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)

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 radiothe...
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Autor*in:	Reijneveld, Jaap C. [verfasserIn] Machingura, Abigirl [verfasserIn] Coens, Corneel [verfasserIn] Taphoorn, Martin J. B. [verfasserIn] Taal, Walter [verfasserIn] Clement, Paul M. [verfasserIn] Idbaih, Ahmed [verfasserIn] de Vos, Filip Y. F. [verfasserIn] Klein, Martin [verfasserIn] Wick, Wolfgang - 1970- [verfasserIn] Mulholland, Paul J. [verfasserIn] Lewis, Joanne [verfasserIn] Golfinopoulos, Vassilis [verfasserIn] Ghislain, Irina [verfasserIn] Bottomley, Andrew [verfasserIn] van den Bent, Martin J. [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	September 2023

Schlagwörter:	Bevacizumab EORTC Glioma Health-related quality of life RCTs Temozolomide

Anmerkung:	Online verfügbar: 19. Juni 2023, Artikelversion: 13. Juli 2023 Gesehen am 11.10.2023
Umfang:	Illustrationen 15

Übergeordnetes Werk:	Enthalten in: European journal of cancer - Amsterdam [u.a.] : Elsevier, 1992, 190(2023) vom: Sept., Artikel-ID 112946, Seite 1-15
Übergeordnetes Werk:	volume:190 ; year:2023 ; month:09 ; elocationid:112946 ; pages:1-15 ; extent:15

Links:	Volltext Volltext

DOI / URN:	10.1016/j.ejca.2023.112946

Katalog-ID:	1861514581

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245	1	0	\|a 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) \|c Jaap C. Reijneveld, Abigirl Machingura, Corneel Coens, Martin J. B. Taphoorn, Walter Taal, Paul M. Clement, Ahmed Idbaih, Filip Y. F. de Vos, Martin Klein, Wolfgang Wick, Paul J. Mulholland, Joanne Lewis, Vassilis Golfinopoulos, Irina Ghislain, Andrew Bottomley, Martin J. van den Bent, on behalf of the EORTC Brain Tumor Group
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520			\|a 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.
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700	1		\|a Ghislain, Irina \|e verfasserin \|4 aut
700	1		\|a Bottomley, Andrew \|e verfasserin \|4 aut
700	1		\|a van den Bent, Martin J. \|e verfasserin \|4 aut
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allfields	10.1016/j.ejca.2023.112946 doi (DE-627)1861514581 (DE-599)KXP1861514581 (OCoLC)1425210755 DE-627 ger DE-627 rda eng Reijneveld, Jaap C. verfasserin (DE-588)1243671963 (DE-627)1774659212 aut 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, Abigirl Machingura, Corneel Coens, Martin J. B. Taphoorn, Walter Taal, Paul M. Clement, Ahmed Idbaih, Filip Y. F. de Vos, Martin Klein, Wolfgang Wick, Paul J. Mulholland, Joanne Lewis, Vassilis Golfinopoulos, Irina Ghislain, Andrew Bottomley, Martin J. van den Bent, on behalf of the EORTC Brain Tumor Group September 2023 Illustrationen 15 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Online verfügbar: 19. Juni 2023, Artikelversion: 13. Juli 2023 Gesehen am 11.10.2023 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. Bevacizumab EORTC Glioma Health-related quality of life RCTs Temozolomide Machingura, Abigirl verfasserin aut Coens, Corneel verfasserin aut Taphoorn, Martin J. B. verfasserin aut Taal, Walter verfasserin aut Clement, Paul M. verfasserin aut Idbaih, Ahmed verfasserin aut de Vos, Filip Y. F. verfasserin aut Klein, Martin verfasserin aut Wick, Wolfgang 1970- verfasserin (DE-588)120297736 (DE-627)080586929 (DE-576)186221320 aut Mulholland, Paul J. verfasserin aut Lewis, Joanne verfasserin aut Golfinopoulos, Vassilis verfasserin aut Ghislain, Irina verfasserin aut Bottomley, Andrew verfasserin aut van den Bent, Martin J. verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1992 190(2023) vom: Sept., Artikel-ID 112946, Seite 1-15 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-0852 nnns volume:190 year:2023 month:09 elocationid:112946 pages:1-15 extent:15 https://doi.org/10.1016/j.ejca.2023.112946 Verlag Resolving-System kostenfrei Volltext https://www.sciencedirect.com/science/article/pii/S0959804923002988 Verlag kostenfrei Volltext GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 GBV_ILN_2403 GBV_ILN_2403 ISIL_DE-LFER AR 190 2023 9 112946 1-15 15 2013 01 DE-16-250 4383905919 00 --%%-- --%%-- --%%-- --%%-- l01 11-10-23 2403 01 DE-LFER 4404110332 00 --%%-- --%%-- n --%%-- l01 08-11-23 2403 01 DE-LFER https://doi.org/10.1016/j.ejca.2023.112946 2403 01 DE-LFER https://www.sciencedirect.com/science/article/pii/S0959804923002988 2013 01 DE-16-250 00 s hd2023 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_16 2013 01 DE-16-250 03 s s_15 2013 01 DE-16-250 04 p (DE-627)1450189326 Wick, Wolfgang 2013 01 DE-16-250 04 k (DE-627)1416741267 Neurologische Universitätsklinik 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_10
spelling	10.1016/j.ejca.2023.112946 doi (DE-627)1861514581 (DE-599)KXP1861514581 (OCoLC)1425210755 DE-627 ger DE-627 rda eng Reijneveld, Jaap C. verfasserin (DE-588)1243671963 (DE-627)1774659212 aut 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, Abigirl Machingura, Corneel Coens, Martin J. B. Taphoorn, Walter Taal, Paul M. Clement, Ahmed Idbaih, Filip Y. F. de Vos, Martin Klein, Wolfgang Wick, Paul J. Mulholland, Joanne Lewis, Vassilis Golfinopoulos, Irina Ghislain, Andrew Bottomley, Martin J. van den Bent, on behalf of the EORTC Brain Tumor Group September 2023 Illustrationen 15 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Online verfügbar: 19. Juni 2023, Artikelversion: 13. Juli 2023 Gesehen am 11.10.2023 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. Bevacizumab EORTC Glioma Health-related quality of life RCTs Temozolomide Machingura, Abigirl verfasserin aut Coens, Corneel verfasserin aut Taphoorn, Martin J. B. verfasserin aut Taal, Walter verfasserin aut Clement, Paul M. verfasserin aut Idbaih, Ahmed verfasserin aut de Vos, Filip Y. F. verfasserin aut Klein, Martin verfasserin aut Wick, Wolfgang 1970- verfasserin (DE-588)120297736 (DE-627)080586929 (DE-576)186221320 aut Mulholland, Paul J. verfasserin aut Lewis, Joanne verfasserin aut Golfinopoulos, Vassilis verfasserin aut Ghislain, Irina verfasserin aut Bottomley, Andrew verfasserin aut van den Bent, Martin J. verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1992 190(2023) vom: Sept., Artikel-ID 112946, Seite 1-15 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-0852 nnns volume:190 year:2023 month:09 elocationid:112946 pages:1-15 extent:15 https://doi.org/10.1016/j.ejca.2023.112946 Verlag Resolving-System kostenfrei Volltext https://www.sciencedirect.com/science/article/pii/S0959804923002988 Verlag kostenfrei Volltext GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 GBV_ILN_2403 GBV_ILN_2403 ISIL_DE-LFER AR 190 2023 9 112946 1-15 15 2013 01 DE-16-250 4383905919 00 --%%-- --%%-- --%%-- --%%-- l01 11-10-23 2403 01 DE-LFER 4404110332 00 --%%-- --%%-- n --%%-- l01 08-11-23 2403 01 DE-LFER https://doi.org/10.1016/j.ejca.2023.112946 2403 01 DE-LFER https://www.sciencedirect.com/science/article/pii/S0959804923002988 2013 01 DE-16-250 00 s hd2023 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_16 2013 01 DE-16-250 03 s s_15 2013 01 DE-16-250 04 p (DE-627)1450189326 Wick, Wolfgang 2013 01 DE-16-250 04 k (DE-627)1416741267 Neurologische Universitätsklinik 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_10
allfields_unstemmed	10.1016/j.ejca.2023.112946 doi (DE-627)1861514581 (DE-599)KXP1861514581 (OCoLC)1425210755 DE-627 ger DE-627 rda eng Reijneveld, Jaap C. verfasserin (DE-588)1243671963 (DE-627)1774659212 aut 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, Abigirl Machingura, Corneel Coens, Martin J. B. Taphoorn, Walter Taal, Paul M. Clement, Ahmed Idbaih, Filip Y. F. de Vos, Martin Klein, Wolfgang Wick, Paul J. Mulholland, Joanne Lewis, Vassilis Golfinopoulos, Irina Ghislain, Andrew Bottomley, Martin J. van den Bent, on behalf of the EORTC Brain Tumor Group September 2023 Illustrationen 15 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Online verfügbar: 19. Juni 2023, Artikelversion: 13. Juli 2023 Gesehen am 11.10.2023 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. Bevacizumab EORTC Glioma Health-related quality of life RCTs Temozolomide Machingura, Abigirl verfasserin aut Coens, Corneel verfasserin aut Taphoorn, Martin J. B. verfasserin aut Taal, Walter verfasserin aut Clement, Paul M. verfasserin aut Idbaih, Ahmed verfasserin aut de Vos, Filip Y. F. verfasserin aut Klein, Martin verfasserin aut Wick, Wolfgang 1970- verfasserin (DE-588)120297736 (DE-627)080586929 (DE-576)186221320 aut Mulholland, Paul J. verfasserin aut Lewis, Joanne verfasserin aut Golfinopoulos, Vassilis verfasserin aut Ghislain, Irina verfasserin aut Bottomley, Andrew verfasserin aut van den Bent, Martin J. verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1992 190(2023) vom: Sept., Artikel-ID 112946, Seite 1-15 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-0852 nnns volume:190 year:2023 month:09 elocationid:112946 pages:1-15 extent:15 https://doi.org/10.1016/j.ejca.2023.112946 Verlag Resolving-System kostenfrei Volltext https://www.sciencedirect.com/science/article/pii/S0959804923002988 Verlag kostenfrei Volltext GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 GBV_ILN_2403 GBV_ILN_2403 ISIL_DE-LFER AR 190 2023 9 112946 1-15 15 2013 01 DE-16-250 4383905919 00 --%%-- --%%-- --%%-- --%%-- l01 11-10-23 2403 01 DE-LFER 4404110332 00 --%%-- --%%-- n --%%-- l01 08-11-23 2403 01 DE-LFER https://doi.org/10.1016/j.ejca.2023.112946 2403 01 DE-LFER https://www.sciencedirect.com/science/article/pii/S0959804923002988 2013 01 DE-16-250 00 s hd2023 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_16 2013 01 DE-16-250 03 s s_15 2013 01 DE-16-250 04 p (DE-627)1450189326 Wick, Wolfgang 2013 01 DE-16-250 04 k (DE-627)1416741267 Neurologische Universitätsklinik 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_10
allfieldsGer	10.1016/j.ejca.2023.112946 doi (DE-627)1861514581 (DE-599)KXP1861514581 (OCoLC)1425210755 DE-627 ger DE-627 rda eng Reijneveld, Jaap C. verfasserin (DE-588)1243671963 (DE-627)1774659212 aut 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, Abigirl Machingura, Corneel Coens, Martin J. B. Taphoorn, Walter Taal, Paul M. Clement, Ahmed Idbaih, Filip Y. F. de Vos, Martin Klein, Wolfgang Wick, Paul J. Mulholland, Joanne Lewis, Vassilis Golfinopoulos, Irina Ghislain, Andrew Bottomley, Martin J. van den Bent, on behalf of the EORTC Brain Tumor Group September 2023 Illustrationen 15 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Online verfügbar: 19. Juni 2023, Artikelversion: 13. Juli 2023 Gesehen am 11.10.2023 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. Bevacizumab EORTC Glioma Health-related quality of life RCTs Temozolomide Machingura, Abigirl verfasserin aut Coens, Corneel verfasserin aut Taphoorn, Martin J. B. verfasserin aut Taal, Walter verfasserin aut Clement, Paul M. verfasserin aut Idbaih, Ahmed verfasserin aut de Vos, Filip Y. F. verfasserin aut Klein, Martin verfasserin aut Wick, Wolfgang 1970- verfasserin (DE-588)120297736 (DE-627)080586929 (DE-576)186221320 aut Mulholland, Paul J. verfasserin aut Lewis, Joanne verfasserin aut Golfinopoulos, Vassilis verfasserin aut Ghislain, Irina verfasserin aut Bottomley, Andrew verfasserin aut van den Bent, Martin J. verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1992 190(2023) vom: Sept., Artikel-ID 112946, Seite 1-15 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-0852 nnns volume:190 year:2023 month:09 elocationid:112946 pages:1-15 extent:15 https://doi.org/10.1016/j.ejca.2023.112946 Verlag Resolving-System kostenfrei Volltext https://www.sciencedirect.com/science/article/pii/S0959804923002988 Verlag kostenfrei Volltext GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 GBV_ILN_2403 GBV_ILN_2403 ISIL_DE-LFER AR 190 2023 9 112946 1-15 15 2013 01 DE-16-250 4383905919 00 --%%-- --%%-- --%%-- --%%-- l01 11-10-23 2403 01 DE-LFER 4404110332 00 --%%-- --%%-- n --%%-- l01 08-11-23 2403 01 DE-LFER https://doi.org/10.1016/j.ejca.2023.112946 2403 01 DE-LFER https://www.sciencedirect.com/science/article/pii/S0959804923002988 2013 01 DE-16-250 00 s hd2023 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_16 2013 01 DE-16-250 03 s s_15 2013 01 DE-16-250 04 p (DE-627)1450189326 Wick, Wolfgang 2013 01 DE-16-250 04 k (DE-627)1416741267 Neurologische Universitätsklinik 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_10
allfieldsSound	10.1016/j.ejca.2023.112946 doi (DE-627)1861514581 (DE-599)KXP1861514581 (OCoLC)1425210755 DE-627 ger DE-627 rda eng Reijneveld, Jaap C. verfasserin (DE-588)1243671963 (DE-627)1774659212 aut 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, Abigirl Machingura, Corneel Coens, Martin J. B. Taphoorn, Walter Taal, Paul M. Clement, Ahmed Idbaih, Filip Y. F. de Vos, Martin Klein, Wolfgang Wick, Paul J. Mulholland, Joanne Lewis, Vassilis Golfinopoulos, Irina Ghislain, Andrew Bottomley, Martin J. van den Bent, on behalf of the EORTC Brain Tumor Group September 2023 Illustrationen 15 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Online verfügbar: 19. Juni 2023, Artikelversion: 13. Juli 2023 Gesehen am 11.10.2023 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. Bevacizumab EORTC Glioma Health-related quality of life RCTs Temozolomide Machingura, Abigirl verfasserin aut Coens, Corneel verfasserin aut Taphoorn, Martin J. B. verfasserin aut Taal, Walter verfasserin aut Clement, Paul M. verfasserin aut Idbaih, Ahmed verfasserin aut de Vos, Filip Y. F. verfasserin aut Klein, Martin verfasserin aut Wick, Wolfgang 1970- verfasserin (DE-588)120297736 (DE-627)080586929 (DE-576)186221320 aut Mulholland, Paul J. verfasserin aut Lewis, Joanne verfasserin aut Golfinopoulos, Vassilis verfasserin aut Ghislain, Irina verfasserin aut Bottomley, Andrew verfasserin aut van den Bent, Martin J. verfasserin aut Enthalten in European journal of cancer Amsterdam [u.a.] : Elsevier, 1992 190(2023) vom: Sept., Artikel-ID 112946, Seite 1-15 (DE-627)266883400 (DE-600)1468190-0 (DE-576)090954173 1879-0852 nnns volume:190 year:2023 month:09 elocationid:112946 pages:1-15 extent:15 https://doi.org/10.1016/j.ejca.2023.112946 Verlag Resolving-System kostenfrei Volltext https://www.sciencedirect.com/science/article/pii/S0959804923002988 Verlag kostenfrei Volltext GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 GBV_ILN_2403 GBV_ILN_2403 ISIL_DE-LFER AR 190 2023 9 112946 1-15 15 2013 01 DE-16-250 4383905919 00 --%%-- --%%-- --%%-- --%%-- l01 11-10-23 2403 01 DE-LFER 4404110332 00 --%%-- --%%-- n --%%-- l01 08-11-23 2403 01 DE-LFER https://doi.org/10.1016/j.ejca.2023.112946 2403 01 DE-LFER https://www.sciencedirect.com/science/article/pii/S0959804923002988 2013 01 DE-16-250 00 s hd2023 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_16 2013 01 DE-16-250 03 s s_15 2013 01 DE-16-250 04 p (DE-627)1450189326 Wick, Wolfgang 2013 01 DE-16-250 04 k (DE-627)1416741267 Neurologische Universitätsklinik 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_10
language	English
source	Enthalten in European journal of cancer 190(2023) vom: Sept., Artikel-ID 112946, Seite 1-15 volume:190 year:2023 month:09 elocationid:112946 pages:1-15 extent:15
sourceStr	Enthalten in European journal of cancer 190(2023) vom: Sept., Artikel-ID 112946, Seite 1-15 volume:190 year:2023 month:09 elocationid:112946 pages:1-15 extent:15
format_phy_str_mv	Article
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institution	findex.gbv.de
selectbib_iln_str_mv	2013@01 2403@01
topic_facet	Bevacizumab EORTC Glioma Health-related quality of life RCTs Temozolomide
sw_local_iln_str_mv	2013:hd2023 DE-16-250:hd2023 2013:wissenschaftlicher Artikel (Zeitschrift) DE-16-250:wissenschaftlicher Artikel (Zeitschrift) 2013:per_16 DE-16-250:per_16 2013:s_15 DE-16-250:s_15 2013:Wick, Wolfgang DE-16-250:Wick, Wolfgang 2013:Neurologische Universitätsklinik DE-16-250:Neurologische Universitätsklinik 2013:Verfasser DE-16-250:Verfasser 2013:pos_10 DE-16-250:pos_10
isfreeaccess_bool	true
container_title	European journal of cancer
authorswithroles_txt_mv	Reijneveld, Jaap C. @@aut@@ Machingura, Abigirl @@aut@@ Coens, Corneel @@aut@@ Taphoorn, Martin J. B. @@aut@@ Taal, Walter @@aut@@ Clement, Paul M. @@aut@@ Idbaih, Ahmed @@aut@@ de Vos, Filip Y. F. @@aut@@ Klein, Martin @@aut@@ Wick, Wolfgang @@aut@@ Mulholland, Paul J. @@aut@@ Lewis, Joanne @@aut@@ Golfinopoulos, Vassilis @@aut@@ Ghislain, Irina @@aut@@ Bottomley, Andrew @@aut@@ van den Bent, Martin J. @@aut@@
publishDateDaySort_date	2023-09-01T00:00:00Z
hierarchy_top_id	266883400
id	1861514581
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a2200265 4500</leader><controlfield tag="001">1861514581</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20240329080824.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">231011s2023 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.ejca.2023.112946</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)1861514581</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)KXP1861514581</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)1425210755</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Reijneveld, Jaap C.</subfield><subfield code="e">verfasserin</subfield><subfield code="0">(DE-588)1243671963</subfield><subfield code="0">(DE-627)1774659212</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">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)</subfield><subfield code="c">Jaap C. Reijneveld, Abigirl Machingura, Corneel Coens, Martin J. B. Taphoorn, Walter Taal, Paul M. Clement, Ahmed Idbaih, Filip Y. F. de Vos, Martin Klein, Wolfgang Wick, Paul J. Mulholland, Joanne Lewis, Vassilis Golfinopoulos, Irina Ghislain, Andrew Bottomley, Martin J. van den Bent, on behalf of the EORTC Brain Tumor Group</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">September 2023</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="b">Illustrationen</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">15</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Online verfügbar: 19. Juni 2023, Artikelversion: 13. Juli 2023</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Gesehen am 11.10.2023</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Bevacizumab</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">EORTC</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Glioma</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Health-related quality of life</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">RCTs</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Temozolomide</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Machingura, Abigirl</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Coens, Corneel</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Taphoorn, Martin J. 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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)
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title_full	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, Abigirl Machingura, Corneel Coens, Martin J. B. Taphoorn, Walter Taal, Paul M. Clement, Ahmed Idbaih, Filip Y. F. de Vos, Martin Klein, Wolfgang Wick, Paul J. Mulholland, Joanne Lewis, Vassilis Golfinopoulos, Irina Ghislain, Andrew Bottomley, Martin J. van den Bent, on behalf of the EORTC Brain Tumor Group
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author_browse	Reijneveld, Jaap C. Machingura, Abigirl Coens, Corneel Taphoorn, Martin J. B. Taal, Walter Clement, Paul M. Idbaih, Ahmed de Vos, Filip Y. F. Klein, Martin Wick, Wolfgang Mulholland, Paul J. Lewis, Joanne Golfinopoulos, Vassilis Ghislain, Irina Bottomley, Andrew van den Bent, Martin J.
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title_sort	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)
title_auth	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. Online verfügbar: 19. Juni 2023, Artikelversion: 13. Juli 2023 Gesehen am 11.10.2023
abstractGer	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. Online verfügbar: 19. Juni 2023, Artikelversion: 13. Juli 2023 Gesehen am 11.10.2023
abstract_unstemmed	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. Online verfügbar: 19. Juni 2023, Artikelversion: 13. Juli 2023 Gesehen am 11.10.2023
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title_short	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)
url	https://doi.org/10.1016/j.ejca.2023.112946 https://www.sciencedirect.com/science/article/pii/S0959804923002988
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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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