Improvement In QOL Research Articles

(286) Impact of Hormonal Treatment in Patients with Gender Dysphoria in the First Six Months of Treatment

Abstract Introduction Gender dysphoria (GD) is a mismatch of how we feel our identity, male or female, with the biological sex. This incongruity can lead to discomfort and suffering. Prejudice and discrimination may result in additional stress, with impact on quality of life (QV). Hormonal therapy (HT) is an important part of the treatment of patients with GD and can have an impact on sexual life and QV. Objective To assess the impact of HT on sexual desire and quality of life in patients with GD throughout the first 3 to 6 months of treatment. Methods Longitudinal study of quality of life (QL) and sexual desire (SD), before and 3 to 6 months after starting HT, using the WHO WHOQOL-BREF questionnaire, which assesses the physical, psychological, social and environmental domains, of DS (dyadic and solitary) through the Sexual Desire Inventory- 2 (SDI-2) questionnaire and obtaining sociodemographic, clinical and laboratory data on patients who came to our consultation with a diagnosis of GD. Results 52 patients, with a mean age of 25.11 (18–56) years, completed the WHOQOL-BREF and SDI-2 questionnaires. 30 FtM (57.7%) and 22 MtF (42.3%). Almost half 49% (n= 26) had a comorbid psychiatric disorder. In FtM the average total testosterone (TT) increased from 0.320 ng/mL to 7.190 (+/- 2.340) ng/mL and in MtF the average TT increased from 6.86 ng/mL to 0.59 (+/- 41) ng/mL 3 to 6 months after starting HT, without serious side effects. FtM showed a significant increase in DS (p < 0.01), both dyadic and solitary, while MtF showed a non-significant decrease in SD after the start of HT. There was a non-significant improvement in the physical, social relationships and environment domains and a significant improvement in the psychological domain (p < 0.01). In the physical domain, FtM patients showed a significant improvement compared to MtF patients. 20% of patients reduced or stopped psychiatric medication. Despite the negative impact of HT on SD in MtF, there was an improvement in QoL and a reduction in the need for psychiatric medication. In FtM there was a significant improvement in the psychological and physical domain. Conclusions HT is safe, improves QoL and reduces the need for psychiatric medication in patients with GD. This improvement was significant in the psychological domain. Disclosure No.

Fezolinetant impact on health-related quality of life for vasomotor symptoms due to the menopause: Pooled data from SKYLIGHT 1 and SKYLIGHT 2 randomised controlled trials.

To assess the effect of fezolinetant treatment on health-related quality of life using pooled data from SKYLIGHT 1 and 2 studies. Prespecified pooled analysis. USA, Canada, Europe; 2019-2021. 1022 women aged ≥40 to ≤65 years with moderate-to-severe vasomotor symptoms (VMS; minimum average seven hot flushes/day), seeking treatment for VMS. Women were randomised to 12-week double-blind treatment with once-daily placebo or fezolinetant 30 or 45 mg. Completers entered a 40-week, active extension (those receiving fezolinetant continued that dose; those receiving placebo re-randomised to fezolinetant received 30 or 45 mg). Mean changes from baseline to weeks 4 and 12 on Menopause-Specific Quality of Life (MENQoL) total and domain scores, Work Productivity and Activity Impairment questionnaire specific to VMS (WPAI-VMS) domain scores, Patient Global Impression of Change in VMS (PGI-C VMS); percentages achieving PGI-C VMS of 'much better' (PGI-C VMS responders). Mean reduction was estimated using mixed model repeated measures analysis of covariance. Fezolinetant 45 mg mean reduction over placebo in MENQoL total score was -0.57 (95% confidence interval [CI] -0.75 to -0.39) at week 4 and -0.47 (95% CI -0.66 to -0.28) at week 12. Reductions were similar for 30 mg. MENQoL domain scores were also reduced and WPAI-VMS scores improved. Twice as many women receiving fezolinetant reported VMS were 'much better' than placebo based on PGI-C VMS assessment. Fezolinetant treatment was associated with improvement in overall QoL, measured by MENQoL, and work productivity, measured by WPAI-VMS. A high proportion receiving fezolinetant felt VMS were 'much better' based on PGI-C VMS responder analysis.

Short-term assessment of functional outcomes and quality of life after thoracic and lumbar spinal metastasis surgery.

Because of improvements in initial tumor identification and treatment, as well as longer life expectancies, more people are receiving diagnoses for spinal metastases. The aim of this study was to assess early functional outcomes and quality of life (QOL) after surgical management of patients with spinal metastases. In this prospective cohort study, a total of 33 patients with thoracic and lumbar spine metastases who underwent surgical management between November 2021 and August 2023 were followed up for 1 year or until death. Oswestry Disability Index and the Eastern Cooperative Oncology Group Performance Status were used for the functional outcome; QOL was assessed using European Quality of Life 5-Dimensions (EuroQOL-5D). Scores were recorded preoperatively, 4 weeks postoperatively, and 6 and 12 months postoperatively. The mean age was 52.12 ± 13.4 years (range: 23-70 years), 22 (66.7%) were females, and 11 (33.3%) were males. Patients were divided into three groups according to the revised Katagiri score: 12 (36.4%) patients were at low risk (0-3), 18 (54.5%) patients were at intermediate risk (4-6), and 3 (9.1%) patients were at high risk (7-10). The mean survival was 5.44 ± 3.46 months (range 1-13), and there was no perioperative death (within 1 month postoperative). Sixteen (48.5%) patients survived for more than 1 year and 17 (51.5%) patients died from different causes related to the natural history of tumor metastasis. Following surgical treatment of the spinal metastases, improvements in QoL and functional results were seen in the short-term. For patients with a projected life expectancy of longer than 3 months, surgery is a good alternative.

Health-related quality of life (HrQoL) of first-line treatments in metastatic renal cell carcinoma (mRCC): A network meta-analysis.

412 Background: Previously we have reported comparative effectiveness data regarding survival of first line (1L) treatment options in mRCC. However, it is not known how the life-prolonging frontline combinations compare to patient-reported outcomes. Methods: Electronic databases including MEDLINE and EMBASE were searched from each database’s inception through July 1st 2023. Phase III randomized controlled trials (RCTs) assessing 1L immune-checkpoint inhibitor (ICI) combination therapies for mRCC and reporting HrQoL were included. Small sample size adjusted standardized mean differences (SMD; Hedges’ g) with 95% confidence intervals (CI) were computed for global, physical, functional, and emotional QoL. Positive SMD indicated an improvement. A network meta-analysis was conducted to assess the comparative HrQoL across different treatment options. P-scores were computed to assess relative treatment rankings. Results: Of 5770 citations identified, five trials (nine references) were included in this analysis. Patient-reported outcomes have not been reported in the JAVELIN Renal 101 or COSMIC-313 trials yet. Global QoL was significantly improved with cabozantinib-nivolumab (CaboNivo) as compared to Nivo-ipilimumab (SMD 2.74, 95% CI 2.54; 2.93), lenvatinib-pembrolizumab (LenPem; 2.79, 2.53; 3.06), sunitinib (2.87, 2.72; 3.03), Pem-axitinib (PemAxi; 3.09, 2.89; 3.30) and atezolizumab-bevacizumab (AteBev; 3.24, 3.04; 3.45). Global QoL improvement was also observed with NivoIpi compared to sunitinib (0.14, 0.02; 0.25), PemAxi (0.36, 0.18; 0.54) and AteBev (0.51, 0.33; 0.68). Physical QoL improvement were consistent with CaboNivo. Likewise, LenPem significantly improved QoL compared to sunitinib (0.26, 0.04; 0.47), PemAxi (0.38, 0.13; 0.64) and NivoIpi (0.51, 0.27; 0.76). Significant functional QoL benefits were only observed with CaboNivo (0.32, 0.17; 0.48) and NivoIpi (0.19, 0.08; 0.31) compared to sunitinib. No significant mixed treatment comparisons were observed for emotional QoL, however, currently available data suggests that LenPem (rank 1) may potentially improve QoL (Table). Conclusions: CaboNivo and NivoIpi as 1L therapy may offer an improved overall HrQoL compared to other contemporary treatment options in mRCC. [Table: see text]

P984 VEST: The UK vedolizumab real life experience study in Inflammatory Bowel Disease

Abstract Background The characteristics and outcomes of patients treated with vedolizumab in routine healthcare settings have not been widely evaluated in the UK. Methods Prospective, multicentre observational study of 364 patients started on vedolizumab in UK practice from January 2017 until February 2019 using the UK IBD Registry clinical web-based tool. For the present analysis, the primary outcome was drug survival (persistence) at 1-year, defined as attendance for infusion ≥48 weeks after the first dose. Secondary outcomes were: Clinical remission (CR, based on partial Mayo score [≤1] or Harvey Bradshaw index [≤4]), physician global assessment (PGA), IBD-Control Questionnaire (IBD-Control-8, IBD-Control-VAS and individual item scores), laboratory parameters and adverse events. Results Age (mean): 44 yrs; Males: 48%; IBD duration (mean): 6 yrs; Prev. resection: 18%; Steroids at baseline: 39%; Outcomes are summarized in Table 1. 37% of CD patients were assessed as being in clinical remission at baseline. Overall, 210 (58%) continued treatment beyond 48 weeks. At 1 year, 67.1% and 52.3% of CD and UC patients were in clinical remission with a clear improvement in QoL as assessed by IBD-Control -8. There were significant improvements across each IBD-Control-8 domain, including fatigue, with few patients considering switching treatment at that point (Figure 1). Conclusion Vedolizumab was effective in clinical practice with 58% of patients remaining on treatment at one-year. Baseline status differed significantly from those recruited into RCTs. Patient reported outcomes demonstrated significant and meaningful improvements across physical, psychological, social and treatment domains.

P859 Sodium Butyrate supplementation significantly improved clinical outcomes and quality of life in patients with Crohn’s Disease – results from a randomized placebo-controlled study

Abstract Background Butyrate has shown anti-inflammatory effects and plays an important role in maintaining gut homeostasis, providing symptomatic relief when orally supplemented in patients suffering from various colonic diseases. Methods In this randomised, double-blind, placebo-controlled study 140 IBD patients in remission or with mild disease (n=60 Crohn's disease, CD and n=80 Ulcerative Colitis, UC) were randomized to oral administration of BLM/placebo for 90 days in addition to conventional therapy. As primary aim: changes in microbiome composition induced by BLM treatment. Fecal microbiota from stool samples was assessed by 16S sequencing. Clinical disease activity assessed by using Harvey Bradshaw Index (HBI) for CD and partial-Mayo Score (pMS) for UC, quality of life assessed by using Inflammatory Bowel Disease Questionnaire 32 (IBDQ-32) and adherence-dietary-raccomandation( WCRF) were evaluated before and after treatment. Results Demographics, clinical and dietary characteristics were similar between the two populations. The microbiota sequencing highlighted two different enterotypes in CD population: the first one was characterized by a low F/B ratio (with a genus prevalence of Fusobacteriota, Alistipes, and Blautia). The second enterotype was characterized by a higher F/B ratio (with a genus prevalence of Escherichia-Shigella and Lachnoclostridium)(Fig1). BLM had a more pronounced effect on enterotype-1 where the taxa associated with intestinal comfort, SCFA production, increased after treatment, while the taxa associated with CRC and intestinal inflammation, decreased. After treatment was observed: a)improved quality of life (IBDQ-32: CD: treat. 170/184 vs Pb. 188/197 p<0.001 vs p=0.021; UC: treat.185/195 vs Pb.188/188 p=0.003 vs p=0.4), b)lower disease activity in CD patients (the HBI score, showed a significant improvement for those treated with BLM as compared to placebo (McNemar’s p=0.013 vs p>0.9).c) reduced Calprotectin levels (Table1.) Finally, a significant separation was observed in samples from patients who have undergone minor surgery (ileo-colon), compared to non-surgery patients. The variable "surgery" seems to be associated with the enterotype-1. Conclusion Sodium butyrate supplementation significantly improved clinical outcomes and quality of life in patients with CD. Our data showed that the differential response to BLM treatment is based on enterotype, suggesting that Enterotype-1 patients may experience greater clinical benefits and improvements in QoL compared to Enterotype-2 patients in both UC and CD populations.

P792 Real-world evidence comparison of the effectiveness of ustekinumab with anti-TNF or vedolizumab in ulcerative colitis: 1-year maintenance therapy results from the prospective, observational RUN-UC study

Abstract Background Observational real-world evidence (RWE) studies on the effectiveness of ustekinumab (UST) in ulcerative colitis (UC) are needed in addition to RCTs, which may not represent everyday clinical practice. For this reason, the prospective, controlled, propensity score (PS)-adjusted RUN-UC study was conducted on UC patients starting a new biologic therapy with a follow-up period of up to 3 years. The aim of the present analysis was to evaluate the 1-year maintenance therapy effectiveness of UST vs. anti-TNF or vedolizumab (VDZ). Methods Between 2020-2022, 507 UC patients starting a new therapy with UST or other biologics were enrolled in 34 IBD-experienced centres in Germany. After the exclusion of patients with a stoma, small molecules and missing outcomes, the final sample consisted of 476 patients. Response modified (reduction in partial Mayo score (pMayo) by ≥3 points from baseline to month 12 and a reduction of at least 30% or achievement of remission at month 12), clinical remission (CR) (pMayo ≤ 1 plus a bleeding subscore=0) and steroid-free remission (pMayo ≤ 1, bleeding subscore=0 and no systemic use of steroids or oral budesonide use in the previous 8 weeks) were considered as outcomes. To reduce the effect of confounders, PS adjustment with inverse probability of treatment weighting (IPTW) was implemented. Health-related QoL was assessed by using the visual analogue scale (EQ-VAS) of the EQ-5D. Results A total of 476 UC-patients [147 UST (bio-naïve: 12), 168 anti-TNF (ADA: 32.7%, IFX: 59.5%, GOL: 7.7%) (bio-naïve: 114) and 161 VDZ (bio-naïve: 105)] were included in the analysis. The PS-adjustment eliminated systemic differences in the baseline parameters (UST/anti-TNF/VEDO: 42.2/47.0/50.3% males, 25.2/25.0/19.9% EIMs), in particular, the "bio-experienced" characteristic was also equalised, between the groups. Treatment persistence over 12 months was different between UST (93.9%), VDZ (87.0%) and anti-TNF (75.0%) (Fig. 1). The PS-weighted effectiveness of UST (mITT analysis) in terms of response, clinical and steroid-free remission at month 12 (Tab. 1) was comparable to that of anti-TNF and VDZ, as was also the case without PS-weighting (CR: UST 33.1%, anti-TNF 38.5%, VDZ 38.1%). Patients of all treatment groups showed significant improvements in QoL measured as the EQ-VAS after 12 months of treatment. Conclusion In this prospective RUN-UC study with PS-weighted groups, UST showed similar maintenance effectiveness compared to established biologics in UC (anti-TNF and VDZ) with a relatively higher treatment persistence of UST, probably serving as a proxy for effectiveness, suggesting that additional criteria, such as safety and patients´ profile, may play an important role in the selection of biologics.

Effect of Radioiodine Treatment on Quality of Life in Patients with Subclinical Hyperthyroidism: A Prospective Controlled Study.

Study aim was to evaluate thyroid-related QoL in patients with subclinical hyperthyroidism mostly due to toxic nodular goitre undergoing RIT, compared to a control group of euthyroid subjects. Study design was monocentric, prospective, controlled. Fifty control subjects were enrolled and 51 RIT patients. Most subjects were examined at least twice at an interval of 6 months, with visits immediately before and 6 months after treatment in the RIT group. QoL was estimated with the ThyPRO questionnaire, using its composite scale as primary outcome. Treatment effect was the mean adjusted difference (MAD) between groups over time, using repeated? measures mixed? effects models. TSH concentrations were lower in the RIT group prior to treatment and recovered thereafter slightly above the level of the control group. Correspondingly, QoL improved significantly after 6 months from a worse level in the RIT group, compared to controls (MAD -10.3 [95% CI -14.9, -5.7], p<0.001). QoL improvements were strong for general items, but less pronounced for the hyperthyroid domain. Compared to controls, thyroid volume, thyroid functional capacity (SPINA-GT) and deiodinase activity (SPINA-GD) were significantly reduced in the RIT group. Patients with subclinical hyperthyroidism improve both biochemically and in their QoL after RIT, compared to controls. QoL assessment should have a wider role in clinical practice to complement biochemical tests and help with treatment decisions.

Connectome-Based Neurosurgery in Primary Intra-Axial Neoplasms: Beyond the Traditional Modular Conception of Brain Architecture for the Preservation of Major Neurological Domains and Higher-Order Cognitive Functions.

Despite the therapeutical advancements in the surgical treatment of primary intra-axial neoplasms, which determined both a significative improvement in OS and QoL and a reduction in the incidence of surgery-induced major neurological deficits, nowadays patients continue to manifest subtle post-operative neurocognitive impairments, preventing them from a full reintegration back into social life and into the workforce. The birth of connectomics paved the way for a profound reappraisal of the traditional conception of brain architecture, in favour of a model based on large-scale structural and functional interactions of a complex mosaic of cortical areas organized in a fluid network interconnected by subcortical bundles. Thanks to these advancements, neurosurgery is facing a new era of connectome-based resections, in which the core principle is still represented by the achievement of an ideal onco-functional balance, but with a closer eye on whole-brain circuitry, which constitutes the foundations of both major neurological functions, to be intended as motricity; language and visuospatial function; and higher-order cognitive functions such as cognition, conation, emotion and adaptive behaviour. Indeed, the achievement of an ideal balance between the radicality of tumoral resection and the preservation, as far as possible, of the integrity of local and global brain networks stands as a mandatory goal to be fulfilled to allow patients to resume their previous life and to make neurosurgery tailored and gentler to their individual needs.

A case of improvement of oral-related QOL by occlusal support with fixed implants for non-vertical stop occlusion

A case of improvement of oral-related QOL by occlusal support with fixed implants for non-vertical stop occlusion

Longitudinal Patient-Reported Outcomes and Clinical Outcomes By VES-13 and Comprehensive Geriatric Assessment in Older Adults with Aggressive Non-Hodgkin Lymphomas

Background: Older adults with aggressive non-Hodgkin lymphoma (NHL) can experience durable remissions with therapy but also substantial toxicities and healthcare utilization. The Vulnerable Elders Survey (VES-13) is a 13-item tool assessing age, self-rated health, and ability to perform physical and functional activities (score of 3+ indicates vulnerability). The Fondazione Italiana Linfomi comprehensive geriatric assessment (CGA) assesses age, comorbidities, and ability to perform physical and functional activities and classifies patients as fit, unfit, or frail. Both the VES-13 and CGA hold promise to risk stratify older adults for poor outcomes. Few data are available comparing these tools in assessing risk for poor survival and healthcare utilization, and prior studies have not examined the impact of therapy on longitudinal patient-reported outcomes (PROs). Methods: We conducted a longitudinal prospective study of 105 older adults with aggressive NHL at Massachusetts General Hospital or the Dana-Farber Cancer Institute between 9/2020 and 1/2023. Eligible patients were age &amp;gt;= 65 years at time of treatment initiation receiving combination chemoimmunotherapy. Patients could enroll up until cycle 1 day 8 of therapy. Patients completed questionnaires at baseline and 6 weeks, 12 weeks, 18 weeks, and 6 months post therapy initiation assessing demographics, quality of life (QOL-Functional Assessment of Cancer Therapy-Lymphoma [FACT-Lym]), depression and anxiety (Hospital Depression and Anxiety Scale [HADS]), and physical symptoms (Edmonton Symptom Assessment Scale-revised [ESAS-r]). At baseline patients also completed the VES-13 and underwent CGA evaluated by an oncologist. We utilized linear mixed models to examine longitudinal QOL, depression, anxiety, and physical symptoms. We assessed univariate factors associated with longitudinal QOL. Using Cox regression models controlling for gender, age-adjusted International Prognostic Index (IPI), hypoalbuminemia, Charlson comorbidity index (CCI), and lymphoma subtype, we assessed the relationship of VES-13 and CGA in separate models with overall survival (OS). We also examined factors associated with unplanned hospitalization within 6 months of therapy start using logistic regression. Results: We enrolled 106/163 (65.0%) patients. 1 patient was excluded due to treatment with an ineligible therapy. Patients had a median age of 73 years (range: 65-99, 38.1% &amp;gt;75, 21.9% &amp;gt;=80); most were male gender (64.8%), White race (96.2%), and married/with a life partner (72.4%). The most common lymphoma subtypes were DLBCL (73.0%), DLBCL/high grade B-cell lymphoma with MYC and BCL2 translocations (12.4%), and mantle cell lymphoma (10.5%). The majority (56/104, 53.8%) had an age-adjusted IPI of 2 or 3, over a third (34.3%) had a CCI score of 2+, and 82.9% had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1. 45.7% (48/105) had a VES-13 score of 3+. 40.0%, 9.5%, and 50.5% were fit, unfit, and frail, respectively, on CGA. QOL, depression, anxiety, and physical symptoms all improved over time (Figure 1). QOL improved regardless of age group, VES-13 category (&amp;lt;3 vs 3+), or CGA result (Figure 1). Compared to other patients, those 80+ years with either VES-13 score 3+ (β= -2.90, p=0.045) or frail on CGA (β= -3.68, p=0.007) had a worse QOL trajectory. Income &amp;gt; $50,000 annually (β=2.41; p=0.041) was associated with better QOL trajectory. VES-13 score of 3+ (HR=6.08; p=0.014) and frail on CGA (HR=5.20; p=0.028) were both associated with worse survival. Of those with follow up (N=66), 8 died within 1 year (1-year OS=87.9%), all of whom were both frail on CGA and had VES-13 score 3+. 25.8% (8/31) of the CGA frail patients and 28.6% (8/28) of those with VES-13 3+ died within 1 year. VES-13 score (OR=1.16, p=0.028) was associated with greater likelihood of unplanned hospitalization. Conclusion: Older adults with aggressive NHL often experience improvement in QOL and other PROs with treatment, even across age and frailty categories. VES-13 score and CGA identify patient groups at high risk for early death and poor QOL trajectory, for whom novel therapies and supportive care interventions are warranted. Higher VES-13 score is also associated with higher risk of unplanned hospitalization. Routine assessment of VES-13 and CGA has high potential for early identification of high risk patients and implementation of appropriate interventions.

Quality of life of children with acute lymphoblastic leukemia

Background Acute lymphoblastic leukemia (ALL) is the most common cancer in children worldwide, which requires long treatment. This condition and its subsequent treatment change the body's physiology, reducing children’s quality of life. &#x0D; Objective To describe the quality of life in children with acute lymphoblastic leukemia in Java, Indonesia.&#x0D; Methods This descriptive study with a cross-sectional approach included parents who had children with ALL at three referral hospitals in Java, Indonesia, between January 2021 and May 2022. We recruited 188 mothers or fathers who accompanied their children for follow-up visits or hospitalization. Children’s quality of life as the primary outcome was evaluated by parent proxy using the PedsQL 3.0 cancer module.&#x0D; Results Most parents were mothers (81.9%); parents’ ages ranged from 22 to 59 years. The mean age of children was 7.63 (SD 3.85) years, with 63.3% boys and 147 (78.2%) treated in maintenance phase during the study. The mean overall children’s QoL score was 84.37 and it classified as high (73.9% of subjects), no children had very low QoL. The lowest mean sub-scale QoL score was in procedural anxiety (72.25), whereas the highest sub-scale score was in communication (91.56). &#x0D; Conclusion There is an improvement in QoL of children with ALL in Indonesia. However, the procedural anxiety sub-scale requires more interventions to reduce anxiety and alleviate pain during invasive procedures.

Clinical Effects of Oral Supplementation of Gamma-Cyclodextrin Curcumin Complex in Male Patients with Moderate-To-Severe Benign Prostatic Hyperplasia-Related Lower Urinary Tract Symptoms

Introduction: Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms (LUTSs) in males. Curcumin exhibits anti-inflammatory and anti-tumor properties which may be effective for BPH. This multi-arm observational study evaluated the real-world efficacy of QURMIN^® (Gamma-cyclodextrin-curcumin Complex-CAVACURMIN^®) as single or combination therapy for BPH. Methods: Men with moderate-severe LUTS/BPH, receiving a 6-month supplementation with QURMIN^® alone or in combination with BPH-specific medication were propensity score matched with patients not taking curcumin and then divided into subgroups based on concomitant baseline treatment. Cohorts were compared in the 6-month variation of IPSS, quality of life (IPSS-QoL), Benign Prostatic Hyperplasia Impact Index (BII) and uroflowmetry parameters. Curcumin tolerability was evaluated in terms of discontinuations and adverse effects. Results: The 1:1 propensity score matching resulted in a treatment-naïve (n = 152), an alpha-blocker only (AB) (n = 138) and AB + 5-alpha reductase inhibitors (5-ARIs) (n = 78) subgroup. After 6 months, drug-naïve patients taking curcumin reported significant improvement in IPSS-storage (−3.9, p < 0.001), IPSS-voiding (−2.0, p = 0.011), IPSS-total (−5.9, p < 0.001), IPSS-QoL (−3.9, p < 0.001), BII (−2.0, p < 0.001), Q_max (+3.1 mL/s, p < 0.001), Q_mean (+1.9 mL/s, p = 0.005), post-void residual volume (−7.7 mL, p < 0.001), and PSA (−0.3 ng/mL, p = 0.003), compared to controls. Patients taking ABs and curcumin showed improvement in IPSS-storage (−2.7, p < 0.001), IPSS-voiding (−1.3, p = 0.033), IPSS-total (−3.5, p < 0.001), IPSS-QoL (−1.1, p = 0.004), BII (−1.7, p = 0.006), Q_max (+1.0 mL/s, p = 0.006), and PSA (−0.2 ng/mL, p = 0.01). Patients taking curcumin and AB + 5-ARI showed improvement in IPSS-storage (−1.3, p = 0.007), IPSS-total (−1.6, p = 0.034), IPSS-QoL (−1.1, p < 0.001), and BII (−2.0, p < 0.001). No adverse reactions were reported for curcumin supplementation. Conclusion: QURMIN^® (CAVACURMIN^®) led to significant improvements in symptom burden, uroflow parameters, and QoL, without significant additional side effects, thus proving to be a potential new treatment for BPH, either as a single therapy or in addition to standard treatment.

Effects of a high-protein, increased-fibre, dry diet supplemented with omega-3 fatty acids on quality of life in dogs undergoing chemotherapy.

Quality of life (QOL) in dogs with cancer is a key consideration in the assessment of cancer treatment options. Despite interest in dietary strategies to improve management of oncology patients, there have been very few clinical studies showing the impact of diet on adverse effects of chemotherapy in dogs. This study was a randomised, controlled, double-blinded, multicenter clinical trial to investigate a high-protein, increased-fibre diet supplemented with omega-3 fatty acids, for dogs with cancer undergoing standard-of-care chemotherapy. Client-owned dogs with newly diagnosed grade 2 or higher mast cell tumours (or non-resectable/incompletely resected tumours) or multicentric lymphoma were randomised to receive the test diet (n = 24) or control diet (n = 21) for 8 weeks. Primary outcomes were QOL assessments, faecal scores, and blood concentrations of C-reactive protein and monocyte chemoattractant protein-1. Of 12 QOL parameters, 10 significantly improved from baseline to Week 8 in the test group compared with one in the control group. However, differences between the two groups were only statistically significant for 'frequency of signs of illness' (P = .009). There were no significant differences in the incidence of any adverse events, including gastrointestinal adverse events or clinically significant differences in laboratory parameters or faecal scores between the two groups. The absence of an observed negative impact of the test diet, combined with the magnitude of QOL improvements associated with the diet, suggest that a larger trial is warranted.

Abstract 16279: Does the Number of Antianginals Influence Clinical Outcomes and Quality of Life in Stable Ischemic Heart Disease? Insights From the BARI2D Trial

Introduction: Medical therapy is essential for managing stable ischemic heart disease (SIHD), including anti-anginals. remains unclear whether combining anti-anginal agents provides benefits beyond monotherapy in terms of QoL and cardiovascular outcomes. Hypothesis: The use of a single anti-anginal (β-Blockers, calcium channel blockers, or nitrates) is non-inferior to ≥2 anti-anginals Methods: We utilized data from the BARI-2D trial, which compared cardiovascular and QoL outcomes in patients with SIHD and diabetes mellitus (DM) randomized to revascularization with intensive medical therapy or intensive medical therapy alone. We categorized patients into three groups: ≥2 vs 1 vs 0 anti-anginals. We compared patient characteristics, QoL metrics, and cardiovascular endpoints at baseline and at 5 years, creating a multivariable model to adjust for key clinical confounders. Results: Among 2,368 patients, 348 patients (14.7%) were on 0 anti-anginals, 1,020 patients (43.1%) were on 1 anti-anginal, and 1,000 patients (42.2%) were on ≥2 anti-anginals at baseline. The most common anti-anginal class was β-Blockers. At baseline, patients on 0 anti-anginals had better QoL metrics than patients on ≥2 anti-anginals. However, at a 1-year follow-up, patients taking only 1 anti-anginal showed greater QoL improvement than those taking 0 anti-anginal; this superiority in QoL metrics was not seen in patients taking ≥2 anti-anginal agent, even after adjusting for multiple covariates such as age, heart failure, diabetes control and myocardial jeopardy index. (Figure 1) Lastly, at 5-year follow-up, after adjustment, there were no differences in all-cause mortality, major adverse cardiovascular events, or myocardial infarction between patients taking different numbers of anti-anginals. Conclusion: Treating adults with SIHD and DM with a single anti-anginal was at least as effective in improving QoL compared to two or more anti-anginal agents at one year of follow-up.

Patient-reported outcomes (PROs) in patients (pts) with primary advanced or recurrent endometrial cancer (pA/rEC) treated with dostarlimab (D) plus carboplatin/paclitaxel (CP) compared with CP in the ENGOT-EN6/GOG3031/RUBY trial.

332 Background: In RUBY (NCT03981796), a phase 3, global, randomized, double-blind trial, D+CP demonstrated significant and clinically meaningful improvement in PFS vs placebo + CP (P+CP) in pA/rEC. Methods: 494 pts with pA/rEC were randomized 1:1 to D+CP or P+CP Q3W for 6 cycles (C), followed by D or placebo monotherapy Q6W for ≤2 y. EORTC QLQ-C30 and EN24 (prespecified secondary endpoints) were administered on day 1 of each C, at end of treatment (EOT), and at safety and survival follow-ups. Change (chg) from baseline (BL) to C7 (end of chemotherapy) and C13 (1 y) was calculated in the overall and mismatch repair–deficient (dMMR)/microsatellite instability–high (MSI-H) populations. Least-squares means (LSM) were generated using mixed models for repeated measures, adjusting for correlations across multiple assessments within a pt and controlling for BL global, pain, fatigue, and physical function (PF) scores. Results: In the overall population, PROs were similar with D+CP and P+CP through C7, and no differences between arms across the 3-y period were reported; mean chg from BL to EOT showed numerical improvement with D+CP in back/pelvic pain and deterioration with P+CP in global QOL/GHS, social function (SF), body image, and chg in taste. In the dMMR/MSI-H population, at C7, nominally significant improvements in QOL, PF, role function (RF), pain, and back/pelvic pain were seen with D+CP vs P+CP (Table). Conclusions: Dostarlimab+CP significantly improved PFS and maintained HRQOL in dMMR/MSI-H and overall populations, further supporting its use as a standard of care in pA/rEC. Clinical trial information: NCT03981796 .[Table: see text]

Telehealth-based, geriatric assessment-guided supportive care interventions (GAIN-S) for older adults with advanced cancer: A randomized clinical trial in Brazil.

215 Background: Older adults with cancer in developing countries often encounter obstacles in accessing specialized medical services. We conducted a randomized clinical trial to investigate the feasibility and preliminary efficacy of integrating telehealth-based multimodal geriatric assessment (GA)-guided supportive care interventions (GAIN) for older adults with advanced cancer in Brazil. Methods: Patients aged 65 and above with metastatic cancer receiving first- or subsequent-line treatment were recruited from Brazilian cancer practices and randomly assigned 1:1 to usual care or GAIN-S. Baseline assessments included telehealth-based measures of physical function (Instrumental Activities of Daily Living), depression symptoms (Geriatric Depression Scale), and quality of life (QOL, Functional Assessment of Cancer Therapy-General). The intervention group received multi-modal interventions entailed reviewing patients' needs based on baseline GA and providing remote consultation with supportive care services such as physical activity (supervised resistance, aerobic, and mobility exercises), nutrition, psychosocial support based on their needs. Usual care patients could be referred to the supportive care team upon request. Follow-up at 3 months included GA for both groups. Feasibility was defined as the proportion of patients who followed the intervention. T-tests were used to compare the means of two groups related to physical function, depression symptoms, and QOL. Results: Among 46 approached patients, 40 were included, with 20 allocated to each arm. Clinical characteristics were balanced between groups. Median age was 71 years (range: 65-88). Generally, patients were female (62%), married (57%), and had at least a college degree (52%). Breast (27%), gastrointestinal (22%), and genitourinary (15%) were the most common diagnoses. In the GAIN-S arm, 80% completed all aspects of the intervention, with few refusals (10%) and reports of worsened symptoms (5%). GAIN-S arm patients were most often referred for physical activity (85%), psychologists (55%), nutritionists (55%), and psychiatrists (20%). Notably, GAIN-S arm patients demonstrated significant improvements compared to control arm patients (Table). Conclusions: These findings highlight the feasibility and promising potential efficacy of integrating GAIN-S for older adults with advanced cancer. The significant improvements in physical function, depression symptoms, and QOL emphasize the importance of tailored supportive services and the potential of remote intervention in overcoming outcomes barriers and improving outcomes for older patients with cancer.[Table: see text]

One-year outcomes after prostate artery embolization versus laser enucleation: A network meta-analysis.

Although holmium laser enucleation (HoLEP) is considered a size-independent procedure for treatment of an enlarged prostate, prostate artery embolization (PAE) is emerging as an alternative modality to treat moderate and large benign prostatic hyperplasia. This study aims to compare the early post-operative and short-term efficacy of PAE and HoLEP. PubMed, Cochrane Library and EMBASE databases were searched. Network meta-analysis was performed following PRISMA-N-guidelines. Post-operative parameters analysed include international prostate symptom score (IPSS), quality of life (QOL), post-void residual urine (PVR), maximal uroflow rate (Qmax) and serious adverse events (SAE). Random effects model calculated weighted mean differences (WMD). If 95%CI crossed the line of no effect (WMD =0), evidence indicated no statistically significant difference between treatments compared. Qualitative and quantitative syntheses included 20 and 18 studies with 1991 and 1606 patients, respectively. At 3months, there was no statistically significant difference between PAE and HoLEP in IPSS score improvement [WMD: -2.21: 95%CI: (-10.20, 5.78), favouring PAE], QoL score improvement [WMD: -0.22:95%CI: (-1.75, 1.32), favouring PAE] and PVR improvement [WMD: 26.97: 95%CI: (-59.53, 113.48), favouring HoLEP]. However, PAE was found inferior to HoLEP for Qmax improvement [WMD: 8.47, 95%CI: (2.89, 14.05), favouring HoLEP]. At 1-year follow-up, there was no statistically significant was found between PAE and HoLEP for IPSS score improvement [WMD:6.03, 95%CI: (-1.30, 13.35)], QoL score improvement [WMD: 0.03, 95%CI: (-1.19, 1.25)], PVR improvement [WMD:4.11, 95%CI: (-32.31, 40.53)] and Qmax improvement [WMD:2.60, 95%CI: (-2.20, 7.41)] with all differences favouring HoLEP. PAE was superior to HoLEP for SAE [PAE vs. HoLEP-OR: 0.68, 95%CI: (0.25, 1.37)]. HoLEP was superior to PAE at 3months for Qmax improvement. There was no significant difference in IPSS, QoL, PVR and Qmax improvement at 1year between PAE and HoLEP. PAE was also associated with lesser SAE compared to HoLEP. Studies on the long-term outcome of PAE are needed to establish the durability of early outcomes after PAE.

Catheter ablation of atrial fibrillation in elderly and very elderly patients: safety, outcomes, and quality of life.

Atrial fibrillation (AF) risk increases with age. We aim to assess the efficacy and safety of catheter ablation in the older population. All patients undergoing AF ablation (2013-2021) at our institution were enrolled in a prospectively maintained registry. The primary endpoint was AF recurrence. Patients were divided into 3 groups: non-elderly (< 65 years), elderly (65-75 years), and very elderly (> 75 years). Patient surveys at baseline and during follow-up were used to calculatequality of life (QoL)metrics: the AF severity score as well as the AF burden. A total of 7020 patients were included (42% non-elderly, 42% elderly, and 16% very elderly). Periprocedural major complications were low (< 1.5%) and similar in all groups besides pericardial effusion which was more frequent with older age and similar between the elderly and very elderly. At 3 years, AF recurrence for persistent AF (PersAF) was highest in the very elderly group (48%), followed by the elderly group (42%), and was the lowest in the non-elderly group (36%). In paroxysmal AF (PAF), there was no difference in AF recurrence between the elderly and non-elderly, while the very elderly remained associated with a significantly increased risk. Multivariable Cox analysis confirmed these findings (PersAF; elderly: HR = 1.23, P = 0.003; very elderly: HR = 1.44, P < 0.001) (PAF; elderly: HR = 1.04, P = 0.62; very elderly: HR = 1.30, P = 0.01). Catheter ablation resulted in a significant improvement in quality of life, irrespective of age group. Catheter ablation in elderly and very elderly patients is safe, efficacious, and associated with QoL benefits. Overall, major complications were minimal and did not differ significantly between age groups, with the exception of pericardial effusions which were higher in the elderly and very elderly compared to non-elderly adults. Very elderly patients had a higher rate of AF recurrence when compared with elderly or non-elderly patients. Nevertheless, ablation resulted in a remarkable improvement in QoL and a reduction of AF burden and AF symptoms with a similar magnitude, irrespective of age.

Effects of Moracizine Combined with Metoprolol on Hemodynamic Indices of the Left Atrium and Quality of Life in Patients with Atrial Fibrillation.

Drugs are the first choice of treatment for atrial fibrillation (AF), but there is currently a lack of efficient drug treatment options. The aim of this study was to investigate a combination drug treatment plan which may serve as a reference for the treatment of AF. A total of 316 AF patients admitted to Jiaozhou Central Hospital in Qingdao from October 2020 to October 2022 were selected for this retrospective study. They were divided into a control group (CG, metoprolol, n = 156) and an observation group (OG, moracizine combined with metoprolol, n = 160) based on the treatment they received. The CG and OG groups were compared for clinical efficacy, occurrence of AF, cardiac output (CO), cardiac indexes (CI), stroke volume (SV), stroke indexes (SI) and improvement in QOL. The OG had a better effective rate of treatment, higher levels of CO, CI, SV and SI, and higher QOL scores compared to the CG, as well as a lower AF recurrence rate and AF burden (all p < 0.05). Moracizine combined with metoprolol is an effective treatment for AF patients. This drug combination was found to reduce the AF recurrence rate and burden in AF patients, and to improve their hemodynamic indices and QOL.