Table 2.

Univariate analysis of OS by biomarker status in EMILIA

CLT-DM1
NMedian OS, monMedian OS, moStratified HRa (95% CI)
All patients49625.149530.90.68 (0.54–0.85)
EGFR mRNA concentration ratio
 ≤Median (0.145)21424.620233.90.59 (0.42–0.83)
 >Median (0.145)21025.220626.50.79 (0.56–1.10)
HER2 mRNA concentration ratio
 ≤Median (13.3)20423.723026.50.80 (0.59–1.09)
 >Median (13.3)23524.819734.10.53 (0.37–0.76)
HER3 mRNA concentration ratio
 ≤Median (0.438)21823.1214NE0.64 (0.47–0.88)
 >Median (0.438)21827.121031.90.71 (0.51–1.00)
PIK3CA mutation statusb
 Mutated3917.340NE0.26 (0.12–0.57)
 Wild type8727.893NE0.68 (0.40–1.15)
PTEN
 None/decreased/slightly decreased11823.6113NE0.52 (0.32–0.86)
 Equivalent/increased1914.821NE0.43 (0.14–1.32)
  • Abbreviation: NE, not estimable.

  • aThe 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).

  • bTumors 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.