pre-menopausal HR 1.65, 95% CI 1.34-2.04, p .0001), receiving any chemotherapy (HR 1.36, 95% CI 1.04-1.77), and anthracycline-based chemotherapy followed by ET (HR 1.60, CI 1.01-2.45). Anti-HER-2 therapy and transition from pre- to post-menopausal during the 2-year study period were not significant factors in weight gain. In multivariate analysis, menopausal status remained the only significant variable related to weight gain when adjusted for treatment. For all treatment combinations, pre-menopausal women had significantly more weight gain.Weight gain, weight loss, and stable weight in women with early breast cancer vary greatly by treatment plan. However, pre-menopausal patients have the highest risk for weight gain.

Geriatric assessment (GA) is used in oncology to identify deficits in older patients with cancer that may affect treatment choice. We examine GA in 550 patients with early breast cancer, including both younger (

Background: The American Society of Clinical Oncology (ASCO) Position Statement on Obesity and Cancer notes that the oncology care team is in a unique position to initiate weight management convers...

Breast cancer is the most common cancer and leading cause of cancer death in women. Body composition parameters, especially those related to muscle, have become a growing focus of cancer research. In this review, we summarize the literature on breast cancer and muscle parameters as well as combine their outcomes for overall survival (OS), time to tumor progression (TTP), and chemotherapy toxicity in a meta-analysis. A systematic search of the literature for randomized controlled trials and observational studies was conducted on MEDLINE, Cochrane CENTRAL, and EMBASE through May 1, 2019. Two reviewers independently searched and selected. Meta-analysis was conducted using a random-effects model. The risk of bias was evaluated using the Newcastle–Ottawa quality assessment for cohorts and GRADE summary of findings tool from Cochrane. A total of 754 articles were screened from which 6 articles and one abstract were selected. Using skeletal muscle index (SMI), patients classified as sarcopenic had a 68% greater mortality risk compared to non-sarcopenic patients (HR 1.68 95% CI 1.09–2.59, 5 studies) (p = .02) (i2 = 70%). Low muscle density was not predictive of OS (HR 1.44 95% CI 0.77–2.68, 2 studies) (p = .25) (i2 = 87%). Patients with sarcopenia (56%) had more grade 3–5 toxicity compared to non-sarcopenic (25%) (RR 2.17 95% CI 1.4–3.34, 3 studies) (p = .0005) (i2 = 0%). TTP was nearly 71 days longer in advanced/metastatic patients classified as non-sarcopenic compared to patients with sarcopenia (MD − 70.75 95% CI − 122.32 to − 19.18) (p = .007) (i2 = 0%). Our synthesis of the literature shows that patients with sarcopenia have more severe chemotherapy toxicity as well as shorter OS and TTP, and that low muscle density is prognostic of OS for women with metastatic breast cancer. Our findings suggest that in clinical practice, body composition assessment is valuable as a prognostic parameter in breast cancer.

Establishing accurate estimates of physical activity at baseline is essential for interventions assessing the potential benefits of exercise in adults with cancer. This study compares self-reported physical activity with independent data from activity trackers in women with early breast cancer (BC) recruited into a “walking” intervention during chemotherapy. Baseline (pre-intervention) questions inquired about self-reported physical activity—number of walking days/week and minutes/day—in women who were initiating chemotherapy for Stage I–III BC. Activity trackers measured steps per day during the first full week of chemotherapy. Weighted Kappa statistic and Pearson correlation coefficients were used to evaluate agreement and association between self-reported and objectively tracked physical activity levels, respectively. Univariate analyses were conducted to identify variables that may influence congruence between the two measures. In a sample of 161 women, 77% were white, with mean age 56 years. Agreement between self-reported and objectively tracked physical activity was “fair” (kappa coefficient = 0.31), with most patients (59%) over-reporting their physical activity levels. There was weak correlation between the two measures (r = 0.24); however, correlation was strong in participants who were not married (r = 0.53) and/or living alone (r = 0.69). Objective methods for assessing physical activity (activity trackers, accelerometers) should be used as a complement to self-reported measures to establish credible activity levels for intervention studies seeking to increase physical activity and/or measure the impact of increased physical activity in women with breast cancer.

12109 Background: Up to 75% of patients with breast cancer report cognitive decline following chemotherapy. There is no standard of care prevention or treatment of cognitive problems in these patients. This trial (NCT04033419) examines the feasibility of using memantine to prevent cognitive decline during chemotherapy for breast cancer. Methods: We enrolled patients with stage I-III breast cancer scheduled to receive neo/adjuvant chemotherapy. Participants completed a cognitive battery (4 traditional neuropsychological measures and 3 computerized tests) and surveys of self-reported cognition (PROMIS Cognitive Function Short Form 8a) and other neuropsychiatric symptoms at pre-treatment (baseline) and 4 weeks after the last cycle of chemotherapy (post-assessment). Memantine (10 mg BID) was initiated within 1 week of starting chemotherapy and continued until the post-assessment. Adherence and adverse event (AE) monitoring occurred every 2-3 weeks during chemotherapy infusion visits. We used descriptive statistics to evaluate recruitment, retention, and tolerability, adherence, and acceptability of memantine. To evaluate objective cognition, we standardized individual measures using population-based data and averaged them to calculate composite scores of 1) global cognition; 2) attention, working memory, and executive function; and 3) learning and memory. Improvement or decline was defined as ≥ 0.5 SD change between the two assessments. For self-reported cognition, established cutpoints were used to define clinically meaningful change. Results: Of 154 eligible patients approached, 56 (36%) enrolled. Of 51 who completed the baseline assessment and started memantine, 44 (86%) completed the post-assessment; 2 remain active. Among evaluable participants, 92% reported taking ≥ 90% of scheduled doses. Only 36% self-reported cognitive decline, while no change was reported in 57% and improvement in 7%. Decline in objective cognitive domains was observed in 7 - 14% (see Table). There were 7 ≥ grade 3 AEs 2 were possibly related to memantine (diarrhea and hypokalemia). Only 3 participants expressed worry about memantine and only 2 felt that taking memantine disrupted their lives. Conclusions: Our findings suggest that memantine is a safe and feasible intervention for chemotherapy-related cognitive decline and may ameliorate cognitive loss. Randomized controlled trials are needed to determine its preliminary efficacy. Clinical trial information: NCT04033419. [Table: see text]

Advances in breast cancer research are making treatment options increasingly effective and reducing mortality. Body composition is an example of a prognostic tool that can help personalize breast cancer treatments and further increase their effectiveness. In this study, we examine the association of several body composition measures with comorbidities, physical function, and quality of life. This study is a cross-sectional analysis of 99 women with early breast cancer scheduled for chemotherapy. Univariate regression models were used to identify significant associations of body composition metrics with patient demographics, clinical characteristics, measures of physical function, and patient-reported outcomes (PRO)s. Multivariable modeling was used to evaluate associations adjusted for age. Median age was 58 (range 24–83), 27% were non-white, and, 47% were obese (≥ 30 kg/m2). Increasing age was associated with lower Skeletal Muscle Density (SMD) (p = 0.0001), lower Skeletal Muscle Gauge (SMG) (p = 0.0005), and higher Visceral Adipose Tissue (VAT) (p 14 s), mean VAT was 57.87 higher (p = 0.004), SMD 5.70 lower (p = 0.04), and SMG 325.4 lower (p = 0.02). For each point of higher performance on the Short Physical Performance Battery (SPPB), VAT decreased 12.24 (p = 0.002) and SMD rose 1.22 (p = 0.02). In multivariable analysis adjusting for age, the association of TUG > 14 with higher VAT remained significant (p = 0.02). Suboptimal body composition prior to treatment is associated poor physical function and may be an indicator of clinical importance.

Background The National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, collected alongside the clinician-reported Common Terminology Criteria for Adverse Events, enables comparisons of patient and clinician reports on treatment toxicity. Methods In a multisite study of women receiving chemotherapy for early-stage breast cancer, symptom reports were collected on the same day from patients and their clinicians for 17 symptoms; their data were not shared with each other. The proportions of moderate, severe, or very severe patient-reported symptom severity were compared with the proportions of clinician-rated grade 2, 3, or 4 toxicity. Patient-clinician agreement was assessed via κ statistics. Chi-square tests investigated whether patient characteristics were associated with patient-clinician agreement. Results Among 267 women, the median age was 58 years (range, 24-83 years), and 26% were nonwhite. There was moderate scoring agreement (κ = 0.413-0.570) for 53% of symptoms, fair agreement for 41% (κ = 0.220-0.378), and slight agreement for 6% (κ = 0.188). For example, patient-reported and clinician-rated percentages were 22% and 8% for severe or very severe fatigue, 41% and 46% for moderate fatigue, 32% and 39% for mild fatigue, and 6% and 7% for none. Clinician severity scores were lower for nonwhite patients in comparison with white patients for peripheral neuropathy, nausea, arthralgia, and dyspnea. Conclusions Although clinician reporting of symptoms is common practice in oncology, there is suboptimal agreement with the gold standard of patient self-reporting. These data provide further evidence supporting the integration of patient-reported outcomes into oncological clinical research and clinical practice to improve monitoring of symptoms as well as timely interventions for symptoms.

BACKGROUND. This study explores the incidence of patient‐reported major toxicity—symptoms rated “moderate,” “severe,” or “very severe”—for chemotherapy regimens commonly used in early breast cancer. PATIENTS AND METHODS. Female patients aged 21 years or older completed a validated Patient‐Reported Symptom Monitoring instrument and rated 17 symptoms throughout adjuvant or neoadjuvant chemotherapy. Fisher's exact tests compared differences in percentages in symptom ratings, and general linear regression was used to model the incidence of patient‐reported major toxicity. RESULTS. In 152 patients, the mean age was 54 years (range, 24–77), and 112 (74%) were white; 51% received an anthracycline‐based regimen. The proportion of patients rating fatigue, constipation, myalgia, diarrhea, nausea, peripheral neuropathy, and swelling of arms or legs as a major toxicity at any time during chemotherapy varied significantly among four chemotherapy regimens (p < .05). The mean (SD) number of symptoms rated major toxicities was 6.3 (3.6) for anthracycline‐based and 4.4 (3.5) for non‐anthracycline‐based regimens (p = .001; possible range, 0–17 symptoms). Baseline higher body mass index (p = .03), patient‐reported Karnofsky performance status ≤80 (p = .0003), and anthracycline‐based regimens (p = .0003) were associated with greater total number of symptoms rated major toxicities (alternative model: chemotherapy duration, p < .0001). Twenty‐six percent of dose reductions (26 of 40), 75% of hospitalizations (15 of 20), and 94% of treatment discontinuations (15 of 16) were in anthracycline‐based regimens. CONCLUSION. Capturing multiple toxicity outcomes throughout chemotherapy enables oncologists and patients to understand the range of side effects as they discuss treatment efficacies. Continuous symptom monitoring may aid in the timely development of interventions that minimize toxicity and improve outcomes. IMPLICATIONS FOR PRACTICE. This study investigated patient‐reported toxicities for 17 symptoms recorded prospectively during adjuvant and neoadjuvant chemotherapy regimens for early breast cancer. An analysis of four commonly used chemotherapy regimens identified significant differences among regimens in both individual symptoms and total number of symptoms rated moderate, severe, or very severe. Longer chemotherapy regimens, such as anthracycline‐based regimens followed by paclitaxel, had higher proportions of symptoms rated major toxicities. The inclusion of patient perspectives on multiple toxicity outcomes at the same time at multiple time points during chemotherapy has the potential for improving patient‐provider communication regarding symptom management, patient satisfaction, and long‐term clinical outcomes.

This study investigates weight trajectories in pre- versus postmenopausal breast cancer (BC) survivors diagnosed with hormone receptor-positive tumors, with a specific focus on discerning menopausal status and type of endocrine treatment (ET) as risk factors for weight gain during ET. We conducted a retrospective review of electronic medical records. Descriptive statistics and Chi-squared and t tests were used to compare pre- and postmenopausal women. Chi-squared tests and ANOVA were used for within-group associations between patient characteristics and weight trajectories. Log-binomial regression models were used to estimate relative risk for weight gain. The final sample was 32% premenopausal (n = 140) and 68% postmenopausal (n = 298). Relative risk (RR) for weight gain during ET was highest in women who were premenopausal (RR = 1.29, 1.03–1.52) and had Stage 3 BC (RR = 2.12, 1.59–2.82), mastectomy (RR = 1.49, 1.19–1.88), axillary node dissection (RR = 1.39, 1.11–1.73), and chemotherapy (RR = 1.80, 1.37–2.36). For each kg of weight gained between BC diagnosis and start of ET, and for each additional year of age, RR of gaining weight during ET decreased (RR = 0.98, 0.97–0.99, and RR = 0.99, 0.98–0.99, respectively). Menopausal status and type of ET were not significant predictors of weight gain. In multivariable analysis, only weight loss between BC diagnosis and start of ET was significant. The association of weight loss prior to ET and subsequent substantial weight gain during ET warrants further investigation.

For most breast cancer survivors experiencing aromatase inhibitor‐associated arthralgia (AIAA), pharmacological remedies such as analgesics and antidepressants provide little or no joint symptom relief, and these medications have their own adverse side effects. There is a need to identify effective, easy‐to‐use, sustainable, and safe alternative or adjunctive approaches to AIAA management. This article describes an evidence‐based walking program that is effective in reducing symptoms in adults with arthritis and investigates whether the program could have similar benefits for women experiencing AIAA., Background. In postmenopausal women diagnosed with breast cancer (BC), most BC tumors are hormone receptor positive and guidelines recommend adjuvant endocrine therapy that includes an aromatase inhibitor (AI). This study investigates the impact of a 6‐week, home‐based, self‐directed walking program on the commonly reported side effect of AI‐associated arthralgia (AIAA). Materials and Methods. In this phase II trial, consented BC patients were randomized to walking Intervention (n = 31) or Wait List Control (WLC; n = 31). Eligibility criteria included: stage 0–III BC, on AI for at least 4 weeks, ≥3 on a 5‐point scale inquiring about joint symptom intensity “at its worst,” and exercising ≤150 minutes per week. Outcomes were self‐reported joint symptoms and psychosocial measures. Analyses comparing Intervention and WLC groups were conducted on an intention‐to‐treat basis to assess intervention impact at 6 weeks (postintervention) and at 6‐months follow‐up. Adjusted means were calculated to assess differences in two groups. Results. In our final sample (n = 62), mean age was 64 years, 74% were white, and 63% had a body mass index of 30 or higher. At postintervention, Intervention group participants reported significantly increased walking minutes per week, reduced stiffness, less difficulty with activities of daily living (ADL), and less perceived helplessness in managing joint symptoms. At 6‐months follow‐up (postwalking period in both Intervention and WLC), walking minutes per week had decreased significantly; however, improvements in stiffness and difficulty with ADLs were maintained. Conclusion. This study adds to the growing evidence base suggesting exercise as a safe alternative or adjunct to medications for the management of AIAA. Implications for Practice. Breast cancer survivors whose adjuvant endocrine treatment includes an aromatase inhibitor (AI) often experience the side effect of AI‐associated arthralgia (AIAA). This study investigates the impact of a 6‐week, home‐based, self‐directed walking program in the management of AIAA. Compared with Wait List Control, women in the Intervention group reported significantly increased walking minutes per week, reduced stiffness, less difficulty with activities of daily living, and less perceived helplessness in managing joint symptoms. This study adds to the growing evidence base suggesting exercise as a safe alternative or adjunct to medications for the management of AIAA.

Obesity and weight gain after breast cancer (BC) diagnosis can affect cancer outcomes. This study explores the question of weight change during the first 2 years of endocrine treatment (ET) to identify the independent effects of BC diagnosis and treatment on post-diagnosis weight trajectories in early-stage postmenopausal BC survivors. The study design is a retrospective chart review. Chi square tests and ANOVA were used to compare patients who gained >2 kg, lost >2 kg, or had stable weight. Log-binomial regression models were used to evaluate associations between patient characteristics and weight trajectories. The final sample is N = 300, with mean age at BC diagnosis of 65 years and 76% white. After 2 years of ET, 39% of study participants had gained >2 kg, 27% had lost >2 kg, and 34% had stable weight. Relative risks (RR) for weight gain were as follows: age at diagnosis = 0.98 (0.96, 0.99), being married = 1.48 (1.04, 2.12), weight change between BC diagnosis and start of ET = 0.98 (0.97, 0.99), Stage II = 1.42 (1.01, 2.01) or Stage III = 1.99 (1.41, 2.82), PR negative = 0.70 (0.51, 0.96), HER2 positive = 1.51 (1.07, 2.13), mastectomy = 1.49 (1.12, 1.98), axillary node dissection = 1.67 (1.27, 2.20), adjuvant chemotherapy = 1.49 (1.02, 2.19), and neoadjuvant chemotherapy = 2.29 (1.67, 3.14). Type of ET (tamoxifen or aromatase inhibitor) was not significant. In our sample of postmenopausal early-stage BC survivors, a majority had stable or lost weight during the first 2 years of ET. Higher disease complexity and associated treatment posed higher RR for weight gain.

Background The loss of muscle mass, known as sarcopenia, is a natural process of aging that is associated with adverse health outcomes regardless of age. Because cancer is a disease of aging, interest in sarcopenia and its potential impact in multiple cancer populations has increased significantly. Bioelectrical impedance analysis (BIA) is a guideline-accepted method for sarcopenia detection. This systematic review assesses the literature pertaining to BIA use in the detection of sarcopenia in adults with cancer. Materials and Methods In this systematic review, a search of the literature for randomized controlled trials and observational studies was conducted using MEDLINE, Cochrane CENTRAL, and EMBASE, through July 15, 2019. The study is registered at Prospero (CRD 42019130707). For study inclusion, patients had to be aged 18 years or older and diagnosed with solid or hematological neoplasia, and BIA had to be used to detect sarcopenia. Results Through our search strategy, 5,045 articles were identified, of which 24 studies were selected for inclusion in the review (total number of 3,607 patients). In five studies, BIA was rated comparable to axial computed tomography (CT) scan, calf circumference, or grip strength for sarcopenia screening. In 14 studies, BIA-identified sarcopenia was associated with adverse clinical outcomes. Conclusion BIA is an accurate method for detecting sarcopenia in adults with cancer prior to treatment and is a viable alternative to CT, dual-energy x-ray absorptiometry, and magnetic resonance imaging in oncology clinical practice.

BACKGROUND In the current study, the authors investigated the incidence of moderate to severe chemotherapy-induced peripheral neuropathy (CIPN) for chemotherapy regimens commonly used in current clinical practice for the treatment of patients with early breast cancer. Patient-reported and clinician-assessed CIPN severity scores were compared, and risk factors for CIPN severity were identified. METHODS Patients completed a Patient-Reported Symptom Monitoring form and oncologists completed a Common Terminology Criteria for Adverse Events form. CIPN reports were collected prospectively during regularly scheduled infusion visits throughout the duration of chemotherapy. RESULTS The sample included 184 women with a mean age of 55 years; approximately 73% were white. The 4 chemotherapy regimens used were doxorubicin and cyclophosphamide plus paclitaxel (60 patients); docetaxel and cyclophosphamide (50 patients); docetaxel, carboplatin, and anti-human epidermal growth factor receptor 2 (HER2) (24 patients); and doxorubicin and cyclophosphamide plus paclitaxel and carboplatin (18 patients). All patients treated with doxorubicin and cyclophosphamide plus paclitaxel and doxorubicin and cyclophosphamide plus paclitaxel and carboplatin received paclitaxel; all patients treated with docetaxel and cyclophosphamide and docetaxel, carboplatin, and anti-HER2 received docetaxel. The chemotherapy dose was reduced in 52 patients (28%); in 15 patients (29%), this reduction was due to CIPN. Chemotherapy was discontinued in 26 patients (14%), 8 because of CIPN. Agreement between patient-reported and clinician-assessed CIPN severity scores was minimal (weighted Cohen kappa, P = .34). Patient-reported moderate to severe CIPN was higher for paclitaxel (50%) compared with docetaxel (17.7%) (P

e20004 Background: Multiple myeloma (MM) and immunoglobulin light chain (AL) amyloidosis are clonal plasma cell disorders (PCDs) of aging, with median ages at diagnosis of 69 and 76 years, respectively. The care of adults with these disorders is often challenging due to the higher prevalence of vulnerabilities with advancing age. We examined the prevalence of physical or cognitive impairments and associations with quality-of-life (QoL) ratings in a longitudinal cohort of adults with PCDs. Methods: Adults undergoing treatment for PCDs were recruited to a longitudinal observational study (NCT03717844) from 2018 to 2020. A modified Cancer and Aging Research Group (CARG) geriatric assessment (GA) was administered at enrollment. Patients also completed the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30), which provided subscales of physical function, cognitive function, and global QoL (range 0-100; higher values indicate better function or QoL). Univariate linear regression was used to evaluate associations at the time of enrollment. Results: Among 121 consecutive adults, the mean age was 69 years, 65.8% were aged ≥ 65 years, and 71.9% were white. Diagnoses included MM in 73.6%, AL amyloidosis in 14.0%, and both disorders in 7.4%. The remaining 5.0% had another PCD warranting chemotherapy. Time from diagnosis at enrollment was ≤ 6 months for 25.6%, 6 to 24 months for 18.1%, and ≥ 24 months for 56.3%. In this cohort, 80.2% had a clinician-assessed Karnofsky Performance Status (KPS) score ≥ 80. GA-identified impairments (Timed Up and Go ≥ 14 seconds and dependence in ≥ 1 instrumental activity of daily living [IADL]) were seen in 29.8% and 35.6%, respectively, with 13.5% reporting ≥ 1 fall in the prior 6 months. Polypharmacy (≥ 5 medications) was identified in 80.0%. Self-reported physical and cognitive impairments on QLQ-C30 were described by 48.7% and 20.2%, respectively. Patients with functional deficits had worse EORTC QoL scores compared to those without deficits: dependence in ≥ 1 IADL (mean QoL score 66.3 vs. 79.9, p = 0.0009), ≥ 1 fall (56.7 vs. 76.8, p = 0.0009), self-reported physical impairment on QLQ-C30 (64.0 vs. 84.5, p < 0.0001), and self-reported cognitive impairment on QLQ-C30 (61.2 vs. 77.7, p = 0.0012). Conclusions: Using a modified CARG GA and the EORTC QLQ-C30, we identified physical and cognitive impairments among adults undergoing treatment for PCDs. GA-identified impairments in physical function were more prevalent than clinician-assessed KPS would suggest. Patients with physical and cognitive impairments had worse QoL scores than those without deficits. Future research involving this cohort will investigate the longitudinal trajectory of physical and cognitive functioning, evaluate trends in QoL measurements, and test the feasibility of implementing GA-guided interventions for this population.

6537 Background: Despite recent cancer advances, racial disparities in outcomes persist. Our objective was to examine racial differences in GA impairments, HRQOL, and body composition metrics as a novel way to understand outcome disparities in older adults with GI malignancies. Methods: The CARE registry at the University of Alabama at Birmingham (UAB) is an ongoing prospective cohort study that consecutively enrolls older adults (≥60y) with GI malignancies. The CARE registry utilizes a patient-reported GA that measures a broad range of aging-related health issues. HRQOL is measured using PROMIS Global-10. Computed-Tomography (CT) images are procured to measure skeletal muscle index (SMI) and skeletal muscle density (SMD) from the L3 cross-section. For this study, we examined the adjusted odds ratio (aOR) for racial differences in GA impairments, HRQOL, sarcopenia (defined as men BMI < 25, SMI ≤43 cm2/m2; men BMI ≥25, SMI < 53 cm2/m2; women SMI < 41 cm2/m2), and myosteatosis (defined as BMI < 25, < 41 Hounsfield Units [HU]; BMI ≥25, < 33 HU), adjusting for age, sex, education, cancer type, cancer stage, and comorbidity. Results: We included 448 patients with GI malignancies, with self-reported race as White or Black, a completed GA and available CT imaging +/- 60 days of GA completion. Mean age at enrollment was 70±7.2y, 58% were male and 25% were Black. Primary cancer diagnoses included colorectal cancer (33%), pancreatic cancer (25%), and other GI malignancies (52%). Black participants had lower education (high school or < 54% vs. 38%, p< 0.01) and were less likely to be married (55% vs 71%, p< 0.01). Black participants reported more limitations in activities of daily living (aOR = 2.0 (95% confidence level [CI] 1.01-3.9, p= 0.03) and frailty (aOR = 1.9, 95% CI 1.1-3.3, p= 0.02). Similarly, Black participants reported lower HRQOL (physical: β coefficient, -2.7; p= 0.03; mental: β coefficient, -2.4; p= 0.03). Conversely, Black participants were less likely to have sarcopenia (aOR = 0.5, 95% CI 0.3-0.9, p= 0.02) and myosteatosis (aOR = 0.12, 95% CI 0.02-0.8, p= 0.02). Conclusions: Differences in frailty, HRQOL, and body composition between Black and White participants present the first step towards understanding disparities in cancer outcomes amongst older adults.

423 Background: Malnutrition and sarcopenia are linked to decreased functional status in older adults with malignancy, but their effect on geriatric assessment (GA) impairment in patients with bladder cancer (BC) undergoing radical cystectomy (RC) is unknown. We investigated the association between malnutrition and sarcopenia with GA impairment and postoperative outcomes. Methods: Patients with BC undergoing RC between 2012 – 2019 were enrolled in a prospective cohort study of GA before RC. Malnutrition was evaluated by a dietitian pre-RC per the Academy of Nutrition and Dietetics and American Society for Parenteral and Enteral Nutrition diagnostic criteria. Sarcopenia, defined by a skeletal muscle index of < 52.4 cm2/m2 in males and < 38.5 cm2/m2 in females, was determined using SliceOmatic software to analyze pre-RC CT images at the L3 vertebra. Patients with vs without malnutrition and those with vs without sarcopenia were compared using Fisher’s exact and Wilcoxon rank sum tests. Results: Of 73 patients, 59 had GA + nutrition evaluation and 51 had GA + sarcopenia assessment (overall median age 68 [IQR 62-74], 76% male). The prevalence of malnutrition was 7% and sarcopenia was 63%. A numerically greater proportion of patients with malnutrition or sarcopenia were impaired on ≥ 1 GA measure compared to those without malnutrition (100% vs 78%, p=0.57) or sarcopenia (78% vs 68%, p=0.52), although this was not statistically significant (Table). Median hospital length of stay (LOS) was increased for patients with vs without sarcopenia (4 vs 5 days, p=0.005). Post-RC complication rate was similar for patients with vs without malnutrition (100% vs 75%, p=0.56) and patients with vs without sarcopenia (81% vs 74%, p=0.73), but malnourished patients were more likely to have Clavien-Dindo grade 3+ complications than those without malnutrition (100% vs 27%, p = 0.009). Conclusions: In our cohort of patients with BC undergoing RC, those with malnutrition or sarcopenia may have an increased rate of impairment on GA compared to those without malnutrition or sarcopenia. Sarcopenia was associated with increased LOS while malnutrition was associated with increased major complications. Our results are limited by small sample size, and future work is needed to elucidate whether addressing these modifiable factors improves functional status and postoperative outcomes. Research Sponsor: U.S. National Institutes of Health[Table: see text]

Most breast cancer (BC) tumors are early stage and hormone receptor positive, where treatment generally includes adjuvant endocrine treatment (ET). Oncology providers and women about to start ET want to know about side effects, including potential weight gain. The aim of this study was a literature review to identify the independent effect of ET on post-diagnosis weight gain. Weight gain is of concern with regard to potential associations with BC recurrence, mortality, and quality of life in survivorship. We conducted a targeted review of the literature. Thirty-eight studies met our inclusion criteria. Patient-reported weight gain ranged widely from 18 to 52 % of patients in Year 1 and from 7 to 55 % in Year 5. Some studies reported categories of weight change: lost weight (9-17 %), stable weight (47-64 %), and gained weight (27-36 %). Most studies comparing ET with placebo or tamoxifen with AI reported no significant difference between the two groups. Wide-ranging and inconsistent results point to the need for further research to clarify annual weight change (loss, gain, stability) from BC diagnosis through 5 years of ET and beyond. There is also a need to explore weight change by type of ET and to explore risk factors for weight gain in women on ET, including tumor type, sociodemographic characteristics, and health behaviors. More specific information is needed to identify high-risk BC patients who could be targeted for weight management interventions.

e13601 Background: Overall survival in women with early breast cancer (EBC) (Stage I-III) has made great strides over the past several decades, with survivors more likely to die from causes other than breast cancer. This study investigates the differential effect of obesity on pre-treatment comorbidity risk in younger versus older women with EBC. Methods: This is a retrospective chart review of women with EBC, age 21 and older, seen at a single institution. Differences in 18 common comorbidities were assessed by age ( > = 65 vs < 65) and Body Mass Index/BMI ( > = BMI 30 vs < 30), with relative risks (RR) estimated from log-binomial regression. Results: In a sample of 590 women, 24% were age 65+, 32% non-white, and 39% had obesity. Patients age 65+ were more likely to report 2+ comorbidities compared to age < 65 (RR 1.62, 69% v 43%). Obese patients (BMI > = 30) were more likely to report 2+ comorbidities compared to BMI < 30 (RR: 1.73, 66% v 38%). Women with obesity were more likely to have hyperlipidemia (RR: 1.85, 28% v 15%) as well as diabetes (RR: 2.51, 17% v 7%). The impact of BMI on comorbidity risk (2+ v < 2) differed by age group (interaction p < 0.001). In the < 65 group, obese patients were more likely to have 2+ comorbidities compared to non-obese (RR: 2.12, 62% v 29%, p < 0.0001). The difference was not as large in the 65+ group (RR: 1.28, 81% v 63%, p = 0.02). Conclusions: This study demonstrates increased comorbidity burden, including hyperlipidemia and diabetes, in women with obesity and EBC, especially those < 65. Providers should ensure that patients with obesity and EBC are appropriately screened and treated for underlying comorbidities. Future research should assess the impact of weight loss on overall survival in EBC patients.

e17010 Background: Older patients with muscle-invasive bladder cancer (MIBC) may not be offered standard of care treatment with neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) based on their chronological age and concern for functional decline following therapy. Age-based differences in post-RC functional status or time to recovery are unknown. Methods: A total of 80 patients were included in this study. Patients ≥ 70 years were categorized as “older” and < 70 years as “younger.” To measure functional status, patients completed an initial geriatric assessment (GA) post-NAC and pre-RC, which was repeated at 1, 3, and 12 months post-RC. Results: Median age was 62 years for younger patients (41-69 years; n = 42) and 75 years for older patients (70-83 years; n = 38). Clinical stage at presentation was not different between groups, but older patients were significantly less likely to receive NAC (63% vs 83%, p = 0.047). There was no significant difference between groups in any physical function measure at baseline. At 1 month post-RC, older patients had significantly lower clinician (c) and patient (p) rated Karnofsky Performance Status (KPS) than younger patients (cKPS: 70 vs 80, p = 0.02; pKPS 60 vs 80, p = 0.03), with a significantly greater decrease from baseline (20 points vs 0 points) in both KPS scores compared to younger patients (cKPS p = 0.001; pKPS p = 0.005). Both groups had a significant decline in ability to complete instrumental activities of daily living (IADLs), but older patients also had significantly increased social activity limitations. At 3 months post-RC, older patients took significantly longer to complete the timed up and go test than younger patients (10.2 secs vs 9 secs, p = 0.02), but had no other differences in physical function measures. Older patients had no significant difference in any measure at 3 months post-RC compared to baseline, while younger patients had a significant improvement in social activity over this time frame. Conclusions: Older patients with MIBC experience a greater short-term decline in functional status post-RC compared to younger patients. However, they return to their baseline status within the same time frame as younger patients.

e19061 Background: Both comorbidities and obesity (body mass index/BMI 30 or higher) are observed in women at the time of early breast cancer (EBC) diagnosis. This study investigates age and obesity and their association with disparities in comorbidities between black and white women at EBC diagnosis. Methods: This is a retrospective chart review of women with EBC (Stage I-III) treated at a single institution. Relative risk (RR) with 95% Confidence Interval (CI) for individual comorbidities are calculated for black compared to white patients, adjusted for age and BMI. Results: In a sample of 548 women, 26% are black and 74% are white. 18% of black patients vs 28% of white patients were age 65 or older (p = .01). 62% of black vs 33% of white patients had obesity (p < .0001). 63% of black vs 47% of white patients had 2 or more total comorbidities at diagnosis (p = .003). 33% of black vs 10% of white patients had 2 or more obesity-related comorbidities (p < .0001). 60% of black vs 32% of white patients had hypertension (p < .0001); 23% of black vs 6% of white patients had diabetes (p < .0001); and 28% of black vs 18% of white patients had high cholesterol (p = .02). In multivariable (MV) analysis adjusted for age and BMI, black women had 45% higher risk for hypertension [RR 1.45 (1.19-1.75), p = .0002)] and 44% higher risk for diabetes [RR 1.44 (1.02-5.86), p < .0001)] at EBC diagnosis. However, after adjustment, differences by race were no longer seen for > = 2 total comorbidities, > = 2 obesity-related comorbidities, heart disease, or thyroid disease. Conclusions: This study documents significant disparities between black and white women with EBC with regard to high rates of obesity, overall comorbidities and obesity-related comorbidities. Future research should assess the potential impact of weight management (avoiding weight gain) interventions in the first 2 years post diagnosis on improving OS and BCSS among patients with obesity and in reducing OS and BCSS disparities between black and white women.

e16754 Background: Myosteatosis (adipose deposits in muscle) can be detected on cross-sectional imaging through variations in Skeletal Muscle Density (SMD). Patients with myosteatosis tend to have lower overall survival, increased chemotherapy toxicity, and shorter progression-free intervals across cancer types. We investigated whether changes in myosteatosis during neoadjuvant chemotherapy can predict postoperative morbidity risk in patients with pancreatic ductal adenocarcinoma (PDAC). Methods: This is a retrospective cohort study from 2014-2019 of patients with biopsy-proven PDAC who completed neoadjuvant chemotherapy and R0/1 resection (R1: margin < 1mm or microscopically positive). We obtained preoperative patient (age at diagnosis, baseline body mass index (BMI), sex, race, comorbidities) and treatment data (neoadjuvant chemotherapy regimen and duration, time from completion of systemic therapy to surgery, type of operation). Primary outcomes were postoperative complications and 90-day readmission. Average SMD was measured using imaging analysis software at the L3 level on axial abdominal CT scans at the time of diagnosis and at completion of neoadjuvant therapy (SliceOmatic TomoVision QC, Can). We defined SMDΔ as the decrease in SMD during neoadjuvant chemotherapy. Descriptive statistics and Student’s t-test were performed with STATA. Results: We identified 44 patients who received neoadjuvant chemotherapy, achieved a R0/1 resection, and had available CT scans for body composition evaluation. The postoperative complication rate was 43% (n = 19) and 90-day readmission rate was 30% (n = 13). Lower SMD at diagnosis was associated with increased postoperative delirium (p < 0.01) and 90-day readmission (p = 0.02). Greater SMDΔ was associated with increased ICU utilization (p < 0.01) and tube feeding upon discharge (p = 0.03). There was no significant association between preoperative BMI or albumin and our primary outcomes. Conclusions: Preoperative SMD and SMDΔ, rather than albumin or BMI, can predict postoperative morbidity in PDAC patients who received neoadjuvant chemotherapy. This study provides the framework for future studies to develop and validate a tool to predict postoperative morbidity risk in these patients.

12114 Background: Cognitive decline related to cancer and its treatments is a common concern among patients receiving treatment for cancer. Routine cognitive screening in oncology practice has been limited by the absence of a reliable, cancer-specific cognitive test. The Blessed Orientation Memory Concentration Test (BOMC) [1], has been incorporated in cancer-specific geriatric assessments, but there is no established cutpoint for cancer-related cognitive impairment. Recent research suggests that BOMC scores ≥ 5 may represent cognitive impairment in older patients with cancer. The purpose of this study was to identify cognitive impairment and associated characteristics in chemotherapy-naïve patients with breast cancer. Methods: Women with stage I-III breast cancer were recruited between 2009 and 2018. The BOMC (range 0-28, higher is worse function) was administered prior to chemotherapy. Associations between cognitive dysfunction (BOMC ≥ 5) and functional, psychosocial, medical variable were assessed using log binomial regression analysis. Results: In a sample of 331 women with breast cancer, the mean age was 65.2 years and 68.6% were 65 and older. Twenty-seven percent demonstrated cognitive impairment prior to treatment. Patients with Time Up and Go Test (TUG) ≥ 14 had increased risk of cognitive impairment compared to those with TUG < 14 (44% vs. 23%, p = 0.0002). After controlling for demographic factors, the estimated increase in risk was 66% (RR: 1.66, 95% CI (1.20, 2.31), p = 0.002). For Medical Outcomes Survey (MOS) Physical Function, after controlling for demographic factors, each 1 point increase in physical function (range 0-20, higher is better function) was associated with a 5% decrease in risk of cognitive impairment (p = 0.0004). Conclusions: Using a newly proposed BOMC cutpoint of ≥ 5, our study identified cognitive impairment in over 25% of older, chemotherapy naïve women with breast cancer. This is similar to what has been reported using rigorous neuropsychological testing in comparable populations. Additionally, we found that this degree of cognitive dysfunction was associated with both patient-reported and clinician-assessed impairment in physical function, further supporting the clinical relevance of this new cutpoint. Reference: [1] Katzman et al. Am. J. Psychiatry. 140 (1983) 734–739.

e13084 Background: Health related quality of life (HRQOL) and physical function are greatly impacted by the diagnosis and treatment of metastatic breast cancer (MBC). This study investigates the ability of women with MBC to engage in moderate walking during active treatment, with exercise monitored through a FitbitTM activity tracker. Methods: This is a single-site feasibility study of a home-based, self-directed physical activity intervention for women with MBC who could have had up to three lines of treatment. Questionnaires were completed at baseline, 12 weeks, and 24 weeks. Results: Sixty patients were consented, with mean age 55 (SD 11.1), 21% non-white, and 56% ECOG = 0. 36% were in their 3rd or 4th line of chemotherapy treatment. 65% had metastases to the bone, 46% to the lung, and 33% to the liver; mean number of metastasis sites was 2 (range 1 to 4). N = 52 completed all baseline measurements; N = 40 remained in the study at 3 months, and N = 29 at 6 months. Of the N = 31 (52%) lost to attrition, N = 6 were due to death, N = 5 due to deterioration, and N = 20 due to patient withdrawal from the study. Mean walking steps per day of at least 4000 was achieved in months 1, 2 and 3 by 41%, 50%, and 41% of participants. In months 4, 5 and 6, these percentages were 45%, 51% and 39%. On a scale from 1 = very confident to 10 = not at all confident about “continuing to walk or be physically active after completing the study”, confidence scores were 2.8 (SD 2.8) at 3 months and 2.9 (2.9) at 6 months. Conclusions: Forty-nine percent of women with MBC who signed up for a home-based walking program during active treatment were able to complete the 24-week intervention, with high proportions of these women walking more than 4000 steps per day. Moderate walking is feasible for women with MBC on active treatment.

e17008 Background: Standard of care treatment for muscle-invasive bladder cancer (MIBC) includes neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC), which can be associated with major toxicity. It is unknown whether patients who receive NAC have differences in functional impairment prior to RC, degree of functional decline post-RC, or time to return to baseline functional status post-RC compared to patients who do not receive NAC. Methods: A total of 80 patients were included in this study. Patients completed an initial geriatric assessment (GA) post-NAC but prior to RC, which was repeated at 30, 90 days, and 1 year post-cystectomy. Patients were classified as impaired or not impaired on each GA domain based on previously established cut points. Percentage impairment was calculated as the number of domains impaired out of the total number of domain assessments completed for each patient at each time point. Results: Median age was 68 for patients who received NAC (66% received gemcitabine/cisplatin) and 72 for patients who did not (p = 0.06), with elevated creatinine as the most common reason for not receiving NAC (57%). Overall, 74% of patients were impaired on at least 1 GA domain pre-surgery (NAC 75%; no NAC 71%) and 86% at 30 days post-RC (NAC 86%; no NAC 87%). Groups did not differ significantly in percentage of patients impaired on each GA domain or median percentage impairment at any time point. For both groups, median percentage impairment increased significantly at 30 days post-RC compared to pre-RC (NAC: 36% vs. 15%, p < 0.001; No NAC: 32% vs. 15%, p = 0.002), followed by a decrease in percentage impairment at 90 days post-RC compared to 30 days post-RC (NAC: 14% vs. 36%, p < 0.001; No NAC: 16% vs. 32%, p = 0.15). There was no difference in impairment at 90 days post-RC compared to pre-RC (NAC: 14% vs. 15%, p = 0.41; No NAC: 16% vs. 15%, p = 0.31). Conclusions: Patients with MIBC frequently have functional impairments at baseline, and their degree of impairment worsens in the short term post-RC. However, patients return to their baseline function by 3 months post-RC. Receipt of NAC was not associated with increased levels of functional impairment at any time point or a delayed return to baseline.

e12506 Background: Skeletal Muscle Density (SMD) is the amount of fat infiltration in the muscle, Low SMD (myosteatosis), is associated with chemotherapy toxicity in women with breast cancer (BC); however, cut points are not consistent across studies. We investigated the association of alternative cut-points for low SMD at BC diagnosis and adverse outcomes during chemotherapy in women with early BC. Methods: This is a retrospective chart review. Axial CT images were evaluated at the L3 level to calculate average SMD in Hounsfield Units (HU). Three cut points (Table) classified patients as low versus normal SMD. T-test was used to calculate the relative risk (RR) for adverse events. Results: In 340 patients, the mean age was 51. Table shows RR for three adverse events (dose reduction, early treatment discontinuation, hospitalization) for each of the three cut points. Conclusions: All three cut-points described in the literature are reliable for stratification of patients with EBC for myosteatosis and associated chemotherapy-related adverse events. [Table: see text]

Background The decision whether to treat older adults with advanced cancer with standard therapy (ST) or reduced therapy (RT) is complicated by heterogeneity in aging. We assessed the potential utility of the chemotherapy toxicity risk score (CTRS) [J Clin Oncol 2011;29:3457–3465] for treatment decisions in older adults. Materials and Methods This was a prospective observational study of patients aged ≥65 years receiving first-line chemotherapy for advanced cancer for which combination chemotherapy is the standard of care. Patients were categorized as high risk (CTRS ≥10), for whom RT (dose-reduced combination or single-agent chemotherapy) is deemed appropriate, or nonhigh risk (CTRS Results Fifty-eight patients (median age, 71 years) were enrolled. Thirty-eight patients received ST (21 had CTRS Conclusion Older patients with cancer with a high CTRS who receive combination chemotherapy have an exceedingly high rate of severe toxicity and hospitalization. Implications for Practice The potential utility of the chemotherapy toxicity risk score (CTRS) in old adults with advanced solid tumors receiving first-line chemotherapy was assessed. Little agreement was found between chemotherapy treatment decisions based on the clinical impression versus what was recommended based on the CTRS. Among patients treated with standard-dose combination chemotherapy, patients with CTRS ≥10 had a very high incidence of grade 3–4 toxicities and hospitalization, which was significantly greater than that of patients with a low CTRS (

BACKGROUND National guidelines recommend that patients with a cancer diagnosis engage in regular physical activity to reduce cancer-related fatigue, maintain quality of life and physical function, and improve overall prognosis and survival. This study investigates oncology provider communications about physical activity during routine clinic visits with patients with early-stage breast, colon, or prostate cancer. METHODS This study used a retrospective chart review for documentation of inquiries or recommendations pertaining to physical activity in clinician notes and after-visit patient summaries. RESULTS In a 1-month period, 55 oncology providers had 361 encounters (clinic visits) with early-stage cancer patients. Thirty-five percent of these encounters included a provider communication about “physical activity,” “exercise,” or “activity.” Encounters with a medical oncologist resulted in a physical activity communication 55% of the time, whereas encounters with other clinician specialties did so 20% of the time (P

Background. We investigated whether a brief geriatric assessment (GA) would identify important patient deficits that could affect treatment tolerance and care outcomes within a sample of older cancer patients rated as functionally normal (80%–100%) on the Karnofsky performance status (KPS) scale. Methods. Cancer patients aged ≥65 years were assessed using a brief GA that included both professionally and patient-scored KPS and measures of comorbidity, polypharmacy, cognition, function, nutrition, and psychosocial status. Data were analyzed using descriptive statistics and multivariable logistic regression. Results. The sample included 984 patients: mean age was 73 years (range: 65–99 years), 74% were female, and 89% were white. GA was conducted before (23%), during (41%), or after (36%) treatment. Overall, 54% had a breast cancer diagnosis (n = 528), and 46% (n = 456) had cancers at other sites. Moreover, 81% of participants (n = 796) had both professionally and self-rated KPS ≥80, defined as functionally normal, and those patients are the focus of analysis. In this subsample, 550 (69%) had at least 1 GA-identified deficit, 222 (28%) had 1 deficit, 140 (18%) had 2 deficits, and 188 (24%) had ≥3 deficits. Specifically, 43% reported taking ≥9 medications daily, 28% had decreased social activity, 25% had ≥4 comorbidities, 23% had ≥1 impairment in instrumental activities of daily living, 18% had a Timed Up and Go time ≥14 seconds, 18% had ≥5% unintentional weight loss, and 12% had a Mental Health Index score ≤76. Conclusion. Within this sample of older cancer patients who were rated as functionally normal by KPS, GA identified important deficits that could affect treatment tolerance and outcomes.

Background Compared with chemotherapy, significant improvement in survival outcomes with the programmed death receptor-1 (PD-1) inhibitors nivolumab and pembrolizumab and the programmed death-ligand 1 (PD-L1) inhibitor atezolizumab has been shown in several types of advanced solid tumors. We conducted a systematic review and meta-analysis to compare safety and tolerability between PD-1/PD-L1 inhibitors and chemotherapy. Methods PubMed and American Society of Clinical Oncology (ASCO) databases were searched 1966 to September 2016. Eligible studies included randomized controlled trials (RCTs) comparing single-agent U.S. Food and Drug Administration-approved PD-1/PD-L1 inhibitors (nivolumab, pembrolizumab, or atezolizumab) with chemotherapy in cancer patients reporting any all-grade (1-4) or high-grade (3-4) adverse events (AEs), all- or high-grade treatment-related symptoms, hematologic toxicities and immune-related AEs, treatment discontinuation due to toxicities, or treatment-related deaths. The summary incidence, relative risk, and 95% confidence intervals were calculated. Results A total of 3,450 patients from 7 RCTs were included in the meta-analysis: 4 nivolumab, 2 pembrolizumab, and 1 atezolizumab trials. The underlying malignancies included were non-small cell lung cancer (4 trials) and melanoma (3 trials). Compared with chemotherapy, the PD-1/PD-L1 inhibitors had a significantly lower risk of all- and high-grade fatigue, sensory neuropathy, diarrhea and hematologic toxicities, all-grade anorexia, nausea, and constipation, any all- and high-grade AEs, and treatment discontinuation. There was an increased risk of all-grade rash, pruritus, colitis, aminotransferase elevations, hypothyroidism, and hyperthyroidism, and all- and high-grade pneumonitis with PD1/PD-L1 inhibitors. Conclusion PD-1/PD-L1 inhibitors are overall better tolerated than chemotherapy. Our results provide further evidence supporting the favorable risk/benefit ratio for PD-1/PD-L1 inhibitors. The Oncologist 2017;22:470-479 IMPLICATIONS FOR PRACTICE: We conducted a systematic review and meta-analysis to compare summary toxicity endpoints and clinically relevant adverse events between programmed death receptor-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors and chemotherapy. PD1/PD-L1 inhibitors were associated with a lower risk of treatment-related symptoms (fatigue, anorexia, nausea, diarrhea, constipation, and sensory neuropathy) but a higher risk of immune-related adverse events (AEs). Summary toxicity endpoints favor PD1/PD-L1 inhibitors (any all- and high-grade AEs and treatment discontinuation). PD1/PD-L1 inhibitors are overall better tolerated than chemotherapy. In addition to efficacy data from trials, our findings provide useful information for clinicians for well-balanced discussions with their patients on the risks and benefits of treatment options for advanced cancer.

Purpose: Poor body composition metrics (BCM) are associated with inferior cancer outcomes; however, in early breast cancer (EBC), there is a paucity of evidence regarding the impact of BCM on toxicities. This study investigates associations between BCM and treatment-related toxicity in patients with EBC receiving anthracyclines and taxane–based chemotherapy. Experimental Design: Pretreatment computerized tomographic (CT) images were evaluated for skeletal muscle area (SMA), skeletal muscle density (SMD), and fat tissue at the third lumbar vertebrae. Skeletal muscle index (SMI = SMA/height2) and skeletal muscle gauge (SMG = SMI × SMD) were also calculated. Relative risks (RR) are reported for associations between body composition measures and toxicity outcomes, after adjustment for age and body surface area (BSA). Results: BCM were calculated for 151 patients with EBC (median age, 49 years; range, 23–75 years). Fifty patients (33%) developed grade 3/4 toxicity, which was significantly higher in those with low SMI (RR, 1.29; P = 0.002), low SMG (RR, 1.09; P = 0.01), and low lean body mass (RR, 1.48; P = 0.002). Receiver operating characteristic analysis showed the SMG measure to be the best predictor of grade 3/4 toxicity. Dividing SMG into tertiles showed toxicity rates of 46% and 22% for lowest versus highest tertile, respectively (P = 0.005). After adjusting for age and BSA, low SMG ( Conclusions: Poor BCMs are significantly associated with increased treatment-related toxicities. Further studies are needed to investigate how these metrics can be used to more precisely dose chemotherapy to reduce treatment-related toxicity while maintaining efficacy. Clin Cancer Res; 23(14); 3537–43. ©2017 AACR.

Background: Most breast cancer cases diagnosed among postmenopausal women are hormone receptor positive (HR+); standard adjuvant endocrine treatment usually includes an aromatase inhibitor (AI). Joint pain/stiffness/achiness (arthralgia) is a common AI side-effect, and AI discontinuation due to this side-effect is an estimated 20-32%. There is a need for effective alternative or adjunctive approaches to arthralgia management that enable survivors to remain on AI therapy while optimizing as pain-free a life as possible. This pilot study investigates the feasibility of a highly scalable 6-week self-directed physical activity (PA) program – Walk With Ease (WWE) – among elderly female breast cancer survivors on AIs who report joint pain. WWE goal: minimum of 30 minutes of walking 5 days a week (150 minutes/week). Methods: Recruitment: BC survivors age 65+ were recruited through the oncology clinic of a university-affiliated hospital. Eligibility: age 65+; Stage I-III breast cancer; currently on AI therapy; self-reported joint pain/stiffness; physician permission to engage in PA; English speaking. Measures: (1) walking – number of days per week and number of minutes per walk, (2) visual analog scales (VAS) for joint pain, fatigue and stiffness, and (3) arthritis self-efficacy (ASE) to manage joint pain and fatigue. Statistics: t-test evaluation of changes in mean values. Results: Sample (N = 20) – mean age 71 (65-87), 85% Caucasian, 35% < high school, mean BMI 29. 63% chemotherapy, 61% radiation therapy. 90% completed the 6-week intervention. Compared to baseline, total minutes of walking per week increased from 95 (0-450) to 172 (45-700) (p Conclusions: A moderate-intensity self-directed walking program is feasible for older breast cancer patients on AI therapy and almost doubled the total time of walking per week over a 6 week period. Joint pain, stiffness, and fatigue decreased, and the walking program was perceived as informative and motivational. These data are promising and the WWE intervention warrants testing in a larger randomized trial of breast cancer survivors on AI therapy. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-08-10.

Purpose: Severe skeletal muscle (SM) loss (sarcopenia) is associated with poor cancer outcomes, including reduced survival and increased toxicity. This study investigates SM measures in metastatic breast cancer (MBC) patients receiving first-line taxane-based chemotherapy and evaluates associations with treatment toxicity and other outcomes. Experimental Design: Using computerized tomography (CT) images taken for the evaluation of disease burden, skeletal muscle area (SMA), and density (SMD) were measured at the third lumbar vertebrae. Sarcopenia was defined as skeletal muscle index (SMI = SMA/height2) ≤ 41. Skeletal muscle gauge (SMG) was created by multiplying SMI × SMD. Fisher exact tests, t tests, the Kaplan–Meier method, and Cox regression modeling were used. Results: MBC patients (N = 40), median age 55 (range, 34–80), 58% sarcopenic, median SMG 1296 AU (SD, 522). Grade 3–4 toxicity was found in 57% of sarcopenic versus 18% of non-sarcopenic patients (P = 0.02). Toxicity-related hospitalizations were also higher in sarcopenic patients (39% vs. 0%, P = 0.005) as were any adverse events—defined as any grade 3–4 toxicities, hospitalizations, dose reductions, or dose delay—(74% vs. 35%, P = 0.02). Low SMG was associated with grade 3–4 toxicity (P = 0.04), hospitalization (P = 0.01), and time to treatment failure (for progression or toxicity; P = 0.03). Low SMG had a borderline significant association with any adverse event (P = 0.06) and overall survival (P = 0.07). Conclusions: SM measures are associated with toxicity outcomes and survival in MBC patients receiving first-line taxane-based chemotherapy. Further studies are needed to explore how routinely obtained CT scans can be used to individualize dosing and improve treatment planning. Clin Cancer Res; 23(3); 658–65. ©2016 AACR.