A combined analysis of two prospective randomised studies exploring the impact of extended post-radiation temozolomide on survival outcomes in newly diagnosed glioblastoma

被引：2

作者：

Gately, L. ^{[1
,2
]}

Mesia, C. ^{[3
]}

Sepulveda, J. M. ^{[4
]}

del Barco, S. ^{[5
]}

Pineda, E. ^{[6
]}

Girones, R. ^{[7
]}

Fuster, J. ^{[8
]}

Hong, W. ^{[1
]}

Dumas, M. ^{[1
]}

Gill, S. ^{[2
]}

Navarro, L. M. ^{[9
]}

Herrero, A. ^{[10
]}

Dowling, A. ^{[11
]}

de las Penas, R. ^{[12
]}

Vaz, M. A. ^{[13
]}

Alonso, M. ^{[14
]}

Lwin, Z. ^{[15
]}

Harrup, R. ^{[16
]}

Peralta, S. ^{[17
]}

Long, A. ^{[18
]}

Perez-Segura, P. ^{[19
]}

Ahern, E. ^{[20
]}

Garate, C. O. ^{[21
]}

Wong, M. ^{[22
]}

Campbell, R. ^{[23
]}

Cuff, K. ^{[24
]}

Jennens, R. ^{[25
]}

Gallego, O. ^{[26
]}

Underhill, C. ^{[27
]}

Martinez-Garcia, M. ^{[28
]}

Covela, M. ^{[29
]}

Cooper, A. ^{[30
]}

Brown, S. ^{[31
]}

Rosenthal, M. ^{[32
]}

Torres, J. ^{[33
]}

Collins, I. M. ^{[34
]}

Gibbs, P. ^{[1
]}

Balana, C. ^{[35
,36
]}

机构：

[1] Walter & Eliza Hall Inst Med Res, Personalised Oncol Div, Melbourne, Vic, Australia

[2] Alfred Hlth, Dept Med Oncol, Melbourne, Vic, Australia

[3] Inst Catala Oncol, Med Oncol Serv, Barcelona, Spain

[4] Hosp Univ 12 Octubre, Med Oncol Serv, Madrid, Spain

[5] Inst Catala Oncol Girona, Med Oncol Serv, Girona, Spain

[6] Hosp Clin Barcelona, Med Oncol Serv, Barcelona, Spain

[7] Hosp Univ La Fe, Med Oncol Serv, Valencia, Spain

[8] Hosp Son Espases, Med Oncol Serv, Palma De Mallorca, Spain

[9] Hosp Salamanca, Med Oncol Serv, Salamanca, Spain

[10] Hosp Miguel Servet, Med Oncol Serv, Zaragoza, Spain

[11] St Vincents Hosp Melbourne, Dept Med Oncol, Melbourne, Vic, Australia

[12] Hosp Prov Castellon, Med Oncol Serv, Castellon de La Plana, Spain

[13] Hosp Ramon & Cajal, Med Oncol Serv, Madrid, Spain

[14] Hosp Virgen del Rocio, Med Oncol Serv, Seville, Spain

[15] Royal Brisbane & Womens Hosp, Dept Med Oncol, Brisbane, Qld, Australia

[16] Royal Hobart Hosp, Dept Med Oncol, Hobart, Tas, Australia

[17] Hosp St Joan de Reus, Med Oncol Serv, Reus, Spain

[18] Sir Charles Gairdner Hosp, Dept Med Oncol, Perth, WA, Australia

[19] Hosp Clin San Carlos, Med Oncol Serv, Madrid, Spain

[20] Monash Hlth, Dept Med Oncol, Melbourne, Vic, Australia

[21] Hosp Univ Fdn Alcorcon, Med Oncol Serv, Alcorcon, Spain

[22] Westmead Hosp, Dept Med Oncol, Westmead, NSW, Australia

[23] Bendigo Hlth, Dept Med Oncol, Bendigo, Vic, Australia

[24] Princess Alexandra Hosp, Dept Med Oncol, Brisbane, Qld, Australia

[25] Epworth Hlth, Dept Med Oncol, Richmond, Vic, Australia

[26] Hosp Santa Creu & Sant Pau, Med Oncol Serv, Barcelona, Spain

[27] Border Med Oncol, Dept Med Oncol, East Albury, NSW, Australia

[28] Hosp del Mar, Med Oncol Serv, Barcelona, Spain

[29] Hosp Lucus Augusti, Med Oncol Serv, Lugo, Spain

[30] Liverpool Hosp, Dept Med Oncol, Liverpool, NSW, Australia

[31] Ballarat Hlth Serv, Dept Med Oncol, Ballarat, Vic, Australia

[32] Peter MacCallum Canc Ctr, Dept Med Oncol, Melbourne, Vic, Australia

[33] Goulburn Valley Hlth, Dept Med Oncol, Shepparton, Vic, Australia

[34] South West Reg Canc Ctr, Dept Med Oncol, Geelong, Vic, Australia

[35] Inst Catala Oncol, Med Oncol Serv, Badalona, Spain

[36] Inst Invest Germans Trias & Pujol IGTP, Badalona Appl Res Grp Oncol B ARGO, Badalona, Spain

来源：

JOURNAL OF NEURO-ONCOLOGY | 2024年 / 166卷 / 03期

关键词：

ADJUVANT TEMOZOLOMIDE; PHASE-II; 6; CYCLES; BEVACIZUMAB; TRIAL; THERAPY; SAFETY;

D O I：

10.1007/s11060-023-04513-1

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

PurposeThe optimal duration of post-radiation temozolomide in newly diagnosed glioblastoma remains unclear, with no published phase III randomised trials. Standard-of-care stipulates 6 months. However, in routine care, it is often extended to 12 months, despite lacking robust supporting data.MethodsGEINO14-01 (Spain) and EX-TEM (Australia) studies enrolled glioblastoma patients without progression at the end of 6 months post-radiation temozolomide. Participants were randomised 1:1 to six additional months of temozolomide or observation. Primary endpoint was 6-month progression free survival from date of randomisation (6mPFS). Secondary endpoints included overall survival (OS) and toxicity. 204 patients were required to detect an improvement in 6mPFS from 50 to 60% (80% power). Neither study recruited sufficient patients. We performed a combined analysis of individual patient data.Journal instruction requires a city for affiliations; however, these was missing in affiliations [1, 2, 11,15, 16, 18,20, 22, 23, 24, 25, 27, 30, 31, 32, 33, 34]. Please verify if the provided city is correct and amend if necessary.CompletedResults205 patients were recruited: 159 in GEINO14-01 (2014-2018) and 46 in EX-TEM (2019-2022). Median follow-up was 20.0 and 14.5 months. Baseline characteristics were balanced. There was no significant improvement in 6mPFS (57.2% vs 64.0%, OR0.75, p = 0.4), nor across any subgroups, including MGMT methylated; PFS (HR0.92, p = 0.59, median 7.8 vs 9.7 months); or OS (HR1.03, p = 0.87, median 20.1 vs 19.4 months). During treatment extension, 64% experienced any grade adverse event, mainly fatigue and gastrointestinal (both 54%). Only a minority required treatment changes: 4.5% dose delay, 7.5% dose reduction, 1.5% temozolomide discontinuation.As keywords are mandatory for this journal, please provide 3-6 keywordsglioblastoma; temozolomide; survivalConclusionFor glioblastoma patients, extending post-radiation temozolomide from 6 to 12 months is well tolerated but does not improve 6mPFS. We could not identify any subset that benefitted from extended treatment. Six months should remain standard-of-care.

引用

页码：407 / 415

页数：9

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