Introduction
Patients and methods
Materials
VeraTag assays
Study population
Statistical methods
Results
H3T assay design and performance characteristics
Impact of HER3 expression on clinical outcomes in trastuzumab-treated MBC
Biomarkers |
N
| Progression-free survival | ||
---|---|---|---|---|
Hazard ratio vs. best group |
p value | Median PFS (months) | ||
H2T > 13.8, H3T ≤ 3.5 | 44 | 1 | – | 12.1 |
H2T > 13.8, H3T > 3.5 | 13 | 2.7 | 0.0021 | 5.0 |
H2T ≤ 13.8 | 28 | 2.9 | <0.0001 | 4.2 |
FISH(+), H3T ≤ 3.5 | 54 | 1 | – | 11.1 |
FISH(+), H3T > 3.5 | 12 | 2.1 | 0.031 | 5.7 |
FISH(−) | 21 | 2.8 | <0.0001 | 4.2 |
Biomarkers |
N
| Overall survival | ||
---|---|---|---|---|
Hazard ratio vs. best group |
p value | Median OS (months) | ||
H2T > 13.8, H3T ≤ 3.5 | 44 | 1 | – | 37.4 |
H2T > 13.8, H3T > 3.5 | 13 | 1.4 | 0.44 | 31.8 |
H2T ≤ 13.8 | 28 | 1.7 | 0.060 | 26.6 |
FISH(+), H3T ≤ 3.5 | 54 | 1 | – | 37.4 |
FISH(+), H3T > 3.5 | 12 | 1.2 | 0.73 | 31.8 |
FISH(−) | 21 | 1.6 | 0.15 | 25.7 |
Impact of HER3 expression on clinical outcomes independent of p95 and very high H2T levels
Group | Biomarkers |
N
| Progression-free survival | ||
---|---|---|---|---|---|
Hazard ratio vs. group A |
p value | Median PFS (months) | |||
A | 16.1 ≤ H2T ≤ 68.3, p95 ≤ 3.75, H3T ≤ 3.89 | 26 | 1 | – | 15.7 |
B | 16.1 ≤ H2T ≤ 68.3, p95 > 3.75 | 10 | 2.7 | 0.0063 | 7.8 |
C | 16.1 ≤ H2T ≤ 68.3, H3T > 3.89 | 9 | 5.8 | <0.0001 | 6.4 |
D | H2T > 68.3 | 14 | 3.3 | 0.0002 | 4.5 |
E | H2T < 16.1 | 30 | 4.6 | <0.0001 | 4.0 |
Group | Biomarkers |
N
| Overall survival | ||
---|---|---|---|---|---|
Hazard ratio vs. group A |
p value | Median OS (months) | |||
A | 16.1 ≤ H2T ≤ 68.3, p95 ≤ 3.75, H3T ≤ 3.89 | 26 | 1 | – | 47.6 |
B | 16.1 ≤ H2T ≤ 68.3, p95 > 3.75 | 10 | 2.5 | 0.040 | 22.9 |
C | 16.1 ≤ H2T ≤ 68.3, H3T > 3.89 | 9 | 3.7 | 0.0043 | 28.9 |
D | H2T > 68.3 | 14 | 3.7 | 0.0009 | 28.6 |
E | H2T < 16.1 | 30 | 3.7 | <0.0001 | 26.6 |