bluuebunny/crossref_metadata_2025_split huggingface dataset:
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.