Table 2. Univariate analysis of OS by biomarker status in EMILIA.
| CL | T-DM1 | ||||
|---|---|---|---|---|---|
|
|
|
||||
| N | Median OS, mo | n | Median OS, mo | Stratified HRa (95% CI) | |
| All patients | 496 | 25.1 | 495 | 30.9 | 0.68 (0.54–0.85) |
| EGFR mRNA concentration ratio | |||||
| ≤Median (0.145) | 214 | 24.6 | 202 | 33.9 | 0.59 (0.42–0.83) |
| >Median (0.145) | 210 | 25.2 | 206 | 26.5 | 0.79 (0.56–1.10) |
| HER2 mRNA concentration ratio | |||||
| ≤Median (13.3) | 204 | 23.7 | 230 | 26.5 | 0.80 (0.59–1.09) |
| >Median (13.3) | 235 | 24.8 | 197 | 34.1 | 0.53 (0.37–0.76) |
| HER3 mRNA concentration ratio | |||||
| ≤Median (0.438) | 218 | 23.1 | 214 | NE | 0.64 (0.47–0.88) |
| >Median (0.438) | 218 | 27.1 | 210 | 31.9 | 0.71 (0.51–1.00) |
| PIK3CA mutation statusb | |||||
| Mutated | 39 | 17.3 | 40 | NE | 0.26 (0.12–0.57) |
| Wild type | 87 | 27.8 | 93 | NE | 0.68 (0.40–1.15) |
| PTEN | |||||
| None/decreased/slightly decreased | 118 | 23.6 | 113 | NE | 0.52 (0.32–0.86) |
| Equivalent/increased | 19 | 14.8 | 21 | NE | 0.43 (0.14–1.32) |
Abbreviation: NE, not estimable.
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.