Table 3.
Clinical Outcomes for Cohorts and Correlative Markers
DCR | OS | PFS | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
|
||||||||||
N | N (%) | P-Value* | Events | Median (95% CI) |
P-Value | Events | Median (95% CI) | P-Value | ||
All** | 75 | 18 (24.0%) | 70 | 6.6 (5.6,7.4) | 74 | 1.8 (1.6,1.9) | ||||
Cohort | NC | NC | NC | |||||||
Original** | 50 | 11 (22%) | 46 | 6.7 (5.2,7.7) | 49 | 1.8 (1.6,1.9) | ||||
High-dose** | 20 | 7 (35%) | 19 | 6.2 (4.9,10.2) | 20 | 2.0 (1.6,2.7) | ||||
dMMR | 5 | 0 (0%) | 5 | 6.5 (1.8,17.8) | 5 | 1.4 (1.0,1.8) | ||||
KRAS | 0.78 | 0.62 | 0.83 | |||||||
Mutant | 38 | 8 (21.1%) | 33 | 6.6 (4.9,9.7) | 38 | 1.8 (1.6,1.9) | ||||
WT | 29 | 7 (24.1%) | 29 | 6.3 (5.2,7.2) | 28 | 1.8 (1.5,2.1) | ||||
Missing | 8 | 3 (37.5%) | ||||||||
MGMT | >0.99 | 0.15 | 0.88 | |||||||
NEG | 26 | 6 (23.1%) | 25 | 6.2 (4.8,7.0) | 26 | 1.7 (1.6,2.1) | ||||
POS | 22 | 5 (22.7%) | 19 | 7.6 (5.2,12.7) | 21 | 1.8 (1.5,2.0) | ||||
Missing | 27 | 7 (25.9%) | ||||||||
MMR | 0.21 | 0.38 | 0.001 | |||||||
Indeterminate | 2 | 0 (0.0%) | 1 | NR (5.1,NR) | 2 | 1.0 (0.5,1.5) | ||||
Stable | 49 | 14 (28.6%) | 45 | 6.7 (5.4,7.9) | 49 | 1.8 (1.6,2.1) | ||||
dMMR | 6 | 0 (0.0%) | 6 | 5.6 (0.7,17.8) | 6 | 1.3 (0.2,1.8) | ||||
Missing | 18 | 4 (22.2%) | ||||||||
PTEN | 0.69 | 0.76 | 0.40 | |||||||
LOSS | 30 | 4 (13.3%) | 29 | 6.2 (5.1,7.9) | 29 | 1.7 (1.5,1.8) | ||||
NO LOSS | 19 | 4 (21.1%) | 16 | 6.3 (4.2,12.7) | 19 | 1.8 (1.6,2.0) | ||||
Missing | 26 | 10 (38.5%) |
DCR=Disease Control rate; OS=Overall Survival; PFS=Progression-Free Survival; CI=Confidence Interval; NC=Not Calculated; NR=Not Reached.
p-value calculations included patients with non-missing marker information.
All responses were SD except 2 PRs in the original cohort