作者
Mark R Gilbert, James Dignam, Minhee Won, Deborah T Blumenthal, Michael A Vogelbaum, Kenneth D Aldape, Howard Colman, Arnab Chakravarti, Robert Jeraj, Terri S Armstrong, Jeffrey Scott Wefel, Paul D Brown, Kurt A Jaeckle, David Schiff, James Norman Atkins, David Brachman, Maria Werner-Wasik, Ritsuko Komaki, Erik P Sulman, Minesh P Mehta
发表日期
2013/6/20
来源
Journal of Clinical Oncology
卷号
31
期号
18_suppl
页码范围
1-1
出版商
American Society of Clinical Oncology
简介
1
Background: Chemoradiation (CRT) with temozolomide (TMZ/RT→TMZ) is the standard of care for newly diagnosed GBM. This trial determined if the addition of Bev to standard CRT improves survival (OS) or progression-free survival (PFS) in newly diagnosed GBM. Methods: This phase III trial was conducted by the RTOG, NCCTG, and ECOG. Neurologically stable pts > 18 yrs with KPS ≥ 60, and > 1cm3 tumor tissue block, were randomized to Arm 1: standard CRT + placebo or Arm 2: standard CRT plus Bev (10 mg/kg iv q 2wks). Experimental treatment began at wk 4 of radiation then thru 6-12 cycles of maintenance chemotherapy. Protocol specified co-primary endpoints were OS and PFS, with significance levels of .023 and .002, respectively. At progression, treatment was unblinded and pts allowed to crossover or continue Bev. Symptom, QOL and neurocognitive (NCF) testing was performed in the …
引用总数
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