Table 2.
Key Late-Phase Clinical Trials for Newly Diagnosed Glioblastoma
Trial Designation | Author | Year | Phase | n | Age | Study Design | Median OS | Median PFS |
---|---|---|---|---|---|---|---|---|
N/A | Walker[116] | 1978 | III | 222 | NR |
HGG patients BCNU/RT+ BCNU vs BCNU vs RT vs Supportive care |
34.5 wks vs 18.5 wks vs 35 wks vs 14 wks | NR |
N/A | Westphal[117] | 2003 | III | 240 | 18–65 y |
HGG patients BCNU-wafers + RT vs Placebo-wafers + RT |
13.9 mo vs 11.6 mo in HGG patients 13.5 mo vs 11.4 mo in GBM subgroup |
5.9 mo vs 5.9 mo in HGG patients |
EORTC 26981/22981; NCIC CE3 |
Stupp[63–64] | 2005 | III | 573 | 18–71 y | RT/TMZ + TMZ vs RT | 14.6 mo vs 12.1 mo | 6.9 mo vs 5.1 mo |
N/A | Keime-Guibert[61] | 2007 | N/A | 85 | ≥ 70y | RT/supportive care vs Supportive care | 29.1 wks vs 16.9 wks | 14.9 wks vs 5.4 wks |
RTOG 0525 | Gilbert[72] | 2013 | III | 833 | ≥ 18 y | RT/TMZ + TMZ [150–200 mg/m2/d for 5/28 d) vs RT/TMZ + TMZ (75 mg/m2/d for 21/28 d] | 16.6 mo vs 14.9 mo | 5.5 mo vs 6.7 mo |
RTOG 0825 | Gilbert[73] | 2014 | III | 637 | ≥ 18 y | RT/TMZ/bev + TMZ/bev vs RT/TMZ + TMZ | 15.7 mo vs 16.1 mo | 10.7 mo vs 7.3 mo |
AVAglio | Chinot[74] | 2014 | III | 921 | ≥ 18 y | RT/TMZ/bev + TMZ/bev vs RT/TMZ + TMZ | 16.8 mo vs 16.7 mo | 10.6 mo vs 6.2 mo |
CENTRIC EORTC 26071–22072 | Stupp[118] | 2014 | III | 545 | ≥ 18 y |
MGMT methylated RT/TMZ/cilengitide + TMZ/cilengitide vs RT/TMZ + TMZ |
26.3 mo vs 26.3 mo | 10.6 mo vs 7.9 mo |
GLARIUS | Herrlinger[107] | 2016 | II | 182 | NR | RT/bev + bev/CPT11 vs RT/TMZ + TMZ | 16.6 mo vs 17.5 mo | 9.7 mo vs 5.99 mo |
TMZ/rindopepimut vs TMZ | 21.1 mo vs 20.0 mo | 8.0 mo vs 7.4 mo | ||||||
TMZ/TTFields vs TMZ | 20.9 mo vs 16.0 mo | 6.7 mo vs 4.0 mo | ||||||
CCTG CE.6, EORTC 26062–22061, TROG 08.02 | Perry[82] | 2017 | III | 562 | ≥ 65 y | Short-course RT/TMZ + TMZ vs Short-course RT | 9.3 mo vs 7.6 mo | 5.3 mo vs 3.9 mo |
RT/TMZ + TMZ vs RT/CCNU/TMZ + CCNU/TMZ | 31.4 mo vs 48.1 mo | 16.7 mo vs 16.7 mo |
bev = bevacizumab; BCNU-wafers = carmustine wafers; CCNU = lomustine; CCTG = Canadian Cancer Trials Group; CPT11 = irinotecan; EORTC = European Organisation for Research and Treatment of Cancer; GBM = glioblastoma; HGG = high-grade glioma, including glioblastoma; N/A = not available; NCIC = National Cancer Information Center; NR = not reported; OS = overall survival; PFS = progression-free survival; RT = radiotherapy; RTOG = Radiation Therapy Oncology Group; TMZ = temozolomide; TROG = Trans Tasman Radiation Oncology Group; TTFields = tumor-treating fields.