Table 4.

Effect of biomarkers on clinical efficacy (FAS)

Biomarker parametersEverolimus 70 mg/wkEverolimus 10 mg/d
KRASMutantWild-typeMutantWild-type
n33464140
DCR, n (%)11 (33.3)10 (21.7)7 (17.1)14 (35.0)
 OR (95% CI)2.357 (0.784–7.085)0.301 (0.099–0.917)
P0.1270.035
PFS, mo, median (95% CI)1.77 (1.64–2.37)1.71 (1.64–1.81)1.71 (1.68–1.84)1.77 (1.64–3.22)
 HR (95% CI)0.803 (0.495–1.301)1.357 (0.837–2.201)
P0.3720.216
OS, mo, median (95% CI)6.18 (2.40–8.05)4.90 (3.65–6.60)5.59 (4.24–7.69)7.06 (5.32-NA)
 HR (95% CI)1.196 (0.723–1.978)2.210 (1.225–3.989)
P0.4870.008
PTEN ExpressionLowNormalLowNormal
n43302646
DCR, n (%)9 (20.9)10 (33.3)7 (26.9)12 (26.1)
 OR (95% CI)0.533 (0.167–1.700)0.933 (0.289–3.015)
P0.2870.908
PFS, mo, median (95% CI)1.71 (1.64–1.81)1.77 (1.64–3.48)1.81 (1.68–2.14)1.68 (1.64–1.94)
 HR (95% CI)1.543 (0.898–2.651)0.976 (0.555–1.715)
P0.1170.932
OS, mo, median (95% CI)5.98 (3.48–7.92)4.37 (2.43–7.26)10.38 (5.52–14.69)6.34 (4.63–9.63)
 HR (95% CI)1.333 (0.789–2.254)0.687 (0.343–1.376)
P0.2830.290

NOTE: ORs and accompanying 95% CIs for DCR were obtained using a logistic regression model adjusted for WHO performance status (0 vs. ≥1) and baseline lactate dehydrogenase. HRs and accompanying 95% CIs for PFS and OS were obtained using a Cox model adjusted for WHO performance status (0 vs. ≥1) and baseline lactate dehydrogenase.