Table 4.

Effect of Biomarkers on Clinical Efficacy (Full Analysis Set)

Biomarker Parameters	Everolimus 70 mg/week		Everolimus 10 mg/day
KRAS	Mutant	Wild-type	Mutant	Wild-type
N	33	46	41	40
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)
P value	.127		.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)
P value	.372		.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)
P value	0.487		0.008
PTEN expression	Low	Normal	Low	Normal
N	43	30	26	46
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)
P value	.287		.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)
P value	.117		.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)
P value	.283		.290

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.

CI, confidence interval; DCR, disease control rate; HR, hazard ratio; OR, odds ratio; OS, overall survival; PFS, progression-free survival; WHO, World Health Organization.