bluuebunny/crossref_metadata_2025 huggingface dataset:
Association of nutrition with psychological health and quality of life among older adults with advanced cancer.
Authors: Singhal Surbhi , Qin Zhaoyang , Peterson Derick R. , Dunne Richard Francis , Wang Ying , Culakova Eva , Targia Valerie , Melnyk Nataliya , Onitilo Adedayo A. , Conlin Alison Katherine , Mohile Supriya Gupta , Loh Kah Poh
Published: June 2023

12043

Background: Impaired nutrition is associated with greater treatment toxicity and reduced overall survival in patients with advanced cancer. We aimed to evaluate the association of impaired nutrition with psychological health and quality of life among older adults with advanced cancer who were starting cancer treatment with palliative intent. Methods: This secondary analysis was performed on baseline data from a nationwide cluster randomized clinical trial (ClinicalTrials.gov identifier: NCT02107443; PI: Mohile; funding NCI UG1CA189961). Adults age ≥70 with advanced cancer and≥1 geriatric assessment impairment were enrolled from 2014 to 2017. Patients with BMI < 21 kg/m2, > 10% involuntary weight loss in the past 6 months, or Mini Nutritional Assessment Short Form (MNA-SF) score of ≤11 were considered to have impaired nutrition. We used separate multivariable linear regressions to evaluate the association of impaired nutrition with each measure of psychological health and quality of life, which included Geriatric Depression Scale (GDS-15, range 0-15), Generalized Anxiety Disorder-7 (GAD-7, range 0-21), NCCN Distress Thermometer (NCCN DT, range 0-10) and Functional Assessment of Cancer Therapy-General (FACT-G, range 0-108). Analyses were adjusted for baseline patient demographics, clinical characteristics, and geriatric assessment. Results: Among 541 patients, mean age was 77 (range 70-96) and 60% had impaired nutrition. Among the 326 patients with impaired nutrition, 95% had MNA-SF ≤11, 23% had > 10% weight loss in the last six months, and 20% had BMI < 21 kg/m2. Mean baseline GDS-15 was 3.1 (standard deviation [SD] 2.7), GAD-7 was 2.9 (SD 4.0), NCCN DT was 2.9 (SD 2.7), and FACT-G was 80 (SD 14). In the adjusted model, compared to those with normal nutrition, older adults with impaired nutrition had greater depression (mean 0.65 points higher on the GDS-15, p < 0.01) and lower quality of life (mean 6.0 points lower on the FACT-G, p < 0.01). There was insufficient evidence of an association between nutrition and anxiety (β = 0.67, p = 0.06) or distress (β = 0.26, p = 0.28). Conclusions: Recognition of malnutrition by oncology providers is crucial for older adults with advanced cancer. Impaired nutrition is associated with greater depression and lower quality of life among older adults with advanced cancer. Tailored resources to improve psychological health and quality of life are needed to support older adults with impaired nutrition receiving cancer treatment.
An evaluation of the financial toxicity amongst older patients with cancer in India.
Authors: Ramaswamy Anant , Rao Abhijith Rajaram , Noronha Vanita , Basu Renee , Kumar Anita , Pillai Anupa , Sehgal Arshiya , Kumar Sharath , Gota Vikram , Banavali Shripad Dinanath , Prabhash Kumar , Badwe Rajendra A.
Published: June 2023

12048

Background: Financial toxicity (FT) of cancer is prevalent among older patients in high-income countries, but there is no data about the financial burden faced by older patients in India. This study aimed to explore the FT of cancer among older Indian patients. Methods: This was a cross-sectional observational study conducted in the geriatric oncology clinic of Tata memorial hospital (Mumbai, India). Patients aged 60 years and above with cancer were included. Patients and their relatives were enquired regarding their occupations, monthly income, and source of funding for cancer treatment. The modified Kuppuswamy scale was used for stratification of socio-economic status (SES). The financial burden was evaluated using the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) scale. In addition, the Consumer Financial Protection Bureau Financial Well-Being Scale and the 28th question of QORTC QLQ-C30 were used to assess the financial quality of life. Results: Between June 2022 and January 2023, 498 patients were included. The median age was 67 (IQR, 63-72) years, and 360 (72.3%) were male. Common malignancies included gastrointestinal (199, 40.0%), lung (169, 34.0%) and urological (63, 12.7%); 320 (64.4%) had metastatic disease. According to the modified Kuppuswamy scale, most of the participants belonged to upper-lower SES (223, 44.8%), followed by lower-middle (115, 23.1%), upper-middle (97, 19.5%), lower (59,11.8%) and only 4 (0.8%) belonged to upper SES. The source of funding was mostly from family members (264, 53.9%), insurance (72, 14.7%), while 59 patients (12.0%) did not require external support. Sixty-one (12.4%) had to borrow money, twenty-one (4.3%) participants had taken a loan, and 13 (2.6%) had sold their assets for the purposes of treatment. Moderate-severe burden on COST-FACIT was present in 165 (33.1%), whereas 333 (66.9%) experienced no or mild burden. High FT was associated with lower socioeconomic status (OR: 4.69, 95%CI 2.47-8.91, p-value < 0.001), poor financial well-being (OR: 9.35, 95%CI 5.52-16.46, p-value < 0.001) and poor score on Financial quality of life (OR: 5.16, 95%CI 3.39-7.86, p-value < 0.001). Conclusions: In older Indian patients with cancer, there is a high prevalence of financial burden and is associated with poor socioeconomic status, poor financial well-being and poor financial quality of life. More than half the patients depended on their family members to meet the cost of cancer treatment.
Feasibility of daily physical activity monitoring and associations with treatment toxicity in older adults with metastatic prostate cancer.
Authors: Feng Gregory , Parthipan Milothy , Breunis Henriette , Timilshina Narhari , Soto Pérez de Celis Enrique , Santa Mina Daniel , Emmenegger Urban , Hansen Aaron Richard , Finelli Antonio , Tomlinson George , Krzyzanowska Monika K. , Matthew Andrew , Clarke Hance , Puts Martine , Alibhai Shabbir M.H.
Published: June 2023

12055

Background: Accelerometry research suggests physical activity may be associated with treatment toxicity, but generalizability to geriatric oncology is unclear. As many older adults have low levels of physical activity and technology use, further exploration is warranted. This study explores the feasibility of daily physical activity monitoring and the association between step counts and symptoms. Methods: Older adults aged 65+ starting treatment (chemotherapy, enzalutamide/abiraterone, or Radium-223) for metastatic prostate cancer were enrolled in a prospective cohort study. Participants reported step counts (measured via smartphone and a free commercial app) and symptoms (Edmonton Symptom Assessment Scale (ESAS)) daily for their first treatment cycle (~1 month). The feasibility of daily monitoring was assessed with descriptive statistics and thematic analysis. The association between a 15% decline in steps (compared to pre-treatment baseline) and the emergence of moderate-to-severe symptoms and pain (ESAS ≥4) in the next 24 hours was assessed using logistic regression. The utility of a 15% step count decline in predicting the development of moderate-to-severe symptoms and pain was evaluated using sensitivity and positive predictive value (PPV). Results: Of 90 participants, 47 engaged in step count monitoring (mean age 75y; 52.2% participation rate). Daily physical activity monitoring was found to be feasible (90.5% median response rate; 94% retention rate) with numerous patient-reported benefits including increased self-awareness and motivation to engage in physical activity. During the first treatment cycle, instances of a 15% decline in steps were common (n=37, 78.7%), as was the emergence of moderate-to-severe symptoms overall (n=40, 85.1%) and pain (n=26, 55.3%). Overall, daily physical activity did not appear to be significantly predictive of symptoms (OR=1.8, 95% CI=0.42-7.74) overall or pain (OR=0.95, 95% CI=0.22-3.81). Predictive validity estimates revealed reasonable sensitivity for both moderate to severe symptoms overall (sensitivity=88.8%, 95% CI=68.7-95.0; PPV=73.0%, 95% CI=58.7-87.3) but poor PPV for pain (sensitivity=77.8%, 95% CI=58.6-97.0; PPV=37.8%, 95% CI=22.2-53.5). Conclusions: Despite recent studies framing physical activity changes as predictive of toxicity, PPV was only poor to fair. However, daily activity monitoring in older cancer patients appears feasible and may have other uses. Clinical trial information: NCT04193657 .
A study of frontline therapy in adults >80 years with chronic lymphocytic leukemia (CLL).
Authors: Tsang Mazie , Hampel Paul Joseph , Rabe Kari G. , Ding Wei , Leis Jose Francisco , Kenderian Saad , Wang Yucai , Muchtar Eli , Koehler Amber , Hanson Curtis A , Shi Min , Slager Susan L. , Kay Neil E. , Parikh Sameer Ashok
Published: June 2023

12057

Background: AlthoughCLL primarily affects older adults (median age 71 years), limited data exists about the outcomes of adults who are ≥80 years old because they are under-enrolled on clinical trials. Methods: The Mayo Clinic CLL Database was used to conduct a retrospective cohort study of adults ≥80 years at the time of frontline CLL treatment. Kaplan-Meier analysis was used to plot OS, and cumulative incidence was used to plot TTNT, accounting for competing risk of death. The Mayo Clinic IRB approved the study. Results: Our study included 216 patients with CLL who were age ≥80 years at the time of frontline CLL therapy between 1/1995 and 11/2022 (Table). The median time from CLL diagnosis to initiation of frontline therapy was 3.1 years. The median OS after start of frontline therapy was 3.9 years. The median OS was 3.3 years (95% CI 2.6–4.2) for patients who received alkylating agents (e.g., chlorambucil, n=96), 3.8 years (95% CI 2.8–not reached [NR]) for purine analogues (e.g., fludarabine, n=11), 3.9 years (95% CI 3.2–4.9) for anti-CD20 monoclonal antibody monotherapy (e.g., obinutuzumab, n=64), and not reached (95% CI 3.3-NR) for novel agents (n=43) (P=0.02). The types of novel agents included ibrutinib (n=19), acalabrutinib (n=16), venetoclax (n=7), and orelabrutinib (n=1). There was no difference in OS between 36 patients who received a BTKi compared to the 7 patients who received venetoclax-based therapy. At a median follow-up time of 6.7 years from the first visit, 143 patients died from the following: progressive CLL (n=63), infections (n=12), other cancer (n=11), non-CLL reasons (n=21). Cause of death was unavailable for 36 patients. On multivariable analyses, older age (i.e., any 5-year increase in age) was associated with a 50% increased risk of death (HR 1.5, 95% CI 1.2-1.9, p=0.001), and treatment with non-novel agents was associated with 3.2 times increased risk of death (HR 3.2, 95% CI 1.2-8.9, p=0.02). Of the 216 patients, 76 patients required second-line therapy; the median TTNT was 4.2 years (95% CI 2.9-NE). The most used second-line agents were monoclonal antibodies alone (20/76, 26%) and single-agent alkylators (18/76, 24%). Conclusions: When compared to all other CLL treatments, novel agents such as BTKi and venetoclax-based treatments are associated with significantly improved OS in patients with CLL ≥80 years old when used in the frontline setting. [Table: see text]
Dissecting the prognostic role of baseline body mass index (BMI) in early breast cancer (BC): Individual patient-level analysis from five mammella interGruppo (MIG) and gruppo italiano mammella (GIM) randomized clinical trials (RCTs).
Authors: Soldato Davide , Blondeaux Eva , Bruzzone Marco , Mura Silvia , De Laurentiis Michelino , Turletti Anna , De Placido Sabino , Bisagni Giancarlo , Rimanti Anita , Michelotti Andrea , Fabi Alessandra , Russo Antonio , Gori Stefania , Durando Antonio , Nader Marta Guilherme , de Azambuja Evandro , Di Meglio Antonio , Vaz-Luis Ines , Lambertini Matteo , Del Mastro Lucia
Published: June 2023

12067

Background: Nearly half of patients (pts) are overweight or obese at BC diagnosis (dx). Higher BMI at dx has been associated with cardiometabolic comorbidities, higher risk of severe treatment-related sequelae, and worse quality of life. Previous studies showed inferior survival outcomes among patients with early BC and high BMI, although not consistently. The aim of this study was to explore the prognostic role of BMI at dx using data from five RCTs of adjuvant therapy for early stage BC with long-term follow-up. Methods: Pts with known BMI at dx, randomized in the MIG-1, MIG-5, GIM-2, GIM-3 and GIM-6 phase III RCTs were included. BMI was categorized as lean ( < 25 kg/m2), overweight (25-30 kg/m2) or obese (≥ 30 kg/m2). Outcomes included disease-free survival (DFS), breast cancer free-interval (BCFI) and overall survival (OS). Survival estimates were compared using the Kaplan-Meier method and log-rank test. Multivariable Cox proportional hazard models stratified by trial and relevant prognostic factors assessed associations between BMI and outcomes. Results: Among 7334 pts in the overall population, mean age was 56.4 years (SD 11.2), 67.8% had node-positive disease, 76.9% received chemotherapy and 83.0% endocrine therapy. Most pts were overweight (33.1%) or obese (21.0%) and 45.9% were lean. Higher BMI was associated with older age, larger tumor size, higher nodal status, and HR+/HER2- subtype. At a median follow-up of 10.0 years (IQR 6.1-15.1) there were 2165 DFS, 1674 BCFI and 1354 OS events. Pts with higher BMI had worse DFS and OS (log-rank p = 0.007 and p < .0001, respectively), but similar BCFI (p = 0.48). BMI at dx was an independent risk factor for worse OS, but not for DFS and BCFI (Table). Results in the HR+/HER2- population (n = 4093) were consistent: pts with higher BMI had worse DFS, BCFI, and OS (log-rank p = 0.001, p < .006, and p < .0001, respectively) and BMI at dx was an independent risk factor only for worse OS (aHR [95%CI] 1.06 [0.84-1.32] and 1.31 [1.02-1.67] for overweight and obese vs lean pts, respectively). Conclusions: In this large study of pts with early BC treated in RCTs with long-term follow-up, higher BMI at dx was an independent risk factor for overall mortality but not for BC-specific outcomes. Weight loss interventions may mitigate the detrimental effect of excess body weight on outcomes of BC survivors, including by reducing the burden and risks of associated cardiometabolic comorbidities. [Table: see text]
Dietary and lifestyle profiles between patients with and without cancer in the national health interview survey.
Authors: Gong Emma , Song Mingyang , Allar Benjamin G , Seto Darren , Ma Wenchao
Published: June 2023

12073

Background: Although poor diet and lifestyle has been associated with cancer development and progression, it is unclear how the diagnosis of cancer impacts diet and lifestyle. We examined the dietary patterns and overall nutrition of adults diagnosed with cancer versus those never diagnosed with cancer in the 2015 National Health Interview Survey (NHIS). Methods: NHIS adults who reported having cancer (n=2,853) and not having cancer (n=27,002) were identified. A dietary/lifestyle score was developed based on World Cancer Research Fund and American Institute for Cancer Research Cancer Prevention Recommendations (Table). Participants were given a score for each recommendation which was then summed as an overall score, with seven meeting all requirements fully and zero meeting none of the requirements. Results: The mean composite score for the cancer population was 4.28 ± 0.88 and for the noncancer population was 4.30 ± 0.90 (p = 0.18). Compared to patients without cancer, those with a cancer diagnosis had higher rates of adherence to recommendations for fruit/vegetable consumption (0.08 vs. 0.07, p <0.001) and limitation of sugar-sweetened beverages (0.77 vs. 0.74, p <0.001), but had lower rates of the recommended physical activity (0.43 vs. 0.49, p <0.001). Conclusions: Patients with and without diagnosis of cancer had mediocre adherence (4.3 out of 7) to lifestyle recommendations, although those with diagnosis of cancer had a higher consumption of fruits/vegetables, lower consumption of sugary beverages, and lower level of physical activity than those without cancer. The data suggests a cancer diagnosis may prompt change in people’s diet, but may limit their ability to exercise. The magnitude of lifestyle change that one can make after a cancer diagnosis may also be influenced by age or social connections. There is great opportunity for integrating healthy lifestyle interventions into routine cancer care. [Table: see text]
Propensity score matched analysis of major adverse cardiac events in patients with localized prostate cancer receiving short term vs long term ADT.
Authors: Yuan Ye , Hui Gavin , Gombar Saurabh , Aghdam Nima
Published: June 2023

12096

Background: ADT is often used with radiation for dose-intensification in intermediate-risk prostate cancer (PrCa). ADT includes gonadotropin-releasing hormone (GnRH) agonists, often started with antiandrogens to prevent the initial surge in serum testosterone as well as GnRH antagonists. Studies have reported associations of ADT with increased risks of cardiovascular events. This is thought to be related to atherosclerosis, dyslipidemia and insulin resistance. Therefore, there is an opportunity to individualize ADT use to balance risk of PrCa specific outcomes with risk of MACE. To address this, we assessed whether there is a difference in major adverse cardiac events (MACE) between ST-ADT ( < 6 months) or LT-ADT ( > 6 months) in patients with localized PrCa. Methods: A nationally representative EHR-derived dataset was queried for patients with at least 90 days of longitudinal records and 90 days of continuous follow up. The inclusion criteria was a diagnosis of PrCa based on standardized diagnoses codes (ICD9 and ICD10). Patients who had a history of MACE (defined as combination of diagnosis and procedure codes associated with CAD, MI, unstable angina, CABG, PCI, catheterization) metastases, PSA above 10ng/mL, imaging for metastatic PrCa, or having received abiraterone or docetaxel within 3 months of inclusion were excluded. Patients were defined as receiving ADT if they received leuprolide, goserelin, bicalutamide, triptorelin, degarelix, flutamide, or nilutamide. The primary outcome of risk of any new MACE was compared between arms with Cox proportional hazards regression. Secondary outcomes including 10 year rates of new diagnoses of CAD, metastases, and new heart procedures were compared between arms with the Chi-square test. Significance was set at a two sided p-value of 0.05. All analyses were performed without matching, with age and gender matching, and high dimensional propensity-score matching (hdPS) using R version 4.05. Results: We identified 1209 patients with local PrCa and no prior MACE or use of abiraterone or docetaxel within 3 months of diagnosis. 385 patients received ST-ADT and 824 received LT-ADT. Baseline characteristics were comparable between the two arms with similar ages, and comorbidity scores. There was no significant difference in metastatic recurrence between arms in hdPS-matched analysis HR 0.95 [0.64-1.38] p = 0.8. There was also no significant difference in the composite endpoint of MACE HR 1.42 [0.86-2.36] p = 0.173. More patients in the LT-ADT arm had new CAD, which was significant after hdPS-matched analysis OR 1.84 [1.07-3.14], p = 0.024. Conclusions: In a national dataset analysis of patients with local PrCa and no history of MACE or abiraterone or docetaxel within 3 months of diagnosis LT-ADT was associated with increased odds of CAD but there was no difference in the composite endpoint of MACE or metastatic recurrence.
Patient- versus clinician-reported symptoms in the POLARIX study.
Authors: Thompson Carrie A. , Mehta-Shah Neha , Flowers Christopher , Salles Gilles A. , Tilly Herve , Chua Neil Sun , Casasnovas René-Olivier , Miall Fiona , Kim Tae Min , Tsai Cheng-Hong , Nasta Sunita Dwivedy , Lee Seung Tae , Craine Veronica , Campinha-Bacote Avrita , Hirata Jamie H. , Lee Calvin , Sugidono Matthew Dean Sei , Friedberg Jonathan W.
Published: June 2023

12100

Background: The safety profiles of novel agents are mainly based on clinician-reported adverse events (AEs) from clinical trials. Patient-reported outcomes (PROs) may better represent the treatment burden experienced by patients (pts) compared with clinician-reported AEs. Using data from POLARIX, a double-blind, placebo-controlled, randomized Phase 3 international study (NCT03274492), we previously presented PRO and clinician-reported data showing similar rates of neuropathy (Trněný et al. 2022). Here, we evaluate the reporting of other common symptoms using PRO and clinician-reported data in POLARIX. Methods: POLARIX methods were previously described (Tilly et al. 2022); this analysis included all pts with PRO data. PRO and clinician-reported data described the incidence and severity of fatigue, constipation, diarrhea, nausea, and vomiting. Clinician-reported severity grading was based on the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0. PROs were collected using the European Organisation Research and Treatment of Cancer Quality of Life-Core 30 questionnaire (EORTC QLQ-C30), which was administered to pts at clinic visits on Day 1 of Cycles 1 (baseline), 2, 3, and 5, and end of treatment (EOT). PRO severity scores included ‘A little’, ‘Quite a bit’, and ‘Very much’. Results: Overall, 825 pts were evaluable. From baseline to EOT, PROs showed a higher incidence of symptoms compared with clinicians for fatigue (98% vs 27%), constipation (68% vs 29%), diarrhea (56% vs 26%), nausea (58% vs 40%), and vomiting (24% vs 15%). PRO severity scores of ‘Quite a bit’ or ‘Very much’ were reported in 33% of pts for fatigue, 29% for constipation, 17% for diarrhea, 19% for nausea, and 7% for vomiting. Clinicians reported Grade ≥2 symptoms in 11% of pts for fatigue, 11% for constipation, 11% for diarrhea, 14% for nausea, and 6% for vomiting. Conclusions: In POLARIX, pts reported a higher incidence and severity of symptoms compared with clinicians. Although distinct scales were used, the differences in symptom rates reported by pts and clinicians were clinically meaningful. These data may have implications for symptom management, including physician evaluation and communication of symptom expectations for pts. Reporting of symptoms by PROs should be incorporated into clinical trials as an adjunct to standard AE reporting to better characterize the patient experience. Clinical trial information: NCT03274492 . [Table: see text]
Acupuncture versus massage for pain in patients living with advanced cancer: The IMPACT randomized clinical trial.
Authors: Mao Jun J. , Liou Kevin , Romero Sally A. D. , Baser Raymond E , Wong Greta , Xiao Han , Deng Gary , Mo Zunli , Walker Desiree , MacLeod Jodi Elizabeth , Li Qing Susan , Barton-Burke Margaret , Panageas Katherine , Farrar John T , Epstein Andrew S.
Published: June 2023

12101

Background: Pain represents a challenging symptom for patients living with advanced cancer and is often associated with fatigue and insomnia. While American Society for Clinical Oncology clinical guidelines recommend acupuncture and massage for oncological pain management, the long-term comparative effectiveness between these two therapies is unknown, particularly among those living with advanced cancer. Methods: We conducted a pragmatic randomized clinical trial to compare acupuncture and massage for musculoskeletal pain among patients living with advanced cancer who experienced at least moderate pain and had a life expectancy of at least six months. Patients received weekly acupuncture or massage treatments for ten weeks, followed by monthly booster sessions up to 26 weeks. The primary endpoint was the change in worst pain intensity score measured by the Brief Pain Inventory (BPI) from baseline to 26 weeks. The secondary outcomes included pain-related interference (BPI), pain medication usage, patient-reported fatigue, insomnia, and quality of life. Analyses were performed using linear mixed models adhering to intent to treat. Results: Among 298 participants (mean age [SD] 58.7 [14.1] years, baseline worst pain 6.6 [1.5], 67.1% women, 25.9% non-white, 15.4% Hispanic, cancer types [21.5% hematologic, 19.8% breast, 14.4% gynecological, and 11.7% gastrointestinal, 9.7% lung, and 9.7% prostate]), 242 (81.2%) completed the primary endpoint. From baseline to week 26, acupuncture reduced worst pain by 2.53 points (95% CI 2.15-2.92) while massage reduced worst pain by 3.01 points (95% CI 2.63-3.38); the between-group difference was not significant (0.48, 95% CI -0.03-0.98, p = 0.066). Both treatments reduced pain-related interference and pain medication usage and improved comorbid fatigue, insomnia, and quality of life to a similar degree without between-group differences. Adverse events were mild: bruising was reported by 9 (6.5%) acupuncture patients, and transient soreness was reported by 21(15.1%) massage patients and 8 (5.8%) acupuncture patients. Despite receiving close in-person treatment, no known COVID-19 transmission was reported between patients and providers. Conclusions: Among patients living with advanced cancer, acupuncture and massage produced similar clinically meaningful improvements in pain and comorbid fatigue and insomnia, decreased use of pain medications, and improved quality of life. Integrating these non-pharmacological therapies into comprehensive cancer care can improve symptom management and quality of life for the ever-growing number of patients living with advanced cancer as a chronic illness. Clinical trial information: NCT04095234 .
Self-reported overall wellbeing and physical function among chemotherapy and surgery patients completing symptom questionnaires across six health systems.
Authors: Hassett Michael J. , Cronin Christine , Tramontano Angela , Wong Sandra L. , Uno Hajime , Paudel Roshan , Bian Jessica J , Dizon Don S. , Hazard-Jenkins Hannah W. , Osarogiagbon Raymond U. , Schrag Deborah
Published: June 2023

12110

Background: Health systems have begun using electronic patient reported outcomes (ePROs) to evaluate and ideally mitigate patients’ symptom burden following treatment for cancer and other conditions. However, the optimal number of symptoms and approach to capturing this information is unknown. We hypothesized that self-reported overall wellbeing (OWB) and physical function (PFN) would provide distinctive information, beyond that described by a multi-item symptom questionnaire, and augment the clinical utility of an ePRO system. Methods: eSyM, an EHR-integrated symptom management program, was deployed across six health systems for patients receiving chemotherapy or surgery for a suspected or confirmed thoracic, gastrointestinal, or gynecologic malignancy. eSyM prompts patients to complete a 12-item symptom questionnaire 2-3 times per week. This questionnaire also includes two pictogram questions that assess OWB and PFN – each scored using a four-point scale from 0 (best) to 3 (worst). We sought to identify patient characteristics associated with the lowest OWB and PFN (i.e., score = 3), to describe Spearman correlations between OWB and PFN, and to elucidate the relationships between symptom scores and OWB/PFN. Ordinal logistic regression models were used to adjust for potential confounding. Results: From September 2019-December 2022, 9753 patients submitted 75,166 questionnaires. There were 3846 chemotherapy patients (median age 66, 58% female, 17% non-white) and 5907 surgery patients (median age 61, 73% female, 7% non-white). The plurality of responses indicated mild impairment for OWB and PFN (Table). OWB and PFN scores were moderately correlated with each other (chemotherapy 0.62; surgery 0.59); with the sum of all symptom scores for chemotherapy (OWB 0.48, PFN 0.45) and surgery (OWB 0.51, PFN 0.45) patients; and with pain, fatigue, and anorexia (correlation coefficients 0.40-0.61). No individual symptoms were strongly correlated (coefficient > 0.7) with OWB or PFN. After controlling for other factors, OWB and PFN scores varied significantly by health system. Patients with disability were more likely to report low OWB and PFN (ORs 1.99-3.26; p < 0.05) versus other employment statuses. Conclusions: In a large cohort of chemotherapy and surgery patients from six community-based cancer centers, self-reported OWB and PFN scores were moderately correlated with common symptoms. These items offer discriminant and face validity and provide distinctive information that supplements a multi-item symptom questionnaire. Routine use of OWB and PFN can guide management strategies for symptomatic cancer patients. Clinical trial information: NCT03850912 . [Table: see text]
Apixaban versus rivaroxaban for treatment of acute deep venous thrombosis in patients with cancer.
Authors: Miles Brittany , Young Peter , Bradley Megan , Mackey James David
Published: June 2023

12113

Background: Direct oral anticoagulants (DOAC) such as Apixaban and Rivaroxaban are increasingly used for the treatment of acute venous thromboembolism (VTE) over traditional vitamin K antagonists. Malignant neoplasms predispose to acute VTE and clinical management necessitates anticoagulation to prevent further complications. We compare Apixaban to Rivaroxaban for the treatment of acute VTE in the setting of malignancy with the endpoint of chronic deep venous thrombosis (DVT) development after 2 years. Methods: The TriNetX Research network was used for this study. TriNetX provides access to anonymized medical record information on more than 107 million patients in 76 large healthcare organizations. Two cohorts were created for this study using the International Classification of Disease-10 (ICD-10) codes. All patients were required to have a diagnosis of breast (C50), lung (C34), colon (C18), or prostate cancer (C61). All were diagnosed with acute deep venous thrombosis (DVT) of the lower extremities (I82.409). One cohort was treated with rivaroxaban while the other was treated with apixaban within 3 days of DVT diagnosis. Each cohort was excluded from being treated with the other anticoagulant. The cohorts were balanced for age, race, gender, and ethnicity, then evaluated for the development of chronic DVT (I82.509) within the subsequent twelve months. Results: The development of chronic DVT was significantly more common in the apixaban cohort, with a risk ratio of 1.36 (95% CI (1.12,1.65), p-value 0.0015). See table. Conclusions: Patients with acute VTE in the setting of malignancy were at a significantly higher risk of developing chronic DVT following treatment with Apixaban compared to those who received Rivaroxaban at 2 years post-treatment. These results may contribute to increased discussion between physicians and patients when deciding between these two direct oral anticoagulants for the management of acute VTE. Diagnosis of chronic DVT in cancer patients treated with apixaban and rivaroxaban. [Table: see text]
Opioid use, gabapentinoid use, and pain-related emergency department visits for patients living with advanced cancer.
Authors: Jairam Vikram , Lindsay Meghan , Soulos Pamela R. , Gross Cary Philip , Prsic Elizabeth Horn , Baum Laura Van Metre , Park Henry Soo-Min
Published: June 2023

12119

Background: Regulatory efforts in response to the United States opioid epidemic have resulted in a decrease in opioid prescribing among oncologists and non-oncologists. Understanding how decreased opioid prescribing affects cancer-related pain can provide key insights into the downstream effects of these efforts. In this study, we explored temporal trends in opioid use, gabapentinoid use, and pain-related emergency department (ED) visits in older adult patients with advanced cancer and those without cancer. Methods: We queried the Surveillance, Epidemiology, and End Results (SEER)-Medicare database from 1/1/2012 to 12/31/2017 to identify patients aged 66 years or older diagnosed with advanced solid tumor cancer (defined as stage IV and/or metastatic disease). A cohort of patients without a cancer diagnosis was identified using the Medicare 5% random sample. The three dependent outcomes assessed were opioid use, gabapentinoid use, and pain-related ED visits. Multivariable logistic regression was used to identify predictors of these outcomes and to calculate the predicted probability of each outcome for patients with and without cancer. We determined the absolute change in the predicted probability of each outcome from 2012 to 2017. Results: A total of 294,113 patients were included in the cohort; 45,899 (15.6%) with cancer and 248,214 (84.4%) without cancer. Between 2012 and 2017, the absolute change in predicted probability of opioid use declined less in the cancer [-6.1%; 68.6% to 62.5%] compared to the non-cancer cohort [-8.2%; 35.8% to 27.6%] (p<.001 for difference). Gabapentinoid use increased more in the cancer [3.9%; 10.8% to 14.7%] than non-cancer [1.8%; 10.5% to 12.3%] cohort (p<.001 for difference). There was no statistically significant change in pain-related ED visits in patients with cancer [0.6%; 12.4% to 13.0%] and a decrease in patients without cancer [-0.5%; 2.6% to 2.1%] (p=0.005 for difference). Conclusions: Our findings showed that opioid use decreased to a lesser degree among older patients with advanced cancer compared to patients without cancer, whereas gabapentinoid use increased to a greater degree among patients with cancer. There was no corresponding rise in pain-related ED visits, suggesting that these shifts in medication use may not have adversely affected this important outcome. [Table: see text]
A supervised remote exercising program for patients receiving immunotherapy alone or in combination with chemotherapy in Brazil: ExIO.
Authors: Bergerot Paulo Gustavo , Bergerot Cristiane Decat , Silva Jonas Ribeiro Gomes , Paes Marcio Almeida , Farias Janice , Lages Dr. Paulo Sergio , Fuzita William Hiromi , Morbeck Igor Alexandre Protzner , Buso Daniel Sobreira de Oliveira , Anjos Gabriel dos , Portieri Prata Augusto , Ferreira Ana Carolina Salles de M. , Franca Marcos V S , Patriota Carolina Bezerra , Tapia Camila Donini , de Souza Douglas Manfroi , Vargas Pivato de Almeida Daniel , Buso Murilo , Florez Narjust , Soto Pérez de Celis Enrique
Published: June 2023

12122

Background: Exercise has been shown to ameliorate the side effects of cancer therapy, improve quality of life, and may even enhance treatment response. Since immunotherapy is widely used and approved for over 18 indications, studies are needed to determine the effect of exercise on immunotherapy outcomes Additionally, there is a crucial need for understanding how to make such interventions cost-effective and accessible in low- and middle-income countries. We aimed to explore the feasibility and efficacy of a remote exercise program for patients receiving immunotherapy alone or in combination with chemotherapy in Brazil. Methods: This is a 12-week prospective study of a supervised remote exercise program. Patients diagnosed with any solid cancer receiving immunotherapy alone or in combination are eligible. The program is supervised using the WhatsApp and Vedius platforms and consists of resistance and aerobic exercises for 3 to 5 hours per week (4 to 6 days a week). Outcome measures include treatment-related symptoms (FACT-ICM, scale 0-100), fatigue (BFI, scale 0-90), and overall quality of life (FACT-G, scale 0-108). Descriptive statistics were generated, and RM-ANOVA were used to evaluate changes in outcome measures over time. Results: A total of 40 patients have been enrolled to date, with 87.8% of complete adherence. Participants had a mean age of 59 years (SD = 12.2) and were predominantly female (53.7%), white (68.3%), married (68.3%), and had a college degree or higher education (56.0%). Patients were mostly diagnosed with breast (24.4%) or kidney (22.0%) cancers; 63.4% of patients had stage IV disease. Notably, significant improvements in treatment-related symptoms (M1= 86.5, M2= 96.0, p = 0.001), fatigue (M1= 21.4, M2= 9.6, p = 0.001) and quality of life (M1= 87.5, M2= 98.6, p = 0.001) have been observed. Conclusions: To our knowledge, this is the first study to examine the feasibility and efficacy of a supervised remote exercise program among patients with cancer receiving immunotherapy in Latin America. Our findings suggest that this remote program has high adherence and may improve treatment-related symptoms, fatigue, and overall quality of life while providing a practical and easily accessible alternative to patients. This study will be validated in an upcoming randomized clinical trial.
Risk of severe toxicity from topical fluoropyrimidine treatment in patients carrying DPYD variant alleles.
Authors: Granados Javier , Pasternak Amy , Henry Norah Lynn , Sahai Vaibhav , Hertz Daniel Louis
Published: June 2023

12123

Background: Patients carrying variant alleles of DPYD that reduce activity of dihydropyrimidine dehydrogenase have unacceptably high risk of severe toxicity from systemic fluoropyrimidine chemotherapy. DPYD testing prior to systemic fluoropyrimidine treatment is standard of care across Europe and is increasingly used in USA. There is a published case report of fatal toxicity from topical fluoropyridine chemotherapy in a DPYD variant carrier, but the risk of severe toxicity in these patients is unknown. This information is critical to determine whether patients receiving topical fluoropyrimidine treatment should also undergo DPYD genetic testing. The objective of this retrospective cohort study was to determine whether patients carrying DPYD variant alleles have increased risk of severe toxicity from topical fluoropyrimidine treatment. Methods: Individuals who received topical fluoropyrimidine treatment at Michigan Medicine and had available DPYD genotype data, due to participation in the Michigan Genomics Initiative institutional genetic data repository, were eligible for this analysis. Clinical data for the first cycle of topical fluoropyrimidine treatment was abstracted from the electronic medical record by an investigator blinded to genetic data. Toxicities were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The primary endpoint was grade 3+ toxicity. The secondary endpoint was grade 1+ toxicity. Genotypes for five validated decreased- or null-activity DPYD variant alleles were included: DPYD*2A (rs3918290), DPYD*13 (rs55886062), DPYD p.D949V (rs67376798) DPYD HapB3 (rs56038477) and DPYD p.Y186C (rs115232898). Toxicity rates in DPYD variant carriers vs. wild-type were compared using Fisher’s Exact tests. Results: 201 patients receiving topical fluoropyrimidine therapy who had available DPYD genotype data were included in the analysis. Most patients were self-reported white (97%), male (71%), and received topical fluoropyrimidine for a diagnosis of actinic keratosis (79%). As expected in a US patient cohort, 7.0% (14/201) of patients carried a DPYD variant. No patients experienced grade 3+ toxicity. Patients carrying a DPYD variant allele had nominally higher risk of grade 1+ toxicity (21.4% vs. 10.2%, odds ratio = 2.40 (95% Confidence Interval: 0.10-2.53), p = 0.19). Conclusions: Patients carrying DPYD variant alleles may have increased risk of non-severe toxicity from topical fluoropyrimidines, but the risk of severe toxicity is minimal regardless of genotype. DPYD genetic testing to prevent severe and fatal fluoropyrimidine toxicity should be reserved for patients receiving systemic treatment and need not include patients receiving topical treatment, in whom risk of severe toxicity is minimal.
Concurrent hospice healthcare utilization in the hematology/oncology patient population at veterans affairs.
Authors: Hemrajani Anshu , Lo Shelly S. , Vahlkamp Alexi , Silva Abigail , Limaye Seema
Published: June 2023

12125

Background: The benefits of early hospice enrollment include improved quality of life and overall survival (Kumar, 2017). Yet, most oncology patients continue to receive aggressive treatments including chemotherapy, radiation therapy, and hospitalizations until close to death (Ersek, 2017). Veterans have the unique opportunity to receive concurrent hospice which allows patients enrolled in hospice to receive disease modifying treatments and other interventions not typically provided under the traditional Medicare hospice benefit. Methods: A single institution retrospective review of 72 hematology and oncology patients who enrolled in the concurrent care program at the Hines VA between 12/28/2018-4/3/2021 was conducted. Patients were eligible for the concurrent care program if they (1) had a life-limiting illness with a prognosis of less than six months (2) were willing to enroll in hospice (3) had an oncologist willing to administer cancer-directed therapy. Data were summarized with descriptive statistics including medians and percentages. Results: Patients in the concurrent care hospice program were predominantly White (69.4%) and older than 70 years of age (63.9%). Most patients were diagnosed with primary gastrointestinal (29.2%), thoracic (22.2%), or genitourinary (19.4%) malignancies. While enrolled in concurrent care hospice, 15.3% of patients visited the emergency department and 45.8% had at least one hospitalization. Few patients received cytotoxic chemotherapy (27.8%), immunotherapy (20.8%), palliative radiation (20.8%), or pain procedures (4.2%) while enrolled in concurrent care hospice. Of the 19 patients who received chemotherapy, only one patient received treatment within 7 days prior to death. The minority of patients (11.1%) received a blood product and of those patients that did, 8.3% required one to three transfusions and 2.8% required three or more transfusions. Most (91.7%) patients died while in concurrent care hospice; 21.2% died within 30 days of enrollment and 56.1% died within 31 to 180 days of enrollment. Patients were more likely to die at home (63.6%) or in inpatient hospice (13.6%) as opposed to the hospital (3%). Conclusions: Enrollment in concurrent hospice care prevents patients from having to choose between comfort care and cancer-directed treatments, which is often a barrier to early hospice enrollment (Salz, 2009). At Hines VA, most patients receiving concurrent hospice care rarely or never utilized cancer directed treatments, pain procedures, blood products, or emergency room visits/hospitalizations despite having access to these resources. Furthermore, the majority of patients died with hospice-style care at home or in inpatient hospice rather than in the hospital. This observational study demonstrates that when offered the choice to pursue cancer-directed treatments, most patients opt instead to focus on comfort care at end of life.
Utilization of early integrated palliative medicine among patients with metastatic solid tumor cancers: Findings from a safety net medical center treating a majority African American population.
Authors: Ananthula Aneesha , Sweeney Patrick L , Mishra Pallavi , Gupta Kanika , Worley Jason , Carroll Brandon , Manogna Dharmini , Hoerger Michael , Chowdry Rajasree Pia , Malhotra Sonia
Published: June 2023

12128

Background: Early interdisciplinary Palliative Medicine (PM) involvement is known to provide significant benefits when added to usual oncology care, however a study by Ferrari et al looking at oncologic patients between 2001 to 2016 found that only 36% of patients with cancers with a very poor prognosis received Palliative Medicine services. In 2016 ASCO provided a practice guideline recommending specialty PM services to begin within 8 weeks of diagnosis. Our study aimed to assess the integration of the above recommendation in a newly built academic, safety net hospital serving as a regional tertiary healthcare facility with a newly built PM service that included a free-standing outpatient clinic. Methods: This is a retrospective cohort study of all patients on the tumor registry with de novo stage IV cancer diagnosed in a four-year period from 2018 to 2021. Patient data was collected from the electronic medical record (EMR) and included demographics, health history, PM utilization, and advance care planning documentation. Logistic regression was used to analyze key predictors of PM utilization and advance care planning. Results: The majority of patients (N = 510) were African American (race: Black [56.5%], White [35.7%], all other racial groups [7.8%]; mean age = 59.8 [range from 18 or over 90]; sex: 60.6% male). Diagnoses included gastrointestinal (38.2%), thoracic (27.8%), genitourinary (26.3%), and other (7.7%) cancers. Out of the group, 60.5% of the patients received PM services and 55% of those had a visit within the ASCO recommendations of 8 weeks. A surprising 32.7% of those referred to PM had a first visit within the first 2 weeks via an urgent referral system, most often for symptom management. About 40.0% of initial visits were outpatient rather than inpatient and there were no racial or other demographic differences in the setting of the first visit. Patients receiving cancer care in more recent years (P < .001), who were younger (P = .025), and with non-genitourinary cancers (P = .005) were more likely to receive PM services. Also, patients who received PM were more likely to have a medical power of attorney (P < .001) and living will (P < .001) documented in the EMR. Conclusions: This study demonstrates that in centers with a robust PM team including an outpatient clinic, patients with advanced cancer are receiving early Palliative Medicine evaluation in accordance with the 2016 ASCO guidelines. In contrast to a previous study by Johnson et al our study shows that African-Americans were also equally referred and established with PM services. Our study is limited by the presence of a free-standing PM clinic rather than embedding into a cancer center which may assist with even earlier integration.
Key components of goals of care conversations on determining end-of-life care for advanced cancer patients.
Authors: An Amy , Alio Amina P , Epstein Ronald M. , Seplaki Christopher
Published: June 2023

12130

Background: Early goals of care (GOC) conversations appear to improve end of life (EOL) care in patients with advanced cancer. However, interventions to facilitate GOC conversations may be unsuccessful in changing EOL outcomes due to incomplete understanding of the components of such conversations essential to impacting EOL care. This study seeks to identify the specific components of GOC conversations between patients and oncologists that are associated with less aggressive EOL care. Methods: This was a secondary, sequential mixed-methods analysis of data collected as part of the Values and Options in Cancer Care (VOICE) study, an RCT to improve communication between patients and oncologists. We used qualitative methods to describe and quantify components of GOC conversations occurring in recorded oncology office visits. We then conducted logistic regression analyses to examine the associations between key components identified with less aggressive EOL care. Results: 107 patients who died within 1 year of the recorded visit were included for analysis. Content related to GOC conversations could be found in 80.4% of visits. Most commonly discussed content was related to treatment (72.9%), followed by prognosis (43.9%), EOL care (17.8%), and patient values and preferences (16.8%). In adjusted analyses, discussion of treatment expectation, offer of an alternative to cancer-directed treatment, and mention of hospice were significantly associated with less aggressive EOL care, OR 4.66 (p = 0.047), OR 6.09 (p = 0.008), and OR 7.60 (p = 0.046) respectively. We did not find significant association between discussion of life expectancy and EOL care. Conclusions: GOC conversations may be more effective at impacting EOL care when it includes discussion regarding treatment expectations and offer of an alternative option to cancer-directed therapy, such as hospice.