Global Health Status Research Articles

Health-related quality of life in transplant-eligible patients with newly diagnosed multiple myeloma treated with daratumumab, lenalidomide, bortezomib, and dexamethasone: Patient-reported outcomes from GRIFFIN.

In the phase 2 GRIFFIN trial (ClinicalTrials.gov identifier: NCT02874742), daratumumab added to lenalidomide, bortezomib, and dexamethasone (D-RVd) improved depth of response and progression-free survival (PFS) versus lenalidomide, bortezomib, and dexamethasone (RVd) alone in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM). Here, we present patient-reported outcomes (PROs) collected using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30-item (QLQ-C30), EORTC Quality of Life Questionnaire Multiple Myeloma Module 20-item (QLQ-MY20), and EuroQol 5-Dimension 5-Level (EQ-5D-5L) tools on day 1 of cycles 1, 2, and 3; on day 21 of cycle 4 (end of induction therapy); on day 1 of cycle 5; on day 21 of cycle 6 (end of posttransplant consolidation therapy); and at months 6, 12, 18, and 24 of maintenance therapy. Meaningful improvements from baseline were seen in most of the PRO scales with both treatments after consolidation and were sustained for at least 2 years of maintenance treatment. Large reductions from baseline (~20 points) were especially observed in pain symptoms for both treatment groups, although these were numerically higher for patients receiving D-RVd during the majority of the time points. In addition, improvements in key scales, such as global health status, fatigue symptoms, and physical functioning, were also seen with both D-RVd and RVd. These improvements in health-related quality of life contribute to the totality of evidence supporting the improvement in clinical outcomes such as response rates and PFS with D-RVd in induction, consolidation, and maintenance therapy in TE patients with NDMM.

Long-term quality of life after hybrid robot-assisted and open Ivor Lewis esophagectomy for esophageal cancer in a single center: a comparative analysis

PurposeDue to improved survival of esophageal cancer patients, long-term quality of life (QoL) is increasingly gaining importance. The aim of this study is to compare QoL outcomes between open Ivor Lewis esophagectomy (Open-E) and a hybrid approach including laparotomy and a robot-assisted thoracic phase (hRob-E). Additionally, a standard group of healthy individuals serves as reference.MethodsWith a median follow-up of 36 months after hRob-E (n = 28) and 40 months after Open-E (n = 43), patients’ QoL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30) and the EORTC Esophagus specific QoL questionnaire 18 (QLQ-OES18).ResultsPatients showed similar clinical-pathological characteristics, but hRob-E patients had significantly higher ASA scores at surgery (p < 0.001). Patients and healthy controls reported similar global health status and emotional and cognitive functions. However, physical functioning of Open-E patients was significantly reduced compared to healthy controls (p = 0.019). Operated patients reported reduced role and social functioning, fatigue, nausea and vomiting, dyspnea, and diarrhea. A trend towards a better pain score after hRob-E compared to Open-E emerged (p = 0.063). Regarding QLQ-OES18, hRob-E- and Open-E-treated patients similarly reported eating problems, reflux, and troubles swallowing saliva.ConclusionsThe global health status is not impaired after esophagectomy. Despite higher ASA scores, QoL of hRob-E patients is similar to that of patients operated with Open-E. Moreover, patients after hRob-E appear to have a better score regarding physical functioning and a better pain profile than patients after Open-E, indicating a benefit of minimally invasive surgery.

Quality of Life Analysis of Patients Treated with Percutaneous Hepatic Perfusion for Uveal Melanoma Liver Metastases

PurposePercutaneous hepatic perfusion with melphalan (M-PHP) is a minimally invasive therapy with proven efficacy in patients with uveal melanoma (UM) liver metastases. M-PHP is associated with a short hospital admission time and limited systemic side effects. In this study, we assessed quality of life (QoL) in UM patients treated with M-PHP.Materials and MethodsA prospective, single-center study including 24 patients treated with M-PHP for UM metastases to the liver. QoL questionnaires were collected at baseline, on day 2/3 after M-PHP, and on day 7 and day 21 after M-PHP, according to study protocol. The results were scored according to EORTC-QLQ C30 global health status (GHS), functional scales, and symptom scales. The difference in scores at baseline and subsequent time points was analyzed with the Wilcoxon signed-rank test and multiple testing Bonferroni correction. Adverse events (AE) were registered up to 30 days after M-PHP according to CTCAE v5.0.ResultsTwenty-four patients (14 males; median age 63.0 years) completed 96 questionnaires. Most scores on all scales declined on day 2/3 after M-PHP. On day 21 after M-PHP, 12 out of 15 scores returned to baseline, including median GHS scores. Three variables were significantly worse on day 21 compared to baseline: fatigue (6–33; p = 0.002), physical functioning (100 vs 86.7; p = 0.003), and role functioning (100 vs 66.7; p = 0.001). Grade 3/4 AEs consisted mainly of hematological complications, such as leukopenia and thrombopenia.ConclusionM-PHP causes fatigue and a decline in physical and role functioning in the 1st weeks after treatment, but GHS returns to baseline levels within 21 days.Level of Evidence 3Cohort study.Graphical

Cognition and health-related quality of life in long-term survivors of high-grade glioma: an interactive perspective from patient and caregiver

BackgroundThe health-related quality of life (HRQoL) and cognition are important indicators for the quality of survival in patients with high-grade glioma (HGG). However, data on long-term survivors and their caregivers are scarce. We aim to investigate the interaction between cognition and HRQoL in long-term survivors, their caregivers’ evaluations, and the effect on caregiver strain and burden.Methods21 long-term HGG (8 WHO grade III and 13 WHO grade IV) survivors (survival ≥ 5 years) and 15 caregivers were included. Cognition (verbal memory, attention, executive functioning, and language), HRQoL, anxiety and depression, caregiver strain, and caregiver burden were assessed with standardized measures. Questionnaires were completed by patients and/or their caregivers.ResultsMean survival was 12 years (grade III) and 8 years (grade IV). Cognition was significantly impaired with a large individual variety. Patients’ general HRQoL was not impaired but all functioning scales were deviant. Patient-proxy agreement was found in most HRQoL subscales. Three patients (14%) showed indications of anxiety or depression. One-third of the caregivers reported a high caregiver strain or a high burden. Test scores for attention, executive functioning, language, and/or verbal memory were correlated with perceived global health status, cognitive functioning, and/or communication deficits. Caregiver burden was not related to cognitive deficits.ConclusionsIn long-term HGG survivors maintained HRQoL seems possible even when cognition is impaired in a large variety at the individual level. A tailored approach is therefore recommended to investigate the cognitive impairments and HRQoL in patients and the need for patient and caregiver support.

Health related quality of life and its predictive factors on cervical cancer patients in two teaching hospitals, Addis Ababa, Ethiopia

BackgroundCervical cancer is the second most prevalent and the leading cause of cancer related deaths among Ethiopian women; and about three fourth are diagnosed at advanced stages. Cervical cancer can affect the health-related quality of life (HRQOL) in multiple ways. The main aim of this study was to describe the HRQOL of cervical cancer patients and the predictive factors using validated tools.MethodsInstitution based cross-sectional study was conducted among 264 cervical cancer patients using the validated Amharic version of European Organization for Research and Treatment of Cancer (EORTC) modules; QLQ-C30 and QLQ CX24. Descriptive statistics were used to summarize the raw data. One way ANOVA was used to determine the significance of mean differences between the dependent and independent variables. Binary and multivariable regression analysis were used to measure the association between Global Health Status and independent factors. The level of significance was set at p-value < 0.05.ResultsOn EORTC QLQ-C30 scales, the mean Global Health Status (GHS) was 42.57 ± 23.31. The least and highest affected functions were physical and social, mean (SD) = 76.39 ± 23.24 and 50.40 ± 32.19, respectively. The financial difficulty was the most affected among the symptom scales, 57.83 ± 35.34. Only physical function and financial difficulty have shown an independent association with GHS, (AOR = 0.21, 95% CI = 0.05–0.84), (AOR = 0.21 95% CI = 0.07–0.59), respectively. Illiterate, can read and write, were among the predictor factors that showed an independent association with the Global Health Status. Among the EORTC QLQ-CX24 symptom scales, the highest affected score was for sexual worry, mean (SD) = 51.81 + 32.197.ConclusionsIn an effort to improve the Global Health Status of cervical cancer patients in Ethiopia; physical function and financial difficulty should be the priority areas. The Illiterate and those who lack formal education need due attention in order to improve the health-related quality-of-life.

Continuous Long-Term Assessment of Heart Rate Variability in Adults with Cyanotic Congenital Heart Disease after Surgical Repair.

Background: Heart rate variability (HRV) is an established, non-invasive parameter for the assessment of cardiac autonomic nervous activity and the health status in general cardiology. However, there are few studies on HRV in adults with congenital heart defects (CHDs). The aim of the present study was to evaluate the use of long-term continuous HRV measurement for the assessment of global health status in adults with cyanotic CHD. Methods: This prospective study included 45 adults (40% female, mean age = 35.2 ± 9.2 [range: 19-58] years) after cardiac surgical repair. HRV parameters were calculated from continuous 24 h measurements using a Bittium Faros 180 sensor (Bittium Corp., Oulu, Finland). Results: Postoperative patients with transposition of the great arteries (TGA) (n = 18) achieved significantly higher values of standard deviation of NN intervals (SDNN) (175.4 ± 59.9 ms vs. 133.5 ± 40.6 ms; p = 0.013) compared with patients with other conotruncal anomalies (n = 22). Comparing patients with TGA after a Senning-Brom or Mustard operation (n = 13) with all other heart surgery patients (n = 32), significantly higher HRV parameters were found after atrial switch (root mean square of successive RR interval differences: 53.6 ± 20.7 ms vs. 38.4 ± 18.3 ms; p = 0.019; SDNN: 183.5 ± 58.4 ms vs. 136.3 ± 45.3 ms; p = 0.006). A higher SDNN was also measured after Senning-Brom or Mustard operations than after a Rastelli operations (n = 2) (SDNN: 183.5 ± 58.4 ms vs. 84.5 ± 5.2 ms; p = 0.037). When comparing atrial switch operations (n = 3) with Rastelli operations, the SDNN value was significantly shorter in the Rastelli group (p = 0.004). Conclusions: Our results suggest that continuous HRV monitoring may serve as a marker of cardiac autonomic dysfunction in adults with cyanotic CHD after surgical repair. Impaired cardiac autonomic nervous activity may be associated with an increased risk of adverse reactions in patients with repaired CHD. Therefore, a longitudinal assessment of HRV patterns and trends may provide a deeper insight into dynamic changes in their autonomic regulation and disease progression, lifestyle changes, or treatments. As each person has individual variability in heart rate, HRV may be useful in assessing intra-individual disease progression and may help to improve personalized medicine. Further studies are needed to better understand the underlying mechanisms and to explore the full potential of HRV analysis to optimize medical care for ACHDs.

Impact of Preoperative LUTS on Health-related Quality of Life Following Radical Prostatectomy: A Propensity Score Matched Longitudinal Study

To assess the impact of preoperative lower urinary tract symptoms (LUTS) on long-term health-related quality of life (HRQOL) up to 10 years after radical prostatectomy (RP) for prostate cancer (PC). Within our prospective institutional database of 6487 patients treated with RP for PC (2008-2020), 2727 patients with preoperative LUTS (IPSS score of ≥8) were identified. A 1:1 propensity-score matched analysis of 3056 men (n=1528 LUTS, n=1528 no LUTS) was conducted. Primary endpoint was HRQOL (based on EORTC QLQ-C30 and PR25). Linear regression models tested the effect of preoperative LUTS on the net change in general HRQOL (P<.05). Median follow-up was 48 months. Preoperative mean global health status (GHS) score (67.4 vs75.7) was significantly lower in the LUTS cohort (P<.001). Post-RP the difference in general HRQOL between the LUTS cohort and the no-LUTS cohort became smaller (65.7 vs67.8), however, remaining statistically significant (P=.037). In long-term follow-up, general HRQOL was comparable between both subcohorts (P-range 0.716-0.876). Multivariable linear regression analysis revealed increased preoperative IPSS as an independent predictor for increased perioperative improvement of IPSS (P<.001) CONCLUSION: For patients undergoing RP, preoperative LUTS were associated with a postoperative improvement of HRQOL outcomes. In long-term follow-up, HRQOL was comparable to patients without preoperative LUTS. Hence, RP is an efficient option to treat PC as well as LUTS in those patients.

Quality of Life in Patients Undergoing Emergency Surgery for Complex Colorectal Cancer: Protocol and Piloting of the Surgical Utilization and Recovery Patterns for Advanced Stage Colorectal Cancer Study.

Introduction: Globally, cancer is the leading cause of mortality, with colorectal neoplasia ranking third in terms of incidence and mortality worldwide. Patients face disease- and treatment-specific impacts, which can significantly influence their quality of life (QoL). Aim: This study aimed to propose a protocol to measure in-hospital and long-term QoL in patients with complicated colorectal cancer (CRC). Material and Methods: multicenter prospective observational cohort study. Results: QoL is a multidimensional concept that includes criteria for physical, mental, emotional, and social functionality as perceived by the patient. Periodically evaluating QoL offers measurable and objective tools to intervene at the appropriate time to decrease the Years of Life Lost and Years Lived with Disabilities for CRC patients. However, a structured and functional system requires dedicated and common institutional effort. A pilot study using this protocol included 69 patients, 65.12+-10.92 years, M:F ratio = 56.5:43.5%. Surgical procedure was right hemicolectomy, left colectomy, transverse colectomy, sigmoidectomy, total colectomy, rectal resection, and colorectal resection with stoma (ileostomy or colostomy) in 21.7%, 11.6%, 2.9%, 11.6%, 1.4%, 23.2%, and 27.5% of the cases, respectively. The mean Global Health Status Score, Symptom Score, and Functional Score was 82.36+-18.60, 11.89+-10.27, and 86.27, 74.50-94.11, respectively. Conclusions: CRC diagnosis has major effects on patients physical and psychological status, and concentrated efforts should be made by the involved medical team and healthcare systems to improve QoL throughout the treatment pathway.

Do Complications After Pancreatoduodenectomy Have an Impact on Long-Term Quality of Life and Functional Outcomes?

Our aim was to assess whether complications after pancreatoduodenectomy (PD) impact long-term quality of life (QoL) and functional outcomes. There is an increasing number of long-term post-PD survivors, but few studies have evaluated long-term QoL outcomes. The EORTC QLQ-C30 and QLQ-PAN26 questionnaires were administered to patients who survived >5 years post-PD. Clinical relevance (CR) was scored as small (5-10), moderate (10-20), or large (>20). Patients were stratified based on whether they experienced a complication during the index hospitalization. Of 305 patients >5 years post-PD survivors, with valid contact information, 248 completed the questionnaires, and 231 had complication data available. Twenty-nine percent of patients experienced a complication, of which 17 (7.4%) were grade 1, 27 (11.7%) were grade 2, and 25 (10.8%) were grade 3. Global health status and functional domain scores were similar between both groups. Patients experiencing complications reported lower fatigue (21.4 vs 28.1, P < 0.05, CR small) and diarrhea (15.9 vs 23.1, P < 0.05, CR small) symptom scores when compared to patients without complications. Patients experiencing complications also reported lower pancreatic pain (38.2 vs 43.4, P < 0.05, CR small) and altered bowel habits (30.1 vs 40.7, P < 0.01, CR moderate) symptom scores. There was a lower prevalence of worrying (36.2% vs 60.5%, P < 0.05) and bloating (42.0% vs 56.2%, P < 0.05) among PD survivors with complications. Post-PD complication rates were not associated with long-term global QoL or functionality, and may be associated with less severe pancreas-specific symptoms.

Stereotactic ultrahypofractionated MR-guided radiotherapy for localized prostate cancer – Acute toxicity and patient-reported outcomes in the prospective, multicenter SMILE phase II trial

BackgroundDue to superior image quality and daily adaptive planning, MR-guided stereotactic body radiation therapy (MRgSBRT) has the potential to further widen the therapeutic window in radiotherapy of localized prostate cancer. This study reports on acute toxicity rates and patient-reported outcomes after MR-guided adaptive ultrahypofractionated radiotherapy for localized prostate cancer within the prospective, multicenter phase II SMILE trial. Materials and methodsA total of 69 patients with localized prostate cancer underwent MRgSBRT with daily online plan adaptation. Inclusion criteria comprised a tumor stage ≤ T3a, serum PSA value ≤ 20 ng/ml, ISUP Grade group ≤ 4. A dose of 37.5 Gy was prescribed to the PTV in five fractions on alternating days with an optional simultaneous boost of 40 Gy to the dominant intraprostatic lesion defined by multiparametric MRI. Acute genitourinary (GU-) and gastrointestinal (GI-) toxicity, as defined by CTCAE v. 5.0 and RTOG as well as patient-reported outcomes according to EORTC QLQ-C30 and -PR25 scores were analyzed at completion of radiotherapy, 6 and 12 weeks after radiotherapy and compared to baseline symptoms. ResultsThere were no toxicity-related treatment discontinuations. At the 12-week follow-up visit, no grade 3 + toxicities were reported according to CTCAE. Up until the 12-week visit, in total 16 patients (23 %) experienced a grade 2 GU or GI toxicity. Toxicity rates peaked at the end of radiation therapy and subsided within the 12-week follow-up period. At the 12-week follow-up visit, no residual grade 2 GU toxicities were reported and 1 patient (1 %) had residual grade 2 enteritic symptoms. With exception to a significant improvement in the emotional functioning score following MRgSBRT, no clinically meaningful changes in the global health status nor in relevant subscores were reported. ConclusionDaily online-adaptive MRgSBRT for localized prostate cancer resulted in an excellent overall toxicity profile without any major negative impact on quality of life.

Decline in Mobility and Balance in Persons With Post-COVID-19 Condition.

Post-COVID-19 condition (PCC) may impact mobility and balance and affect physical function. The objectives of the study were to estimate the prevalence of decline in balance and mobility in individuals with PCC; explore the association between comorbidities and sociodemographic characteristics with decline in balance and mobility; and evaluate correlations between decline in mobility and balance with change in performance of usual activities, personal care, and global health perception. The design was a cross-sectional study of persons with a COVID-19 diagnosis that was confirmed at least 3 months before the study. Those with PCC, defined as those still troubled by symptoms, were evaluated for decline in mobility and balance and with associated clinical and demographic factors using bivariate analysis and multivariable logistic regression. Correlations between decline in mobility and balance were also examined with change in ability to perform usual activities, personal care, and global health perception. In 1031 persons with PCC, mobility deteriorated in 44.9%, and balance deteriorated in 37.1%. Older age, hospitalization, comorbidities, and obesity were associated with decline in mobility, while decline in balance was associated with older age and comorbidities. Reduced mobility was associated with changes in ability to carry out usual activities (rp = 0.6), conduct personal care (rp = 0.6), and global health status (rp = 0.5). Correlations between decline in balance and these same outcomes were 0.5, 0.5, and 0.45, respectively. Almost half the participants with PCC had reduced mobility, and over a third reported deterioration in balance, with associated difficulties with daily functioning. Factors associated with greater decline help identify those most at risk. Many people with PCC experience changes in mobility and balance, which can affect functional capacities and lead to physical therapist consultations. Further study should assess specific needs of these patients and determine effective physical therapist interventions to meet these needs. Many persons with post-COVID-19 condition (PCC) experience symptoms resulting in functional problems, such as difficulties with personal care and performing usual activities. This study focused on difficulty in mobility and problems with balance. Almost half of persons with PCC in the study had declines in getting around and over a third had declines in balance. These problems were associated with older age and having other comorbid health conditions and were linked with decline in ability to perform personal care, carry out usual activities, and perceived global health status.

The Effects of Nurse-Led Supportive Care Program on Quality of Life in Women with Breast Cancer Receiving Adjuvant Chemotherapy: A Randomized Controlled Pilot Study

This study was to evaluate the effects of nurse-led supportive care program on quality of life in women with breast cancer receiving adjuvant chemotherapy. The study was carried out a parallel group randomized controlled pilot study with repeated-measures design in general surgery unit of a training and research hospital. Forty-two women with newly diagnosed breast cancer were randomly assigned to the intervention and control groups. The intervention group received nurse-led supportive care program for 8 weeks, 4 weeks in face-to-face sessions and 4 weeks through phone sessions. The control group received only routine treatment. The women in both groups completed the EORTC-QLQ-C30 (version 3.0) Quality of Life questionnaires at baseline and ninth week. There was a significant increase in the mean global health status and functional status scores of the women with breast cancer in the intervention group compared to the women in the control group in the ninth week compared to the baseline. The women in the intervention group had a lower mean symptom status score in the ninth week than the women in the control group and there was a statistically significant difference in the change in the mean scores of the groups over time. Our nurse-led supportive care program is an effective, safe and acceptable method to support women with BC receiving adjuvant chemotherapy. The nurse-led supportive care program can be used as a reliable and effective nursing intervention to increase the quality of life of women breast cancer receiving adjuvant chemotherapy. NCT05399160.

Global health status and fatigue score in isocitrate dehydrogenase-mutant diffuse glioma grades 2 and 3: A longitudinal population-based study from surgery to 12-month follow-up.

At the group level, health-related quality of life (HRQoL) in patients with IDH-mutant diffuse glioma grades 2 and 3 seems to remain stable over time. However, clinical experience indicates that there are patients with unfavorable outcomes on key HRQoL subdomains. The aim of this longitudinal population-based study, following patients over a period of 12 months from surgery, was to describe individual-level data on global health status and fatigue score and explore possible predictors of deterioration. All patients undergoing surgery for presumed glioma grades 2 or 3 at the Sahlgrenska University Hospital during 2017-2022, were screened for the study. Patients were invited to complete the European Organization of Research and Treatment of Cancer core questionnaires and brain module at baseline, 3 and 12 months postoperatively. Data is reported with respect to minimal clinical important difference (MCID). We included 51 patients with IDH-mutant diffuse glioma grades 2 or 3. There was no difference in group-level data of either global health status or fatigue score from baseline to the 12-month follow-up (P-value > .05). Unfavorable individual changes (beyond MCID) in global health status and fatigue score were observed in 12 and in 17 patients, respectively (23.5% and 33.3%). A lower proportion of proton radiotherapy was found in patients with unfavorable changes in fatigue (10/15, 66.7%) compared to all other patients undergoing radiotherapy (22/23, 95.7%, P-value .03). Deterioration beyond MCID was seen in approximately one-third of patients. Changes in global health status could not be predicted, but changes in fatigue may be influenced by tumor-targeted and symptomatic treatment.

Coping strategies mediate the relationship between fear of cancer recurrence and quality of life in postoperative patients with prostate cancer: a multicentre survey

PurposeThe aim of the present study was to investigate the relationships between fear of cancer recurrence and quality of life in patients with prostate cancer. A model based on Lazarus’ and Folkman’s theory tested the specific hypothesis: fear of cancer recurrence has a direct and indirect effect on quality of life mediated by coping strategies.MethodsA questionnaire survey was conducted on 305 patients with prostate cancer who underwent radical surgery, including demographic information, FoP-Q-SF (Fear of Progression Questionnaire), MCMQ (The Medical Coping Modes Questionnaire), QLQ-C30 (Questionnaire for Quality of Life Assessment in patients with cancer, version 3.0), and a mediator model was tested using the PROCESS macro for SPSS.ResultsThe total FoP-Q-SF score of 305 postoperative prostate cancer patients was 34.3 ± 5.856, with approximately 41.6% of the patients scoring higher than 34. There were significant indirect effects of fear of cancer recurrence on global health status through face [a1b1; 0.0394, Boot CIs 0.0025, 0.0819] and yield [a3b3; -0.1075, Boots CIs − 0.1657, -0.0557] but not for evasive [a2b2; 0.0235; Boots CIs − 0.057, 0.0508].ConclusionsCoping strategies are the most important mediating factors between fear of cancer recurrence and QOL among patients with prostate cancer. Our results support the proposed conceptual model, based on Lazarus’ and Folkman’s theory. Medical personnel need to develop corresponding intervention measures based on the different coping methods of patients, promote disease recovery, and improve postoperative quality of life.

Health-related Quality of Life in Patients with Previously Treated Advanced Urothelial Carcinoma from EV-301: A Phase 3 Trial of Enfortumab Vedotin Versus Chemotherapy

Background and objectiveIn comparison to chemotherapy, enfortumab vedotin (EV) prolonged overall survival in patients with previously treated advanced urothelial carcinoma in EV-301. The objective of the present study was to assess patient experiences of EV versus chemotherapy using patient-reported outcome (PRO) analysis of health-related quality of life (HRQoL). MethodsFor patients in the phase 3 EV-301 trial randomized to EV or chemotherapy we assessed responses to the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, weekly for the first 12 wk, and then every 12 wk until discontinuation. We analyzed the QLQ-C30 change from baseline to week 12, the confirmed improvement rate, and the time to improvement or deterioration. Key findings and limitationsBaseline PRO compliance rates were 91% for the EV arm (n = 301) and 89% for the chemotherapy arm (n = 307); the corresponding average rates from baseline to week 12 were 70% and 67%. Patients receiving EV versus chemotherapy had reduced pain (difference in change from baseline to week 12: −5.7, 95% confidence interval [CI] −10.8 to −0.7; p = 0.027) and worsening appetite loss (7.3, 95% CI 0.90–13.69; p = 0.026). Larger proportions of patients in the EV arm reported HRQoL improvement from baseline than in the chemotherapy arm; the odds of a confirmed improvement across ten QLQ-C30 function/symptom scales were 1.67 to 2.76 times higher for EV than for chemotherapy. Patients in the EV arm had a shorter time to first confirmed improvement in global health status (GHS)/QoL, fatigue, pain, and physical, role, emotional, and social functioning (all p < 0.05). EV delayed the time to first confirmed deterioration in GHS/QoL (p = 0.027), but worsening appetite loss occurred earlier (p = 0.009) in comparison to chemotherapy. Conclusions and clinical implicationsHRQoL with EV was maintained, and deterioration in HRQoL was delayed with EV in comparison to chemotherapy. Better results with EV were reported for some scales, with the greatest difference observed for pain. These findings reinforce the EV safety and efficacy outcomes and benefits observed in EV-301. Patient summaryPatients with previously treated advanced cancer of the urinary tract receiving the drug enfortumab vedotin maintained their HRQoL in comparison to patients treated with chemotherapy.The EV-301 trial is registered on ClinicalTrials.gov as NCT03474107 and on EudraCT as 2017-003344-21.

Comparison of Early Inguinal Lymph Node Dissection and Neoadjuvant Chemotherapy in Penile Cancer Patient with Bulky Nodal Metastasis: A Cohort Study.

Penile cancer is a rare malignancy, where extranodal extension in inguinal or pelvic lymph nodes is associated with decreased 5-year cancer-survival rate in this study, we try to assess survival and quality of life in a penile cancer patient with bulky lymph node. We retrospectively reviewed data from penile cancer patients with bulky lymph nodes who underwent treatment between July 2016 and July 2021 at tertiary referral hospital care. The inclusion criteria (age >18 yr, histologically proven penile cancer, and completion of last treatment 6 months prior to this study) yielded a cohort of 20 eligible penile cancer patients with bulky lymph nodes (> 4 cm/bilateral mobile/unilateral fixed). Only patients who had completed therapy at least 6 months prior to the study were included. After obtaining consent, they were asked to complete the EORTC QLQ-C30 questionnaire to evaluate the patient's quality of life. Out of 20 patients, 5 patients underwent direct ILND and 15 patients underwent chemotherapy. Median follow-up after primary diagnosis was 114+32 months in patients with early ILND and 52+11 months in patients who underwent delayed lymph node dissection. Out of 5 patients who underwent early ILND, all of them survived during follow-up, and achieved cancer-free status without residual tumor and with excellent functional outcomes (Karnofsky 90). There was no significant difference in social function (p-value = 0.551), physical function (p-value = 0.272), role function (p-value = 0.546), emotional function (p-value = 0.551), cognitive function (p-value = 0.453), and global health status (p-value = 0.893) between patient which treated with early ILND and Neoadjuvant Chemotherapy. However, patients who underwent early ILND showed a relatively better clinical outcome. Early ILND followed by adjuvant chemotherapy for penile cancer with palpable lymph nodes is more favourable than neoadjuvant TIP chemotherapy.

Influence of Clinical and Demographic Variables 0n the Quality of Life in Patients with Cervical Cancer

Background: Cervical cancer remains a significant public health issue, particularly in low- and middle-income countries, where it disproportionately affects women's quality of life (QoL). Understanding the impact of clinical and demographic variables on the QoL of patients with cervical cancer is crucial for improving care and support strategies. Objective: This study aims to assess how clinical and demographic factors influence the QoL of Pakistani women diagnosed with cervical cancer, comparing these findings against established benchmarks for both healthy individuals and those with malignancies. Methods: Conducted at a leading cancer centre in Pakistan from April to September 2022, this cross-sectional study involved 186 women with histopathologically confirmed cervical cancer, identified through a population-based cancer database. QoL was evaluated using the Organization for Research and Treatment of Cancer QLQ-C30 (Version 3.0) questionnaire, encompassing functional scales, symptom scales, single-item scales, and a global health status score. Data analysis was performed using SPSS version 25, applying logistic regression to identify factors significantly associated with QoL outcomes. Results: The median global health status score for enrolled patients was 50.0 [interquartile range (IQR) 33.3 - 66.7], significantly lower than the reference values for healthy females (58.0 [IQR 41.3 - 82.7]) and those with any malignancy (71.0 at age 55). Functional scale scores indicated compromised physical (65.7 [IQR 60.0 - 75.0]) and social (67.7 [IQR 56.0 - 100]) functioning. Symptom scale scores revealed high levels of pain (84.3 [IQR 65.7 - 84.3]) and fatigue (78.8 [IQR 55.7 - 88.7]). Regression analysis highlighted age and education level as significant predictors of physical health outcomes. Conclusion: The study underscores the profound impact of cervical cancer on the QoL of Pakistani women, with age and education level emerging as key determinants. These findings call for tailored interventions to address the specific needs of this patient population, emphasizing the need for early detection and comprehensive support services.

Efficacy and safety of short-term intravesical gemcitabine vs. long-term intravesical epirubicin in the treatment of moderate to high-risk non-muscle-invasive bladder cancer: a pilot study

PurposeLong-term bladder instillation therapy will bring more infusion side effects and economic consumption to patients. This study aims to compare short-term gemcitabine vs. long-term epirubicin for intravesical chemotherapy in patients diagnosed with moderate- to high-risk NMIBC treated using transurethral resection of bladder tumor (TURBT).Materials and methodsThis randomized controlled trial enrolled patients diagnosed with pT1 bladder cancer who underwent TURBT at Tianjin Medical University Cancer Institute from (01/2015- 07/2018), randomized 1:1 to gemcitabine vs. epirubicin. Recurrence-free survival (RFS) and progression-free survival (PFS) were monitored by cystoscopy. Side-effects after intravesical instillation and QLQ-C30 questionnaire were collected.ResultsFinally, 208 patients were enrolled. The median follow-up was 50.6 (6–69) months. The median RFS of the gemcitabine vs. epirubicin groups were 46.7 (6–69) vs. 47.2 (8–69) months, respectively (P > 0.05); the median PFS was 51.3 (9–69) vs. 50.9 (27–69) months, respectively (P > 0.05). The incidence rates of lower urinary tract symptoms, dysuria, hypo gastralgia, and gastrointestinal symptoms in the epirubicin group were 33.3%, 6.7%, 17.7%, and 18.3%, compared with 8.5%, 3.4%, 8.5% and, 1.2%, respectively, for gemcitabine. The gemcitabine group had a better quality of life than epirubicin in global health status (82.8 ± 8.5 vs. 79.6 ± 4.2, P = 0.01) and pain symptom domain (1.1 ± 2.8 vs. 2.4 ± 3.8, P = 0.04).ConclusionsThere are no significant differences in efficacy between gemcitabine and epirubicin for intravesical chemotherapy in patients with moderate to high-risk NMIBC to prevent tumor recurrence or progression for patients intolerant to BCG or those for whom BCG is not accessible. Patients with gemcitabine suffer fewer adverse events and have a better health status than with epirubicin.

Quality of Life of Patients with Oral Squamous Cell Carcinoma.

Oral squamous cell carcinoma (OSCC) has numerous physical, psychosocial and financial implications, which significantly affect patients' quality of life. We aimed to determine the health-related quality of life (HRQoL) and identify quality of life (QoL) predictors in patients with OSCC. We included 64 consecutive patients aged 40 to 80 yr treated for OSCC from Jan to Dec 2021. Health-related QoL was evaluated using the 30-item Cancer Quality of Life Questionnaire (QLQ-C30) and the 35-item Head and Neck Cancer-Quality of Life Questionnaire (QLQ-H&N35). The demographic questionnaire and clinical parameters were also presented. The functioning scale in the QLQ-C30 questionnaire with the lowest average score was Global health status. The mean QLQ-C30 summary score (80.92 ± 10.4) was higher than the Global health status score (50.5 ± 22.2). In the QLQ-H&N35 questionnaire, the symptoms with highest scores were weight loss, dry mouth, and social eating. Linear regression analysis demonstrated that Global health status score was associated with education level [β-coefficient = 19.33 (95% CI: 10.7-24.9, P=0.004], alcohol consumption [β-coefficient=10.04 (95% CI: 4.5-14.8), P=0.023] and invasive surgical procedure [β-coefficient=22.75 (95% CI: 15.0-30.5), P=0.002]. The QLQ-C30 summary score was associated with living alone [β-coefficient= -20.05 (95% CI: -29.91-(-10.21), P=0.018], smoking status [β-coefficient=4.35 (95% CI: 1.8-6.91), P=0.043] and alcohol consumption [β-coefficient =4.59 (95% CI: 1.99-7.19), P=0.037]. We found several significant predictors of worse perception of HRQoL among patients with OSCC, which may be useful for specific prevention and treatment in order to achieve better QoL.

Long-Term Quality of Life after COVID-19 Infection: Cross-Sectional Study of Health Care Workers.

(1) Background: Post-COVID syndrome is defined as symptoms that occur simultaneously with or after a COVID-19 infection, last for 12 weeks, and are not due to another diagnosis. Limited data are available on people's long-term quality of life following a COVID-19 infection. The aim of this cross-sectional study was to investigate the long-term quality of life after COVID-19 among employees of a hospital in Germany and to identify risk factors. (2) Methods: A monocentric, cross-sectional study was conducted using the validated and digitized WHOQOL-BREF questionnaire via Netigate® between 10/2022 and 02/2023. Data on the quality of life and global health status were collected in the following four domains: physical health, mental health, social relationships, and the environment. (3) Results: The response rate was 73.8 % (923/1250). Furthermore, 63.4 % of the hospital staff respondents reported at least one persistent symptom after a COVID-19 infection, leading to significant differences in quality of life. Pre-existing conditions, persistent symptoms, and disabilities after a COVID-19 infection as well as a high BMI, no partnership, and a low educational level were found to significantly contribute to a low long-term quality of life. (4) Conclusions: Obesity, a lack of partnership, and a low level of education were independent risk factors for a lower quality of life post-COVID-19 infection in this cohort of hospital staff. Further multicenter studies are required to validate the incidence and their suitability as independent risk factors for post-COVID syndrome.