EORTC QLQ-BN20 Questionnaires Research Articles

Meningioma WHOI with involvement of the optical structures-does proton therapy lead to changes in quality of life with regard to subjective visual performance?

In addition to local tumor control, the aim of any curative radio-oncological treatment is to maintain quality of life. In the treatment of patients with meningioma with aclose relationship to optical structures, the preservation of visual performance is aparticular challenge. Use of proton therapy can reduce the dose burden to organs at risk immediately adjacent to the tumor. The aim of this study was to score the subjective assessment of visual performance in patients with meningioma involving the optical structures before and after proton therapy. All proton-treated patients with meningioma WHOI whose planning target volumes (PTV) included parts of the optic nerve and/or chiasm were included in this study. Subjective assessment of visual performance was evaluated using the Visual Disorder Scale (VDS) of the EORTC QLQ-BN20 questionnaire. This scale includes values from 0 to 100, whereby high values reflect ahigh degree of subjective symptom burden and thus subjective visual impairment. The visual acuity in externally performed eye tests at baseline and follow-ups (FU) was also evaluated. The timepoints for testing were before the start of radiotherapy, at the end of treatment, and3, 6, 12,and 24months in FU (times t1-t6). All patients with at least the first annual postradiation FU at the time of the evaluation were included. The correlation between VDS changes and potential influencing factors such as previous therapies, dosimetric data, initial tumor volume, and tumor shrinkage 1year after treatment was assessed. Atotal of 56patients (45female/11male) aged 24-82years (mean ± SD = 53.9 ± 13.3) treated between March 2017 and September 2019 were included in the analysis. The prescription dose was 54.0 Gy (RBE) with active scanned proton therapy. The mean/D2% dose ± SD for the optic chiasm and ipsilateral optic nerve was 43.4 ± 8.9 Gy (RBE)/49.9 ± 7.1 Gy (RBE) and 35.6 ± 11.7 Gy (RBE)/51.7 ± 4.8 Gy (RBE); the mean/D2% dose ± SD of the contralateral optic nerve was 18.8 ± 12.1 Gy (RBE)/42.4 ± 14.6 Gy (RBE), respectively. Atotal of 302 data collections were available (t1/t2/t3/t4/t5/t6: n = 56/56/48/56/52/34). Median observation time was 23.6months. Mean symptom burden decreased over time (mean VDS: t1 29.8 ± 27.9; t2 25.0 ± 27.9; t3 21.8 ± 26.0; t4 22.2 ± 26.0; t5 21.4 ± 26.2; t6 17.3 ± 23.6) with statistically significant improvement at 3‑and 6‑month FU as well as 1year after proton therapy (p = 0.0205; p = 0.0187; p = 0.0054). Objective eye tests available in 41/52patients confirm the trend towards improved visual acuity (97.5% stable/improved until 24-month FU). However, no potential predictor for VDS changes was revealed. Proton treatment of patients with meningioma WHOI with involvement of optical structures does not impair subjective visual performance. After treatment, there is asignificant improvement in perceived visual performance.

OS09.7.A Quality of life outcomes in patients with incidental and operated meningiomas: the QUALMS study

Abstract BACKGROUND Long-term Health-Related Quality of Life (HRQoL) is an important measure of patient wellbeing. There is a paucity of studies evaluating HRQoL in meningioma patients. MATERIAL AND METHODS Cross-sectional study of adult patients with an incidental or symptomatic intracranial meningioma. Patients with less than 5 years of follow-up, a history of craniospinal radiation or neurofibromatosis type 2 were excluded. HRQoL was evaluated with SF-36, EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires. Outcome determinants were evaluated using a multi-variable linear regression analysis, adjusted for patient, tumour and treatment characteristics, and duration of follow-up. RESULTS 699 patients were invited to participate and 246 responded: 118 (48%) had an incidental meningioma. Mean age at diagnosis was 56.8 years (SD=13) and 81% were female. Median time from diagnosis to completion of questionnaire was 8.5 years (IQR 6.8–11.5). During follow-up, 158 patients (64.2%) had at least one operation for their meningioma and 47 patients (19.1%) had radiotherapy. Of those operated, 126 (79.7%) had WHO grade 1 and 24 (15.2%) had grade 2 meningiomas. Compared to normative population values, meningioma patients reported a worse SF-36 general health score (mean 61.9 vs 56.5, P=0.003) but a similar QLQ-C30 global health score (mean 62.3 vs 65.8, P=0.039), worse SF-36 and QLQ-C30 physical functioning scores (mean 74.1 vs 64.6, P<0.001 and mean 81.8 vs 76.5, P=0.007) and similar SF-36 and QLQ-C30 emotional health scores (mean 72.2 vs 70.9, P=0.367 and mean 71.0 vs 71.9, P=0.960). QLQ-C30 cognitive functioning was worse (mean 80.5 vs 71.4, P<0.001). Compared to the meningioma literature, QLQ-BN20 seizure burden was similar (mean 2.0 vs 1.6, P=0.760). A worse performance status at diagnosis was associated with an inferior QLQ-C30 global health score (β-coefficient=-4.9 [95% CI -9.1-(-)0.6] P=0.024). Number of surgeries was significantly associated with a worse QLQ-C30 cognitive functioning score (β-coefficient=-7.0 [95% CI -13.2-(-)0.9], P=0.025). Anti-epileptic drug use was associated with a significantly worse QLQ-C30 emotional health score (β-coefficient=-10.9 [95% CI -21.7-(-)0.01], P=0.050). CONCLUSION Meningioma patients have long-term HRQoL impairments affecting their physical and cognitive functions. An understanding that multiple surgeries affects cognitive function, and the need for anti-epileptic drugs equate to poorer emotional health, could help target appropriate therapies and support in the future.

Development and Validation of Predicting Nomograms for Craniopharyngioma: A Retrospective, Multiple-Center, Cohort Study.

Craniopharyngiomas (CPs) are benign tumors arising from the sellar region. However, little is known about their clinical features and long-term recurrence due to low morbidity and the lack of large cohort studies. Thus, we aimed to develop nomograms to accurately predict the extent of resection and tumor recurrence using clinical parameters. A total of 545 patients diagnosed with CP between 2009 and 2019 were examined: 381 in the development cohort and 164 in the validation cohort. Least absolute shrinkage and selection operator (LASSO) and Cox regression analyses were performed to establish two nomograms. Receiver operating characteristic (ROC) curves, calibration curves, decision curve analysis (DCA) and Kaplan-Meier (KM) curves were used to evaluate their predictive performance and discriminative power, respectively, in the two cohorts. In addition, the EORTC QLQ-BN20 questionnaire was used to assess neuropsychological status in the follow-up. In the development cohort, the area under the curve (AUC) and C-index were 0.760 and 0.758, respectively, for predicting the extent of resection and 0.78 and 0.75, respectively, for predicting 3-year progression-free survival (PFS) and 5-year PFS. Additionally, the model had a predictive accuracy of 0.785. Both nomograms showed acceptable discrimination in the two cohorts. Moreover, DCA demonstrated excellent clinical benefits from the two nomograms. Finally, participants were classified into two distinct risk groups according to the risk score, and an online calculator was created for convenient clinical use. During long term follow-up, hypothyroidism (77.61%) and hypocortisolism (76.70%) were the most common endocrine dysfunction after surgery and significant deficits were observed concerning visual disorder, motor dysfunction and seizures in the recurrent groups. In particular, better quality of life was associated with gross total resection (GTR), postoperative radiation, anterior interhemispheric (AI) approach and transsphenoidal approach. To our knowledge, these are the first nomograms based on a very large cohort of patients with CP that show potential benefits for guiding treatment decisions and long-term surveillance. The current study demonstrated the online calculator serve as the practical tool for individual strategies based on the patient’s baseline characteristics to achieve a better prognosis.

QOLP-35. OUTCOMES AND CORRELATIONS BETWEEN LEGACY QUALITY OF LIFE MEASURES (EORTC-C30/EORTC-BN20) AND THE ELECTRONIC QUALITY OF LIFE MEASURING SYSTEM NIH-PROMIS IN GLIOBLASTOMA PATIENTS

Abstract BACKGROUND Health-related quality of life (QoL) and patient reported outcomes are essential to guide patient-care. The NIH sponsored electronic Patient-Reported Outcomes Measurement Information System (PROMIS) is well established in multiple cancers but not in Glioblastoma (GBM). The aim of this study was to analyze the association of the PROMIS measures with the European Organization for Research and Treatment of Cancer core instrument (EORTC-QLQ-C30) and the brain tumor specific EORTC QLQ-BN20 questionnaire (EORTC-BN20) in GBM patients. METHODS Newly diagnosed patients with GBM were enrolled prospectively to assess association between both tools. The PROMIS modules were selected to reflect the quality of life domains assessed in the EORTC- QLQ-C30 and EORTC-BN20 questionnaires. Pearson’s correlation coefficients were computed between the PROMIS and EORTC-C30/ EORTC-BN20 measures. Due to multiple responses over time, the p-values for the correlation coefficients were adjusted. Because of the large number of correlations computed and many with p-values less than 0.05, the magnitude of the correlation was considered. Correlations greater than 0.5 or less than -0.5 were consider to be “strong” associations, while correlations between 0.3 and 0.499 (or -0.3 and -0.499) were consider to be “moderate”. RESULTS 43 patients with 124 PROMIS/EORTC responses were included in this analysis. The PROMIS measures had strong associations with the QoL functioning and fatigue measures from the EORTC-C30 and future uncertainty, communication deficit, motor dysfunction, social satisfaction and drowsiness from the EORTC-BN20 (all p< 0.001 and correlation >0.5). CONCLUSIONS There are strong and moderate correlations in the majority of PROMIS assessments and the EORTC tools. The PROMIS toolkit may be used to assess core features of the EORTC surveys. GI symptoms, seizures and itchy skin do not correlate. Given the prior documented shorter assessment time, the PROMIS toolkit may be a feasible alternative to established legacy tools to assess QoL in GBM patients.

Quality of Life in Brain Cancer: Clinical Validation of the Mexican-Spanish Version of the EORTC QLQ-BN20 Questionnaire.

Background: Overall survival (OS) of patients with Brain Cancer (BC) is slowly increasing. The disease itself and its treatments deeply impact patient Health-related quality of life (HRQL). Therefore, valid and reliable instruments are needed. In this study, the Mexican-Spanish version of the QLQ-BN20 instrument is psychometrically and clinically validated.Methods: Patients with brain cancer (BC) (primary or metastatic) evaluated at a tertiary cancer center, were invited to respond to the questionnaire, as well as the core-module QLQ-C30. Tests to demonstrate the instrument's internal consistency, the association of HRQL scales with clinical variables and OS were investigated.Results: One hundred and nineteen patients were included in this cohort: 77 women and 42 men (mean age, 46.2 years). Patients answered both instruments in < 30 min.Good convergent [all correlation coefficients (CC) > 0.37] and discriminant validity was observed and was associated with significant overlap (CC 0.007–0.68). All four multi-item scales of QLQ-BN20 also demonstrated good reliability (Cronbach α > 0.7). Several scales of the QLQ-BN20 were significantly associated with performance status and a modified Recursive Partition Analysis. Of the possible scale correlations, 40 of 161 (24.8%) scales in both instruments, were significantly (directly or inversely) correlated. Visual disorders, Motor dysfunction, Seizures and Weakness of the legs presented association with OS (p < 0.05).Conclusion: The Mexican-Spanish version of the BN20 instrument is valid and reliable and can be used in clinical trials in patients with BC. Some HRQL scales were associated with OS and could therefore be incorporated in future studies of prognostic models.

Validation of the Chinese version of EORTC QLQ-BN20 for patients with brain cancer

This is a single centre study in mainland China aiming to evaluate the reliability, validity and responsiveness of the Chinese version of EORTC QLQ-BN20, designed by The European Organization for Research and Treatment of Cancer Quality of Life Group to evaluate the life quality of patients with brain tumour, cancer or metastases. One hundred and eighty-eight patients with primary or secondary brain cancer from Hunan Provincial Tumor Hospital during September 2013 to June 2014 completed the Chinese EORTC QLQ-C30/BN20 questionnaires developed by translation, back translation and cultural adaptation. Results were statistically analysed using SPSS17.0. The internal consistency (Cronbach's α coefficient) was between .753 and .869, the correlation coefficients among items and its own dimension were bigger than .4, and all items had a better correlation with its own dimension. The Spearman was used to analyse the correlation of each dimension between EORTC QLQ-BN20 and EORTC QLQ-C30, and the result showed that individual dimensions were moderately correlated, other dimensions were weakly correlated. In conclusion, the Chinese version of EORTC QLQ BN20 questionnaire had great relevance, reliability, convergent validity and discriminant validity. It provides a valuable tool for the assessment of health-related quality of life in clinical studies of Chinese patients with primary or secondary brain cancer.

Quality of Life in Patients with Primary CNS Lymphoma - a Pooled Analysis from Three Prospective Multicentre Trials

BackgroundPrimary CNS lymphoma (PCNSL) is a rare extra nodal non-Hodgkin lymphoma. High-dose methotrexate (HD-MTX) based treatment has improved prognosis, but little is known about the development of quality of life (QoL) during treatment and follow-up from prospective trials.MethodsWe pooled data from three prospective trials including 225 immunocompetent patients with PCNSL (186 [83%] with newly diagnosed and 39 [17%] with relapsed disease) - all received HD-MTX based polychemotherapy with rituximab. QoL was a pre-specified secondary endpoint in all trials and evaluated using the EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaire at start of treatment, after completion of treatment and during follow-up. We used descriptive statistics to summarize QoL over time. To investigate the development of QoL over time adjusted for age and Karnofsky performance status (KPS), we used multivariable linear regression models with a random effect to account for repeat measurements. We also did two separate analyses for patients with newly diagnosed PCNSL and relapsed disease. Multiple imputations were applied for missing values within a questionnaire, but we did not impute values of questionnaires that were missing completely. We herein report results on the global health status (GHS, item 30 of EORTC QLQ-C30, higher values represent better QoL) and the predominant item of the EORTC QLQ-BN20 (future uncertainty, higher values represent worse QoL). A change of 10% on the respective scale was considered as a clinically meaningful difference (Osoba et al, Eur J Cancer. 2005 Jan;41(2):280-7 and Maringwa et al, Ann Oncol. 2011 Sep;22(9):2107-12).ResultsThe median age and KPS was 62 years (range 20 to 85) and 80% (30% to 100%), respectively, 119 (52%) were female. Before treatment, the median GHS of the EORTC QLQ-C30 was 50 (interquartile range [IQR] 33 to 67) reflecting substantial impaired QoL. After completion of treatment, the median GHS significantly increased by 17 points to a median of 67 (IQR 50 to 71) (P<0.001), which reflects a clinically meaningful difference. This positive effect was consistent in multivariable analysis (beta coefficient 0.37, p<0.001). Patient with a better KPS before starting treatment had a higher chance that their QoL improved over time (beta coefficient 0.26, p=0.0029). There was no difference regarding GHS between patients with newly diagnosed PCNSL or patients with relapsed disease before starting treatment (median GHS both 50). However, in patients with relapsed disease, numerical increase of GHS over time did not reach statistical significance (beta coefficient 0.36, p=0.2185) likely to limited power in the multivariable analysis. The overall development of GHS over time is shown in Figure 1. The dip at months 17 and 18 area is associated with disease relapse. Regarding the EORTC QLQ-BN20 questionnaire, the predominant issue for patients was future uncertainty (median 42, IQR 17 to 67) before starting treatment, which significantly improved after treatment to 25 (IQR 8 to 33) (p<0.001). In multivariable analysis, future uncertainty also improved significantly in separate analyses for patients with newly diagnosed PCNSL (beta coefficient -0.45, p=0.005) and relapsed disease (beta coefficient -0.89, p=0.0049). The overall development of future uncertainty over time is shown in Figure 2. The increase at months 17 and 18 area is associated with disease relapse.ConclusionsPatients with newly diagnosed or relapsed PCNSL reported substantial impaired QoL before starting treatment. However, after treatment with HD-MTX based chemotherapy, QoL significantly improved over time and patients were also more confident regarding their future. Results from our analyses provide a reference for future studies on this important issue in the care of patients with PCNSL. At the meeting we will present further analyses and results from all domains of the EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires. [Display omitted] [Display omitted] DisclosuresKasenda:Riemser: Other: Travel Support. Illerhaus:Riemser, Amgen: Honoraria.

Evaluation of neuropsychological outcome and "quality of life" after glioma surgery.

Extended tumour resection is imperative to improve the outcome of glioma patients but also carries the risk of increasing morbidity and thus, potentially, of decreasing the patient's quality of life (QOL). In this pilot study, we evaluated how postoperative neurological and neuropsychological alterations impacted on QOL in patients who underwent glioma resection. Twenty-two patients were included in this study and tested at three different time points, i.e. 1day before surgery (t1), on the day of discharge (t2) and 3months following surgery (T3). National Institutes of Health Stroke Scale (NIHSS) score, Addenbrook's Cognitive Examination-Revised (ACE-R) and a comprehensive battery of established tests were used to assess neurological and neuropsychological profiles. QOL and subjectively experienced health condition were ascertained through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ C30) and EORTC-QLQ BN20 questionnaires. Postoperatively, 5/22 patients worsened and 5/22 patients improved neurologically. Depending on the neuropsychological test, up to 57.1% of patients experienced deterioration of some sort of neuropsychological function. Most of these functions, however, recovered during the extended observation period (3months). There was no correlation between QOL and a patient's neurological or neuropsychological condition. Our study suggests that extended tumour resection is not necessarily linked to a loss in QOL.

The EORTC QLQ-BN20 questionnaire for assessing the health-related quality of life (HRQoL) in brain cancer patients: A phase IV validation study on behalf of the EORTC QLG, BCG, ROG, NCIC-CTG

2041 Background: While new brain cancer therapies may help extend survival, both the disease and its treatment can have substantial impact on HRQoL. In this analysis we evaluated the psychometric properties of the EORTC QLQ-BN20, a brain cancer specific HRQoL questionnaire. Methods: Data were derived from two completed phase III EORTC / NCIC clinical trials including 891 brain cancer patients from 119 centers in 15 countries. Experimental treatments were surgery followed by radiotherapy and adjuvant PCV chemotherapy for highly anaplastic oligodendroglioma; and surgery followed by concomitant radiotherapy plus temozolomide (TMZ) chemotherapy and adjuvant TMZ chemotherapy for glioblastoma multiforme. Standard treatment consisted of surgery and postoperative radiotherapy alone. HRQoL assessments were performed before randomization, 1 month after ending radiation, and every 3 months after the start of chemotherapy. The BN20 scoring transforms 20 questions into 11 scales to assess neurological deficits (visual disorder, motor dysfunction, communication deficit), future uncertainty, and disease- and treatment-related symptoms. Multi-trait scaling analyses and sensitivity analyses were applied. Results: Baseline compliance was 83 %, decreasing to 58 % and 66% during follow-up. Mean age was 53 years. Missing data at the item level was modest (6% at baseline). All BN20 items correlated more strongly with their own scale (≥ 0.70) than with any other BN20 scale. Internal consistency reliability was high (0.72 ≤ α ≤ 0.88) for each BN20 scale. Known-groups comparisons yielded positive results, with 4 BN20 physical item/scale scores varying as a function of performance status (p < 0,0001); and BN20 communication deficit scores varying as a function of MMSE scores (p < 0.0001). Responsiveness was adequate, with expected patterns of change observed in BN20 physically-oriented scales as a function of performance status (p < 0.01); and BN20 future uncertainty decreasing over time (p < 0.0001). Conclusions: The QLQ-BN20 demonstrates adequate psychometric properties and can be recommended for use in conjunction with the QLQ-C30 in assessing the HRQoL of brain cancer patients. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Temodal/Temodar