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)

doi:10.1016/j.ejca.2023.112946

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)

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Abstract

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.

Original language	English
Article number	112946
Pages (from-to)	1-15
Journal	European Journal of Cancer
Volume	190
Early online date	19 Jun 2023
DOIs	https://doi.org/10.1016/j.ejca.2023.112946
Publication status	Published - Sept 2023

Keywords

Bevacizumab
EORTC
Glioma
Health-related quality of life
RCTs
Temozolomide

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(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). European Journal of Cancer, 190, 1-15. Article 112946. https://doi.org/10.1016/j.ejca.2023.112946

@article{b256fbb5d091454388b4211150436e8e,

title = "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)",

abstract = "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.",

keywords = "Bevacizumab, EORTC, Glioma, Health-related quality of life, RCTs, Temozolomide",

author = "Reijneveld, {Jaap C} and Abigirl Machingura and Corneel Coens and Taphoorn, {Martin J B} and Walter Taal and Clement, {Paul M} and Ahmed Idbaih and {de Vos}, {Filip Y F} and Martin Klein and Wolfgang Wick and Mulholland, {Paul J} and Joanne Lewis and Vassilis Golfinopoulos and Irina Ghislain and Andrew Bottomley and {van den Bent}, {Martin J}",

note = "Funding Information: The trial was supported by an unrestricted educational grant and free supply of BEV by Roche. The drug manufacturer was not involved in trial design, data collection or analysis, interpretation of the data, nor in the writing of this report. JCR, CC, AB, MT and MvdB had full access to all of the data and the final responsibility to submit for publication. Funding Information: We thank all patients and their relatives for their willingness to participate in this clinical trial. We thank the European Organisation for Research and Treatment of Cancer (EORTC) Cancer Research Fund and EORTC staff for their invaluable assistance and support of this trial (Roxana Albu, Pieter Jespers, Jelena Laverty, Sylvie Ledroit, Sara Meloen, Jean-Paul Nzanzu, Christine Olungu, Nabila Sebti, Thibault Smets, Zineb Wadid and Lorraine Wheeler). We also thank all trial staff at the participating sites and the staff at Roche involved in this study. Publisher Copyright: {\textcopyright} 2023 The Authors",

year = "2023",

month = sep,

doi = "10.1016/j.ejca.2023.112946",

language = "English",

volume = "190",

pages = "1--15",

journal = "European Journal of Cancer",

issn = "0959-8049",

publisher = "Elsevier Limited",

}

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)', European Journal of Cancer, vol. 190, 112946, pp. 1-15. https://doi.org/10.1016/j.ejca.2023.112946

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - 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)

AU - Reijneveld, Jaap C

AU - Machingura, Abigirl

AU - Coens, Corneel

AU - Taphoorn, Martin J B

AU - Taal, Walter

AU - Clement, Paul M

AU - Idbaih, Ahmed

AU - de Vos, Filip Y F

AU - Klein, Martin

AU - Wick, Wolfgang

AU - Mulholland, Paul J

AU - Lewis, Joanne

AU - Golfinopoulos, Vassilis

AU - Ghislain, Irina

AU - Bottomley, Andrew

AU - van den Bent, Martin J

N1 - Funding Information: The trial was supported by an unrestricted educational grant and free supply of BEV by Roche. The drug manufacturer was not involved in trial design, data collection or analysis, interpretation of the data, nor in the writing of this report. JCR, CC, AB, MT and MvdB had full access to all of the data and the final responsibility to submit for publication. Funding Information: We thank all patients and their relatives for their willingness to participate in this clinical trial. We thank the European Organisation for Research and Treatment of Cancer (EORTC) Cancer Research Fund and EORTC staff for their invaluable assistance and support of this trial (Roxana Albu, Pieter Jespers, Jelena Laverty, Sylvie Ledroit, Sara Meloen, Jean-Paul Nzanzu, Christine Olungu, Nabila Sebti, Thibault Smets, Zineb Wadid and Lorraine Wheeler). We also thank all trial staff at the participating sites and the staff at Roche involved in this study. Publisher Copyright: © 2023 The Authors

PY - 2023/9

Y1 - 2023/9

N2 - 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.

AB - 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.

KW - Bevacizumab

KW - EORTC

KW - Glioma

KW - Health-related quality of life

KW - RCTs

KW - Temozolomide

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JO - European Journal of Cancer

JF - European Journal of Cancer

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