Validation of single item Linear Analogue Scale Assessments (LASAs) for assessing quality of life (QOL) in patients with newly diagnosed high-grade gliomas

8583 Background: Patient QOL assessment requires balancing the detail provided by multi-item assessments with the reduced burden of single-item assessments. We investigated the psychometric properties of single-item LASA assessments used in 3 North Central Cancer Treatment Group (NCCTG) phase II trials for patients with newly diagnosed high-grade gliomas. Methods: Measures included QOL LASAs (overall, physical, emotional, spiritual, intellectual), Symptom Distress Scale (SDS), Profile of Mood States (POMS), and Functional Assessment for Cancer Therapy (FACT; overall, physical, emotional). Association of LASA measures with SDS, POMS, and FACT domains and with ECOG performance score (PS) and MMSE was assessed with Spearman’s correlation. Repeated measures ANOVA models compared the change over time of LASAs and SDS, POMS, and FACT. Cox regression modeled the association of baseline QOL and survival. Results: 205 patients completed the QOL assessments across 3 time points. LASA mean scores ranged from 60–78; SDS, POMS, and FACT ranged from 68–81. No significant changes across time for overall and emotional scores were observed. FACT physical decreased over time (p<0.001) as did LASA physical (p=0.08). LASA scales were strongly associated with corresponding scales on SDS, POMS, and FACT (0.44<rho<0.65; p<0.001). LASA was negatively associated with PS and positively with MMSE. Baseline scores for overall FACT (p=0.005) and LASA physical (p=0.015) were associated with better survival. Conclusions: The single-item LASA assessments have comparable psychometric properties as longer assessments for the same constructs. Correlations with PS and MMSE were as expected (convergent/concurrent validity). The discriminant validity and prognostic ability of LASA items were similar to the multi-item instruments. Collectively, the data suggest that the single item LASA scales are valid for assessing QOL in patients with newly diagnosed high grade gliomas and are an appropriate alternative when a shorter instrument is warranted. No significant financial relationships to disclose.

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A Prospective Study of Quality of Life in Adults with Newly Diagnosed High-grade Gliomas: The Impact of the Extent of Resection on Quality of Life and Survival

Neurosurgery ◽

10.1227/01.neu.0000170562.25335.c7 ◽

2005 ◽

Vol 57 (3) ◽

pp. 495-504 ◽

Cited By ~ 133

Author(s):

Paul D. Brown ◽

Matthew J. Maurer ◽

Teresa A. Rummans ◽

Bruce E. Pollock ◽

Karla V. Ballman ◽

...

Keyword(s):

Quality Of Life ◽

Extent Of Resection ◽

High Grade ◽

Newly Diagnosed ◽

Total Resection ◽

Multivariable Analyses ◽

High Grade Gliomas ◽

Over Time

ABSTRACT OBJECTIVE: To describe the quality of life (QOL) over time for adults with newly diagnosed high-grade gliomas and to examine the relationship between QOL and outcome data collected in three prospective cooperative group clinical trials. METHODS: The QOL study was a companion protocol for three Phase II high-grade glioma protocols. Five self-administered forms were completed by patients to assess QOL at study entry, 2 months, and 4 months after enrollment. RESULTS: QOL data were available for baseline, first, and second subsequent follow-up evaluations for 89%, 71%, and 69% of patients, respectively. A significant proportion of patients (47.1%) experienced impaired QOL (QOL ≤ 50) in at least one measure at subsequent evaluations, whereas most patients (88%) with impaired QOL at baseline continued to have impaired QOL at subsequent evaluations. On multivariable analyses, baseline QOL measures were predictive of QOL at the time of follow-up. In addition, patients who underwent a gross total resection were much less likely to have impaired QOL (P = 0.006), were less likely to experience worsening depression (P = 0.0008), and were more likely to have improved QOL (P = 0.003) at their first follow-up evaluation. Changes in QOL measures over time were not found to be associated with survival in multivariable analyses that adjusted for known prognostic variables; variables that were independently associated with improved survival were better performance status (P < 0.001), younger age (P < 0.001), and greater extent of resection (P < 0.001). CONCLUSION: Baseline QOL was predictive of QOL over time. Gross total resection was associated with longer survival and improved QOL over time for patients with high-grade gliomas.

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Mebendazole and temozolomide in patients with newly diagnosed high-grade gliomas: Results of a phase 1 clinical trial

Neuro-Oncology Advances ◽

10.1093/noajnl/vdaa154 ◽

2020 ◽

Author(s):

Gary L Gallia ◽

Matthias Holdhoff ◽

Henry Brem ◽

Avadhut D Joshi ◽

Christine L Hann ◽

...

Keyword(s):

Dose Escalation ◽

Plasma Levels ◽

Phase 1 ◽

Progression Free Survival ◽

Maximum Tolerated Dose ◽

High Grade ◽

Newly Diagnosed ◽

Kaplan Meier ◽

High Grade Gliomas ◽

Expansion Cohort

Abstract Background Mebendazole is an anthelmintic drug introduced for human use in 1971 that extends survival in preclinical models of glioblastoma and other brain cancers. Methods A single center dose escalation and safety study of mebendazole in 24 patients with newly diagnosed high-grade gliomas (HGG) in combination with temozolomide was conducted. Patients received mebendazole in combination with adjuvant temozolomide after completing concurrent radiation plus temozolomide. Dose escalation levels were 25, 50, 100 and 200 mg/kg/day of oral mebendazole. A 15-patient expansion cohort was conducted at the maximum tolerated dose of 200 mg/kg/day. Trough plasma levels of mebendazole were measured at 4, 8 and 16 weeks. Results Twenty-four patients (18 glioblastoma, 6 anaplastic astrocytoma) were enrolled with median age of 49.9 years. Four patients (at 200 mg/kg) developed elevated grade 3 ALT and/or AST after one month, which reversed with lower dosing or discontinuation. Plasma levels of mebendazole were variable but generally increased with dose. Kaplan Meier analysis showed a 21-month median survival with 43% of patients alive at two years and 25% at 3 and 4 years. Median progression free survival (PFS) from the date of diagnosis for 17 patients taking more than one month of mebendazole was 13.1 months (95% Confidence Interval: 8.8 to 14.6 months) but for seven patients who received less than one month of mebendazole PFS was 9.2 months (95% CI: 5.8 -13.0 months). Conclusion Mebendazole at doses up to 200 mg/kg demonstrated long-term safety and acceptable toxicity. Further studies are needed to determine mebendazole’s efficacy in patients with HGG.

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Prognostic value of modified systemic inflammatory score in patients with newly diagnosed high-grade gliomas

Clinical Neurology and Neurosurgery ◽

10.1016/j.clineuro.2020.106428 ◽

2021 ◽

Vol 201 ◽

pp. 106428

Author(s):

Tian Xie ◽

Xiaoyu Guo ◽

Hao Duan ◽

Zhenqiang He ◽

Yonggao Mou

Keyword(s):

Prognostic Value ◽

High Grade ◽

Newly Diagnosed ◽

Inflammatory Score ◽

High Grade Gliomas

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EPCT-19. A PHASE I STUDY OF RIBOCICLIB AND EVEROLIMUS FOLLOWING RADIATION THERAPY IN CHILDREN WITH NEWLY DIAGNOSED NON-BIOPSIED DIFFUSE PONTINE GLIOMAS (DIPG) AND RB+ BIOPSIED DIPG AND HIGH GRADE GLIOMAS (HGG)

Neuro-Oncology ◽

10.1093/neuonc/noaa222.141 ◽

2020 ◽

Vol 22 (Supplement_3) ◽

pp. iii307-iii307

Author(s):

Mariko DeWire ◽

James Leach ◽

Christine Fuller ◽

Peter de Blank ◽

Trent Hummel ◽

...

Keyword(s):

Phase I ◽

Phase I Study ◽

Single Agent ◽

Maximum Tolerated Dose ◽

Pharmacokinetic Studies ◽

High Grade ◽

Newly Diagnosed ◽

High Grade Gliomas ◽

Grade 3 ◽

Expansion Cohort

Abstract Genomic aberrations in the cell cycle and mTOR pathways have been reported in diffuse pontine gliomas (DIPG) and high-grade gliomas (HGG). Dual inhibition of CDK4/6 (ribociclib) and mTOR (everolimus) has strong biologic rationale, non-overlapping single-agent toxicities, and adult clinical experience. The maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D) of ribociclib and everolimus administered during maintenance therapy following radiotherapy was determined in the phase I study as a rolling 6 design. Ribociclib and everolimus were administered once daily for 21 days and 28 days, respectively starting two-four weeks post completion of radiotherapy. All HGG patients and any DIPG patient who had undergone biopsy were screened for RB protein by immunohistochemistry. Eighteen eligible patients enrolled (median age 8 years; range: 2–18). Six patients enrolled at dose levels 1,2, and 3 without dose limiting toxicities (DLT). Currently, five patients are enrolled at dose level 3 expansion cohort. The median number of cycles are 4.5 (range: 1–20+). Among the expansion cohort, one dose limiting toxicity included a grade 3 infection and one patient required a dose reduction in course 3 due to grade 3 ALT and grade 4 hypokalemia. The most common grade 3/4 adverse events included neutropenia. Preliminary pharmacokinetic studies on 12 patients suggest an impact of ribociclib on everolimus pharmacokinetics. The MTD/RP2D of ribociclib and everolimus following radiotherapy in newly diagnosed DIPG and HGG is anticipated to be 170 mg/m2/day x 21 days and 1.5 mg/ m2/day every 28 days which is equivalent to the adult RP2D.

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The Outcomes of Concomitant Chemoradiotherapy Followed by Adjuvant Chemotherapy with Temozolomide for Newly Diagnosed High Grade Gliomas : The Preliminary Results of Single Center Prospective Study

Journal of Korean Neurosurgical Society ◽

10.3340/jkns.2008.44.4.222 ◽

2008 ◽

Vol 44 (4) ◽

pp. 222 ◽

Cited By ~ 11

Author(s):

Jung-Won Choi ◽

Min Mi Lee ◽

In Ah Kim ◽

Jee Hyun Kim ◽

Gheeyoung Choe ◽

...

Keyword(s):

Adjuvant Chemotherapy ◽

Prospective Study ◽

High Grade ◽

Newly Diagnosed ◽

Single Center ◽

Concomitant Chemoradiotherapy ◽

Preliminary Results ◽

High Grade Gliomas

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The Diagnostic Value of Preoperative Hematology Makers in the Classification and Molecular Subtypes of Newly Diagnosed High-Grade Gliomas

10.21203/rs.3.rs-569387/v2 ◽

2021 ◽

Author(s):

Xin Jia ◽

Yixuan Zhai ◽

Fengdong Yang ◽

Yiming Wang ◽

Shuxin Wei ◽

...

Keyword(s):

Molecular Subtypes ◽

Diagnostic Value ◽

High Grade ◽

Newly Diagnosed ◽

Wild Type ◽

Serum Globulin ◽

Lower Serum ◽

High Grade Gliomas ◽

Hematological Indicators ◽

Prognostic Nutrition Index

Abstract Objective The purpose of our study is to explore the diagnostic value of the single and combined hematological maker for the classification and isocitrate dehydrogenase (IDH)-1/2 mutations molecular subtypes of high-grade gliomas (HGGs). Methods A total of 354 newly diagnosed HGGs patients were included in this study. Firstly, we compared the levels of hematology indicators in the classification and molecular subtypes of HGGs. Next, the correlation between the levels of hematology indicators with basic clinical features was analyzed. Finally, the diagnostic value of the single and combined hematology indicator for identifying the classification and molecular subtypes from HGGs was performed. Results The level of fibrinogen (FIB) was higher in higher grade gliomas and glioblastoma multiforme IDH wild type (GBM IDH-wt). Nutrition-related indicators such as serum albumin (ALB), albumin/globulin ratio (AGR), and prognostic nutrition index (PNI) were negatively correlated with age, whereas FIB was positively associated with age. Compared with women, men with GBM had significantly higher AGR and lower serum globulin (GLOB). We found that the best single and combined indicator for identifying GBM and GBM IDH-wt from HGGs were FIB [0.595 (0.519–0.672) and 0.615 (0.546–0.684)] and age + FIB [0.712 (0.642–0.783) and 0.726 (0.662–0.791)], respectively. Conclusions Preoperative hematological indicators have high diagnostic value for GBM and GBM IDH-wt from HGGs, especially FIB combined age.

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