Longitudinal Health-related Quality Of Life Research Articles

Longitudinal Health-Related Quality of Life Among Patients With High-Risk Pediatric Hodgkin Lymphoma Treated on the Children's Oncology Group AHOD 1331 Study.

PURPOSEThere have been no previous longitudinal assessments of health-related quality of life (HRQoL) during treatment for pediatric Hodgkin lymphoma (HL). The addition of brentuximab vedotin (BV) to a multidrug chemotherapy backbone demonstrated superior efficacy to standard chemotherapy for patients with pediatric high-risk HL in the AHOD 1331 trial. However, the impact on HRQoL is unknown.PATIENTS AND METHODSAfter treatment random assignment, 268 participants older than 11 years were enrolled in a prespecified, longitudinal, patient-reported outcomes substudy. HRQoL was assessed using the seven-item Child Health Ratings Inventories (CHRIs)-Global scale before treatment (T1) and at cycle 2 (T2), cycle 5 (T3), and end of treatment (T4). A clinically meaningful increase in HRQoL was considered 7 points on the CHRIs-Global. Multivariable linear regression estimated associations between demographic/clinical variables and HRQoL at T1. Linear mixed models estimated changes in HRQoL across the treatment arm.RESULTSParticipant characteristics were balanced by treatment arm. Ninety-three percent of participants completed the CHRIs at T1, 92% at T2, 89% at T3, and 77% at T4. At T1, female sex and fever (P < .05) were each associated with worse HRQoL. By T2, participants in the BV arm experienced a statistically and clinically significant improvement in HRQoL (β = 7.3 [95% CI, 3.2 to 11.4]; P ≤ .001), which was greater than the change in the standard arm (difference in change β = 5.1 [95% CI, -0.2 to 10.3]; P = .057). The standard arm did not experience a statistically or clinically significant increase in HRQoL until T4 (β = 9.3 [95% CI, 4.7 to 11.5]; P < .001).CONCLUSIONThese data demonstrate successful collection of serial HRQoL from youth with high-risk pediatric HL and improvement in HRQoL over the course of initial therapy, sooner and to a greater extent in the group receiving the novel agent BV.

Joint modeling of longitudinal health-related quality of life during concurrent chemoradiotherapy period and long-term survival among patients with advanced nasopharyngeal carcinoma

BackgroundTo investigate the prognosis of longitudinal health-related quality of life (HRQOL) during concurrent chemoradiotherapy (CCRT) on survival outcomes in patients with advanced nasopharyngeal carcinoma (NPC).MethodsDuring 2012–2014, 145 adult NPC patients with stage II-IVb NPC were investigated weekly using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORCT QLQ-C30) during their CCRT period. The effects of longitudinal trends of HRQOL on survival outcomes were estimated using joint modeling, and hazard ratios (HRs) with 95% confidence intervals (95% CIs) were reported as a 10-point increase in HRQOL scores.ResultsAfter a median follow-up of 83.4 months, the multivariable models showed significant associations of longitudinal increasing scores in fatigue and appetite loss during the CCRT period with distant metastasis-free survival: 10-point increases in scores of fatigue and appetite loss domains during CCRT period were significantly associated with 75% (HR: 1.75, 95% CI: 1.01, 3.02; p = 0.047) and 59% (HR: 1.59, 95% CI: 1.09, 2.59; p = 0.018) increase in the risk of distant metastasis, respectively. The prognostic effects of the longitudinal HRQOL trend on overall survival and progress-free survival were statistically non-significant.ConclusionIncreases in fatigue and appetite loss of HRQOL during the CCRT period are significantly associated with high risks of distant metastasis in advanced NPC patients. Nutritional support and psychological intervention are warranted for NPC patients during the treatment period.

Longitudinal health-related quality of life in people with thoracic aortic aneurysms.

Surgical intervention for thoracic aortic aneurysms is high risk. Understanding changes in health-related quality of life before and after endovascular stent grafting and open surgical repair can aid treatment decision-making. The Effective Treatments for Thoracic Aortic Aneurysms ('ETTAA') study (ISRCTN04044627) was a longitudinal, observational study. Adults with new/existing arch or descending thoracic aortic aneurysms greater than or equal to 4 cm in diameter were followed from 2014 to 2022. Five domains of health-related quality of life (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression) were recorded using the EuroQoL, five dimensions, five levels ('EQ-5D-5L') questionnaire and analysed using a range of longitudinal mixed models. Of 886 thoracic aortic aneurysm participants, 824 completed at least 2 questionnaires. Patients had slightly worse health-related quality of life than age-matched norms. Without surgery, deterioration occurred over time in Mobility (0.072/year (95% c.i. 0.042 to 0.101), P < 0.001) and Self-Care (0.039/year (95% c.i. 0.018 to 0.061), P < 0.001) in both sexes and Pain/Discomfort in women (0.069/year (95% c.i. 0.020 to 0.118), P = 0.005). For 6 weeks after endovascular stent grafting, there was a significant impairment in Self-Care (0.214 (95% c.i. 0.112 to 0.316), P < 0.001) and (for women only) in Usual Activities (0.625 (95% c.i. 0.338 to 0.911), P < 0.001), which then returned to pre-endovascular stent grafting levels. Six weeks after open surgical repair, the impairment in health-related quality of life was greater (Mobility 0.492 (95% c.i. 0.314 to 0.669), Self-Care 0.474 (95% c.i. 0.364 to 0.583), Usual Activities 1.469 (95% c.i. 1.042 to 1.896), and Pain/Discomfort 0.561 (95% c.i. 0.363 to 0.760), all P < 0.001) and took longer to return to pre-open surgical repair levels, partly due to increased complications and longer hospitalization. Anxiety/Depression decreased after open surgical repair (-0.214 (95% c.i. -0.326 to -0.101), P < 0.001). Age, sex, frailty, smoking, New York Heart Association class, and chronic obstructive pulmonary disease were significantly associated with health-related quality of life. Without intervention, health-related quality of life declines as age increases. Changes in health-related quality of life should contribute to surgical treatment decision-making.

#2285 Potentially modifiable factors influencing longitudinal health-related quality of life for those with chronic kidney disease in the NURTuRE-CKD cohort

Abstract Background and Aims Factors affecting poor health-related quality of life (HRQoL) for people with chronic kidney disease (CKD) have been previously described in literature, and worse HRQoL is associated with CKD progression and death. Little emphasis has been placed on which factors may be potentially modifiable, and longitudinal HRQoL outcome analyses in non-dialysis dependent CKD cohorts are few in number. Baseline analysis of the NURTuRE-CKD cohort identified several associations between these factors and HRQoL and these associations can now be examined with longitudinal data. Method The NURTuRE-CKD cohort study recruited 2996 participants with non-dialysis dependent CKD between 2017-2019, collecting biochemical, anthropometric, sociodemographic, medical history and patient reported outcome measure (PROM) data. Face-to-face follow-up repeated these measures. Longitudinal worsening overall HRQoL was the main outcome of interest, represented by mapped EQ-5D-3L index value and visual analogue score (VAS). Multivariable linear mixed effects models were fitted in R using the lmer and lmerTest packages. Models for index value were fit separately for each independent variable of interest and collated, as well as fitting models with all variables of interest. Models were adjusted for available confounders, repeated measures and follow-up time. P-values were adjusted for multiple testing using false discovery rate correction. Results 2054/2996 (68.6%) had complete HRQoL data at follow-up, of whom most had CKD stage G3a-G4 (n = 1597, 77.8%). 1817 (88.5%) were white and 1196 (58.2%) were male. Mean age was 63.7 (SD ±14.5) years and the mean number of comorbidities was 3.7 (SD ±2.2). Median (IQR) time between baseline and follow-up was 518 (410) days. At follow-up, mean mapped EQ-5D-3L index value was 0.72 (SD ±0.3) and mean VAS score was 70.4/100 (SD ±20.6). 1595 (77.7%) reported problems in at least one EQ-5D-5L dimension, with 255 (12.4%) developing issues since baseline. 1203 (58.6%) reported worse HRQoL index values at follow up and 910 (44.3%) reported worse VAS. The dimension with the highest number of newly reported issues at follow-up was ‘usual activities’ with 301 (14.7%). Multivariable linear mixed methods models showed independent associations with worse HRQoL (Figs 1 and 2) for those on ten or more medications (β −0.118, CI −0.137 to −0.100, p &amp;lt; 0.001), current smokers (β −0.036, CI −0.067 to −0.006, p = 0.0.012), obesity (β-0.059, CI −0.080 to-0.039, p &amp;lt; 0.001), haemoglobin of &amp;lt;100g/L (β-0.044, CI −0.073 to-0.016, p = 0.014), hospital anxiety and depression scale scores of 8 or above for anxiety (β-0.146, CI −0.161 to-0.130, p &amp;lt; 0.001) and depression (β-0.202, CI-0.219 to −0.186, p &amp;lt; 0.001), worse health literacy (β −0.099, CI −0.136 to −0.063, p &amp;lt; 0.001), and pain (β −0.148, CI −0.161 to −0.135, p ≤ 0.001), weakness (β −0.106, CI −0.120 to −0.092, p &amp;lt; 0.001) and shortness of breath symptoms (β −0.074, CI −0.087 to −0.060, p &amp;lt; 0.001). Conclusion Potentially modifiable factors influencing longitudinal worsening of HRQoL for people with CKD include polypharmacy, smoking, obesity, anaemia, depression and anxiety, limited health literacy, pain, weakness and shortness of breath symptoms. This highlights the need for high quality randomised controlled trials to test interventions addressing these factors with reported HRQoL outcomes. Further work in this cohort is required, examining a third timepoint for HRQoL and linked clinical outcome data.

Bladder Cancer Survivors Who Do Not Smoke Have Better Longitudinal Health-Related Quality of Life Measures: An Assessment of the Comparative Effectiveness and Survivorship Health in Bladder Cancer (CEASE-BC) Study.

Cigarette smoking is the most common risk factor for the development of bladder cancer (BC), yet there is a paucity of data characterizing the relationship between smoking status and longitudinal health-related quality of life (HRQoL) outcomes in patients with BC. We examined the association between smoking status and HRQoL among patients with BC. Data were sourced from a prospective, longitudinal study open between 2014 and 2017, which examined HRQoL in patients aged ≥ 18 years old diagnosed with BC across North Carolina. The QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core instrument) was administered at 3, 12, and 24 months after BC diagnosis. Our primary exposure of interest was current smoking status. Linear regression using generalized estimating equations was used to analyze the relationship between smoking status and various domains of the QLQ-C30. A total of 154 patients enrolled in the study. Eighteen percent were classified as smoking at 3 months from diagnosis, and packs per day ranged from < 0.5 to 2. When controlling for time from diagnosis, demographic covariates, cancer stage, and treatment type, mean differences for physical function (7.4), emotional function (5.6), and fatigue measures (-8.2) were significantly better for patients with BC who did not smoke. Patients with BC who do not smoke have significantly better HRQoL scores in the domains of physical function, emotional function, and fatigue. These results underscore the need to treat smoking as an essential component of BC care.

(1313) - Examining Longitudinal Health-Related Quality of Life from the Quality of Life in Patients with Left Ventricular Assist Device Questionnaire

(1313) - Examining Longitudinal Health-Related Quality of Life from the Quality of Life in Patients with Left Ventricular Assist Device Questionnaire

Longitudinal impact of intracerebral low-grade glioma disease on health-related quality of life.

The aim of this study was to assess health-related quality of life (HRQOL) before and after treatment for intracerebral low-grade glioma. Patients with low-grade glioma who underwent surgical tumor removal between 2012 and 2018 were eligible for this study. All individuals and their closest relatives received thorough preoperative (<seven days before surgery) and posttreatment (12 months after surgery) neuropsychological testing investigating quality of life. The assessment consisted of the Aachen Life Quality Inventory (ALQI) and the Short Form 36 (SF36) questionnaire. Calculated SF36 values were compared with reference values from population-based studies. A set of clinical features were investigated for their association with longitudinal HRQOL deterioration. A total of 25 patients were referred for further analysis, after adjustment to the 2021 WHO classification for central nervous system tumors. Compared to the values of a healthy reference population, the patients expressed significant limitations in several SF36 items, both before and after treatment. Under treatment, there were no significant changes in the SF36 items, but the ALQI questionnaire indicated decreasing HRQOL over time. Data derived from relatives revealed a high degree of concordance with the rating results of the patients. Univariate analysis identified neurological deterioration and ongoing epileptic seizures as predictors for unfavorable HRQOL after one year. Low-grade glioma disease has a significant impact on HRQOL and treatment might contribute to further deterioration. New-onset neurological deficits and ongoing epileptic seizures are predictors of limitations in quality of life. Since the results are based on a small cohort with limited follow-up time, the generalizability of these statements is limited and further studies are required.

De novo financial toxicity in patients with prostate cancer following radical prostatectomy and its impact on health-related quality of life.

318 Background: Financial toxicity (FT), a patient-reported outcome measure (PROM) is defined as the detrimental impact of financial burden caused by a cancer diagnosis on a patient’s well-being. FT is common among cancer patients, yet little is known about FT following radical prostatectomy (RP) for prostate cancer in countries with universal health coverage. We aimed to assess de novo FT and its impact on health-related quality of life (HRQOL) in a large prospective cohort of patients undergoing RP with a systematic follow-up of up to 10 yrs. Methods: 2254 consecutive patients who underwent RP at a large tertiary care center were analyzed. PROMs were prospectively assessed preoperatively, postoperatively at 3mo, then annually until a maximum follow-up of 120mo, applying the validated EORTC QLQ-C30- and the prostate cancer-specific QLQ-PR25 questionnaires. FT was assessed by the “financial toxicity subscale” (FTS) of the EORTC QLQ-C30. Based on previous reports, meaningful FT was defined as FTS ≥ 17. Multivariable regression analysis was used to identify predictors for the development of de novo FT. Separate modeling of longitudinal HRQOL was performed for patients with de novo FT (FT-cohort) and without FT (no-FT-cohort). General HRQOL was assessed by the global health status domain (GHS) of the EORTC QLQ-C30. Results: 298 patients reporting FT prior RP were excluded from further analysis. 20.3% (n=397) of the included patients reported de novo FT within 12 months after RP with a mean FTS-score of 47.3 (SD 21.9). Baseline clinicopathological characteristics did not differ between the FT-cohort and the no-FT-cohort (p-range .060-.173). Multivariable logistic regression analysis revealed subsequent therapies following RP (OR 1.981, 95%CI 1.11-3.53, p=.020), low preoperative emotional functioning (OR 0.990, 95%CI 0.92-0.99, p=.031) and low preoperative social functioning (OR 0.990, 95%CI 0.98-0.99, p=.035) to independently predict development of de novo FT after RP. In longitudinal analysis, significantly worse general HRQOL was observed for patients with de novo FT postoperatively and up to 48mo after RP (p-value each &lt; .001). In the longer term, both cohorts reported no significant difference in general HRQOL up to 10yrs post RP (p-range: .90 - .91). Conclusions: The current study provides prospective data from a unique contemporary patient cohort, which reveals independent predictors for de novo FT in prostate cancer patients following RP. Furthermore, it displays the natural course of general HRQOL for patients who develop de novo FT.

Effect of Adapted Physical Activity in Patients With Advanced Pancreatic Cancer: The APACaP GERCOR Randomized Trial.

The impact of adapted physical activity (APA) on health-related quality of life (HRQoL) in patients with advanced pancreatic ductal adenocarcinoma (aPDAC) is unknown. This study evaluated whether APA in addition to standard care improved HRQoL in patients who have aPDAC who are receiving first-line chemotherapy. Patients with locally advanced/metastatic PDAC and an ECOG performance status of 0 to 2 were randomized (1:1) to receive standard care (standard arm) or standard care plus a home-based 16-week APA program (APA arm). The primary objective was the effect of the APA program on 3 dimensions of the EORTC QLQ-C30: global health status, physical function, and fatigue at week 16 (W16), with a one-sided type I error of 0.017 for each dimension. The primary HRQoL analysis was performed in patients with available baseline and W16 scores for the dimensions (ie, the modified intention-to-treat population 1 [mITT1]), and secondary longitudinal HRQoL analyses using the mixed model for repeated measures (MMRM) and time until definitive deterioration (TUDD) methods were performed in the mITT1 population and in patients with baseline and at least one follow-up questionnaire (mITT2 population). A difference of ≥5 points was considered to be clinically relevant. Of 326 included patients, 313 were randomized to the standard (n=157) or APA (n=156) arms. In the mITT1 population (n=172), the mean differences in global health status, physical function, and fatigue at W16 adjusted from baseline were -0.98 (SD, 23.9; P=.39), -2.08 (SD, 21.3; P=.26), and 4.16 (SD, 29.2; P=.17), respectively, showing a non-statistically significant benefit with APA. In the mITT2 population (n=259), APA was associated with statistically significant and clinically relevant improvement in 5 and 8 dimensions of the HRQoL in the longitudinal MMRM and TUDD analyses, respectively. APA improved several dimensions of HRQoL in patients with aPDAC receiving first-line chemotherapy and standard care.

Longitudinal health-related quality of life in military caregivers no longer providing care.

To examine health-related quality of life (HRQOL) in caregivers when providing care and no longer providing care to service members/veterans with traumatic brain injury. Participants included 466 caregivers enrolled in a 15-year longitudinal study. During an annual follow-up evaluation, a subsample of caregivers self-identified as no longer providing care and were retained in the study as a No Longer Caregiving group (n = 48). Scores on HRQOL measures when providing care (baseline) and no longer providing care (follow-up) were examined. Scores on HRQOL measures were also compared with the remaining 418 caregivers (Caregiving group). The most frequent reasons for no longer caregiving were no longer being in a relationship with the SMV and the SMV had recovered/no longer required care. The No Longer Caregiving group at follow-up reported better scores on five measures compared to baseline, and three measures compared to the Caregiving group. There were no differences in the proportion of clinically elevated scores on HRQOL measures for the No Longer Caregiving group between baseline and follow-up. Compared to the Caregiving group, the No Longer Caregiving group reported a higher prevalence of clinical elevated scores on General Life Satisfaction at baseline and follow-up, and worse scores on Caregiving Relationship Satisfaction and the Couples Satisfaction Index at baseline. While some improvement in HRQOL was noted when caregivers were no longer providing care, many continued to report elevated scores. Services and supports are required for caregivers when providing care, but also when transitioning out of a caregiving role. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Health related quality of life is excellent and sustained at two decades after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in survivors of pseudomyxoma peritonei of appendiceal origin

IntroductionOptimal management of pseudomyxoma peritonei (PMP) is by cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), which can achieve 20-year disease-free, and overall survival. There is limited information on the health-related quality of life (HRQOL) of PMP survivors beyond five years. We report longitudinal HRQOL in patients with PMP of appendiceal origin up to 17-years after their CRS and HIPEC in 2003–2004. MethodsPatients had HRQOL assessed with EORTC QLQ-C30 questionnaires pre-operatively, and at 1-, 10- and 17-years post-operatively. Comparisons in global health-related QOL (global-HRQOL) measures were made with (1) an age- and sex-matched normal European population, (2) between patients who underwent complete cytoreduction (CRS CC0/1) versus maximal tumor debulking (MTD), and (3) between those with and without peritoneal recurrence. ResultsForty-six patients underwent CRS & HIPEC for appendiceal PMP. One patient withdrew from the study. Of the 45 patients, 23 patients were alive at ten and 15 patients at 17-years post-operatively. 21/23 (91%) and 14/15 patients (93%) completed questionnaires respectively.Pre-operatively, patients had significantly lower global-HRQOL compared with the reference population. Over follow-up, patients experienced improvements in their global-HRQOL. By post-operative year-10 and -17, there was no difference between the global-HRQOL of patients and reference population. As expected, patients with CC0/1 and without peritoneal tumor recurrence had better global-HRQOL at ten- and 17-years post-operatively compared with those with MTD or recurrence. ConclusionsOptimal CRS and HIPEC is an effective treatment for appendiceal PMP that can achieve long-term survival. HRQOL is excellent and maintained, in those who have CC0/1 without recurrence.

Machine learning and patient-reported outcomes for longitudinal monitoring of disease progression in metastatic breast cancer: a multicenter, retrospective analysis

BackgroundAssessments of health-related quality of life (HRQoL) play an important role in transition to palliative care for women with metastatic breast cancer. We developed machine learning (ML) algorithms to analyse longitudinal HRQoL data and identify patients who may benefit from palliative care due to disease progression. MethodsWe recruited patients from two institutions and administered the EuroQoL Visual Analog Scale (EQ-VAS) via an online platform over a 6-month period. We trained a regularised regression algorithm using 10-fold cross-validation to determine if a patient was at high or low risk of disease progression based on changes in the EQ-VAS scores using data of one institution and validated the performance on data of the other institution. Progression-free survival (PFS) was the end-point. We conducted Kaplan-Meier and Cox regression analysis adjusted for clinical risk factors. ResultsOf 179 patients, 98 (54.7%) had progressive disease after a median follow-up of 14weeks. Using EQ-VAS scores collected at weeks 1–6 to predict disease progression at week 12, in the validation set (n = 63), PFS was significantly lower in the intelligent EQ-VAS high-risk versus low-risk group: median PFS 7 versus 10weeks, log-rank P < 0.038). Intelligent EQ-VAS had the strongest association with PFS (adjusted hazard ratio 2.69, 95% confidence interval 1.17–6.18, P = 0.02). ConclusionML algorithms can analyse changes in longitudinal HRQoL data to identify patients with disease progression earlier than standard follow-up methods. Intelligent EQ-VAS scores were identified as independent prognostic factor. Future studies may validate these results to remotely monitor patients.

Health-related quality of life in early-stage Hodgkin lymphoma: a longitudinal analysis of the ABVD arm in the randomized controlled trial HD.6.

Early-stage Hodgkin lymphoma has become one of the most curable hematologic malignancies. Depending upon the disease location, possible toxicities, and patient preference, chemotherapy alone with ABVD remains an accepted treatment modality for this disease. There remains a paucity of data regarding the longitudinal trajectory of health-related quality of life (HRQoL) in patients treated for HL. The impact of disease and treatment on HRQoL is increasingly important to understand as the number of long-term survivors increases. We report the longitudinal HRQoL using data prospectively collected from diagnosis up to 10 years post-treatment in the ABVD arm of the HD.6 randomized controlled trial for early-stage HL patients (N=169). We analyzed HRQoL using the EORTC QLQ-C30 collected at baseline, 3 months, 6 months, and 12 months after completion of chemotherapy and yearly up to year 10. Clinically and statistically significant improvements were noted for specific domains including emotional (3 months post-treatment), social (12 months post-treatment) and financial functioning (2 years post-treatment), and the specific symptom of fatigue (6 months post-treatment) during the follow-up period. To our knowledge, this is the first prospective, longitudinal analysis of HRQoL specifically among patients with early-stage HL treated with ABVD therapy alone. Although improvements were noted, sustained clinically and statistically significant improvements were noted only in select symptoms emphasizing the need to better understand and optimize HRQoL among this patient group.

PD15-02 LONG-TERM HEALTH RELATED QUALITY OF LIFE IN PROSTATE CANCER PATIENTS REQUIRING RADIOTHERAPY AFTER RADICAL PROSTATECTOMY

PD15-02 LONG-TERM HEALTH RELATED QUALITY OF LIFE IN PROSTATE CANCER PATIENTS REQUIRING RADIOTHERAPY AFTER RADICAL PROSTATECTOMY

PD44-03 EVALUATION OF GENDER SPECIFIC DIFFERENCES IN HEALTH-RELATED QUALITY OF LIFE FOR BLADDER CANCER PATIENTS AFTER RADICAL CYSTECTOMY - RESULTS FROM A LARGE PROSPECTIVE PROPENSITY SCORE-MATCHED COHORT

You have accessJournal of UrologyCME1 Apr 2023PD44-03 EVALUATION OF GENDER SPECIFIC DIFFERENCES IN HEALTH-RELATED QUALITY OF LIFE FOR BLADDER CANCER PATIENTS AFTER RADICAL CYSTECTOMY - RESULTS FROM A LARGE PROSPECTIVE PROPENSITY SCORE-MATCHED COHORT Thilo Westhofen, Josephine Coleman, Lennert Eismann, Alexander Buchner, Raphaela Waidelich, Christian G. Stief, Severin Rodler, and Alexander Kretschmer Thilo WesthofenThilo Westhofen More articles by this author , Josephine ColemanJosephine Coleman More articles by this author , Lennert EismannLennert Eismann More articles by this author , Alexander BuchnerAlexander Buchner More articles by this author , Raphaela WaidelichRaphaela Waidelich More articles by this author , Christian G. StiefChristian G. Stief More articles by this author , Severin RodlerSeverin Rodler More articles by this author , and Alexander KretschmerAlexander Kretschmer More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003354.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Previous studies have shown gender specific differences in diagnosis and oncologic outcome for patients with bladder cancer (BC). However, in BC patients, gender specific differences in health-related quality of life (HRQOL) outcomes following radical cystectomy (RC) remain unclear. We aimed to assess gender specific differences in HRQOL by providing data from a large prospective propensity score (PS)-matched cohort of patients undergoing RC with a systematic follow-up of up to 10 yrs. METHODS: 1498 consecutive BC patients [n=421 female, n=1077 male] who underwent RC at a large tertiary care center were included. PS-matching of 794 patients [n=397 women, n=397 men] was conducted applying matching variables “age at RC”, “BMI”, “pT-stage” and “type of urinary diversion. HRQOL was assessed systematically, applying EORTC QLQ-C30- as well as the bladder cancer-specific QLQ-BLM30- and FACT-BL-questionnaires. Separate modeling of longitudinal HRQOL for women and men was performed. Spearman’s rank correlation was applied to identify gender specific factors influencing HRQOL. RESULTS: At baseline, female and male patients showed no difference in general HRQOL assessed by the global health status domain (GHS) (p=.162). In longitudinal analysis, a similar course of GHS for women and men was observed till 36mo after RC (p-range: .107 - .856). Between 48mo and 96mo after RC, GHS was significantly better for males (p-range: .002-.045). Spearman’s rank correlation revealed a significant correlation between physical functioning or urinary continence and increased general HRQOL equally for male and female patients (each p<.05). No correlation was found between sexual functioning and increased general HRQOL. While a strong correlation between Social/Family wellbeing and increased general HRQOL was found for women (p=.001), no correlation was shown for male patients (p=.103). CONCLUSIONS: The current study provides prospective data from a large propensity score-matched contemporary patient cohort, which displays gender specific differences in the natural course of general HRQOL and its subdomains. These data might play an important role in guiding gender specific treatment decision-making for patients with BC. Source of Funding: none © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1124 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Thilo Westhofen More articles by this author Josephine Coleman More articles by this author Lennert Eismann More articles by this author Alexander Buchner More articles by this author Raphaela Waidelich More articles by this author Christian G. Stief More articles by this author Severin Rodler More articles by this author Alexander Kretschmer More articles by this author Expand All Advertisement PDF downloadLoading ...

Gender specific differences in health-related quality of life for patients with bladder cancer following radical cystectomy.

437 Background: Previous studies have shown pronounced gender specific differences regarding diagnosis and oncological outcome for patients with bladder cancer (BC). Current literature lacks evidence on gender specific differences in health-related quality of life (HRQOL) outcomes for patients with BC following radical cystectomy (RC). We aimed to assess those gender specific differences by providing HRQOL data from a large prospective propensity score-matched cohort of patients undergoing RC with a systematic follow-up of up to 10 yrs. Methods: 1498 consecutive patients [n=421 women, n=1077 men] who underwent RC at a large tertiary care center were included. A propensity-score matched analysis of 794 patients [n=397 women, n=397 men] was conducted applying the matching- variables “patient age”, “BMI”, “pT-stage” and “type of urinary diversion”. Exclusion criteria encompassed age &lt;30 yr and RC due to benign diseases. HRQOL was assessed preoperatively, at 3 mo, then annually until a maximum follow-up of 120 months applying the validated EORTC QLQ-C30- as well as the bladder cancer-specific QLQ-BLM30- and FACT-BL-questionnaires. Separate modeling of longitudinal HRQOL for women and men was performed. Spearman’s rank correlation was applied to identify gender specific factors influencing HRQOL. Results: At baseline women and men showed no significant difference in general HRQOL assessed by the global health status domain (GHS) (p=.162). Women presented with worse mean emotional (p=.001) and cognitive (p=.007) functioning subscale. In the longitudinal analysis, a similar natural course of the GHS for women and men could be observed up to 36mo after RC (p-range: .107 - .856). Between 48mo and 96mo after RC, general HRQOL was significantly higher for men compared to women (p-range: .002-.045). At 12month a significant correlation between physical functioning or urinary continence and increased general HRQOL could equally be observed for men and women (each p&lt; .05). No significant correlation was found between sexual functioning and increased general HRQOL. While a strong correlation between Social/Family wellbeing and increased general HRQOL was found for women (p=.001), no correlation was found for men (p=.103). Conclusions: The current study provides prospective data from a unique propensity score-matched contemporary patient cohort, which displays gender specific differences in the natural course of general HRQOL and its subdomains. Those data are important to guide gender specific treatment decision-making for patients with BC.

Health-related quality of life in cardiac sarcoidosis: a systematic review.

People living with cardiac sarcoidosis (CS) are likely to have worse clinical outcomes and greater impairment on health-related quality of life (HRQoL) than other sarcoidosis manifestations. CS can result in a constellation of intrusive symptoms (such as palpitations, dizziness, syncope/pre-syncope, chest pain, dyspnoea, orthopnoea, or peripheral oedema) and/or life-threatening episodes, requiring consideration of invasive cardiac procedures for diagnosis and for the management of acute events. Additionally, the presence of multisystemic involvement and persistent non-specific sarcoidosis symptoms negatively affect HRQoL. A systematic review was undertaken to explore the impact of CS on HRQoL in adults with CS. Multiple bibliographic databases were searched for studies with HRQoL as primary or secondary outcomes in CS (PROSPERO registration: CRD42019119752). Data extraction and quality assessments were undertaken independently by two authors. From the initial 1609 identified records, only 11 studies included CS patients but none specifically reported HRQoL scores for CS patients. The average representation of CS patients was 14.5% within these cohorts (range 2-22%). The majority (73%) was conducted in single-centre tertiary care settings, and only one study (9%) included longitudinal HRQoL data. CS patients were among those sarcoidosis patients with impaired HRQoL and worse outcomes, requiring higher doses of sarcoidosis-specific therapy which contribute to further deterioration of HRQoL. Sarcoidosis studies do not incorporate stratified HRQoL scores for CS patients. While there is a need for longitudinal and multicentre studies assessing HRQoL outcomes in CS cohorts, the development of CS-specific tools is also needed.

Patient-Reported Outcomes after Chimeric Antigen Receptor T-Cell (CAR-T) Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphomas

Introduction: Chimeric antigen receptor T-cell (CAR-T) therapy has shown clinical efficacy in refractory and relapsed large B-cell lymphomas, but is associated with serious acute toxicities such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). As part of a larger study evaluating baseline biomarkers in prospective patients receiving CAR-T therapy at the Juravinski Hospital and Cancer Centre, we are reporting preliminary data on patient-reported health-related quality of life (HRQoL). Objective: To measure longitudinal HRQoL in patients receiving CAR-T therapy. We expected HRQoL to worsen in the first 30 days, but improve long term. Methods: A prospective cohort observational study was conducted. Patients with relapsed or refractory large B-cell lymphoma, who were eligible for CAR-T therapy, tisagenlecleucel, were consecutively approached to participate. Demographic data and disease characteristics were collected. Patients received lymphodepleting chemotherapy on days -5 to -3. CAR-T cells were infused on Day 0. CRS and ICANS were assessed using ASTCT criteria. HRQoL was measured using FACT-Lym (Hlubocky et al., Leuk. Lymphoma 2013); a validated 42-item questionnaire answered by the patient on a 5-point Likert scale on days 0 (baseline), day 30, and months 3, 6 and 12. FACT-Lym includes FACT-G (physical, social, emotional and functional well-being domains), plus a lymphoma specific subscale (Lym-S). A score of 0 represents worst HRQoL and higher scores indicate an improvement (score range, 0-168). FACT-Lym Trial Outcome Index (TOI) is a combination of physical and functional well-being and Lym-S. Minimal important differences have been estimated using anchor (performance status and disease progression) and distribution methods for FACT-Lym (Carter et al., Blood 2008). Results: Among 34 patients registered to the study between January 2020 and June 2021, two did not receive their infusion due to progressive disease. Baseline demographics and disease characteristics are described in Table 1. Twenty-one (21/32, 65.7%) patients required bridging therapy prior to CAR-T infusion. Of the 32 patients who received CAR-T infusion, 22 (68.8%) received an outpatient CAR-T infusion; 18/22 (81.8%) were admitted to hospital. 26/32 (81.2%) developed any grade CRS; 6/32 (18.8%) developed grade 3 or 4 CRS. 6/32 (18.8%) developed grade 1 or 2 ICANS and no one developed grade 3 or 4 ICANS. Ten patients died and one withdrew. The remaining 23 patients were followed for one year. Ethics approval for the FACT-Lym questionnaire administration was pending when the first four patients were recruited. Of the 28 patients approached to complete the FACT-lym questionnaire, 26 (92.9%) completed a baseline and at least one follow-up. Fifteen (15/26, 57.7%) completed the 12-month questionnaire. Two remain on study protocol. Attrition was due to death in six patients, two were unknown, and one was due to withdrawal. The median (IQR) FACT-Lym score at baseline was 129 (106, 146), then worsened at day 30, 117.5 (97, 142), and unexpectedly did not improve beyond baseline by month 3, 128 (108, 156). Scores improved by month 6, 136 (114, 154) and month 12, 141.5 (100, 158). Figure 1 illustrates median change from baseline for FACT-Lym total scores and domains. Median change in FACT-Lym total scores at month 12 and FACT-TOI score at months 6 and 12 surpassed a minimal important difference. Conclusions: After initial worsening of HRQoL in patients who received CAR-T therapy, improvements were seen at 6 and 12 months. Future analyses will explore associations between HRQoL and baseline markers, toxicity and treatment response. These results will help enrich our understanding of the patient CAR-T experience and aid in complex and shared decision-making. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Poor Physical Function Trajectory Predicts Impaired Patient Survival in Older Recipients of Deceased Donor Kidneys: A Prospective Cohort Study.

Background.Optimized health-related quality of life (HRQOL) at the time of kidney transplantation (KT) is associated with improved survival. In older KT recipients, we aimed to prospectively evaluate if HRQOL evolution during the first posttransplant year was associated with long-term patient survival.Methods.Recipients older than 65 y at KT who received an organ from a deceased brain-dead donor and survived >12 mo posttransplant were eligible. HRQOL was assessed pre-KT, at 10 wk, 6 mo, and 12 mo post-KT, using the Kidney Disease Quality of Life Short Form version 1.3 survey. A mixed-effect model was used to explore HRQOL evolution during the first posttransplant year in long-term survivors compared with nonsurvivors. Distinct HRQOL clusters were identified using a group-based trajectory modeling and their association with patient survival was investigated with Cox proportional hazard regression models.Results.We included 192 elderly recipients of deceased brain-dead donor kidneys who were transplanted from 2013 to 2020. Eleven died during the first year leaving 181 for evaluation (male, 125; mean age at KT, 72 y [65–84 y]). During a median observation time post-KT of 4.9 y (11.1–8.5 y), 57 recipients died. In survivors, all the generic and kidney-specific HRQOL domains substantially improved during the first year, whereas in nonsurvivors HRQOL deteriorated. Three longitudinal HRQOL trajectories indicating poor, fair, and good HRQOL evolution were identified. Poor physical function trajectory was significantly associated with higher mortality risk independent of covariates, as compared with good physical trajectory (hazard ratio, 2.38; 95% confidence interval, 1.15–5.01).Conclusions.In elderly KT recipients, detection of declining posttransplant physical function may imply impaired survival. Systematic HRQOL monitoring following KT provides added value when evaluating mortality and may guide therapeutic decisions.

Impact of acute toxicities associated with chimeric antigen receptor (CAR) T-cell therapy on health-related quality of life (HRQOL) in relapsed or refractory (R/R) large B-cell lymphoma (LBCL).

294 Background: TRANSCEND NHL 001 (TRANSCEND; NCT02631044) evaluated efficacy and safety of the CAR T cell therapy lisocabtagene maraleucel (liso-cel) as third-line or later treatment in patients with R/R LBCL. Prior research demonstrated improvements in HRQOL with liso-cel; however, evidence of HRQOL in the context of CAR T cell‒specific adverse events was not evaluated. In TRANSCEND, the incidence of all-grade cytokine release syndrome (CRS) and neurological events (NE) was 42% and 30%, respectively. This analysis examined longitudinal HRQOL in the presence of CRS and NEs among clinical responders. Methods: Patients in TRANSCEND who responded to liso-cel treatment (n = 137) were stratified into 3 groups: no CRS or NEs, either CRS or NEs but not both, and both CRS and NEs. HRQOL was evaluated with the European Organisation for Research and Treatment of Cancer core quality of life questionnaire (QLQ-C30) and EQ-5D-5L. Summary statistics and change from baseline (liso-cel infusion; CFBL) were calculated for each time point. Results: For liso-cel‒treated patients who responded to treatment and developed CRS, NEs, or both, clinically relevant QLQ-C30 functional (physical, role, and cognitive) and fatigue scores indicated a noticeable nadir (low point) around 1 month post-baseline after liso-cel infusion, followed by a trend toward restoration of baseline status, generally achieved by 2 months after baseline. The primary difference between CRS/NE subgroups appeared to be the extent of decline or depth of the nadir. Patients with no CRS or NEs after liso-cel infusion did not experience an initial decrease in HRQOL/increase in symptom severity and instead showed a trend toward improvement over time (Table; QLQ-C30 fatigue as an illustrative example). This was also observed for EQ-5D-5L index scores. Conclusions: These findings support the anecdotal clinical experience that CRS/NEs are not associated with any long-term detriment in overall HRQOL and indicate a need for discussion with patients before treatment and early symptom monitoring and management of CRS or NEs. Clinical trial information: NCT02631044. [Table: see text]