Publications by authors named "Hyman B Muss"

211 Publications

Geriatric-assessment-identified functional deficits among adults with multiple myeloma with normal performance status.

J Geriatr Oncol 2021 Aug 10. Epub 2021 Aug 10.

Division of Hematology, Department of Medicine, University of North Carolina at Chapel Hill, 170 Manning Drive, Houpt Building, CB# 7305, Chapel Hill, NC 27599, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, 450 West Drive, Chapel Hill, NC 27599, USA. Electronic address:

Objectives: Findings from a brief geriatric assessment (GA) in a cohort of adults with multiple myeloma (MM) are presented, with particular attention to the utility of the GA in identifying important deficits in adults judged to have a normal Karnofsky Performance Status (KPS ≥ 80).

Materials And Methods: Adults age 18 and older with MM were recruited into an observational study from 2018 to 2020. A modified Cancer and Aging Research Group (CARG) GA was administered at enrollment. Enrollees also completed the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients Core 30 questionnaire (QLQ-C30), with subscales of physical, social, role, and cognitive functioning (range 0-100; higher values indicate better function). Data were analyzed using descriptive statistics for the full cohort and stratified by concurrent KPS (score < 80 vs ≥ 80).

Results: Among 89 adults, the mean age was 69.1 years, 68% were aged ≥65 years, and 70% were white. In this cohort, 78% had KPS ≥ 80. Among those with KPS ≥ 80, functional impairments (Timed Up and Go ≥14 s and dependence in ≥1 instrumental activity of daily living) were seen in 30% and 21%, respectively, with 11% reporting ≥1 fall in the prior 6 months. At least two GA-identified deficits were detected in 50% of the overall cohort and in 41% of those with KPS ≥ 80. Among those with KPS ≥ 80, self-reported physical impairment on EORTC QLQ-C30 was noted by 34%.

Conclusion: Using a modified CARG GA and EORTC questionnaire, functional impairments were identified among adults considered to have a good performance status based on a KPS (≥ 80). Future studies should focus on using GA measures for therapy assignment and identifying opportunities for intervening upon GA-identified deficits.
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http://dx.doi.org/10.1016/j.jgo.2021.08.004DOI Listing
August 2021

Person-centered communication about weight and weight management: Focus group discussions in a diverse sample of women with nonmetastatic breast cancer and obesity.

Cancer 2021 Aug 10. Epub 2021 Aug 10.

School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

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/m : 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.
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http://dx.doi.org/10.1002/cncr.33843DOI Listing
August 2021

A 10-Item Frailty Index Based on a Comprehensive Geriatric Assessment (FI-CGA-10) in Older Adults with Cancer: Development and Construct Validation.

Oncologist 2021 Jul 3. Epub 2021 Jul 3.

Department of Medicine, Division of Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Background: A frailty index (FI) based on domain-level deficits identified through a comprehensive geriatric assessment (CGA) has been previously developed and validated in general geriatric patients. Our objectives were to construct an FI-CGA and to assess its construct validity in the geriatric oncology setting.

Methods: Five hundred forty consecutive Japanese patients with cancer who underwent a CGA on a geriatric oncology service were included (median age 80 years, range 66-96 years). We developed a 10-item frailty index based on deficits in 10 domains (FI-CGA-10): cognition, mood, communication, mobility, balance, nutrition, basic and instrumental activities of daily living, social support, and comorbidity. Deficits in each domain were scored as 0 (no problem), 0.5 (minor problem), and 1.0 (major problem). Scores were calculated by dividing the sum of the scores for each domain by 10 and then categorized as fit (<0.2), pre-frail (0.2-0.35), and frail (>0.35). Construct validity was tested by correlating the FI-CGA-10 with other established frailty measures.

Results: FI-CGA-10 was well approximated by the gamma distribution. Overall, 20% of patients were fit, 41% were pre-frail, and 39% were frail. FI-CGA-10 was correlated with Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale (r = 0.83), CSHA rules-based frailty definition (r = 0.67), and CSHA Function Score (r = 0.77). Increasing levels of frailty were significantly associated with functional and cognitive impairments, high comorbidity burden, poor self-rated health, and low estimated survival probabilities.

Conclusion: The FI-CGA-10 is a user-friendly and construct-validated measure for quantifying frailty from a CGA.

Implications For Practice: This article describes the construction of a user-friendly 10-item frailty index based on a comprehensive geriatric assessment (FI-CGA-10) for older adults with cancer: cognition, mood, communication, mobility, balance, nutrition, basic and instrumental activities of daily living, social support, and comorbidity. The FI-CGA-10 simplifies the original FI-CGA used in the general geriatric setting while maintaining its content validity. The index's construct validity was demonstrated in a cohort of older adults with various cancer types. The advantage of the FI-CGA-10 is that a frailty score can be calculated more readily and interpreted in a more clinically sensible manner than the original FI-CGA.
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http://dx.doi.org/10.1002/onco.13894DOI Listing
July 2021

Impact of community-based exercise program participation on aerobic capacity in women with and without breast cancer.

World J Clin Oncol 2021 Jun;12(6):468-481

Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States.

Background: Evidence for exercise as an efficacious strategy to improve aerobic capacity of breast cancer survivors (BCS) has come largely from intervention studies conducted in laboratory settings. There is an increasing need to translate to community-type settings, but the efficacy of those interventions using gold standard evaluation is not well-established.

Aim: To investigate whether similar improvement in aerobic capacity (maximal oxygen consumption [VO]) measured with gold standard testing can be achieved through a community-based setting in BCS.

Methods: A peak cardiopulmonary exercise test (VO), 6-min walk test (6MWT), and timed up and go test (TUG) were assessed pre- and post-16 wk of progressive intensity aerobic and strength training exercise at a community center.

Results: The sample consisted of 31 early BCS (< 1 year since treatment completion) and 15 controls (CTLs). Both groups significantly improved VO (+1.2 mL/kg/min; = 0.030), 6MWT (+35 meters; < 0.001), and TUG (-0.44 s; < 0.01) following training. Both groups improved peak cycling power during the cardiopulmonary exercise test with BCS improving by +10 watts more than the CTLs ( = 0.020). Average exercise attendance was 71% (34 of 48 possible days), but compliant days averaged only 60% of total days for aerobic, and < 40% for strength in both groups.

Conclusion: Community-based exercise programs can be an effective strategy to improve aerobic capacity and physical function for early-stage BCS but potentially not to the same extent observed in laboratory-based randomized controlled trials. Further research is needed to explore barriers and facilitators of exercise engagement in community-based centers to maximize training benefits for adults with cancer.
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http://dx.doi.org/10.5306/wjco.v12.i6.468DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8223710PMC
June 2021

Exercise training partially rescues impaired mucosal associated invariant t-cell mobilization in breast cancer survivors compared to healthy older women.

Exp Gerontol 2021 09 16;152:111454. Epub 2021 Jun 16.

Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America; Human Movement Science Curriculum, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.

Exercise may attenuate immunosenescence with aging that appears to be accelerated following breast cancer treatment, although limited data on specific cell types exists and acute and chronic exercise have been investigated independently in older adults.

Purpose: To determine the mucosal associated invariant T (MAIT) cell response to acute exercise before (PRE) and after (POST) 16 weeks of exercise training in breast cancer survivors (BCS) and healthy older women (CON).

Methods: Age-matched BCS and CON performed 45 min of intermittent cycling at 60% peak power output wattage. Blood samples were obtained at rest, immediately (0 h) and 1 h after exercise to determine MAIT cell counts, frequency, and intracellular cytokine expression.

Results: At PRE, MAIT cell counts were greater in CON (137%) than BCS at 0 h (46%, p < 0.001), with increased MAIT cell frequency in CON but not BCS. TNFα and IFNγ MAIT cell counts increased at 0 h by ~120% in CON (p < 0.001), while BCS counts and frequencies were unchanged. Similar deficits were observed in CD3 and CD3 CD8 cells. At POST, exercise-induced mobilization and egress of MAIT cell counts and frequency showed trends towards improvement in BCS that approached levels in CON. Independent of group, TNFα frequency trended to improve (p = 0.053).

Conclusions: MAIT mobilization in older BCS following acute exercise was attenuated; however, exercise training may partially rescue these initial deficits, including greater sensitivity to mitogenic stimulation. Using acute exercise before and after interventions provides a unique approach to identify age- and cancer-related immuno-dysfunction that is less apparent at rest.
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http://dx.doi.org/10.1016/j.exger.2021.111454DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8351424PMC
September 2021

Measuring Biologic Resilience in Older Cancer Survivors.

J Clin Oncol 2021 Jul 27;39(19):2079-2089. Epub 2021 May 27.

City of Hope National Medical Center, Duarte, CA.

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http://dx.doi.org/10.1200/JCO.21.00245DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8260901PMC
July 2021

Predictors of Unplanned Hospitalizations Among Older Adults Receiving Cancer Chemotherapy.

JCO Oncol Pract 2021 06 21;17(6):e740-e752. Epub 2021 Apr 21.

City of Hope Comprehensive Cancer Center, Duarte, CA.

Purpose: Hospitalizations during cancer treatment are costly, can impair quality of life, and negatively affect therapy completion. Our objective was to identify risk factors for unplanned hospitalization among older adults receiving chemotherapy.

Methods: This is a secondary analysis of a multisite cohort study (N = 750) of patients ≥ 65 years of age evaluated with a geriatric assessment (GA) to predict chemotherapy toxicity. The primary outcome of this analysis was unplanned hospitalizations during treatment; the secondary outcome was length of stay (LOS) of the first hospitalization. Independent variables included pretreatment GA measures, laboratory values, cancer type and stage, and treatment intensity characteristics. We used logistic regression to estimate the odds of hospitalization and generalized linear models for LOS in multivariable analyses.

Results: The sample median age was 72 years (range, 65-94 years); 59% had stage IV disease. At least one unplanned hospitalization occurred in 193 patients (25.7%) during receipt of chemotherapy. In multivariable analyses controlling for cancer type, the following baseline characteristics were significantly associated with increased odds of hospitalization: needing help bathing or dressing (odds ratio [OR], 1.8; 95% CI, 1.0 to 3.1), polypharmacy (≥ 5 meds) (OR, 1.6; 95% CI, 1.1 to 2.4), more comorbid conditions (OR, 1.1; 95% CI, 1.0 to 1.3), availability of someone to take them to the doctor (OR, 2.0; 95% CI, 1.0 to 4.1), CrCl < 60 mL/min (OR, 1.7; 95% CI, 1.1 to 2.4), and albumin < 3.5 g/dL (OR, 1.8; 95% CI, 1.2 to 2.8). In multivariable analyses, older age, self-reported presence of liver or kidney disease, living alone and depressive symptoms were associated with longer LOS.

Conclusion: Readily available GA variables and laboratory data, but not age, were associated with unplanned hospitalizations among older adults receiving chemotherapy. If validated, these data can inform prediction models and the design of interventions to decrease unplanned hospitalizations.
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http://dx.doi.org/10.1200/OP.20.00681DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8258152PMC
June 2021

Development and Validation of a Risk Tool for Predicting Severe Toxicity in Older Adults Receiving Chemotherapy for Early-Stage Breast Cancer.

J Clin Oncol 2021 02 14;39(6):608-618. Epub 2021 Jan 14.

City of Hope, Duarte, CA.

Purpose: Limited tools exist to predict the risk of chemotherapy toxicity in older adults with early-stage breast cancer.

Methods: Patients of age ≥ 65 years with stage I-III breast cancer from 16 institutions treated with neoadjuvant or adjuvant chemotherapy were prospectively evaluated for geriatric and clinical features predictive of grade 3-5 chemotherapy toxicity. Logistic regression with best-subsets selection was used to identify and incorporate independent predictors of toxicity into a model with weighted variable scoring. Model performance was evaluated using area under the ROC curve (AUC) and goodness-of-fit statistics. The model was internally and externally validated.

Results: In 473 patients (283 in development and 190 in validation cohort), 46% developed grade 3-5 chemotherapy toxicities. Eight independent predictors were identified (each assigned weighted points): anthracycline use (1 point), stage II or III (3 points), planned treatment duration > 3 months (4 points), abnormal liver function (3 points), low hemoglobin (3 points), falls (4 points), limited walking (3 points), and lack of social support (3 points). We calculated risk scores for each patient and defined three risk groups: low (0-5 points), intermediate (6-11 points), or high (≥ 12 points). In the development cohort, the rates of grade 3-5 chemotherapy toxicity for these three groups were 19%, 54%, and 87%, respectively ( < .01). In the validation cohort, the corresponding toxicity rates were 27%, 45%, and 76%. The AUC was 0.75 (95% CI, 0.70 to 0.81) in the development cohort and 0.69 (95% CI, 0.62 to 0.77) in the validation cohort. Risk groups were also associated with hospitalizations and reduced dose intensity ( < .01).

Conclusion: The Cancer and Aging Research Group-Breast Cancer (CARG-BC) score was developed and validated to predict grade 3-5 chemotherapy toxicity in older adults with early-stage breast cancer.
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http://dx.doi.org/10.1200/JCO.20.02063DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8189621PMC
February 2021

Effects of Breast Cancer Adjuvant Chemotherapy Regimens on Expression of the Aging Biomarker, .

JNCI Cancer Spectr 2020 Dec 18;4(6):pkaa082. Epub 2020 Dec 18.

Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Background: Although chemotherapy saves lives, increasing evidence shows that chemotherapy accelerates aging. We previously demonstrated that mRNA expression of , a biomarker of senescence and molecular aging, increased early and dramatically after beginning adjuvant anthracycline-based regimens in early stage breast cancer patients. Here, we determined if changes in expression vary by chemotherapy regimen among early stage breast cancer patients.

Methods: We conducted a study of stage I-III breast cancer patients receiving adjuvant or neoadjuvant chemotherapy. expression was analyzed prechemotherapy and postchemotherapy (median 6.2 months after the last chemotherapy) in peripheral blood T lymphocytes. Chemotherapy-induced change in expression was compared among regimens. All statistical tests were 2-sided.

Results: In 146 women, chemotherapy was associated with a statistically significant increase in expression (accelerated aging of 17 years; < .001). Anthracycline-based regimens were associated with the largest increases (accelerated aging of 23 to 26 years; ≤ .008). Nonanthracycline-based regimens demonstrated a much smaller increase (accelerated aging of 9 to 11 years; ≤ .15). In addition to the type of chemotherapy regimen, baseline levels, but not chronologic age or race, were also associated with the magnitude of increases in . Patients with lower levels at baseline were more likely to experience larger increases.

Conclusions: Our findings suggest that the aging effects of chemotherapy may be influenced by both chemotherapy type and the patient's baseline level. Measurement of expression is not currently available in the clinic, but nonanthracycline regimens offering similar efficacy as anthracycline regimens might be favored.
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http://dx.doi.org/10.1093/jncics/pkaa082DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7771421PMC
December 2020

Obesity, comorbidities, and treatment selection in Black and White women with early breast cancer.

Cancer 2021 Mar 7;127(6):922-930. Epub 2020 Dec 7.

School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

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/m ; 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.
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http://dx.doi.org/10.1002/cncr.33288DOI Listing
March 2021

Patient-reported symptom severity, interference with daily activities, and adverse events in older and younger women receiving chemotherapy for early breast cancer.

Cancer 2021 Mar 20;127(6):957-967. Epub 2020 Nov 20.

School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

Background: To the authors' knowledge, it is unknown whether patient-reported symptom severity and symptom interference with daily activities differ between younger (aged <65 years) and older (aged ≥65 years) women receiving similar chemotherapy regimens for early breast cancer (EBC).

Methods: Study participants rated 17 side effects of chemotherapy regimens currently in use in clinical practice (2014-2019).

Results: Of 284 women with EBC (stage I-III), approximately 57% were aged <65 years and 43% were aged ≥65 years. For anthracycline-based regimens, a higher percentage of younger women reported moderate, severe, or very severe (MSVS) hot flashes (49% vs 18%) (P < .001). For nonanthracycline regimens, a higher percentage of younger women reported MSVS hot flashes (38% vs 19%) (P = .009) and a lower percentage reported MSVS arthralgia (28% vs 49%) (P = .005). With regard to symptom interference with daily activities, a higher percentage of younger women being treated with anthracycline-based regimens reported MSVS hot flashes (32% vs 7%) (P = .001) and myalgia (38% vs 18%) (P = .02). For nonanthracycline chemotherapy, a higher percentage of younger women reported MSVS interference for hot flashes (26% vs 9%) (P = .006) and lower percentages reported abdominal pain (13% vs 28%) (P = .02). Overall, there were no significant differences noted among younger versus older patients with regard to hospitalizations (19% vs 12%; P = .19), dose reductions (34% vs 31%; P = .50), dose delays (22% vs 25%; P = .59), or early treatment discontinuation (16% vs 16%; P = .9546).

Conclusions: Older and younger women with EBC who were treated with identical chemotherapy regimens generally experienced similar levels of symptom severity, symptom-related interference with daily activities, and adverse events.

Lay Summary: In this study, women receiving chemotherapy for early breast cancer rated the severity of 17 symptoms and symptom interference with their activities of daily living. Older (aged ≥65 years) and younger (aged <65 years) women who received identical chemotherapy regimens generally experienced similar levels of symptom severity, symptom-related interference with daily activities, and adverse events.
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http://dx.doi.org/10.1002/cncr.33329DOI Listing
March 2021

Older adult participation in cancer clinical trials: A systematic review of barriers and interventions.

CA Cancer J Clin 2021 01 1;71(1):78-92. Epub 2020 Oct 1.

Department of Supportive Care Medicine, City of Hope National Medical Center, Duarte, California.

Cancer is a disease of aging and, as the world's population ages, the number of older persons with cancer is increasing and will make up a growing share of the oncology population in virtually every country. Despite this, older patients remain vastly underrepresented in research that sets the standards for cancer treatments. Consequently, most of what we know about cancer therapeutics is based on clinical trials conducted in younger, healthier patients, and effective strategies to improve clinical trial participation of older adults with cancer remain sparse. For this systematic review, the authors evaluated published studies regarding barriers to participation and interventions to improve participation of older adults in cancer trials. The quality of the available evidence was low and, despite a literature describing multifaceted barriers, only one intervention study aimed to increase enrollment of older adults in trials. The findings starkly amplify the paucity of evidence-based, effective strategies to improve participation of this underrepresented population in cancer trials. Within these limitations, the authors provide their opinion on how the current cancer research infrastructure must be modified to accommodate the needs of older patients. Several underused solutions are offered to expand clinical trials to include older adults with cancer. However, as currently constructed, these recommendations alone will not solve the evidence gap in geriatric oncology, and efforts are needed to meet older and frail adults where they are by expanding clinical trials designed specifically for this population and leveraging real-world data.
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http://dx.doi.org/10.3322/caac.21638DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7854940PMC
January 2021

Serial Assessment of Depression and Anxiety by Patients and Providers in Women Receiving Chemotherapy for Early Breast Cancer.

Oncologist 2021 02 2;26(2):147-156. Epub 2020 Oct 2.

Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

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.
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http://dx.doi.org/10.1002/onco.13528DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7873340PMC
February 2021

Accelerated aging among childhood, adolescent, and young adult cancer survivors is evidenced by increased expression of p16 and frailty.

Cancer 2020 11 24;126(22):4975-4983. Epub 2020 Aug 24.

Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

Background: Cellular senescence, measured by expression of the cell cycle kinase inhibitor p16 , may contribute to accelerated aging in survivors of childhood, adolescent, and young adult cancer. The authors measured peripheral blood T-lymphocyte p16 expression among pediatric and young adult cancer survivors, hypothesizing that p16 expression is higher after chemotherapy and among frail survivors.

Methods: A cross-sectional cohort of young adult survivors and age-matched, cancer-free controls were assessed for p16 expression and frailty. Newly diagnosed pediatric patients underwent prospective measurements of p16 expression before and after cancer therapy. Frailty was measured with a modified Fried frailty phenotype evaluating sarcopenia, weakness, slowness, energy expenditure, and exhaustion.

Results: The cross-sectional cohort enrolled 60 survivors and 29 age-matched controls with a median age of 21 years (range, 17-29 years). The prospective cohort enrolled 9 newly diagnosed patients (age range, 1-18 years). Expression of p16 was higher among survivors compared with controls (9.6 vs 8.9 log p16 units; 2-sided P = .005, representing a 25-year age acceleration in survivors) and increased among newly diagnosed patients from matched pretreatment to posttreatment samples (7.3-8.9 log p16 units; 2-sided P = .002). Nine survivors (16%) were frail and had higher p16 expression compared with robust survivors (10.5 [frail] vs 9.5 [robust] log p16 units; 2-sided P = .055), representing a 35-year age acceleration among frail survivors.

Conclusions: Chemotherapy is associated with increased cellular senescence and molecular age in pediatric and young adult cancer survivors. Frail survivors, compared with robust survivors, exhibit higher levels of p16 , suggesting that cellular senescence may be associated with early aging in survivors.
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http://dx.doi.org/10.1002/cncr.33112DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7607511PMC
November 2020

Impairment and Longitudinal Recovery of Older Adults Treated with Radical Cystectomy for Muscle Invasive Bladder Cancer.

J Urol 2021 Jan 27;205(1):94-99. Epub 2020 Jul 27.

Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.

Purpose: Treatment for muscle invasive bladder cancer includes radical cystectomy, a major surgery that can be associated with significant toxicity. Limited data exist related to changes in patient global health status and recovery following radical cystectomy. We used geriatric assessment to longitudinally compare health related impairments in older and younger patients with muscle invasive bladder cancer who undergo radical cystectomy.

Materials And Methods: Older and younger patients (70 or older and younger than 70 years) with muscle invasive bladder cancer undergoing radical cystectomy at an academic institution were enrolled between 2012 and 2019. Patients completed the geriatric assessment before radical cystectomy, and 1, 3 and 12 months after radical cystectomy. For each geriatric assessment measure the Wilcoxon rank sum test was used to compare score distribution between age groups at each time point. The Wilcoxon signed rank test was used to compare distributions between time points within each age group.

Results: A total of 80 patients (42 younger and 38 older) were enrolled. Before radical cystectomy 78% of patients were impaired on at least 1 geriatric assessment measure. Both age groups had worsening physical function and nutrition at 1 month after radical cystectomy, with older patients having a greater decline in function than younger patients. Both groups recovered to baseline at 3 months after radical cystectomy and maintained this status at 1 year.

Conclusions: High rates of impairments were found across age groups in the short term after radical cystectomy, followed by recovery to baseline.
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http://dx.doi.org/10.1097/JU.0000000000001323DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7952031PMC
January 2021

Associations of functional, psychosocial, and medical factors with cognitive impairment in older, chemotherapy naïve patients with early breast cancer.

Psychooncology 2020 08 8;29(8):1366-1369. Epub 2020 Jun 8.

Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

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http://dx.doi.org/10.1002/pon.5433DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785297PMC
August 2020

Weathering the Storm: Managing Older Adults With Breast Cancer Amid COVID-19 and Beyond.

J Natl Cancer Inst 2021 04;113(4):355-359

Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.

Caring for older patients with breast cancer presents unique clinical considerations because of preexisting and competing comorbidity, the potential for treatment-related toxicity, and the consequent impact on functional status. In the context of the COVID-19 pandemic, treatment decision making for older patients is especially challenging and encourages us to refocus our treatment priorities. While we work to avoid treatment delays and maintain therapeutic benefit, we also need to minimize the risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposures, myelosuppression, general chemotherapy toxicity, and functional decline. Herein, we propose multidisciplinary care considerations for the aging patient with breast cancer, with the goal to promote a team-based, multidisciplinary treatment approach during the COVID-19 pandemic and beyond. These considerations remain relevant as we navigate the "new normal" for the approximately 30% of breast cancer patients aged 70 years and older who are diagnosed in the United States annually and for the thousands of older patients living with recurrent and/or metastatic disease.
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http://dx.doi.org/10.1093/jnci/djaa079DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7313961PMC
April 2021

Congruence of patient- and clinician-reported toxicity in women receiving chemotherapy for early breast cancer.

Cancer 2020 07 21;126(13):3084-3093. Epub 2020 Apr 21.

School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

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.
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http://dx.doi.org/10.1002/cncr.32898DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7931261PMC
July 2020

Is "Geriatric" Assessment Just for Older Patients?

Oncologist 2020 04 13;25(4):355-358. Epub 2019 Sep 13.

Department of Hematology-Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

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 (<65 years) and older women (aged 65 years or older), to assess the potential value of this tool in younger, presumed "healthier" patients. Although older women have more GA-identified deficits overall, younger patients are more anxious. Suboptimal physical function was problematic across the age spectrum. GA domains can identify major deficits in younger patients beyond those likely to be uncovered in routine investigation.
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http://dx.doi.org/10.1634/theoncologist.2019-0373DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7160411PMC
April 2020

Bioelectrical Impedance Analysis for the Assessment of Sarcopenia in Patients with Cancer: A Systematic Review.

Oncologist 2020 02 12;25(2):170-182. Epub 2019 Nov 12.

Division of Hematology/Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA.

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.

Implications For Practice: Bioelectrical impedance analysis (BIA) is an attractive method for identifying sarcopenic patients in clinical practice because it provides an affordable, noninvasive test that can be completed within a few minutes during a clinic visit. BIA does not require highly skilled personnel, and results are immediately available. This systematic review summarizes the literature pertaining to BIA assessment of sarcopenia in adults with cancer, with a focus on its use in diverse cancer populations.
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http://dx.doi.org/10.1634/theoncologist.2019-0600DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7011645PMC
February 2020

Nab-paclitaxel in older patients with non-small cell lung cancer who have developed disease progression after platinum-based doublet chemotherapy.

Cancer 2020 03 14;126(5):1060-1067. Epub 2020 Jan 14.

Department of Hematology and Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

Background: The selection of later-line treatment for older patients with AJCC (version 7) stage IV non-small cell lung cancer (NSCLC) remains controversial. Nanoparticle albumin-bound (nab)-paclitaxel is approved with carboplatin for the first-line treatment of patients with NSCLC and subgroup analysis of phase 3 data has suggested superior survival in older patients.

Methods: The authors conducted a phase 2 study of nab-paclitaxel in 42 patients aged ≥70 years who had been treated previously with a platinum doublet regimen; patients also could have received a PD-1 inhibitor. The primary endpoint of the current study was grade 3 to 5 toxicity (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]). In addition to response rate, progression-free survival (PFS), and overall survival (OS), geriatric assessments also were performed before and during treatment, associations between baseline sarcopenia and outcomes were explored, and changes in T lymphocyte p16 before and during treatment were measured. The authors also performed a retrospective subgroup analysis of 19 older patients who were treated with nab-paclitaxel as part of a larger, randomized, phase 2 study; data were not combined.

Results: The rate of grade 3 to 5 toxicities was 33.7%. The most common grade 3 to 5 toxicities were decreased white blood cell count (11.9%), neutropenia (9.5%), and fatigue (11.9%). The response rate was 34.2% (2.6% complete response rate and 31.6% partial response rate). The median PFS was 5.2 months and the median OS was 9.3 months. Adverse prognostic factors were common: 42% of patients were frail and 39% of patients were prefrail, whereas 21% had an Eastern Cooperative Oncology Group performance status of 2 and 27% were sarcopenic. Only frailty was found to be predictive of inferior survival. A subgroup analysis of 19 older patients treated with nab-paclitaxel alone in a prior trial demonstrated a response rate of 15.8%, a PFS of 4.2 months, and an OS of 13.6 months.

Conclusions: Fit and prefrail older patients with stage IV NSCLC should be considered for treatment with nab-paclitaxel after disease progression with doublet chemotherapy.
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http://dx.doi.org/10.1002/cncr.32573DOI Listing
March 2020

Nodal positivity decreases with age in women with early-stage, hormone receptor-positive breast cancer.

Cancer 2020 03 20;126(6):1193-1201. Epub 2019 Dec 20.

Division of Surgical Oncology and Endocrine Surgery, Department of Surgery, University of North Carolina School of Medicine, Chapel Hill, North Carolina.

Background: Despite data demonstrating the safety of omitting axillary surgery in older women with early-stage breast cancer, the incidence of axillary surgery remains high. It was hypothesized that the prevalence of nodal positivity would decrease with advancing age.

Methods: The National Cancer Data Base was used to construct a cohort of adult women with early-stage, clinically node-negative, estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative breast cancer treated between 2013 and 2015. Multivariable logistic regression was used to assess the relationship between age and nodal positivity, and this was stratified by the axillary surgery category. Modified Poisson regression was used to estimate the proportion of women receiving adjuvant therapy according to age and nodal status.

Results: The incidence of axillary surgery among women aged 70 and older (n = 51,917) remained high nationwide (86%). There was a significant decrease in nodal positivity with advancing age in women with early-stage, ER+, clinically node-negative breast cancer from the youngest cohort up to patients aged 70 to 89 years, and this was independent of histologic subtype (ductal vs lobular), race, comorbidities, and socioeconomic factors. Overall, less than 10% of women aged 70 or older who underwent surgery had node-positive disease, regardless of axillary surgery type, and almost 95% of node-positive patients aged 70 or older were at pathological stage N1mi or N1.

Conclusions: Axillary surgery may be safely omitted for many older women with ER+, clinically node-negative, early-stage breast cancer. Nodal positivity declines with advancing age, and this suggests varied biology in older patients versus younger patients.
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http://dx.doi.org/10.1002/cncr.32668DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7369168PMC
March 2020

Oncology pharmacist-led medication reconciliation among cancer patients initiating chemotherapy.

J Oncol Pharm Pract 2020 Jul 18;26(5):1156-1163. Epub 2019 Dec 18.

Department of Epidemiology, University of North Carolina, Chapel Hill, NC, USA.

Background: Pharmacist-led medication reconciliation (PMR) ensures adequate recording and use of medications by patients. PMR may be important for cancer patients initiating new therapies, as they have a high burden of medication use and are more susceptible to inadvertent medication discrepancies. To describe medication changes (additions, discontinuations, and modifications) made to the electronic health record during a PMR among cancer patients initiating chemotherapy.

Methods: From October 2011 to March 2012, 397 cancer patients initiating chemotherapy underwent a PMR at the University of North Carolina Cancer Hospital. Self-reported medications and those in the patients' electronic health record were reviewed. Log-binomial regression models were used to estimate adjusted prevalence ratios and 95% confidence intervals for the associations between patient characteristics and medication changes made to the electronic health record.

Results: Mean age at time of the PMR was 58. Median number of medications taken prior to the PMR was 10 and median time to PMR completion was 11 min. Vitamins and herbal supplements accounted for the largest proportion of medication additions (38%) and modifications (20%). Antimicrobials accounted for the largest share of discontinuations (15%). After adjustment for all other covariates, patients aged 60-69 years were more likely to have additions than those aged 50 and under (aPR = 1.47, 95%CI: 1.10-1.97). Patients 70 years and over were more likely to have modifications (aPR = 1.74, 95%CI: 1.07-2.82).

Conclusion: Our results show that most cancer patients had a medication change in the electronic health record. A brief oncology PMR can accurately capture and improve medication safety by preventing prescribing and administration errors.
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http://dx.doi.org/10.1177/1078155219892066DOI Listing
July 2020

Association between a cognitive screening test and severe chemotherapy toxicity in older adults with cancer.

J Geriatr Oncol 2020 03 6;11(2):284-289. Epub 2019 Dec 6.

City of Hope National Medical Center, Department of Supportive Care Medicine, United States of America. Electronic address:

Introduction: Cognitive impairment (CI) increases chemotherapy toxicity risk with need to understand this association utilizing publicly available short screening tools. We evaluated this utilizing a lower threshold on a short screening tool in older adults with cancer.

Materials And Methods: We analyzed data from the Cancer and Aging Research Group (CARG) Chemotherapy Toxicity Risk tool (CARG score) development and validation cohorts (n = 703), which recruited adults age ≥ 65 with cancer from academic centers. Cognition was evaluated with the Blessed Orientation-Memory-Concentration test (BOMC). Patients with BOMC score ≥ 11 were excluded. Utilizing cut-points for older adults, we considered moderate BOMC scores (5-10) as potential CI. Logistic regression was used for analysis.

Results: Patient baseline characteristics included: mean age 73; 85% white; 63% college or higher education; 250 (36%) potential CI; 385 (55%) severe toxicity. Patients with potential CI were more likely non-white (p ≤ 0.01) and to have high school or lower education (p ≤ 0.01) and high CARG score (p = 0.04). Potential CI was associated with increased severe toxicity risk (OR = 1.54, p ≤ 0.01). After adjusting for CARG score, this association became nonsignificant (OR = 1.35; p = 0.08). Among patients with lower education (n = 258; 36.7%), potential CI remained associated with severe toxicity, even after adjusting for CARG score (OR = 1.87, p = 0.03).

Conclusions: Our findings suggest potential cognitive impairment, defined by BOMC score 5-10, in older adults with cancer and lower education is associated with increased severe toxicity risk. Future studies are needed to validate these findings. Healthcare providers should consider cognitive testing before treatment for these vulnerable patients.
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http://dx.doi.org/10.1016/j.jgo.2019.10.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7054133PMC
March 2020

Weight trajectories in women receiving systemic adjuvant therapy for breast cancer.

Breast Cancer Res Treat 2020 Feb 16;179(3):709-720. Epub 2019 Nov 16.

Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Background: 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).

Methods: 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.

Results: 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.

Conclusions And Relevance: 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.
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http://dx.doi.org/10.1007/s10549-019-05501-8DOI Listing
February 2020

Weight-Related Communications Between Oncology Clinicians and Women With Obesity at Early Breast Cancer Diagnosis: Findings From a Review of Electronic Health Records.

Nutr Cancer 2020 26;72(4):576-583. Epub 2019 Jul 26.

Division of Hematology and Oncology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

: 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 conversations that may help patients manage their weight in survivorship.: Qualitative and quantitative content analysis of electronic health records at a university-affiliated cancer hospital was conducted to gather documentation of weight-related communications between oncology clinicians and their patients with obesity (Body Mass Index 30 or higher) at early breast cancer diagnosis.: The sample includes 237 women, mean age 56.5 (range 25-86), 37% black, and mean BMI 36 (range 30-59). Ninety-three patients (39%) had weight-related communications with at least one oncology clinician, for a total of 120 communications. Seventy-three percent of these communications were with a medical oncologist, 17% with a radiation oncologist, and 10% with a surgical oncologist. Examples of communications include referrals to weight management programs (22%), printed patient instructions about diet or diet and exercise (12%), and clinician notes describing weight-related interactions with their patients (67%).: This study provides preliminary but encouraging evidence of weight-related communications during a busy clinic visit with patients who were obese at breast cancer diagnosis.
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http://dx.doi.org/10.1080/01635581.2019.1645863DOI Listing
January 2021

Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial.

J Clin Oncol 2019 09 24;37(26):2338-2348. Epub 2019 Jul 24.

University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.

Purpose: Older women with breast cancer remain under-represented in clinical trials. The Cancer and Leukemia Group B 49907 trial focused on women age 65 years and older. We previously reported the primary analysis after a median follow-up of 2.4 years. Standard adjuvant chemotherapy showed significant improvements in recurrence-free survival (RFS) and overall survival compared with capecitabine. We now update results at a median follow-up of 11.4 years.

Patients And Methods: Patients age 65 years or older with early breast cancer were randomly assigned to either standard adjuvant chemotherapy (physician's choice of either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide and doxorubicin) or capecitabine. An adaptive Bayesian design was used to determine sample size and test noninferiority of capecitabine. The primary end point was RFS.

Results: The design stopped accrual with 633 patients at its first sample size assessment. RFS remains significantly longer for patients treated with standard chemotherapy. At 10 years, in patients treated with standard chemotherapy versus capecitabine, the RFS rates were 56% and 50%, respectively (hazard ratio [HR], 0.80; = .03); breast cancer-specific survival rates were 88% and 82%, respectively (HR, 0.62; = .03); and overall survival rates were 62% and 56%, respectively (HR, 0.84; = .16). With longer follow-up, standard chemotherapy remains superior to capecitabine among hormone receptor-negative patients (HR, 0.66; = .02), but not among hormone receptor-positive patients (HR, 0.89; = .43). Overall, 43.9% of patients have died (13.1% from breast cancer, 16.4% from causes other than breast cancer, and 14.1% from unknown causes). Second nonbreast cancers occurred in 14.1% of patients.

Conclusion: With longer follow-up, RFS remains superior for standard adjuvant chemotherapy versus capecitabine, especially in patients with hormone receptor-negative disease. Competing risks in this older population dilute overall survival benefits.
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http://dx.doi.org/10.1200/JCO.19.00647DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6900836PMC
September 2019

Patient-reported and clinician-reported chemotherapy-induced peripheral neuropathy in patients with early breast cancer: Current clinical practice.

Cancer 2019 09 15;125(17):2945-2954. Epub 2019 May 15.

Department of Medicine, School of Medicine, University of North Carolina, Chapel Hill, North Carolina.

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 < .001). Pretreatment arthritis and/or rheumatism (relative risk [RR], 1.58; 95% CI, 1.06-2.35 [P = .023]) and regimens containing paclitaxel (RR, 2.88; 95% CI, 1.72-4.83 [P < .0001]) were associated with higher CIPN severity. Being married (RR, 0.57; 95% CI, 0.37-0.887 [P = .01]) was found to be associated with lower CIPN severity.

Conclusions: The discrepancy between patient-reported and clinician-assessed CIPN underscores the need for both patient and clinician perspectives regarding this common, dose-limiting, and potentially disabling side effect of chemotherapy.
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http://dx.doi.org/10.1002/cncr.32175DOI Listing
September 2019
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