Table 1.

Univariate analysis of PFS by biomarker status in EMILIA

CLT-DM1
NMedian PFS, moNMedian PFS, moStratified HRa (95% CI)
All patients4966.44959.60.65 (0.55–0.77)
EGFR mRNA concentration ratio
 ≤Median (0.145)2146.920210.60.62 (0.48–0.81)
 >Median (0.145)2105.62068.30.71 (0.55–0.91)
HER2 mRNA concentration ratio
 ≤Median (13.3)2046.42308.20.64 (0.50–0.82)
 >Median (13.3)2356.919710.60.65 (0.50–0.85)
HER3 mRNA concentration ratio
 ≤Median (0.438)2185.72149.30.58 (0.45–0.74)
 >Median (0.438)2186.92109.80.80 (0.62–1.04)
PIK3CA mutation statusb
 Mutated394.34010.90.45 (0.25–0.82)
 Wild type876.4939.80.74 (0.50–1.10)
PTEN
 None/decreased/slightly decreased1184.91138.40.55 (0.39–0.78)
 Equivalent/increased197.1219.90.78 (0.32–1.91)
  • 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.