Table 1 Characteristics of oncology basket studies that restrict on genomic biomarker (N = 25 studies and 1966 participants)
From: Umbrella review of basket trials testing a drug in tumors with actionable genetic biomarkers
Trials, median (IQR) or n (%) | Participants, n (%) | |
|---|---|---|
Total number of participants | 48 (30–122) | 1966 (100) |
Age | 60 (58–62) | |
Percent male (n = 24 studies) | 41 (32–49) | |
Males, number (n = 24 studies) | 651 (36.9) | |
Percent female (n = 24 studies) | 59 (51–68) | |
Females, number (n = 24 studies) | 1113 (63.1) | |
Response rate % | 23.1 (8–30) | |
Progression-free survival, months (n = 16 studies) | 4 (3–5) | |
Overall survival, months (n = 13 studies) | 10 (6–14) | |
Phase (n = 24 studies) | ||
I | 1 (4.0) | 22 (1.1) |
II | 23 (92.0) | 1758 (89.4) |
Not indicated | 1 (4.0) | 186 (9.5) |
Intervention model (n = 24 studies) | ||
Randomized | 1 (4.0) | 129 (6.5) |
Single arm | 16 (64.0) | 929 (36.7) |
Parallel, not randomized | 7 (28.0) | 722 (40.6) |
Not indicated | 1 (4.0) | 186 (9.4) |
Year | ||
2001 | 1 (4.0) | 186 (9.5) |
2010 | 1 (4.0) | 298 (15.2) |
2012 | 1 (4.0) | 122 (6.2) |
2013 | 5 (20.0) | 430 (21.9) |
2014 | 5 (20.0) | 468 (23.8) |
2015 | 5 (20.0) | 85 (4.3) |
2016 | 5 (20.0) | 235 (12.0) |
2017 | 1 (4.0) | 13 (0.7) |
2018 | 1 (4.0) | 129 (6.6) |
Biomarker (N = 1839 evaluable patients participants) | ||
AKT | 35 (1.9) | |
ALK | 4 (0.2) | |
BRAF | 246 (14.1) | |
BRCA 1/2 | 298 (16.2) | |
EGFR | 9 (4.8) | |
FGFR | 48 (2.6) | |
HER2 | 292 (15.9) | |
HER3 | 16 (0.9) | |
Hedgehog | 21 (1.1) | |
KIT, PDGFRA, or PDGFRB | 170 (9.2) | |
KRAS | 129 (7.0) | |
MMR/MSI | 128 (7.0) | |
NRAS | 47 (2.6) | |
NTRK | 109 (5.9) | |
PI3K | 165 (9.0) | |
ROS1 | 4 (0.2) | |
RTK | 80 (4.4) | |
TSC1, TSC2, or MTOR | 30 (1.6) | |
TSC1, TSC2, NF1, NF2 or STK11 | 8 (0.4) | |