TY  - JOUR
AU  - Wirsching, H-G
AU  - Tabatabai, G.
AU  - Roelcke, U.
AU  - Hottinger, A. F.
AU  - Jörger, F.
AU  - Schmid, A.
AU  - Plasswilm, L.
AU  - Schrimpf, D.
AU  - Mancao, C.
AU  - Capper, D.
AU  - Conen, K.
AU  - Hundsberger, T.
AU  - Caparrotti, F.
AU  - von Moos, R.
AU  - Riklin, C.
AU  - Felsberg, J.
AU  - Roth, P.
AU  - Jones, David
AU  - Pfister, S.
AU  - Rushing, E. J.
AU  - Abrey, L.
AU  - Reifenberger, G.
AU  - Held, L.
AU  - von Deimling, A.
AU  - Ochsenbein, A.
AU  - Weller, M.
TI  - Bevacizumab plus hypofractionated radiotherapy versus radiotherapy alone in elderly patients with glioblastoma: the randomized, open-label, phase II ARTE trial.
JO  - Annals of oncology
VL  - 29
IS  - 6
SN  - 1569-8041
CY  - Oxford
PB  - Oxford Univ. Press
M1  - DKFZ-2019-00020
SP  - 1423 - 1430
PY  - 2018
AB  - The addition of bevacizumab to temozolomide-based chemoradiotherapy (TMZ/RT → TMZ) did not prolong overall survival (OS) in patients with newly diagnosed glioblastoma in phase III trials. Elderly and frail patients are underrepresented in clinical trials, but early reports suggested preferential benefit in this population.ARTE was a 2 : 1 randomized, multi-center, open-label, non-comparative phase II trial of hypofractionated RT (40 Gy in 15 fractions) with bevacizumab (10 mg/kg×14 days) (arm A, N = 50) or without bevacizumab (arm B, N = 25) in patients with newly diagnosed glioblastoma aged ≥65 years. The primary objective was to obtain evidence for prolongation of median OS by the addition of bevacizumab to RT. Response was assessed by RANO criteria. Quality of life (QoL) was monitored by the EORTC QLQ-C30/BN20 modules. Exploratory studies included molecular subtyping by 450k whole methylome and gene expression analyses.Median PFS was longer in arm A than in arm B (7.6 and 4.8 months, P = 0.003), but OS was similar (12.1 and 12.2 months, P = 0.77). Clinical deterioration was delayed and more patients came off steroids in arm A. Prolonged PFS in arm A was confined to tumors with the receptor tyrosine kinase (RTK) I methylation subtype (HR 0.25, P = 0.014) and proneural gene expression (HR 0.29, P = 0.025). In a Cox model of OS controlling for established prognostic factors, associations with more favorable outcome were identified for age <70 years (HR 0.52, P = 0.018) and Karnofsky performance score 90
LB  - PUB:(DE-HGF)16
C6  - pmid:29648580
DO  - DOI:10.1093/annonc/mdy120
UR  - https://inrepo02.dkfz.de/record/142206
ER  -