Health-related quality-of-life results from the randomised phase II TAVAREC trial on temozolomide with or without bevacizumab in 1p/19q intact first-recurrence World Health Organization grade 2 and 3 glioma (European Organization for Research and Treatment of Cancer 26091) - Sorbonne Université Access content directly
Journal Articles European Journal of Cancer Year : 2023

Health-related quality-of-life results from the randomised phase II TAVAREC trial on temozolomide with or without bevacizumab in 1p/19q intact first-recurrence World Health Organization grade 2 and 3 glioma (European Organization for Research and Treatment of Cancer 26091)

Jaap C Reijneveld
  • Function : Author
  • PersonId : 1297362
Abigirl Machingura
Corneel Coens
  • Function : Author
Martin J.B. Taphoorn
  • Function : Author
Walter Taal
Paul M Clement
  • Function : Author
Ahmed Idbaih
Filip Y.F. de Vos
  • Function : Author
Martin Klein
Wolfgang Wick
  • Function : Author
Paul J Mulholland
  • Function : Author
Joanne Lewis
  • Function : Author
Vassilis Golfinopoulos
Irina Ghislain
  • Function : Author
Andrew Bottomley
  • Function : Author
Martin J van den Bent
  • Function : Author

Abstract

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 contrastenhancing 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.
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hal-04251278 , version 1 (20-10-2023)

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Jaap C Reijneveld, Abigirl Machingura, Corneel Coens, Martin J.B. Taphoorn, Walter Taal, et al.. Health-related quality-of-life results from the randomised phase II TAVAREC trial on temozolomide with or without bevacizumab in 1p/19q intact first-recurrence World Health Organization grade 2 and 3 glioma (European Organization for Research and Treatment of Cancer 26091). European Journal of Cancer, 2023, 190, pp.112946. ⟨10.1016/j.ejca.2023.112946⟩. ⟨hal-04251278⟩
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