EORTC Quality Of Life Research Articles

Health-related quality of life of patients with prostate cancer initiating GnRH agonist therapy: the PRISME study

Objectives To compare the evolution of health-related quality of life (HRQoL) over 6 months of GnRH agonist (GnRHa) therapy among age groups for patients with prostate cancer (PCa). Patients and methods PRISME (NCT03516110) was a non-interventional, prospective study conducted in France in patients aged ≥60 years with PCa initiating GnRHa therapy within routine care. HRQoL was evaluated at baseline and after 6 months using the EORTC quality of life in ELDerly cancer patients 14 items (QLQ-ELD14) questionnaire. Cognitive status was assessed using the Mini Mental State Examination (MMSE). Analyses of covariance compared the evolution of the change from baseline of the QLQ-ELD14 scores among age groups. Results 814 patients were enrolled (245, 60–70 years; 314, 70–75 years; 252, ≥75 years). Slight or no changes were observed in each QLQ-ELD14 dimension between baseline and 6 months, overall and by age. In the primary effectiveness analysis, there was no difference among age groups in the change from baseline in QLQ-ELD14 scores. Baseline cognitive status was lower in the oldest age group, but there were no changes in all age groups. As expected, sexual function declined in all age groups. Conclusion GnRHa therapy influence on HRQoL, cognition and sexuality appeared independent of age.

Radiation dose esclation with contact X-ray brachytherapy (Papillon) and quality of life in patients with rectal cancer: Results from the phase 3 randomised trial OPERA.

e23180 Background: Organ preservation has been increasingly offered to patients with rectal cancer as most patients wish to avoid extirpative surgery and a stoma if they have a choice. The standard of care is to offer external beam chemo radiotherapy (EBCRT) to those who are fit. OPERA (Organ Preservation in Early Rectal Adenocarcinoma) has shown improved organ preservation rate with addition of contact X-ray brachytherapy(CXB-Arm B) compared to EBCRT with EBRT boost. We evaluate whether addition od CXB boost compromise the patients Quality of Life (QOL) compared to EBRT boost and if so by how much. We report our results at 38.2 months follow up. Methods: From June 2015 to June 2020, there were 148 patients randomised of which 141 were evaluable. We used EORCT QLQ -C30, QLQ -CR29 and modified LARS score at FU visits every 3 months during FU visit 1(8 weeks)-9 (32 weeks). Results: At screening (baseline) we enrolled 126 patients (Arm A: 59, Arm B: 66). At FU -1 we received questionnaire back from 78 patients (Arm A: 35, Arm B: 43). At FU-5 there were 55 patients (Arm A:18, Arm B: 37). Finally, at FU 8 there were 43 patients (Arm A: Arm B xx). Using EORTC QOL-C30 and QOL CR-29, global QOL score for Arm A was 77.6 vs Arm B 72.22 (p = 0.14). Mean functional scale (1-5) for Arm A was 95.2 vs Arm B 92.1 (p = 0.09). Role functioning scale (6-7) for Arm A was 91.2 vs Arm B 93.18 (p = 0.57). Emotional functioning (21-24) for Arm A was 77.5 vs Arm B 73.99 (p = 0.33). Cognitive functioning (20-25) for Arm A 87.85 vs Arm B 91.92(p = 0.17). Social functioning (26-27) for Arm A 95.2 vs Arm B 92.93 (p = 0.31). Conclusions: In our analysis so far, we do not detect significant difference in QOL between Arm A and Arm B. Consider Contact x-ray brachytherapy first in patients with rectal cancer < 3cm (Arm B1) which has shown higher organ preservation rate without effecting their QOL compare to EBCRT (Arm A1). Clinical trial information: NCT02505750 .

Linking in with advice and supports for men impacted by metastatic cancer: The LIAM Mc trial (NCT05946993).

TPS1646 Background: Multidisciplinary supportive care interventions are key to preventing and managing adverse effects of cancer and its treatment for patients, reducing symptom and psychological burdens and enhancing quality of life (QoL). However, the optimal composition of these interventions for men with genitourinary (GU) cancers is poorly understood. The LIAM Mc Trial is an enhanced supportive care programme, funded by the Irish Cancer Society and designed with the input of patient representatives who highlighted the unmet needs of cancer survivors. An important aspect of the trial is to demonstrate how to improve the survivorship supports and services for underserved communities of men who experience disparities in cancer incidence, prognosis, outcome and QoL, and have not traditionally been the focus of such initiatives. Methods: Using an embedded mixed-method process evaluation this prospective trial aims to assess the feasibility and impact of a holistic 12-week survivorship programme amongst men with advanced GU cancers at an Irish Cancer Centre. The programme involves twice-weekly sessions with input from a dedicated physiotherapist, dietitian, and nurse specialist, along with education sessions from medical social worker and psycho-oncology specialists, and programme oversight provided by medical oncologists. Outcomes are measured at three timepoints; pre-intervention, immediately post-intervention and at 6 months post intervention, and will include EORTC QoL; muscle strength; body composition through bioelectrical impedance analysis and ultrasound; diet quality; cancer related symptom control; cancer related fatigue scores; feasibility outcomes, qualitative interviews and a process evaluation. Any man with a locally advanced or metastatic GU cancer who has recently completed a course of treatment or is stable on active anti-cancer treatment is eligible for the programme. Over the two-year study period the sample size target is 72 participants. The primary endpoint of the study is to evaluate the feasibility of introducing an enhanced supportive care programme as part of routine management for male cancer patients with metastatic disease. Acceptability, satisfaction with the programme and QoL changes are key secondary endpoints. Barriers to participation are also a key outcome under investigation. The study was activated in May 2023 with the first participants enrolled in June 2023. To date 17 men have enrolled with accrual completion anticipated in June 2025. Clinical trial information: NCT05946993 .

Association of the muscle mass phenotype as assessed by a grading system with the quality of life of patients with incurable cancer in palliative care

BackgroundLoss of muscle mass (MM) is common in advanced stages of cancer, with an impact on worsening quality of life (QoL). In the current study the relationship of a previously proposed simple grade system to assess MM phenotypes with QoL was investigated to strengthen its clinical significance. AimTo verify whether the MM phenotypes, which were evaluated by using a grading system, are associated with the quality of life (QoL) of patients with incurable cancer. MethodsSecondary data from a cohort of patients with incurable cancer in palliative care, were analyzed. The grade system considers measurements of the muscle area arm and handgrip strength. Based on these measurements, patients are classified as probably non-sarcopenic (Nsarc), probably sarcopenic (PSarc), and sarcopenic (Sarc). The outcome measure was QoL domains assessed by the EORTC QoL Questionnaire Core-15. Logistic regression models were used to verify the association of the domains of QoL with the MM phenotypes. ResultsA total of 770 patients were included, median age 62 years and 56.6% females. The PSarc group had significantly worse scores in the QoL domains when compared to the Nsarc group (physical p= 0.001, emotional p= 0.018, fatigue p<0.001, nausea p= 0.017, insomnia p= 0.001, appetite loss p= 0.002, and global health p= 0.043). Adjusted logistic regression analysis showed an increased risk of worse QoL in the PSarc and Sarc, when compared to NSarc, respectively (Odds ratio [OR], 95% confidence interval [CI]): physical (OR: 2.54, CI: 1.78-3.62 and OR: 7.18, CI: 4.24-12.17), emotional (OR: 1.61, CI: 1.15-2.24 and OR: 1.49, CI: 1.01-2.20), fatigue (OR: 1.89, CI: 1.35-2.64 and OR: 1.83, CI: 1.23-2.71), insomnia (OR: 2.01, CI: 1.43-2.83 and OR: 3.11, CI: 2.04-4.75), while an appetite loss was associated with the PSarc (OR: 1.40, CI: 1.02-1.96), together with global health in the Sarc group (OR: 1.56, CI: 1.06-2.29). ConclusionThe severity of the MM phenotype was associated with a worse QoL domains. Our results highlight the importance of MM preserving to affecting QoL status. The grading system can be useful for predicting the QoL in those patients, and its usefulness can potentially impact clinical and therapeutic decision-making.

Erectile function preservation after salvage radiation therapy for biochemically recurrent prostate cancer after prostatectomy: Five-year results of the SAKK 09/10 randomized phase 3 trial

ObjectivesTo evaluate effects of dose intensified salvage radiotherapy (sRT) on erectile function in biochemically recurrent prostate cancer (PC) after radical prostatectomy (RP). Materials and methodsEligible patients had evidence of biochemical failure after RP and a PSA at randomization of ≤ 2 ng/ml. Erectile dysfunction (ED) was investigated as secondary endpoint within the multicentre randomized trial (February 2011 to April 2014) in patients receiving either 64 Gy or 70 Gy sRT. ED and quality of life (QoL) were assessed using CTCAE v4.0 and the EORTC QoL questionnaires C30 and PR25 at baseline and up to 5 years after sRT. Results344 patients were evaluable. After RP 197 (57.3 %) patients had G0-2 ED while G3 ED was recorded in 147 (42.7 %) patients. Subsequently, sexual activity and functioning was impaired. 5 years after sRT, 101 (29.4 %) patients noted G0-2 ED. During follow-up, 44.2 % of patients with baseline G3 ED showed any improvement and 61.4 % of patients with baseline G0-2 ED showed worsening. Shorter time interval between RP and start of sRT (p = 0.007) and older age at randomization (p = 0.005) were significant predictors to more baseline ED and low sexual activity in the long-term. Age (p = 0.010) and RT technique (p = 0.031) had a significant impact on occurrence of long-term ED grade 3 and worse sexual functioning. During follow-up, no differences were found in erectile function, sexual activity, and sexual functioning between the 64 Gy and 70 Gy arm. ConclusionED after RP is a known long-term side effect with significant impact on patients’ QoL. ED was further affected by sRT, but dose intensification of sRT showed no significant impact on erectile function recovery or prevalence of de novo ED after sRT. Age, tumor stage, prostatectomy and RT-techniques, nerve-sparing and observation time were associated with long-term erectile function outcome.ClinicalTrials.gov. Identifier: NCT01272050.

Baseline functioning scales of EORTC QLQ-C30 predict overall survival in patients with gastrointestinal cancer: a meta-analysis.

A consensus has not been reached on the value of quality of life (QoL) as a prognostic factor for survival in gastrointestinal cancer. This meta-analysis aimed to investigate the association between functioning scales of the EORTC QoL Questionnaire Core 30 (QLQ-C30) and the overall survival (OS) in patients with gastrointestinal cancer. A systematic literature search was conducted in PubMed, Web of Science, and Embase databases, until February 7, 2023. The studies included were those that investigated the association between baseline QoL measured by the functioning scales of EORTC QLQ-C30 and OS in patients with gastrointestinal cancer. The prognostic capacity of QoL was calculated by pooling the adjusted hazard ratios (HR) with 95% confidence intervals (CI). Twenty-four studies' analyses reported by 22 eligible articles involving 11,609 patients were included. When compared with good parameters of QoL, poor global QoL (HR 1.81; 95% CI 1.53-2.13), physical functioning (HR 1.51; 95% CI 1.31-1.74), social functioning (HR 1.67; 95% CI 1.30-2.15), and role functioning scale (HR 1.42; 95% CI 1.20-1.29) were significantly associated with decreased OS. For each 10-point increase in QLQ-C30 parameters, the pooled HR of OS was 0.87 (95% CI 0.83-0.92) for global QoL, 0.87 (95% CI 0.83-0.92) for physical functioning, and 0.93 (95% CI 0.88-0.97) for role functioning. However, each 10-point increase in social, emotional, or cognitive functioning scale did not significantly predict OS. Baseline health-related QoL defined by the physical functioning or global QoL scale of EORTC QLQ-C30 significantly predicts OS in patients with gastrointestinal cancer.

Lifestyle Behaviors and Health-Related Quality of Life in Long-Term Survivors of Acute Myeloid Leukemia: An International Survivorship Study By the Gimema, EORTC Quality of Life and Leukemia Groups

Background Major advances have been made in the treatment of acute myeloid leukemia (AML), and the number of survivors is expected to rise over the coming years. Therefore, a better understanding of the relationships between lifestyle behaviors and health-related quality of life (HRQoL) is important to better inform survivorship care programs. Although valuable evidence exists in this area of research for survivors of solid tumors, little data is available on patients with AML. Objective We aimed to investigate the prevalence of lifestyle behaviors of long-term AML survivors and to identify associations with HRQoL profile. A secondary objective was to describe the prevalence of clinically important functional problems and symptoms by level of physical activity (PA). Methods: In this international AML survivorship study, patients were eligible if they were diagnosed at least 5 years before and were disease-free at study entry. Patients were invited to participate by their treating hematologist and all consenting patients were requested to complete a survey booklet. Clinical data were retrieved via hospital medical records. The following lifestyle behaviors were assessed: PA, maintaining a healthy weight, eating pattern, smoking status, and alcohol consumption. PA was assessed by the Godin Leisure-Time Exercise questionnaire. Using only moderate and strenuous scores, those with a leisure score index≥24 were classified as active and those with a score≤23 were classified as insufficiently active. Maintaining a healthy weight was evaluated by the BMI and patients were categorized into: non-overweight/obese (BMI &amp;lt;25) and overweight/obese (BMI ≥25). HRQoL profile was assessed by the EORTC QLQ-C30 questionnaire. Univariable and multivariable linear regression analyses were used to investigate the associations of lifestyle behaviors and HRQoL. The summary score of the EORTC QLQ-C30 was used as outcome variable in regression analyses and the following covariates were considered: sex, age at study entry, time since AML diagnosis, ECOG performance status at diagnosis, education, living arrangements, hematopoietic stem cell transplantation history, being treated within a randomized controlled trial (RCT), and current comorbidity. Prevalence of clinically important problems and symptoms, by PA, was assessed based on recently developed thresholds for the EORTC QLQ-C30. Results Overall, 225 AML survivors with a median time from diagnosis to study entry of 8.8 years (IQR 6.4-11.9) were enrolled across 24 centers in 6 countries (Italy, France, Turkey, North Macedonia, Belgium, Slovenia). Median age at study entry was 58.0 years (IQR 47.3-66.9) and 119 (52.9%) were women. Overall, there were 165 (73.7%) patients who received at least one stem cell hematopoietic transplantation, and 70 (31.1%) patients treated in the setting of a RCT as first line therapy. One hundred ninety-five survivors (88.6%) reported at least one comorbidity and 103 (46.8%) reported four or more comorbidities. Overall, 74 (33.8%) patients were considered physically active, 121 (55.3%) were considered as overweight/obese, and 43 (19.8%) reported healthy eating habits. The majority of patients were non-smoker (n=184, 83.6%) and reported low alcohol consumption (n=209, 95.9%). In univariable analyses, no comorbidity (p=.046), no smoking habits (p=.035), higher level of education (p=.017), and being physically active (p&amp;lt;.001) were associated with a higher EORTC QLQ-C30 summary score. However, in multivariable analysis, only being physically active (p=.005) remained independently associated with a higher EORTC QLQ-C30 summary score. Marked differences were observed in the prevalence of clinically important functional problems and symptoms between the two groups. For example, the prevalence of patients reporting clinically important fatigue and dyspnea in patients who were physically active versus those who were not, was: 8.1% vs. 23.6% and 23% vs 43.1%, respectively. Likewise, patients who were physically active tended to report a lower prevalence of clinically important functional problems (Figure 1). Conclusion: We found an independent association between being physically active and reporting a better HRQoL profile in long-term survivors of AML. Our findings suggest that interventions aimed to increase PA in survivors of AML may be critical to improve their functional outcomes and reduce symptom burden.

Younger Age and Parenchyma-Sparing Surgery Positively Affected Long-Term Health-Related Quality of Life after Surgery for Pancreatic Neuroendocrine Neoplasms.

(1) Background: Patients with pancreatic Neuroendocrine Neoplasms (PanNENs) often have a long overall survival. We evaluated determinants of quality of life (QoL) after surgery for PanNENs. (2) Methods: Patients operated on for a PanNEN in our center (1990-2021) received three EORTC QoL questionnaires (QLQ-C30, QLQ-GI.NET21, QLQ-PAN26). Six domains were selected as outcome variables (global QoL, physical function -PF, social function -SF, disease-related worries -DRWs, pain, upper-gastrointestinal (GI) symptoms) and evaluated in relation to the clinical variables. Statistical analysis was performed using R software v 4.2.2. (3) Results: One hundred and four patients enrolled showed a good global QoL (median 83.3). Old age was a determinant of worse global QoL (p 0.006) and worse PF (p 0.003). Multiple comorbidities (p 0.002) and old age (p 0.034) were associated with pain, while male gender was related to better PF (p 0.007) and less pain (p 0.012). Patients who had undergone parenchyma-sparing surgery demonstrated better PF (p 0.037), better SF (p 0.012), and less upper-GI symptoms (p 0.047). At multivariable analysis, age (p 0.005) and type of surgery (p 0.028) were confirmed as determinants of global QoL. (4) Conclusions: In patients operated on for a PanNEN, a good HRQoL is generally reported; notably, younger age and parenchyma-sparing surgery seem to positively affect HRQoL.

Comparison of Quality of Life after Robotic, Video-Assisted, and Open Surgery for Lung Cancer.

Post-operative quality of life (QOL) has become crucial in choosing operative approaches in thoracic surgery. However, compared to VATS and thoracotomy, QOL results post-RATS are limited. We compared QOL before and after RATS and between RATS, VATS, and thoracotomy. We conducted a retrospective review of lung cancer surgical patients from 2015 to 2020. Patients completed validated EORTC QOL questionnaires (QLQ-C30 and QLQ-LC13). Results were analysed using the EORTC Scoring Guide, with statistical analysis. A total of 47 (94%) pre- and post-RATS questionnaires were returned. Forty-two patients underwent anatomical lung resections. In addition, 80% of patients experienced uncomplicated recovery. All global and functional QOL domains improved post-operatively, as did most symptoms (13/19). Only four symptoms worsened, including dyspnoea (p = 0.017), with two symptoms unchanged. Of the 148 returned questionnaires for all approaches (open-22/VATS-79/RATS-47), over 70% showed a high pre-operative performance status. Most patients underwent anatomical lung resection, with only VATS patients requiring conversion (n = 6). Complications were slightly higher in RATS, with one patient requiring re-intubation. RATS patients demonstrated the highest global and functional QOL. Physical QOL was lowest after thoracotomy (p = 0.002). RATS patients reported the fewest symptoms, including dyspnoea (p = 0.046), fatigue (p < 0.001), and pain (p = 0.264). Overall, RATS results in a significantly better post-operative QOL and should be considered the preferred surgical approach for lung cancer patients.

Factors associated with quality of life among patients with a newly diagnosed oral cavity and oropharyngeal cancer

PurposeThe objectives of this report were 1) to examine the quality of life (QOL) of patients with a newly diagnosed oral cavity or oropharyngeal (OCOP) cancer; and 2) to examine factors contributing to QOL before cancer treatment. MethodsThe sample included 115 participants with a new diagnosis of OCOP cancer. Participants completed the demographic form, oral cancer disease and treatment form, Hospital Anxiety and Depression Scale (HADS), Brief Health Literacy Screen (BHLS), and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Pearson correlations and linear regressions were used for data analysis. ResultsParticipants had a median global health related QOL score of 66.7 (interquartile range, IQR = 50.0, 83.4) with median scores for the subdomains being generally high (all >80 of possible 100). Anxiety and depression were significantly inversely correlated with all areas of EORTC QOL (r = - 0.48 to −0.78, all p < .001). Multivariable associations were strongest with the physical functioning domain (R = 0.56, p < .001), with younger age, higher income, Stage I/II cancer (compared to Stage III/IV) significant contributors to the multiple correlation (beta > ± 0.20, p < .05). ConclusionsHealth care providers should be attentive to OCOP cancer patients with older age, lower household income, advanced cancer stage, and presence of anxious and/or depressive symptoms for indicators of poor QOL. Clinicians should consider the benefit ofinitiating supportive interventions before cancer treatment among OCOP cancer patients with poor QOL.

Combined Couple Therapy Based on Acceptance and Commitment and Schema Therapy for Quality of Life and Recovery Process of Patients With Breast Cancer During Medical Treatment

Introduction: Cancer can affect the process of recovery and the quality of life (QoL) of individuals. This study determined the effectiveness of combined couple therapy based on acceptance and commitment and schema therapy on the QoL and recovery process of patients with breast cancer (BC) during medical treatment. Methods: The research method is semi-experimental with pre-test, post-test, follow-up, and control group. The study’s statistical population included all married patients with BC (stage one) who received treatment in Mashhad in 2019. A total of 30 samples were selected through the convenience sampling method and then randomly assigned to the control and treatment groups. The exceptional EORTC QoL questionnaire (QLQ-C30) was used in patients with cancer to collect data, and the recovery symptoms were checked according to medical records and the relevant specialist’s opinion. The data were also analyzed by repeated measures analysis of variance to analyze the obtained data. Results: The findings demonstrated that the combined couple therapy based on Acceptance and commitment therapy (ACT) had a significant effect on the QoL and recovery process of patients with cancer during medical treatment (P&gt;0.01). Conclusion: The results imply that couple schema therapy-based ACT could positively affect the QoL and treatment processes among cancer patients.

Evaluation of Scores to Reflect Toxicity Impact on Quality of Life of Patients With Platinum-Resistant Ovarian Cancer: AURELIA Substudy.

Current standards for toxicity reporting do not fully capture the impact of adverse events (AEs) on patients' quality of life (QoL). This study aimed to evaluate the association between toxicity and QoL by using toxicity scores that take into account CTCAE grade grouping and AE duration and cumulation. Analyses were performed on the AURELIA trial dataset, including 361 patients with platinum-resistant ovarian cancer treated with chemotherapy alone or with bevacizumab. Global and physical functioning QoL were issued from the EORTC QoL Questionnaire-Core 30 (QLQ-C30), collected at baseline and 8/9 and 16/18 weeks after treatment initiation. Four toxicity scores were computed: the total number of AEs, multiplied by their grade and not, and the cumulative duration of AEs, weighted by their grade and not. Each score included all AEs or only grade 3/4 nonlaboratory or treatment-related AEs. The relationship between toxicity scores and QoL was assessed through linear mixed regression. We found that 171 (47.5%) and 43 (11.9%) patients experienced at least one grade 3 or 4 AE, respectively, whereas 113 (31.4%) experienced grade 2 AEs only. Physical QoL was negatively associated with all toxicity scores when computed with all grades of AEs (all P<.01), with a weaker association when treatment-related AEs were considered. Global QoL was negatively associated with toxicity scores computed with nonlaboratory all-grade AEs only (β, -3.42 to -3.13; all P<.01). Degrees of association were lower when considering the AE duration. In this analysis of patients with platinum-resistant ovarian cancer, toxicity scores based on the cumulative number of AEs, modulated or not by grade, were more effective at predicting QoL changes than those based on AE duration. Toxicity impact on QoL was better reflected when grade 2 AEs were taken into account together with grade 3/4 AEs, whatever their treatment imputability, and when laboratory AEs were excluded.

Quality of life in QUILT 3.032 study: Patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) receiving IL-15RαFc superagonist N-803 plus BCG.

495 Background: Patients (pts) with BCG-unresponsive NMIBC have limited treatment options and are at an increased risk for cystectomy. Nogapendekin alfa inbakicept (NAI, also known as N-803), is an interleukin-15 superagonist (IL-15RαFc), which synergizes with BCG to elicit innate immune memory resulting in durable complete responses (CRs) in this patient population. In an open-label, 3-cohort, multicenter Phase 2/3 study of intravesical BCG plus NAI in BCG-unresponsive high-grade NMIBC (QUILT 3.032; NCT03022825), pts with carcinoma in situ (CIS; Cohort A) have a CR rate of 71% (median duration 26.6 months), 89.2% cystectomy avoidance and 100% bladder cancer specific survival at 24 months. We submit here the first quality of life (QOL) data report in the same pts cohort. Methods: Cohort A: 86 pts (median age 73 years; 87% male) with histologically confirmed BCG-unresponsive CIS with or without Ta/T1 disease, treated with intravesical BCG 50 mg plus NAI 400 μg. Mean baseline ECOG score was 0.183, with 82% of pts having score = 0. QOL was measured by the EORTC QOL Questionnaire Core 30 (QLQ-C30) and QOL NIMBC-Specific 24 Questionnaire (QLQ-NMIBC24). Results: Multivariate analyses have shown no significant changes over time for any of the measured QOL domains. Mild worsening vs. baseline in feeling ill was reported by 6% and 3% of pts by week 27 and 52, while 4% and 6% reported improvement. By week 78 and 104, 7% and 9% of pts reported improvement vs. baseline in their wellbeing with the majority being stable (non-significant). No statistically significant variations were detected in the physical function (PF) score (baseline vs. week 27, 52, 78 and 104). Higher PF scores were observed in pts responding to the therapy vs. non-responders; however, baseline value of PF was also higher in responders vs. non-responders. In contrast to historical results of BCG alone, week 27 physical function scores were numerically higher than baseline, with a subsequent nadir at week 78 and recovery to baseline by week 104 (non-significant). Hospitalizations for any reason remained low (0% - 6% per assessments) during the study. Conclusions: QOL measurement supports good tolerability of the intravesical NAI plus BCG in BCG-unresponsive, high-grade NMIBC pts with CIS. These results further strengthen the evidence of a favorable benefit: risk ratio of this novel combination immunotherapy, in a challenging disease. Clinical trial information: NCT03022825 .

Patient-Reported Outcome Measures in Chemotherapy-Induced Peripheral Neurotoxicity: Defining Minimal and Clinically Important Changes.

Chemotherapy-induced peripheral neurotoxicity (CIPN) is a common complication of cancer treatment that produces functional disability. Increasingly, patient-reported outcome measures (PROMs) are used to assess CIPN, providing a broader symptom perspective than clinician-graded scales. Understanding when a reported change in CIPN symptoms meets the threshold for clinical significance is challenging. This study aimed to provide interpretation guidelines for validated CIPN PROMs, and thereby enable estimation of thresholds to identify clinically relevant symptoms. Patients commencing neurotoxic cancer treatments were assessed at 3 timepoints: baseline, midtreatment, and end-of-treatment. Trajectory of CIPN development was assessed by means of CIPN PROMs, EORTC Quality of Life - Chemotherapy-Induced Peripheral Neuropathy questionnaire (QLQ-CIPN20), and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity questionnaire (FACT/GOG-NTX). Thresholds were estimated for CIPN PROMs using the NCI CTCAE sensory neuropathy scale as the clinical anchor by midtreatment and end-of-treatment. Patients were assigned to a clinical change group according to CIPN development: either no development; grade 1 neuropathy (minimally important difference [MID]); or grade 2 neuropathy (clinically important difference). Distribution-based estimates (SD, 0.5) were also evaluated as supportive evidence. In total, 406 patients were recruited to the study, of whom 62% (n=199/320) developed CIPN by midtreatment and 80% (n=274/343) by end-of-treatment. Anchor-based MID estimates by midtreatment were 5.06 (95% CI, 4.26-5.86) for the QLQ-CIPN20 and 3.54 (95% CI, 2.87-4.20) for the FACT/GOG-NTX. End-of-treatment MIDs were estimated to be 7.32 (95% CI, 6.23-8.40) for the QLQ-CIPN20 and 4.84 (95% CI, 3.98-5.70) for the FACT/GOG-NTX. Distribution-based MID estimations yielded lower values than anchor-based methods, at 3.73 for the QLQ-CIPN20 and 2.64 for the FACT/GOG-NTX at midtreatment and 5.52 for the QLQ-CIPN20 and 3.64 for the FACT/GOG-NTX at end-of-treatment. Findings from the present series aid meaningful interpretation for commonly used validated CIPN PROMs and provide thresholds that serve as guidance on how to interpret score changes, which will be useful for design and evaluation of clinical trials and clinical practice.

Quality of Life of Emirati Women with Breast Cancer.

To examine the quality of life (QoL) of Emirati women with breast cancer (BC) and determine its relationships with their sociodemographic characteristics and clinical factors. The study will play a leading role in providing information about the QoL of Emirati women with BC and will help in recognizing the aspects of QoL in BC survivorship that requires special attention. A population-based cross-sectional study was conducted on 250 Emirati women using a multistage stratified clustered random sampling. The participants were interviewed face-to-face using a structured questionnaire composed of sociodemographic variables, reproductive characteristics, and the European Organization for Research and Treatment of Cancer Quality of Life Cancer-Specific version (EORTC QLQ-C30, v.3.0) and the EORTC QoL Breast Cancer-Specific version (EORTC QLQ-BR23) translated into Arabic. Emirati BC survivors reported good QoL overall. The most bothersome symptoms were sleep disturbance, fatigue, pain, hair loss and arm symptoms. Emirati women scored average on all functional scales, which indicates mediocre functioning, but high on the symptom scales, which indicates worse symptoms. Factors associated with a decline in the domains of QoL included higher age, lower income, and history of metastases, mastectomy, and lymph node dissection.

Novel Home-Based Transfusion Model of Palliative Care in Malignant Hematology

Background: Patients with hematologic malignancies often receive aggressive care at the end of life (EOL) and utilize hospice services less frequently than patients with solid tumors1. Hospice utilization rates are low, and patients enroll late in the disease, spending an average of 3 days on hospice2, thereby limiting the potential benefit of hospice care1,3. Access to transfusions has been identified as a major barrier to hospice enrollment in hematologic malignancies despite representing an important strategy that can help improve quality of life (QOL) and symptoms for these individuals4,5. Therefore, we hypothesized that the creation of a home-based transfusion system that allows patients to receive blood and platelet transfusions while enrolled in hospice would improve their QOL and symptom burden. Furthermore, we created a program with symptom-based triggers for transfusion, rather than the standard transfusion practices with complete blood count (CBC) triggers. In this interim analysis of our novel home-based transfusion pilot study, we sought to investigate feasibility, transfusion reaction incidence, QOL and symptom improvement, and hospice outcomes. Methods: Patients enrolled in hospice and participated in the home-based transfusion system from 8/17/2020 to 2/16/2022 (n=12 out of a planned 20). Eligibility criteria included: age ≥18 years, primary hematologic malignancy, transfusion dependence and an absence of previous blood transfusion reactions or difficulty with blood typing. Evaluable patients received one unit of packed red blood cells (RBCs) and/or platelet transfusions weekly based on trigger symptoms (Common Terminology Criteria for Adverse Events [CTCAE] defined grade 2+ symptoms secondary to anemia and/or thrombocytopenia) continued until unacceptable toxicities or death. Patients were assessed by study personnel via a phone call at the start of every week. All patients who received transfusions, received follow-up phone calls 48-72 hours after transfusion to assess for post-transfusion reactions, symptoms, and QOL via the EORTC QLQ C30 questionnaire. The primary end point was feasibility of home based transfusion system with secondary endpoints assessing QOL and symptoms, transfusion rate and reaction incidence, length of time on hospice, incidence of revocation of hospice, hospitalization while on hospice and site of death. Weekly CBC data was collected throughout the course of this study and CBC data was blinded to the study personnel until study completion. Results: 12 patients were enrolled. Median patient age was 66 (range 31-83) years. Patients’ diseases included Acute Myeloid Leukemia (9 [75%]), Non-Hodgkin Lymphoma (2 [16.7%]), and Myelodysplastic Syndrome (1 [8.3%]). The average number of transfusions per patient was 2.91 (n=11) with no reported transfusion reactions. The average number of reported grade 2+ symptoms decreased from 2.93 to 1.97, pre- and post-infusion respectively. Patients reported that pre-transfusion dyspnea and fatigue were the most common symptoms, both of which improved after transfusions by 55% (patients reported dyspnea 66.67% of the time pre-transfusion vs 30% post transfusion) and 22% (patients reported fatigue 90% of the time pre-transfusion and 70% post transfusion), respectively. Median time on hospice was 11.5 days. The mean number of transfusions per patient while on hospice was 2.67 (n=11) packed RBCs and 1.50 (n=10) platelets. The mean EORTC QOL score pre-transfusion was 50.49 and post transfusion 51.95 with a mean difference of 1.46. There was one hospitalization (for fever and severe thrombocytopenia), no ICU admissions and no hospice revocations. All 12 patients died at home. Conclusion: In this interim analysis, we described the potential feasibility of a novel home-based transfusion system, with high enrollment rates and no transfusion reactions. Notably, the number of transfusions required was quite small, and we found that patients’ most common symptoms improved following transfusion. In our small pilot study, the time on hospice increased from a standard 3 days to 11.5 days. No transfusion reactions were noted, and transfusions improved QOL. Future work is needed in a larger demonstration project to evaluate if home-based transfusion system could improve hospice utilization and quality of hospice care in patients with hematologic malignancies.

Dynamic Change in Patient Reported Quality of Life is a Predictor for Survival in Localized Prostate Cancer: Exploratory Analysis from a Phase III Randomized Controlled Trial

<h3>Purpose/Objective(s)</h3> Patient reported quality of life (QOL) outcomes are pivotal endpoints to determine treatment efficacy and safety. However, it remains unknown if treatment induced change in patient reported QOL outcomes correlate with survival in localized prostate cancer (LPCa). We performed an exploratory analysis of a phase III randomized controlled study to determine the association of treatment induced dynamic change in patient reported global QOL with long-term overall survival (OS) and disease-free survival (DFS) in LPCa treated with radiotherapy (RT) and androgen deprivation therapy (ADT). <h3>Materials/Methods</h3> LPCa patients with Gleason score ≤7, clinical stage T1b-T3a, and PSA <30 ng/mL were randomized to neoadjuvant and concurrent ADT for 6 mos starting 4 mos before prostate RT or concomitant and adjuvant ADT for 6 mos starting concurrently with RT. Patient reported QOL outcomes were collected using EORTC QOL questionnaires. We used the global QOL (G-QOL) score from C30 questionnaire. Increase in G-QOL score indicated improvement in global QOL. To capture the association between the dynamic change in the G-QOL of each patient and the hazard of outcome, we utilized the framework of multivariate joint modeling for longitudinal and survival outcomes. For the time-to-event submodel, a Cox proportional hazard regression model was built with covariables including treatment arm, baseline PSA, tumor stage, Gleason score, and age. For the longitudinal submodel, a linear mixed effect model was built with an interaction term for treatment arm and time of evaluation in addition to fixed covariables - treatment arm, time of evaluation, baseline G-QOL score and age. Time of assessment was included as a random slope while patients were included as random intercepts in the mixed models. The two submodels were linked through a random effect. Baseline hazard was modeled using penalized splines. A two-sided p-value <0.025 was chosen to be the threshold for statistical significance. <h3>Results</h3> A total of 388 patients were eligible for this study – 191 belonged to the neoadjuvant arm while 197 to the adjuvant arm. At a median follow-up of 148 mos, a total of 133 deaths were recorded. On joint modelling, an increase in G-QOL score by 10 units (the threshold for clinically meaningful change) was associated with a 11.2% decrease in the hazard of death (hazard ratio [HR] per 1 unit increase G-QOL: 0.988, 95% CI: 0.980-0.996; p=0.007). An increase in G-QOL score by 10 units was associated with 10% decrease in the hazard of progression or death (HR per 1 unit increase in G-QOL: 0.990; 95% CI: 0.984-0.999; p=0.023). <h3>Conclusion</h3> Treatment induced improvement in global QOL is a predictor for improved DFS and OS in LPCa. This suggests a significant interplay of patient-reported quality of life and quantity of life in LPCa which could mainly be driven by the non-cancer specific mortality in this patient population. Judicious use of these QOL metrics could guide risk stratification and potentially inform treatment decision in these patients

High dose chemoradiotherapy increases chance of organ preservation with satisfactory functional outcome for rectal cancer

BackgroundHigh dose chemoradiotherapy offers a curative chance for patients with rectal cancer that are unfit or unwilling to undergo surgical resection, yet its long-term survival and functional outcomes have been rarely investigated.MethodsPatients with non-metastatic rectal adenocarcinoma who received pelvic radiation for curative intent from April 2006 to July 2017 were retrospectively investigated. Survival rates were analyzed using the Kaplan–Meier method. Quality of life and functional outcomes were evaluated using the EORTC quality of life questionnaire.ResultsA total of 57 patients were included, with a median age of 59.0 (range, 29–84) years. The numbers of patients who were diagnosed as stage I, II and III were 5 (8.8%), 16 (28.1%) and 36 (63.2%), respectively. 53 (93.0%) patients had tumor located within 5 cm from the anal verge. All patients received fluorouracil-based concurrent chemoradiotherapy with a median radiation dose of 80 (range, 60–86) Gy. All kinds of grade 3–4 adverse events occurred in 18 (31.6%) patients. 42 (73.7%) patients achieved a clinical complete response after chemoradiotherapy. After a median follow-up of 43.5 (range 14.9–163.2) months, 12 (21.1%) patients had local progression and 11 (19.3%) developed distant metastasis. The 3-year local recurrence-free survival and distant metastasis-free survival were 77.3% (95% CI, 65.7–88.8%) and 79.2% (95% CI, 68.2–90.2%), while the 3-year progression-free survival, cancer-specific survival, overall survival were 61.9% (95% CI, 48.8–75.0%), 93.1% (95% CI, 85.8–100.0%) and 91.4% (95% CI, 83.6–99.2%), respectively. For patients who had tumor located within 3 cm from the anal verge, the sphincter preservation rate was 85.3% at last follow-up. Long-term adverse events mainly were anal blood loss. 21 patients completed the quality-of-life questionnaire and had a score of the global health status of 78.57 ± 17.59. Of them, 95.2% reported no urinary incontinence and 85.7% reported no fecal incontinence.ConclusionsHigh dose chemoradiation demonstrated promising survival outcomes with acceptable short-term and long-term side effects, and satisfying long-term functional outcomes and quality of life. It could be considered as a non-invasive alternative for rectal cancer patients who refuse surgery.

PD54-10 DIFFERENCES OF QUALITY OF LIFE BETWEEN GERMAN AND DUTCH PROSTATE CANCER PATIENTS, WHO ARE TREATED WITH ROBOT-ASSISTED RADICAL PROSTATECTOMY: IMPLICATIONS FOR INTERNATIONAL MULTICENTER RANDOMIZED CONTROLLED TRIALS

You have accessJournal of UrologyCME1 May 2022PD54-10 DIFFERENCES OF QUALITY OF LIFE BETWEEN GERMAN AND DUTCH PROSTATE CANCER PATIENTS, WHO ARE TREATED WITH ROBOT-ASSISTED RADICAL PROSTATECTOMY: IMPLICATIONS FOR INTERNATIONAL MULTICENTER RANDOMIZED CONTROLLED TRIALS Christian Wagner, Jorn Witt, Merkourios Kolvatzis, Nikolaos Liakos, Theodoros Karagiotis, Mikolaj Mendrek, Lukas Esch, Thomas Jankowski, Andreas Schuette, and Sami-Ramzi Leyh-Bannurah Christian WagnerChristian Wagner More articles by this author , Jorn WittJorn Witt More articles by this author , Merkourios KolvatzisMerkourios Kolvatzis More articles by this author , Nikolaos LiakosNikolaos Liakos More articles by this author , Theodoros KaragiotisTheodoros Karagiotis More articles by this author , Mikolaj MendrekMikolaj Mendrek More articles by this author , Lukas EschLukas Esch More articles by this author , Thomas JankowskiThomas Jankowski More articles by this author , Andreas SchuetteAndreas Schuette More articles by this author , and Sami-Ramzi Leyh-BannurahSami-Ramzi Leyh-Bannurah More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002631.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Validated tools such as the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire Core 30 (EORTC QLQ -C30) are essential to measure QoL impact of treatment modalities such as radical prostatectomy (RP) in prostate cancer (PCa) patients and are regularly utilized in international randomized controlled trials. Previous series indicated international differences in EORTC functional, symptom scales and QoL. We explore differences in Dutch and German patients treated with robot-assisted radical prostatectomy (RARP) within the same high-volume center. METHODS: We identified consecutive Dutch and German PCa patients, who were treated with RARP at our institution between 5/2006 and 12/2018 and had complete information of pre- vs. postoperative EORTC QLQ-C30 global quality of life (QL) and EORTC Summary Score. A multivariable linear mixed model for repeated measurement analyses (MVA) examined the effect of nationality on the respective EORTC QLQ-C30 scales for a) the QoL and b) the Summary Score. The model was also adjusted for the EORTC QLQ-C30 scale baseline values, patient age, Charlson Comorbidity Index, PSA value at RP, surgical expertise, pathological and nodal stage Gleason ISUP Grade, nerve sparing status, surgical margin status, 30-d Clavien-Dindo Classification, events of urinary continence recovery, biochemical recurrence (BCR) and adjuvant/salvage radiotherapy (RT). RESULTS: Overall, 1,934 Dutch and 6,594 German RARP patients were identified. For QoL, MVA revealed higher preoperative QL (est. 0.36 95%CI 0.34-0.38), urinary continence recovery (est. 8.8 95%CI 7.7-10) and Dutch nationality (est. 6.0 95%CI 4.4-7.6) as positive estimates for higher QL, whereas e.g. BCR (est.-3.7 95%CI-4-4—2.9) and RT (est. 1.9 95%CI -2.8- -0.96) were negative (each <0.001). MVA of the EORTC Summary Score were similar including Dutch nationality as a significant positive estimate, indicating an average EORTC Summary Score increase of +2.9 (95%CI 2.5-3.4; p <0.001). CONCLUSIONS: Our multivariable analyses of international PCa patients treated with RARP suggest differences between Dutch and German patients with regard to patient reported QoL and functional and symptom scales. Accordingly, randomized control trials should account for such potential differences, which might be aggravated if certain populations are unproportionally represented in international studies. Source of Funding: This research received no specific grant © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e919 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Christian Wagner More articles by this author Jorn Witt More articles by this author Merkourios Kolvatzis More articles by this author Nikolaos Liakos More articles by this author Theodoros Karagiotis More articles by this author Mikolaj Mendrek More articles by this author Lukas Esch More articles by this author Thomas Jankowski More articles by this author Andreas Schuette More articles by this author Sami-Ramzi Leyh-Bannurah More articles by this author Expand All Advertisement PDF DownloadLoading ...

Quality-of-life analysis of pembrolizumab vs brentuximab vedotin for relapsed/refractory classical Hodgkin lymphoma

AbstractKEYNOTE-204 (NCT02684292) demonstrated a progression-free survival advantage for pembrolizumab over brentuximab vedotin (BV) in patients who had relapsed or refractory classical Hodgkin lymphoma (R/R cHL) following, or who were ineligible for, autologous stem cell transplantation (ASCT). Health-related quality of life (HRQoL), measured by patient-reported outcomes (PROs) from KEYNOTE-204, are reported from patients who received ≥1 dose of study treatment and completed ≥1 PRO assessment. The EORTC QoL Questionnaire Core 30 (QLQ-C30) and EuroQoL EQ-5D were administered at baseline, every 6 weeks until week 24, and every 12 weeks thereafter. Prespecified end points included least squares mean (LSM) changes from baseline to week 24 and time to true deterioration (TTD; ≥10-point decline from baseline). Comparisons were evaluated using 2-sided P values uncontrolled for multiplicity. High compliance at baseline (>90%) and through week 24 (>80%) was demonstrated across treatment groups (PRO analysis set: pembrolizumab, n = 146; BV, n = 150). The EORTC QLQ-C30 global health status (GHS)/quality of life (QoL) score improved from baseline to week 24 on pembrolizumab and worsened on BV and demonstrated significant LSM differences at 24 weeks (GHS/QoL: 8.60 [95% confidence interval, 3.89-13.31]; P = .0004). Significant improvements were observed in each QLQ-C30 domain except emotional and cognitive functioning. Compared with BV, pembrolizumab prolonged TTD for GHS/QoL (hazard ratio, 0.40 [95% CI, 0.22-0.74]; P = .003) and each QLQ-C30 domain except cognitive functioning. In conclusion, pembrolizumab demonstrated overall improvements in PROs of HRQoL measures over BV in the KEYNOTE-204 study. These data and previously reported efficacy results support pembrolizumab as the preferred treatment option for patients with R/R cHL who are ineligible for or experience relapse after ASCT.