Format:
15
,
Illustrationen
ISSN:
1879-0852
Content:
Background - In an international randomised controlled phase II study of temozolomide (TMZ) versus TMZ in combination with bevacizumab (BEV) in locally diagnosed non-1p/19q co-deleted World Health Organization grade 2 or 3 gliomas with a first and contrast-enhancing recurrence after initial radiotherapy, and overall survival at 12 months was not significantly different (61% in the TMZ arm and 55% in the TMZ + BEV arm). - Objectives - Health-related quality of life (HRQoL) was a key secondary end-point in this trial, and the main objective of this study was to determine the impact of the addition of BEV to TMZ on HRQoL. - Methods - HRQoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 (version 3) and QLQ-BN20 at baseline, and then every 12 weeks until disease progression. The pre-selected primary HRQoL end-point was the QLQ-C30 global health scale, with self-perceived cognitive functioning and pain selected as secondary HRQoL issues. Analysis was undertaken using linear mixed modelling and complemented with sensitivity analyses using summary statistics. A difference was considered clinically relevant with ≥10 points difference on a 100-point scale. - Results - Baseline compliance was high at 94% and remained above 60% until 72 weeks, limiting the analysis to 60 weeks. Compliance was similar in both arms. We found no statistically significant or clinically significant differences between the primary HRQoL end-point in both treatment arms (p = 0.2642). The sensitivity analyses confirmed this finding. The overall test for post-baseline differences between the two treatment arms also showed no statistically or clinically significant differences regarding the selected secondary end-point scales. - Interpretation - The addition of BEV to TMZ in this patient group neither improves nor negatively impacts HRQoL.
Note:
Online verfügbar: 19. Juni 2023, Artikelversion: 13. Juli 2023
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Gesehen am 11.10.2023
In:
European journal of cancer, Amsterdam [u.a.] : Elsevier, 1992, 190(2023) vom: Sept., Artikel-ID 112946, Seite 1-15, 1879-0852
In:
volume:190
In:
year:2023
In:
month:09
In:
elocationid:112946
In:
pages:1-15
In:
extent:15
Language:
English
DOI:
10.1016/j.ejca.2023.112946
URL:
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