QLQ-C30 Summary Score Research Articles

Quality of life of women with a screen-detected versus clinically detected breast cancer in the Netherlands: a prospective cohort study.

Breast cancer (BC) screening enables early detection of BC, which may lead to improved quality of life (QoL). We aim to compare QoL between women with a screen-detected and clinically detected BC in the Netherlands. We used data from the 'Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaluation' (UMBRELLA) between October 2013 and March 2022. Patients were categorized as screen-detected or clinically detected. We analysed three questionnaires, namely EORTC QLQ C-30, BR23, and HADS (Hospital Anxiety and Depression Scale) completed by BC patients shortly after diagnosis (T1) and one-year after treatment (T2). Independent t-tests were performed to compare QoL average differences between the two groups. Bonferroni-corrected p-value significance threshold of 0.00057 was used. The magnitude of differences was calculated using Cohen's d. The clinical relevance of QLQ-C30 differences was assessed based on interpretation guideline of EORTC-QLQ-C30 results. After applying inclusion and exclusion criteria, there were 691 women with screen-detected BC and 480 with clinically detected BC. Generally, screen-detected BC patients reported a better QoL. At T1, their average QLQ-C30 summary score was higher (86.1) than clinically detected BC patients (83.0) (p < 0.0001). Cohen's d for all items ranged between 0.00 and 0.39. A few QLQ-C30 score differences were clinically relevant, indicating better outcomes in emotional functioning, general health, constipation, and fatigue for women with screen-detected BC. In the Netherlands, women with screen-detected BC reported statistically significant and better QoL than women with clinically detected BC. However, clinical relevance of the differences is limited.

Supervised, structured and individualized exercise in metastatic breast cancer: a randomized controlled trial

Physical exercise both during and after curative cancer treatment has been shown to reduce side effects. Evidence in the metastatic cancer setting is scarce, and interventions that improve health-related quality of life (HRQOL) are much needed for patients with metastatic breast cancer (MBC). The multinational randomized controlled PREFERABLE-EFFECT trial assessed the effects of exercise on fatigue and HRQOL in patients with MBC. In total, 357 patients with MBC and a life expectancy of ≥6 months but without unstable bone metastases were recruited at eight study centers across five European countries and Australia. Participants were randomly assigned (1:1) to usual care (control group, n = 179) or a 9-month supervised exercise program (exercise group, n = 178). Intervention effects on physical fatigue (European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-FA12 scale) and HRQOL (EORTC QLQ-C30 summary score) were determined by comparing the change from baseline to 3, 6 (primary timepoint) and 9 months between groups using mixed models for repeated measures, adjusted for baseline values of the outcome, line of treatment (first or second versus third or higher) and study center. Exercise resulted in significant positive effects on both primary outcomes. Physical fatigue was significantly lower (−5.3 (95% confidence interval (CI), −10.0 to −0.6), Bonferroni–Holm-adjusted P = 0.027; Cohen's effect size, 0.22) and HRQOL significantly higher (4.8 (95% CI, 2.2–7.4), Bonferroni–Holm-adjusted P = 0.0003; effect size, 0.33) in the exercise group than in the control group at 6 months. Two serious adverse events occurred (that is, fractures), but both were not related to bone metastases. These results demonstrate that supervised exercise has positive effects on physical fatigue and HRQOL in patients with MBC and should be recommended as part of supportive care.ClinicalTrials.gov Identifier: NCT04120298.

Magnitude and Temporal Variations of Socioeconomic Inequalities in the Quality of Life After Early Breast Cancer: Results From the Multicentric French CANTO Cohort.

Socioeconomic status (SES) influences the survival outcomes of patients with early breast cancer (EBC). However, limited research investigates social inequalities in their quality of life (QoL). This study examines the socioeconomic inequalities in QoL after an EBC diagnosis and their time trends. We used data from the French prospective multicentric CANTO cohort (ClinicalTrials.gov identifier: NCT01993498), including women with EBC enrolled between 2012 and 2018. QoL was assessed using the European Organisation for Research and Treatment of Cancer QoL Core 30 questionnaire (QLQ-C30). summary score at diagnosis and 1 and 2 years postdiagnosis. We considered three indicators of SES separately: self-reported financial difficulties, household income, and educational level. We first analyzed the trajectories of the QLQ-C30 summary score by SES group. Then, social inequalities in QLQ-C30 summary score and their time trends were quantified using the regression-based slope index of inequality (SII), representing the absolute change in the outcome along socioeconomic gradient extremes. The analyses were adjusted for age at diagnosis, Charlson Comorbidity Index, disease stage, and type of local and systemic treatment. Among the 5,915 included patients with data on QoL at diagnosis and at the 2-year follow-up, social inequalities in QLQ-C30 summary score at baseline were statistically significant for all SES indicators (SIIfinancial difficulties = -7.6 [-8.9; -6.2], SIIincome = -4.0 [-5.2; -2.8]), SIIeducation = -1.9 [-3.1; -0.7]). These inequalities significantly increased (interaction P < .05) in year 1 and year 2 postdiagnosis, irrespective of prediagnosis health, tumor characteristics, and treatment. Similar results were observed in subgroups defined by menopausal status and type of adjuvant systemic treatment. The magnitude of preexisting inequalities in QoL increased over time after EBC diagnosis, emphasizing the importance of considering social determinants of health during comprehensive cancer care planning.

Abstract PO2-09-12: The magnitude and temporal variations of socioeconomic inequalities in quality of life after early breast cancer: results from the multicentric French CANTO cohort

Abstract Objective Previous studies showed that various outcomes in patients with early breast cancer (EBC), from incidence to survival, were influenced by social factors. However, there is limited research on the socioeconomic inequalities in quality of life (QoL) after treatment for EBC, and the magnitude and changes over time of these inequalities have not been quantified. This study examines the socioeconomic inequalities in QoL and their time trends among a large cohort of patients with EBC. Methods We conducted a comprehensive longitudinal analysis using data from the prospective multicentric CANTO study (CANcer TOxicity, NCT01993498), which included participants with EBC enrolled between 2012 and 2018. QoL was assessed using the summary score of the EORTC QLQ-C30 questionnaire at the time of diagnosis and 1 and 2 years post-diagnosis. We included patients with complete QoL data at diagnosis and 2 years post-diagnosis. Analyses were conducted for three indicators of socioeconomic status separately: self-reported financial difficulties, household income and educational level. We first analyzed trajectories of QoL by socioeconomic status from diagnosis to Year 1 and Year 2. Then, social inequalities in QoL were estimated using the regression-based slope indexes of inequality (SII) and compared across the follow-up periods. The SII represents the absolute change in the QLQ-C30 summary score along the two extremes of the socioeconomic gradient, taking into account the intermediate groups and their relative sizes. The analyses were adjusted for age at diagnosis, Charlson comorbidity index, disease stage, use and type of endocrine therapy, use and type of chemotherapy, breast surgery, radiotherapy use, and lymph node management. Results In the 5915 analyzed patients, compared to those with higher socioeconomic status, those reporting a high level of financial difficulty, lower income, or lower education were younger, most often premenopausal, with comorbidities, diagnosed with stage III BC, and treated with mastectomy and axillary lymph node dissection. There were no differences between socioeconomically-defined groups concerning BC histology, grade and IHC-defined subtype. Social inequalities in QoL at baseline were statistically significant for all socioeconomic status indicators (SIIfinancial difficulties = -7.6 [-8.9;-6.2], SIIincome= -4.0 [-5.2;-2.8]) and SIIeducation= -1.9 [-3.1;-0.7]). In multivariable analyses, social inequalities significantly increased (interaction p&amp;lt; 0.05) in Year 1 (SIIfinancial difficulties = -11.1 [-12.8;-9.4], SIIincome= -6.5 [-8.0;-5.0] and SIIeducation= -5.0 [-6.6;-3.5]) and Year 2 (SIIfinancial difficulties = -10.7 [-12.2;-9.1], SIIincome= -6.7 [-8.0;-5.3] and SIIeducation= -4.7 [-6.1;-3.3]) suggesting a widening socioeconomic gap in QoL outcomes irrespective of pre-diagnosis health, tumor characteristics and treatment. Similar results were observed in subgroups defined by menopausal status (pre/postmenopausal) and type of systemic treatment (chemotherapy, endocrine therapy). Conclusion Our study highlights and quantifies the association of several individual socioeconomic indicators with the QoL of patients with EBC in France. The magnitude of socioeconomic inequalities in QoL increased over time after EBC diagnosis in a country with a strong welfare system and universal healthcare coverage. In the era of precision medicine, these results underscore the importance of developing interventions to improve precision care, considering the conditions in which people are born, grow, work, live and age and the wider set of forces and systems shaping the conditions of daily life. Citation Format: José Luis Sandoval, Antonio Di Meglio, Arlindo Ferreira, Maria Alice Franzoi, Fabrice André, Barbara Pistilli, Christelle Jouannaud, Marion Fournier, Philippe Rouanet, Asma Dhaini Mermeche, Paul Cottu, Sibille Everhard, Anne-Laure Martin, Silvia Stringhini, Idris Guessous, Ines Vaz Luis, Gwenn Menvielle. The magnitude and temporal variations of socioeconomic inequalities in quality of life after early breast cancer: results from the multicentric French CANTO cohort [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-09-12.

STRUCTURED EXERCISE IMPROVES FATIGUE AND HEALTH-RELATED QUALITY OF LIFE IN METASTATIC BREAST CANCER PATIENTS: THE MULTINATIONAL RANDOMIZED CONTROLLED PREFERABLE-EFFECT STUDY

INTRODUCTION &amp; AIMS Exercise has been proven safe and effective for patients with breast cancer in the curative setting, however evidence in patients with metastatic breast cancer (mBC) is scarce. The aim of the PREFERABLE - EFFECT study (NCT04120298) was to evaluate the effects of a structured exercise program on fatigue, health-related quality of life (HRQoL), and other cancer- and treatment-related side effects in patients with mBC. METHODS The randomized controlled trial included patients with mBC from five European countries (Germany, Spain, Netherlands, Poland, Sweden) and Australia. Participants were randomly assigned to usual care (UC) or a 9-month supervised and individualized exercise program (EX) involving twice weekly aerobic, resistance, and balance exercises. The primary outcomes, physical fatigue (EORTC QLQ-FA12 subscale) and HRQoL (EORTC QLQ-C30 summary score) were assessed at baseline, 3, 6, and 9 months. Among other physical fitness outcomes, maximal short exercise capacity was assessed with the Steep Ramp Test. Changes from baseline to 3, 6 (primary endpoint) and 9 months were compared between groups using adjusted mixed models for repeated measures. RESULTS A total of 357 patients were randomized (EX=178, UC=179). On average, participants were 55.4 years of age (SD=11.1) and 73.9% had bone metastases. EX resulted in a significant reduction in physical fatigue (-5.3 [-10.0; -0.6], p=.027, ES=0.22) and improvement in HRQoL (+4.8 [2.2; 7.4], p=.0003, ES=0.33) compared to UC at 6 months (primary endpoint), as well as at 3 and 9 months. EX also improved physical fitness (+24.3 Watts, [15.5; 33.1], ES=0.42, at 6 months) and numerous relevant QLQ-C30 scales, including social functioning, pain, and dyspnoea. CONCLUSION This large multinational study demonstrates that supervised exercise improves fatigue, HRQoL, and other clinically relevant outcomes in patients with mBC. Based on these findings, supervised exercise should be recommended to patients with mBC.

Pretreatment Patient-reported Overall Health: A Prognostic Factor for Early Overall Mortality After Primary Curative Treatment of Prostate Cancer

Background and objectiveRegistry-based studies for prostate cancer (PCa) document higher overall mortality (OM) after high-dose radiotherapy (RT) than after radical prostatectomy (RP). Our aim was to explore the association between pretreatment patient-reported health (“OverallHealth”: OH) and curative treatment type, and the impact on early OM. MethodsNew PCa patients registered between 2017 and 2019 in the Cancer Registry of Norway (n = 1949) completed the European Organisation for Research and Treatment of Cancer Quality-of-Life Core 30 (QLQ-C30) questionnaire before RP (n = 592) or RT (n = 610) or after allocation to active surveillance (AS; n = 747). We dichotomised the QLQ-C30 summary score to classify patients with un-impaired versus impaired OH. Standard univariable and multivariable analyses with treatment type or OM as the outcome were conducted. The mean observation time was 4.7 years (standard deviation 1.0). Statistical significance was set at p < 0.05. Key findings and limitationsImpaired OH was more frequent in the RT group (38%) than in the RP (25%) or AS (28%) group (p < 0.001). Higher age, higher risk group, and impaired OH increased the probability of undergoinRT rather than RP (p < 0.001). Impaired OH was associated with a twofold higher early OM rate in the RT group (16% vs 8%; p = 0.009) and fourfold higher OM rate in the AS group (13% vs 3%; p < 0.001). These findings remained significant in Cox regression analyses controlled for age and risk group. After RP, only locally advanced high-risk tumours were significantly associated with OM. Unknown psychometrics for the OH variable is the main study limitation. Conclusions and clinical implicationsPretreatment patient-reported impaired OH, measured as the QLQ-C30 summary score, was positively associated with allocation to RT or AS and is a prognostic factor for early OM. Before allocation to RT or AS, elderly patients with PCa should be screened and treated for health problems that can be remedied. Future studies should determine the psychometrics of the QLQ-C30 summary score in comparison to established frailty screening instruments. Patient summaryPatient-reported scores reflecting their overall health can help in choosing curative treatment for prostate cancer and are associated with survival during the first 5 years after treatment.

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.

Health-related quality of life and quality-adjusted progression free survival for carfilzomib and dexamethasone maintenance following salvage autologous stem-cell transplantation in patients with multiple myeloma: a randomized phase 2 trial by the Nordic Myeloma Study Group

BackgroundDecisions regarding maintenance therapy in patients with multiple myeloma should be based on both treatment efficacy and health-related quality of life (HRQL) consequences. In the CARFI trial, patients with first relapse of multiple myeloma underwent salvage autologous stem cell transplantation (salvage ASCT) before randomization to carfilzomib-dexamethasone maintenance therapy (Kd) or observation. The primary clinical endpoint was time to progression, which was extended by 8 months by Kd. The aim of this paper is to present the all HRQL endpoints of the CARFI trial including the HRQL effect of Kd maintenance therapy relative to observation. The primary HRQL endpoint was assessed by EORTC QLQ-C30 Summary score (QLQ-C30-sum) at 8 months follow-up. A key secondary HRQL endpoint was quality-adjusted progression-free-survival (QAPFS).MethodsHRQL was assessed with EORTC QLQ-C30, EORTC QLQ-MY20 and FACT/GOG-Ntx at randomization and every second month during follow-up. HRQL data were analyzed with linear mixed effect models until 8 months follow-up. QAPFS per individual was calculated by multiplying progression-free survival (PFS) by two quality-adjustment metrics, the QLQ-C30-sum and EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D). The QAPFS per treatment group was estimated with the Kaplan-Meier method. P < 0.05 was used for statistical significance, and a between-group minimal important difference of 10 points was interpreted as clinically relevant for the QLQ-C30-sum.Results168 patients were randomized. HRQL questionnaire compliance was 93%. For the QLQ-C30-sum, the difference of 4.62 points (95% confidence interval (CI) -8.9: -0.4, p = 0.032) was not clinically relevant. PFS was 19.3 months for the Kd maintenance group and 16.8 months for the observation group; difference = 2.5 months (95% CI 0.5; 4.5). QAPFS based on the QLQ-C30-sum for the Kd maintenance group was 18.0 months (95% CI 16.4; 19.6) and for the observation group 15.0 months (95% CI 13.5; 16.5); difference = 3.0 months (95% CI 0.8–5.3). QAPFS based on the QLU-C10D for the Kd maintenance group was 17.5 months (95% CI 15.9; 19.2) and 14.0 months (95% CI 12.4; 15.5) for the observation group; difference = 3.5 months (95% CI 1.1–5.9).ConclusionsKd maintenance therapy after salvage ASCT did not adversely affect overall HRQL, but adjustment for HRQL reduced the PFS compared to unadjusted PFS. PFS of maintenance therapy should be quality-adjusted to balance the benefits and HRQL impact.

Evaluating a shared care pathway intervention for people receiving chemotherapy to reduce post-treatment unplanned hospital presentations: a randomised controlled trial

PurposeThe aim of this randomised controlled trial (RCT) was to explore whether a community nursing intervention for outpatients receiving systemic therapy reduced unplanned hospital presentations and improved physical and psychosocial health outcomes over the first three cycles of treatment compared to a control group receiving standard care.MethodsThe number of and reasons for unplanned presentations were obtained for 170 intervention and 176 control group adult patients with solid tumours starting outpatient chemotherapy. Poisson regression was used to compare the number of presentations between the intervention and control groups. Patients self-completed the Hospital Anxiety and Depression Scale, the Cancer Behavior Inventory and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) at the start of the first four cycles. Linear regression techniques were used to compare quality of life outcomes.ResultsThe reduction in unplanned presentations in the intervention group relative to the control group was 12% (95% CI, − 25%, 37%; P = 0.48). At the start of cycle 4, there was no difference in anxiety (difference = 0.47 (95% CI, − 0.28, 1.22; P = 0.22)), depression (difference = 0.57 (95% CI, − 0.18, 1.31; P = 0.13)) or EORTC QLQ-C30 summary score (difference = 0.16 (95% CI, − 2.67, 3.00; P = 0.91)). Scores for self-efficacy as measured by the Cancer Behavior Inventory were higher in the intervention group (difference = 4.3 (95% CI, 0.7, 7.9; P = 0.02)).ConclusionThis RCT did not demonstrate a benefit in reducing unplanned presentations to hospital. The trial identified improved cancer-based self-efficacy in patients receiving the intervention.Trial registrationRegistered at Australian and New Zealand Clinical Trials Registry: ACTRN12614001113640, registered 21/10/2014.

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.

Health-related quality of life in patients with lung cancer

Lung cancer has been the most common type of cancer worldwide for several decades. 55 patients treated for lung cancer with a mean age of 60.9±4.2 evaluated through Health-related QoL (HRQoL) were assessed individually using the valid and reliable questionnaires Cancer Quality of Life EORTC (QLQ) - C30 and QLQ - H&amp;N35. The functioning scale in the QLQ-C30 questionnaire with the lowest average score was global health status. The mean QLQ-C30 summary score (77.17 ± 11.4). The symptoms with the highest scores were dyspnea, weight loss, and muscle atrophy. Linear regression analysis demonstrated that Global health status score was associated with education level [β-coefficient = 15.21 (95% CI: 10.2-21.9, P=0.01], alcohol consumption [β-coefficient=11.02 (95% CI: 5.3-16.3), P=0.01]. In conclusion. This study demonstrated several predictors of worse perception of HRQoL through study. Moreover, these predictors should be the focus of preventive measurements, early detection of lung cancer, and target therapy.

Patient-Reported Outcomes Evaluating the Impact of Hypo-Fractionated Palliative Quadshot Radiotherapy and Concurrent CDDP Treatment on Health-Related Quality of Life in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck

In locally advanced squamous cell carcinoma of the head and neck (LAHNSCC), the main goal of treatment remains survival while improving quality of life (QOL). In recent decades, there has been a paradigm shift in the measurement of clinical outcomes in patients diagnosed with cancer, focusing on the patient perspective by incorporating patient-reported outcomes (PROs). The primary objective of this study was to evaluate the improvement in quality of life with the use of cyclic hypo-fractionated palliative QUAD SHOT radiotherapy (RT) with concurrent cisplatin (CDDP) in previously untreated patients with incurable LAHNSCC. In this prospective interventional phase- II study, 60 patients with locally advanced squamous cell carcinoma of the head and neck, majority stage IVB, ECOG PS ≤ 3, were treated with QUAD SHOT RT (14 Gy/4 fractions/2 days - BD with 6-hour interval and concurrent CDDP at 6 mg/m2. This treatment was repeated at 4-week intervals for 2 additional cycles if tumor progression did not occur. Serial changes in HR -QoL were assessed using EORTC QLQ C-30 and H&N-35) at 4 different time points. Statistical methods such as the Wilcoxon signed-rank test and Friedman test were used to compare QoL values at different time points with Bonferroni correction for multiple comparisons to control for type I errors. The median global health score (GHS) at baseline was 41.667, with an initial increase in score at 4 weeks (50.00) and at 8 weeks (54.167) that did not continue at 12 weeks (41.667). Symptoms related to toxicities (speech, social contact, sticky saliva, dry mouth, senses in H&N 35) were lower after 4 weeks. Application of the Friedman test for four time points revealed significant improvement in role function at 4 weeks, which remained constant at 8 weeks but was not sustained at 12 weeks. Comparison of HN-35 symptom scores between the four time points showed improvement in symptoms such as pain, swallowing, and mouth opening at 4 and 8 weeks. The mean QLQ C30 summary score for these patients improved at four weeks but did not remain constant at 8 and 12 weeks. Our study showed significant improvement in quality-of-life parameters and reduction in symptom burden at 4 and 8 weeks due to disease control and symptom palliation by QUADSHOT CTRT, while quality-of-life scores worsened and symptom scores were not maintained at 12 weeks due to disease progression and occurrence of acute toxicities. This phase II study may serve as the basis for designing a phase III randomized control trial to compare quality of life changes with QUADSHOT CTRT and other palliative CTRT regimens.

Long-term longitudinal patterns of patient-reported quality of life (QOL) after breast cancer (BC) to inform the implementation of personalized pathways of care.

12081 Background: There is substantial inter individual variability in long-term trajectories of patient-reported quality of life (QOL) after early BC. Previous work focused on a selected group of patients (pts) treated with chemotherapy (CT) identified a cluster of pts with upfront poor QOL but also pts with severe, persistent post-chemotherapy QOL deterioration. We aimed to expand this work to a non-selected group of pts with early BC to identify latent clusters of pts at risk for QOL deterioration, and to assess the relationship of actionable host factors and health behaviors with trajectory group membership. Methods: We performed a detailed longitudinal analysis of QOL using a large ongoing national prospective clinical cohort (CANcer TOxicity, NCT01993498) of pts with stage I-III BC treated from 2012-2018. QOL (EORTC QLQ-C30 summary score) was assessed at diagnosis (dx, baseline) and year 1, 2, 4 and 6 post-dx. Baseline clinical, sociodemographic, behavioral, tumor-related, and treatment-related characteristics were available. Trajectories of QOL and group membership associations were identified by iterative estimations of group-based trajectory models and multivariable multinomial logistic regression, respectively, among the whole cohort. Results: Among 10,792 pts, 5,695 received adjuvant CT and 8,805 received adjuvant endocrine therapy (ET). Four QOL trajectory groups were identified: excellent (N = 4,934, 45.8%), very good (N = 3,596, 33.3%), deteriorating (N = 1,745, 16.1%), and poor (N = 517, 4.8%). The deteriorating trajectory group reported fairly good baseline QOL (73.3 [95% CI], [72.4 to 74.2]), which significantly worsened at year-1 (63.0 [62.1 to 63.9]) and never recovered to pretreatment values through year-6 (64.7 [63.3 to 66.0]) post diagnosis. Factors associated with membership to the deteriorating group included younger age (aOR, 10-years decrement 1.10 [95% CI, 1.05 to 1.16]), overweight or obesity (aOR v lean, 1.90 [95% CI, 1.60 to 2.25]; 1.25 [95% CI, 1.07 to 1.46], respectively), physical inactivity (aOR v active, 1.13 [95% CI, 1.04 to 1.35]), former smoking behavior (aOR v never, 2.14 [95% CI, 1.80 to 2.54]), Charlson comorbidity score ≥1 (aOR v 0, 1.56 [95% CI, 1.33 to 1.83]), lower household income ( &lt; 3000 EU/month) (aOR v ≥3000, 1.50 [95% CI, 1.30 to 1.72]), receipt of adjuvant CT (aOR v no, 1.35 [95% CI, 1.14 to 1.59]) and receipt of adjuvant ET (aOR v no, 1.46 [95% CI, 1.22 to 1.75]). Conclusions: This study will help identify latent clusters of pts who are at risk of persistent QOL deterioration after BC, independently of receipt of CT. Trajectory clustering can help facilitate the creation of personalized pathways that may include early addressal of actionable factors, including referral to social work and healthy lifestyle interventions. Clinical trial information: NCT01993498 .

Health-related quality of life in patients with steroid-refractory acute graft-versus-host disease.

Evidence regarding health-related quality of life (HRQoL) in patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD) is lacking. Evaluating HRQoL was a secondary objective of the HOVON 113 MSC trial. Here we describe the outcomes of the EQ-5D-5L, EORTC QLQ-C30, and FACT-BMT for all adult patients who completed these questionnaires at baseline (i.e., before the start of treatment; n = 26). Descriptive statistics were used to describe baseline patient and disease characteristics, EQ-5D dimension scores and values, EQ VAS scores, EORTC QLQ-C30 scale/item and summary scores, and FACT-BMT subscale and total scores. The mean EQ-5D value was 0.36. In total, 96% of the patients reported problems with usual activities, 92% with pain/discomfort, 84% with mobility, 80% with self-care, and 72% with anxiety/depression. The mean EORTC QLQ-C30 summary score was 43.50. Mean scale/item scores ranged from 21.79 to 60.00 for functioning scales, from 39.74 to 75.21 for symptom scales, and from 5.33 to 91.67 for single items. The mean FACT-BMT total score was 75.31. Mean subscale scores ranged from 10.09 for physical well-being to 23.94 for social/family well-being. Our study showed that HRQoL in patients with SR-aGvHD is poor. Improving HRQoL and symptom management in these patients should be a top priority.

Cost-effectiveness of general practitioner- versus surgeon-led colon cancer survivorship care: an economic evaluation alongside a randomised controlled trial

PurposeThe aim of this study is to assess cost-effectiveness of general practitioner (GP) versus surgeon-led colon cancer survivorship care from a societal perspective.MethodsWe performed an economic evaluation alongside the I CARE study, which included 303 cancer patients (stages I–III) who were randomised to survivorship care by a GP or surgeon. Questionnaires were administered at baseline, 3-, 6-, 12-, 24- and 36-months. Costs included healthcare costs (measured by iMTA MCQ) and lost productivity costs (SF-HLQ). Disease-specific quality of life (QoL) was measured using EORTC QLQ-C30 summary score and general QoL using EQ-5D-3L quality-adjusted life years (QALYs). Missing data were imputed. Incremental cost-effectiveness ratios (ICERs) were calculated to relate costs to effects on QoL. Statistical uncertainty was estimated using bootstrapping.ResultsTotal societal costs of GP-led care were significantly lower compared to surgeon-led care (mean difference of − €3895; 95% CI − €6113; − €1712). Lost productivity was the main contributor to the difference in societal costs (− €3305; 95% CI − €5028; − €1739). The difference in QLQ-C30 summary score over time between groups was 1.33 (95% CI − 0.049; 3.15). The ICER for QLQ-C30 was − 2073, indicating that GP-led care is dominant over surgeon-led care. The difference in QALYs was − 0.021 (95% CI − 0.083; 0.040) resulting in an ICER of 129,164.ConclusionsGP-led care is likely to be cost-effective for disease-specific QoL, but not for general QoL.Implications for cancer survivorsWith a growing number of cancer survivors, GP-led survivorship care could help to alleviate some of the burden on more expensive secondary healthcare services.

Surveillance of Symptom Burden Using the Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events in Patients With Various Types of Cancers During Chemoradiation Therapy: Real-World Study

Over 90% of patients with cancer experience 1 or more symptoms caused directly by cancer or its treatment. These symptoms negatively impact on the completion of planned treatment as well as patients' health-related quality of life (HRQoL). It often results in serious complications and even life-threatening outcomes. Thus, it has been recommended that surveillance of symptom burden should be performed and managed during cancer treatment. However, differences in symptom profiles in various patients with cancer have not been fully elucidated for use in performing surveillance in the real world. This study aims to evaluate the burden of symptoms in patients with various types of cancers during chemotherapy or radiation therapy using the PRO-CTCAE (Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events) and its impact on quality of life. We performed a cross-sectional study of patients undergoing outpatient-based chemotherapy, radiation therapy, or both at the National Cancer Center at Goyang or at the Samsung Medical Center in Seoul, Korea between December 2017 and January 2018. To evaluate cancer-specific symptom burden, we developed 10 subsets for using the PRO-CTCAE-Korean. To measure HRQoL, we used the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Participants answered questions prior to their clinic appointments on tablets. Multivariable linear regression was used to analyze symptoms based on cancer type and to evaluate the association between the PRO-CTCAE items and the EORTC QLQ-C30 summary score. The mean age (SD) of the patients was 55.0 (11.9) years, and 39.94% (540/1352) were male. Overall, symptoms in the gastrointestinal category were the most dominant in all cancers. Fatigue (1034/1352, 76.48%), decreased appetite (884/1352, 65.38%), and numbness and tingling (778/1352, 57.54%) were the most frequently reported. Patients reported more local symptoms caused by a specific cancer. In terms of nonsite-specific symptoms, patients commonly reported concentration (587/1352, 43.42%), anxiety (647/1352, 47.86%), and general pain (605/1352, 44.75%). More than 50% of patients with colorectal (69/127, 54.3%), gynecologic (63/112, 56.3%), breast (252/411, 61.3%), and lung cancers (121/234, 51.7%) experienced decreased libido, whereas 67/112 (59.8%) patients with gynecologic cancer and lymphoma/myeloma reported pain during sexual intercourse. Patients with breast, gastric, and liver cancers were more likely to have the hand-foot syndrome. Worsening PRO-CTCAE scores were associated with poor HRQoL (eg, fatigue: coefficient -8.15; 95% CI -9.32 to -6.97), difficulty in achieving and maintaining erection (coefficient -8.07; 95% CI -14.52 to -1.61), poor concentration (coefficient -7.54; 95% CI -9.06 to -6.01), and dizziness (coefficient -7.24; 95% CI -8.92 to -5.55). The frequency and severity of symptoms differed by cancer types. Higher symptom burden was associated with poor HRQoL, which suggests the importance of appropriate surveillance of PRO symptoms during cancer treatment. Considering patients had comprehensive symptoms, it is necessary to include a holistic approach in the symptom monitoring and management strategies based on comprehensive patient-reported outcome measurements.

Patient-reported outcomes for patients with locally advanced or metastatic urothelial carcinoma under pembrolizumab: A prospective multicenter observational study.

490 Background: Evaluation of Patient-Reported Outcomes (PROs) is a major element used by health authorities for treatment approval. Pembrolizumab is a validated second-line treatment for locally advanced or metastatic urothelial carcinoma (la/mUC). In this real-life study, we aimed to describe la/mUC patients’ health-related quality of life (HRQoL) and patient/clinician-reported symptoms before and after pembrolizumab initiation. Here, we present interim results to assess clinical relevance for further analysis. Methods: A multicenter prospective French study was designed. PROs were assessed before pembrolizumab initiation (baseline) and at each treatment visit for seven timepoints. We report the analyses of the first three timepoints. HRQoL was measured using the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire-Core 30 (EORTC QLQ-C30) and the EuroQoL 5-dimensions 5-level (EQ-5D-5L) questionnaires. PRO-Common Terminology Criteria for Adverse Events (PRO-CTCAE) and CTCAE were assessed for 20 selected symptoms by both patients and clinicians in a blinded manner. Agreement in severity between clinicians and patients for all grade ≥3 symptoms was calculated with Cohen's kappa coefficient. Results: 39 patients were analyzed. Baseline completion rates were 69%, 62%, 59% and 12.8% for EORTC QLQ-C30, EQ-5D-5L, PRO-CTCAE and CTCAE respectively. Baseline median EORTC QLQ-C30 global health and summary scores were respectively 66.7 [interquartile range; 54.2, 79.2] and 83.6 [73.9, 94]. Improvement in EORTC QLQ-C30 global health median score to cycle 2 was observed in 33.3% patients, while the remaining patients experienced worsening score. Baseline mean EQ-5D-5L Visual Analog Scale score was 65.3 (Standard deviation (SD), 21.6), and 63.5 (SD, 16.1) at cycle 2. EQ-5D-5L domains scored level 1 decreased between baseline and cycle 2 for mobility (16 vs 14 patients) (p=0.0143), self-care (16 vs 14 patients) (p=0.0048), and usual activities (15 vs 14 patients) (p=0.015). Of 17 severity assessed symptoms, the Cohen's kappa coefficient was fair ĸ=0.35 (95% confidence interval (CI) [-0.08; 0.78]) for general pain, and bad ĸ=-0.063 (95%CI [-0.17; -0, 04]) for abdominal pain. In terms of symptom frequency, patients reported 19 symptoms at each visit. However, clinicians reported 13 and 14 symptoms respectively at baseline and cycle 2. Conclusions: HRQoL for la/mUC patients after first pembrolizumab infusion showed contradictory results with previous reports with a trend for HRQoL degradation after one treatment cycle. Comparative symptom severity assessment showed poor agreement between patients and clinicians. Clinicians graded symptoms less severely than patients. The final analysis will provide more complete data with longitudinal analysis to strengthen our preliminary conclusions. Clinical trial information: NCT03584659 .

Differences in Quality of Life between German and Dutch Patients with Prostate Cancer Treated with Robot-assisted Radical Prostatectomy: Implications for International Multicenter Randomized Controlled Trials

BackgroundAs a local treatment for prostate cancer (PCa), robot-assisted radical prostatectomy (RARP) may have a quality of life (QoL) benefit over open surgery. Recent analyses revealed substantial between-country differences in the function and symptom scale scores for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), which is typically used to assess patient-reported QoL. Such differences could have implications for multinational studies in PCa. ObjectiveTo examine whether nationality is significantly associated with patient-reported QoL. Design, setting, and participantsThe study cohort comprised Dutch and German patients with PCa treated with RARP in a single high-volume prostate center from 2006 to 2018. Analyses were restricted to patients who were preoperatively continent with at least one follow-up time point. Outcome measurements and statistical analysisQoL was measured in terms of the global Quality of Life (QL) scale score and the overall summary score for the EORTC QLQ-C30. Linear mixed models for repeated-measures multivariable analyses (MVAs) were used to examine the association between nationality and both the global QL score and the summary score. MVAs were further adjusted for QLQ-C30 baseline values, age, Charlson comorbidity index, preoperative prostate-specific antigen, surgical expertise, pathological tumor and nodal stage, Gleason grade, degree of nerve-sparing, surgical margin status, 30-d Clavien-Dindo grade complications, urinary continence recovery, and biochemical recurrence/postoperative radiotherapy. Results and limitationsFor Dutch (n = 1938) versus German (n = 6410) men, the mean baseline scores were 82.8 versus 71.9 for the global QL scale score and 93.4 versus 89.7 for the QLQ-C30 summary score. Urinary continence recovery (QL: +8.9, 95% confidence interval [CI] 8.1–9.8; p < 0001) and Dutch nationality (QL: +6.9, 95% CI 6.1–7.6; p < 0001) were the strongest positive contributors to the global QL and summary scores, respectively. The main limitation is the retrospective study design. In addition, our Dutch cohort may not be representative of the general Dutch population and reporting bias cannot be ruled out. ConclusionsOur findings provide observational evidence under specific conditions involving the same setting for patients of two different nationalities suggesting that cross-national patient-reported QoL differences appear to be real and may need to be taken into consideration in multinational studies. Patient summaryWe observed differences in the quality-of-life scores reported by Dutch and German patients with prostate cancer after they underwent robot-assisted removal of the prostate. These findings should be taken into consideration in cross-national studies.

Reference values of EORTC QLQ-C30, EORTC QLQ-BR23, and EQ-5D-5L for women with non-metastatic breast cancer at diagnosis and 2 years after

PurposeTo obtain reference norms of EORTC QLQ-C30, EORTC QLQ-BR23, and EQ-5D-5L, based on a population of Spanish non-metastatic breast cancer patients at diagnosis and 2 years after, according to relevant demographic and clinical characteristics.MethodsMulticentric prospective cohort study including consecutive women aged ≥ 18 years with a diagnosis of incident non-metastatic breast cancer from April 2013 to May 2015. Health-related quality of life (HRQoL) questionnaires were administered between diagnosis and beginning the therapy, and 2 years after. HRQoL differences according to age, comorbidity and stage were tested with ANOVA or Chi Square test and multivariate linear regression models.Results1276 patients were included, with a mean age of 58 years. Multivariate models of EORTC QLQ-C30 summary score and EQ-5D-5L index at diagnosis and at 2-year follow-up show the independent association of comorbidity and tumor stage with HRQoL. The standardized multivariate regression coefficient of EORTC QLQ-C30 summary score was lower (poorer HRQoL) for women with stage II and III than for those with stage 0 at diagnosis (− 0.11 and − 0.07, p < 0.05) and follow-up (− 0.15 and − 0.10, p < 0.01). The EQ-5D-5L index indicated poorer HRQoL for women with Charlson comorbidity index ≥ 2 than comorbidity 0 both at diagnosis (− 0.13, p < 0.001) and follow-up (− 0.18, p < 0.001). Therefore, we provided the reference norms at diagnosis and at the 2-year follow-up, stratified by age, comorbidity index, and tumor stage.ConclusionThese HRQoL reference norms can be useful to interpret the scores of women with non-metastatic breast cancer, comparing them with country-specific reference values for this population.

Health-Related Quality of Life Following Robotic-Assisted or Video-Assisted Lobectomy in Patients With Non-Small Cell Lung Cancer: Results From the RVlob Randomized Clinical Trial

Robot-assisted lobectomy (RAL) is increasingly used as an alternative to video-assisted lobectomy (VAL) for resectable non-small cell lung cancer (NSCLC). However, there is little evidence of any difference in postoperative health-related quality of life (HRQoL) between these two approaches. Is RAL superior to VAL in improving quality of life in patients with resectable NSCLC? We performed a single-center, open-label randomized clinical trial from May 2017 to May 2020 with 320 enrolled patients undergoing RAL or VAL for resectable NSCLC (RVlob trial; NCT03134534). Postoperative pain was evaluated by visual analog score or numeric rating score on postoperative day 1 and at weeks 4, 24, and 48. The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30), EORTC Quality of Life Questionnaire in Lung Cancer (QLQ-LC13), and the European Quality of Life 5 Dimensions (EQ-5D) questionnaire were also administered at weeks 4, 24, and 48 after surgery. One hundred and fifty-seven patients underwent RAL and 163 underwent VAL. The mean pain score of patients after RAL was significantly lower at week 4 (2.097 ± 0.111 vs2.431 ± 0.108; P= .032). QLQ-C30 and QLQ-LC13 summary scores (P > .05) were similar for both RAL and VAL during the first 48weeks of follow-up. HRQoL scores assessed with the EQ-5D questionnaire were also comparable between the two groups (P > .05) during the whole study period. Both RAL and VAL showed satisfactory and comparable HRQoL and postoperative pain up to 48weeks after surgery, despite some minor statistical differences at week4. ClinicalTrials.gov; No.: NCT03134534; URL: www. gov.