Table 3. Cox proportional hazard regression for ERCC1 expression by PFS.
ERCC1 (FL297)
N=88 |
ERCC1 (4F9)
N=88 |
ERCC1 (8F1)
N=90 |
||||
---|---|---|---|---|---|---|
Estimate (95% CI) | P-value | Estimate (95% CI) | P-value | Estimate (95% CI) | P-value | |
A. Continuous ERCC1 expression | ||||||
Hazard ratio (e.g. H-score of 3 vs 2 or 2 vs 1) |
2.5 (1.1–5.9) |
0.03* |
3.0 (1.2–7.8) |
0.02* |
1.4 (0.8–2.5) |
0.21 |
B. ERCC1 expression categorised by pre-determined H-score cutpointsa | ||||||
Hazard ratio | ||||||
Normal/increased vs decreased | 3.4 (0.4–25.9) | 0.24 | 1.8 (0.4–8.1) | 0.42 | — | — |
Increased vs normal/decreased |
4.8 (1.7–13.2) |
0.003* |
5.5 (1.6–18.9) |
0.007* |
— |
— |
C: Categorised ERCC1, also controls for p16 (p16-positive oropharyngeal tumour vs other)a | ||||||
Hazard ratio | ||||||
Normal/increased vs decreased | 3.4 (0.4–25.5) | 0.24 | 1.9 (0.4–8.3) | 0.40 | — | — |
Increased vs normal/decreased | 4.6 (1.6–13.2) | 0.004* | 5.2 (1.5–18.3) | 0.01* | — | — |
Models were stratified by randomization strata (including N-stage) and controlled for treatment arm.
Exploratory analysis, excluding 8F1 antibody based on results of primary analysis (3A).
Indicates statistical significance.