Table 1. Univariate analysis of PFS by biomarker status in EMILIA.
| CL | T-DM1 | ||||
|---|---|---|---|---|---|
|
|
|
||||
| N | Median PFS, mo | N | Median PFS, mo | Stratified HRa (95% CI) | |
| All patients | 496 | 6.4 | 495 | 9.6 | 0.65 (0.55–0.77) |
| EGFR mRNA concentration ratio | |||||
| ≤Median (0.145) | 214 | 6.9 | 202 | 10.6 | 0.62 (0.48–0.81) |
| >Median (0.145) | 210 | 5.6 | 206 | 8.3 | 0.71 (0.55–0.91) |
| HER2 mRNA concentration ratio | |||||
| ≤Median (13.3) | 204 | 6.4 | 230 | 8.2 | 0.64 (0.50–0.82) |
| >Median (13.3) | 235 | 6.9 | 197 | 10.6 | 0.65 (0.50–0.85) |
| HER3 mRNA concentration ratio | |||||
| ≤Median (0.438) | 218 | 5.7 | 214 | 9.3 | 0.58 (0.45–0.74) |
| >Median (0.438) | 218 | 6.9 | 210 | 9.8 | 0.80 (0.62–1.04) |
| PIK3CA mutation statusb | |||||
| Mutated | 39 | 4.3 | 40 | 10.9 | 0.45 (0.25–0.82) |
| Wild type | 87 | 6.4 | 93 | 9.8 | 0.74 (0.50–1.10) |
| PTEN | |||||
| None/decreased/slightly decreased | 118 | 4.9 | 113 | 8.4 | 0.55 (0.39–0.78) |
| Equivalent/increased | 19 | 7.1 | 21 | 9.9 | 0.78 (0.32–1.91) |
a
The following stratification factors were used: world region (U.S., Western Europe, other), number of prior chemotherapeutic regimens (0–1 vs. >1), and site of disease involvement (visceral vs. nonvisceral).
b
Tumors were analyzed for the following mutations: exon 1, R88Q; exon 4, N345K; exon 7, C420R; exon 9, E542K, E545A, E545D, E545G, E545K, and Q546E, Q546K, Q546L, Q546R; exon 20, M1043I, H1047L, H1047R, H1047Y, and G1049R.