Table 1:
Distribution of pre-treatment patient characteristics for the TMZ+RT arm of three clinical studies and three RWE studies.
Study | DFCI-cohort | UCLA-cohort | AVAglio | |||
---|---|---|---|---|---|---|
NCT ID | --- | |||||
PubMed ID | PM21135282 | PM25910950 | PM22120301 | PM24552318 | ||
Datatype | RWE | RWE | RWE | Phase II | Phase II | Phase III |
Arm | TMZ+RT | TMZ+RT | TMZ+RT | TMZ+RT | TMZ+RT | TMZ+RT |
Enrollment period | 8/06–11/08 | 2/09–6/11 | 8/05–2/11 | 6/09–3/11 | ||
Enrollments to SOC | 378 | 305 | 110 | 29 | 16 | 460 |
OS Events | 269 | 265 | 89 | 24 | 15 | 344 |
Age | ||||||
Median | 58 | 57 | 59 | 58 | 59 | 57 |
Range | 18–91 | 20–84 | 20–90 | 26–73 | 36–69 | 18–79 |
SD | 13 | 13 | 14 | 11 | 11 | 10 |
Sex (%) | ||||||
Females | 0.43 | 0.36 | 0.36 | 0.45 | 0.5 | 0.36 |
Males | 0.57 | 0.64 | 0.64 | 0.55 | 0.5 | 0.64 |
KPS (%) | ||||||
<=80 | 0.55 | 0.39 | 0.32 | 0.24 | 0.44 | 0.31 |
>80 | 0.45 | 0.61 | 0.68 | 0.76 | 0.56 | 0.69 |
Data missing (n) | 27 | 17 | 0 | 0 | 0 | 0 |
RPA (%) | ||||||
3 | NA | 0.22 | 0.25 | NA | 0.12 | 0.16 |
4 | NA | 0.42 | 0.41 | NA | 0.75 | 0.61 |
5 | NA | 0.34 | 0.33 | NA | 0.13 | 0.23 |
6 | NA | 0.02 | 0.01 | NA | 0 | 0 |
Data missing (n) | 378 | 0 | 0 | 29 | 1 | 0 |
Resection (%) | ||||||
Biopsy | 0.14 | 0.22 | 0.21 | 0.21 | 0 | 0.09 |
Sub Total | 0.47 | 0.47 | 0.36 | 0.48 | 0.31 | 0.49 |
Gross Total | 0.39 | 0.31 | 0.43 | 0.31 | 0.69 | 0.42 |
Data missing (n) | 12 | 15 | 0 | 0 | 0 | 0 |
MGMT (%) | ||||||
Unmethylated | 0.43 | 0.71 | 0.60 | 0.86 | 0.43 | 0.67 |
Methylated | 0.57 | 0.29 | 0.40 | 0.14 | 0.56 | 0.32 |
Data missing (n) | 194 | 128 | 40 | 7 | 0 | 0.23 |
IDH1 (%) | ||||||
Wildtype | 0.91 | 0.91 | 0.98 | 0.83 | NA | NA |
Mutant | 0.09 | 0.09 | 0.02 | 0.17 | NA | NA |
Data missing (n) | 188 | 0.46 | 52 | 6 | 16 | 344 |
Abbreviations: KPS, Karnofsky performance status; MGMT, O6-methylguanine-DNA methyltransferase; RPA, recursive partitioning analysis; IDH1, isocitrate dehydrogenase 1.