bluuebunny/crossref_metadata_2025_split huggingface dataset:
Web-based patient-reported outcome measures (PROMs) in elderly cancer patients: A French multicentric prospective feasibility trial (the FASTOCH study).
Authors: Cancel Mathilde , Sauger Carine , Biogeau Julie , Dardaine Véronique , Lecomte Thierry , Deloigne Amandine , Hebrard Philippe , Wilmet Rémy , Solub David , Christiann François , Laplaige Philippe , Combe Pierre , Dorval Etienne 
Published: June 2023

12011 Background: Web-based PROMs in cancer care improve overall survival and quality of life. There is, nonetheless, no data available on this type of follow-up in the elderly population. Methods: From February 2021 to April 2022, 75 or more years-old patients ongoing any active anti-cancer treatment (such as chemotherapy, targeted therapy, hormonotherapy, immune therapy) were included, in six French cancer centers. Feasibility of the web-based PROMs was assessed as the part of the population included that could use the Ana-Health’s web-based application “ANA” to monitor their symptoms, the others being considered as in “primary failure” due to technological barriers or refusal to participate. Among the patients that agreed to participate, we then defined as “active” those who filled at least one form during the three months follow up. We also searched for factors restraining elderly patients to use “ANA” and evaluated their satisfaction. Results: Overall, 473 patients were included in the study. There were 288 patients in “primary failure” (233 without Internet access, 17 not comfortable enough to use web-based PROMs, 38 refusals to participate). Among the 185 patients “willing to participate”, there were 122 “active” patients and 63 “inactive” ones, leading to a 26% feasibility in intention-to-test and a 66% feasibility in per protocol analysis. Patients “willing to participate” were from higher socio-professional category (p = 0.002) and had a significantly higher G8 score (13.5 versus 12, p < 0.001), particularly when considering the autonomy (p = 0.028), cognitive assessment (p = 0.003) and general condition (p < 0.001) items. In the multivariate analysis, the socio-professional category and the general condition were still significantly different (p = 0.009 and 0.002 respectively). The only factor that remained significantly different between the “active” and “inactive” populations was the better general condition in the “active” group (p < 0.001). The “inactive” patients prematurely ended their participation because they lost interest in the web-based follow up significantly more than the “active” group (28 “inactive” patients, i.e. 44%, vs 5 “active” patients, i.e. 4%, p < 0.001). Similarly, the “active” patients were significantly more satisfied with “ANA” than the “inactive” (71% vs 29%, p < 0.001). Conclusions: Our study shows that, in the elderly population treated for a cancer, a web-based application to measure PROs is feasible, however socio-professional category, general condition and above all technological barriers are of some concern.
Association of emotional support with quality of life, mental health, and survival among older adults with gastrointestinal (GI) malignancies.
Authors: Clausing Daniel , Fowler Mackenzie Elisha , Harmon Christian , Outlaw Darryl Alan , Akce Mehmet , El-Rayes Bassel F. , Giri Smith , Williams Grant Richard 
Published: June 2023

12050 Background: Emotional support (ES) is the most frequently reported support need among older adults with cancer. Yet, the association of ES with cancer outcomes is largely unknown. This study examined the association of ES with health-related quality of life (HRQoL), mental health, and survival among older adults with GI malignancies. Methods: We included older adults (≥60y) newly diagnosed with GI cancer and undergoing a self-reported geriatric assessment (GA) at first clinic visit. Self-reported ES, measured by the Medical Outcomes Survey was the primary exposure. Outcomes included physical and mental HRQoL as measured by the Patient-Reported Outcomes Measurement Information System® (PROMIS) 10-item global assessment, anxiety and depression as measured by the PROMIS Anxiety and Depression Short Form 4a, respectively, and one-year, two-year, and overall survival. Linear regression evaluated the association between ES and t-scores of physical/mental HRQoL. Logistic regression evaluated the association of ES with anxiety and depression. Models were adjusted for age, race, sex, and cancer type/stage. Kaplan-Meier curves and log-rank tests evaluated the association between ES and survival outcomes. Results: Overall, 795 participants were included. The median age was 68 (IQR: 64-74) and patients were 58.0% male, and 74.6% White. The most common cancers included colorectal (37.9%) and pancreatic (30.8%), with mostly advanced staged disease (Stage III/IV: 72.1%). A majority (77.6%) had adequate ES. Patients with inadequate ES were more likely to be Black (31.5 vs. 20.8%, p=0.005), disabled (24.1 vs. 10.4%, p<0.001), and widowed/divorced (54.2 vs. 24.8%, p<0.001). After adjustment, patients with inadequate ES had lower physical and mental HRQoL t-scores (Physical β: -3.35, 95% CI: -5.25, -1.46; Mental β: -2.46, 95% CI: -4.11, -0.81) and higher odds of depression (aOR: 2.22, CI: 1.34-3.69). There was no statistically significant association with anxiety (aOR:1.15, CI: 0.73, 1.81). No differences were observed between patients with inadequate versus adequate ES in one-year, two-year, or overall survival (Log-Rank tests: one-year, p=0.952; two-year, p=0.606; overall, p=0.584). Conclusions: Older adults with inadequate ES have higher odds of poor physical and mental HRQoL and depression, but no difference in survival compared to those with adequate ES. Further work is necessary to determine if interventions to improve ES also improve HRQoL and depression.
Safety of checkpoint inhibitors in older patients with genitourinary cancers.
Authors: Ramnaraign Brian Hemendra , Patel Neil Jigish , Chatzkel Jonathan Alexander , Hitchcock Kathryn , Zlotecki Robert , O'Malley Padraic , Crispen Paul 
Published: June 2023

12059 Background: Immune checkpoint inhibitors (ICIs) have revolutionized the care of patients with genitourinary (GU) cancers however many of the clinical trials that have led to the approval of ICIs in GU cancers often have low enrollments of older patients aged 65 and above for which safety data in this cohort is limited. Methods: A retrospective study was performed that included all patients aged 65 and older with kidney, bladder, and upper tract urothelial carcinoma (UTUC), who were treated at the University of Florida Health Cancer Center between January 2018 and September 2022, and received at least one dose of ICI (pembrolizumab, nivolumab, ipilimumab with nivolumab, avelumab, or atezolizumab). Data was collected on all documented immune related adverse events (irAEs) that were deemed attributable to the checkpoint inhibitor by the treating provider. The grading of toxicities was determined by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Results: We identified a total of 139 patients who met the inclusion criteria of our study. The ages of patients ranged from 65 to 93 and the median age was 74. Females accounted for 31 patients (22%) while 108 patients (78%) were male. There were 56 patients (40%) with bladder cancer, 58 patients (42%) with kidney cancer, and 25 patients (18%) with UTUC. An irAE was documented in 76 patients (55%) while 63 patients (45%) had no documented irAE. Patients were categorized by the highest grade of toxicity experienced. A Grade 1 toxicity was found in 15 patients (11%), while a grade 2 toxicity was found in 41 patients (29%), with 18 patients (13%) having a grade 3 toxicity, and 2 patients (1%) experiencing a grade 4 toxicity. There were no documented grade 5 toxicities, i.e. no deaths were directly attributed to treatment. We found that 27 patients (19%) required either oral or intravenous steroids to manage their irAE. Discontinuation of treatment due to an irAE was observed in 16 patients (12%). Inpatient hospitalization due to an irAE occurred in 12 patients (9%). Conclusions: Our study demonstrates that the majority of patients aged 65 and older either have no irAEs or developed mild irAEs when treated with ICIs. Severe and life-threatening adverse events are uncommon, rarely require hospital admission, and did not lead to any deaths. This study should help to provide valuable information on the safety of checkpoint inhibitors in older patients with GU cancers and assist in the shared decision-making process for cancer treatment. [Table: see text]
Nutritional program among patients with prostate cancer receiving androgen deprivation therapy (ADT).
Authors: Lages Dr. Paulo Sergio , Vargas Pivato de Almeida Daniel , Bergerot Cristiane Decat , Bergerot Paulo Gustavo , Barbosa Michelle , Dutra Camila Rosa 
Published: June 2023

12072 Background: Treatment with ADT can lead to changes in body composition, including an increase in body fat and a decrease in muscle mass. To minimize the nutritional risks associated with ADT, a nutritional program was developed. Thus, this study sought to determine the benefit of this program among patients with prostate cancer receiving ADT. Methods: Patients were recruited in a cancer center located in Brasilia, Brazil. Patients were eligible if they were diagnosed with prostate cancer, and about to initiate treatment with ADT. They were assessed before starting ADT and at follow-up assessment (3 months). Based on their risk, patients were instructed to follow either a normocaloric (20-25 kcal/kg) or a hypocaloric (18-20 kcal/kg) diet, and both groups were required to consume a hyperproteic diet (1-1.2 g/kg), including the use of whey protein supplementation as needed. Outcomes measures included nutritional risk (Patient-Generated Subjective Global Assessment; PG-SGA), body composition (Medical software Lookin’Body120), and muscle strength (Jamar Hydraulic Hand Dynamometer). Descriptive statistics were generated, and paired T-test, Wilcoxon signed rank on paired samples and ANOVA-RM were used to evaluate changes in variables over time. Results: A total of 62 patients were included in this program. Participants had a median age of 75 years (range from 41-97) and were predominantly married (87%). A great proportion of patients (65%) were diagnosed with a stage IV disease. Notably, 23% were diagnosed with moderate to severe nutritional risk at baseline; 47% were overweight, 13% were obese and 14% were with sarcopenia. The nutritional program resulted in maintenance of total body weight (median 74.1 vs 75.6 kg, P=0.12), lean body weight (median 29.1 vs 29.4 kg, P=0.11), and muscle strength (median 30 vs 30 kg, P=0.62), while a statistically significant loss of body fat weight (median 22.0 vs 20 kg, P=0.003) was found over the 12-week period. Despite no change in the PG-SGA scores were noted overtime, the rate of sarcopenia has decreased (15% vs 13%, P=0.03) and the proportion of eutrophic patients has increased (18% vs 27%, P=0.001), as seen in the contingency table below. Conclusions: These findings suggest that this program may improve body composition and maintain muscle strength in men receiving treatment with ADT after only three months of intervention. Future studies should validate the benefit of this program in randomized trial with a longer follow-up assessment (6 and 12 months after treatment initiation). [Table: see text]
Impact of exercise on chemotherapy-induced peripheral neuropathy (CIPN) in survivors with post-treatment primary breast cancer.
Authors: Saint Kirin , Lessing Alexie , Nemirovsky David , Chen Yuan , Underwood Whitney P. , Galantino Mary Lou , Jones Lee , Bao Ting 
Published: June 2023

12077 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of neurotoxic chemotherapy with limited treatment options. We examined the association between exercise and CIPN symptoms in patients with post-treatment primary breast cancer. Methods: Using a retrospective design, patients completing a standardized survey assessing exercise exposure, neuropathy symptoms, and pain in a tertiary cancer center survivorship clinic were included. Exercise was assessed using a standardized questionnaire quantified in standardized metabolic equivalent tasks (MET-h/wk). Chi-square tests, Mann-Whitney U-tests, Kendall’s rank correlations, and multivariable logistic regressions adjusting for important clinical covariates examined the relationship between exercise and CIPN and whether this differed as a function of chemotherapy regimen (taxane vs. non-taxane based therapy). Results: A total of 5,444 patients with primary breast cancer previously treated with adjuvant chemotherapy (median age 62 years (IQR: 55, 71); median of 4.7 years post chemotherapy completion (IQR: 3.3, 7.6)) were identified. The overall prevalence of CIPN was 34% (95% CI: 33%, 36%); 33% (95% CI: 31%, 34%) for non-taxane and 37% (95% CI: 35%, 39%) for taxane based chemotherapy. The prevalence of CIPN was 28% (95% CI: 26%, 30%) among exercisers (≥5 days of moderate or ≥3 days of strenuous exercise per week) and 38% (95% CI: 37%, 40%) among non-exercisers (difference 11%; 95% CI: 8%, 13%; p < 0.001). Associations appeared dose-dependent. CIPN prevalence was 42% for < 6 MET-h/wk, 33% for 6-20.24 MET-h/wk and 29% for > 20.25 MET-h/wk (p-value < 0.001). Exercise was associated with reduced prevalence of all individual CIPN symptoms (numbness and tingling, pain, interference in daily living). Higher exercise was associated with lower CIPN regardless of chemotherapy regimen. Conclusions: CIPN is persistent several years following chemotherapy cessation in patients with breast cancer but significantly reduced by exercise in a dose-dependent manner.
A genome-wide association study for doxorubicin-induced cardiomyopathy in childhood cancer survivors from the St. Jude lifetime cohort (SJLIFE) and the childhood cancer survivor (CCSS) studies.
Authors: Petrykey Kateryna , Wang Huiqi , Im Cindy , Dixon Stephanie B , Ehrhardt Matthew J. , Mulrooney Daniel A. , Sharafeldin Noha , Wang Xuexia , Jefferies John L. , Oeffinger Kevin C. , Chow Eric Jessen , Gramatges Maria Monica , Bhatia Smita , Robison Leslie L. , Ness Kirsten K. , Hudson Melissa M. , Burridge Paul , Armstrong Gregory T. , Yasui Yutaka , Sapkota Yadav 
Published: June 2023

12088 Background: Treatment of childhood cancer using doxorubicin is associated with a well-established dose-related risk of cardiomyopathy, which can lead to heart failure and affects ~7-10% of exposed children and adolescents. Here, we identified a genetic variant associated with risk of doxorubicin-induced cardiomyopathy (diCM) in survivors of childhood cancer. Methods: A genome-wide association study using common variants (MAF≥5%; whole-genome sequencing data) was performed among 993 SJLIFE survivors of European ancestry (median age, 36.6 years; range, 8.7-62.2 years) treated with doxorubicin only (210 with diCM; defined as CTCAE grade ≥2 clinically assessed cardiomyopathy). Replication analyses were performed separately among 1,430 CCSS survivors of European ancestry (median age, 35.4 years; range, 15.8-60.7 years) and 159 SJLIFE survivors of African ancestry (median age, 32.6 years; range, 8.9-61.1 years) exposed to doxorubicin only. Analyses were adjusted for age at primary cancer diagnosis, sex, doxorubicin dose, age at last contact and top five principal components. Results: We identified a genome-wide significant association between a novel locus near HS3ST4 and diCM risk in SJLIFE survivors of European ancestry (rs112474856; OR = 2.78; P= 3.3×10-8). This association replicated in CCSS survivors of European ancestry (OR = 1.74, P= 0.036) but had an opposite effect among SJLIFE survivors of African ancestry (OR = 0.34, P= 0.028). SNP rs112474856 did not show significant association with diCM risk in two independent datasets including survivors of European ancestry in SJLIFE (OR = 1.20; P= 0.71) and CCSS (OR = 1.02; P= 0.98) who were not exposed to doxorubicin but were treated with daunorubicin or chest radiotherapy, suggesting doxorubicin specificity. No association was observed between rs112474856 and risks of cardiomyopathy (OR = 1.00; P= 0.88) or heart failure (OR = 1.00; P= 0.59) in 361,194 UK Biobank participants from the general population. HS3ST4 was significantly upregulated ( P= 4.7×10-6) in response to doxorubicin treatment in human induced pluripotent stem-cell-derived cardiomyocytes from patients with diCM. HS3ST4 encodes heparan sulfate, the latter was recently linked to immune activation, cardiac fibrosis, and heart failure. Conclusions: Leveraging the two largest cohorts of childhood cancer survivors in North America, we identified and replicated a novel locus for diCM which was associated with increased risk in survivors of European ancestry but decreased in their African counterpart.
Long-term prospective data on correlation between overall mortality and HADS (Hospital Anxiety and Depression Scale) assessed psychological distress in prostate cancer patients (11 year follow-up data).
Authors: Sundar Santhanam , Shawcroft Ewan , Jones Lauren , O'Cathail Micheal , Hosni Shaymaa Usama , Little Jessica , Walker Georgina , Cox Ashley , Fergusson Eamonn 
Published: June 2023

12091 Background: We prospectively assessed whether Psychological factors such as anxiety and depression can have a detrimental effect on long term overall survival of prostate cancer patients (pts). Methods: Prostate cancer pts participating in an ethics Committee approved, Prospective study evaluating an Andropause rating scale. All pts had radical radiotherapy with androgen deprivation therapy. Pts completed a baseline HADS questionnaire before any treatment was initiated & at 3mths & after completion of hormone therapy. Patient characteristics: Median age: 69 yrs (50 to 78 yrs). Charlson Comorbidity Index (CCI) prevalence at baseline as follows CCI-I 6.1%; CCI-II: 33.8%; CCI-III: 37.2%; CCI-IV: 14.2%; CCI-V: 6.1% and CCI-VI: 2.7%.; At the survival update in Feb 2023, 49.3% of patients have died [n = 148]; Gleeson grade was Low risk in 7.2%; Intermediate in 53.4% and high risk in 39.2%; Baseline PSA was < 10 ug/L in 45.3%; 10-20 ug/L in 33.1% and > 20 ug/L in 21.6% ; Tumour stage was T1 in 8.1% ; T2 in 63.5% and T3 in 28.4%. Baseline Median serum testosterone was 11.9 nmol/l (min 2.6 and max 26.7). Hormone duration was < 3 mths in 22.3%; 3-6mths in 35.8% ; 6 to < 36mths in 19.6% and > 36mths in 22.3%. Cox regression models estimated hazard ratios (HR) and 95% confidence intervals (CI) of overall mortality, while controlling for the following covariates (Age, T stage, Gleeson risk category, PSA Category, Baseline Serum Testosterone, ADT duration category and Charlson Comorbidity index). Results: Higher anxiety at time of diagnosis had a statistically significant adverse effect on overall survival (table); Higher depression symptoms at baseline did not affect survival but depressive symptoms after completing cancer treatment did affect all-cause mortality in this mature dataset with a median follow up of more than 11 years. Conclusions: Higher anxiety and depression symptoms in prostate cancer patients are associated with significantly higher long-term all-cause mortality. [Table: see text]
Phase 3 RCT of dexamethasone versus placebo for chemotherapy induced fatigue in patients with advanced solid malignancies.
Authors: Radhakrishnan Venkatraman , Gopalakrishnan Vidhya , Vihari Vamsi , Dasapathi Venkata Siva Kiran Kumar , Rajaraman Swaminathan , Perumal Kalaiyarasi Jayachandran , Iyer Priya , Krishnamurthy Arvind , V Sridevi , Veeraiah Surendran 
Published: June 2023

12112 Background: Short-term steroids (<2 weeks) have been used to alleviate fatigue in patients with advanced cancer. However, the efficacy and safety of long-term steroids (12 weeks) in patients with advanced cancer receiving palliative chemotherapy have not been studied. Methods: The study was an open-label, placebo-controlled, phase 3 RCT to evaluate the efficacy and safety of low dose dexamethasone (DEX) in reducing chemotherapy and cancer associated fatigue. Patients aged 18-60 years with performance status ≤2, undergoing palliative chemotherapy for advanced solid malignancies were randomized 1:1 to receive either DEX (4mg/day) or a placebo for 12 weeks. Fatigue was measured using the Symbolic Assessment of Fatigue Extent (SAFE) scale and EORTC FA12 scale, and quality of life (QOL) was assessed using the EORTC QLQ c30 at baseline, 6 weeks, and 12 weeks. The primary endpoint was to compare fatigue between the study arms at 6 weeks. Secondary endpoints were to compare fatigue at 12 weeks, QOL and toxicities. With a power of 80%, α of 5% (2-sided), 126 patients (including 25% drop-outs) were required to show the superiority of DEX in reducing SAFE fatigue extent score by 50% at 6 weeks. Results: A total of 126 patients were randomized (64 in the placebo arm and 62 in the DEX arm) between Oct 2018-Sep 2022. The median age was 46.5 years and 67% were females. Metastatic breast (28%) and lung (16%) cancer were the common diagnosis. Twelve and 23 patients in the placebo arm and 13 and 22 patients in the DEX arm did not undergo week 6 and 12 assessment respectively due to disease progression. The results showed no significant differences in mean SAFE scores, FA12 scores, or QOL between the study arms at 6 and 12 weeks, except for higher FA12 social sequelae in the DEX arm at 12 weeks (P=0.048) (Table). There were no significant differences in toxicities between the arms. Conclusions: The results of this study suggest that low-dose DEX is not effective in reducing chemotherapy associated fatigue or improving QOL in patients with advanced cancer. Clinical trial information: CTRI/2018/08/015222 . [Table: see text]