Table 2.

Hazard ratios for (A) disease-free^a and (B) overall survival by treatment arm in age and sex subgroups

	No.	Events	Sorafenib vs Placebo (HRb, 95% CI)	Sunitinib vs Placebo (HRb, 95% CI)
(A) DFS
Females
≤56	317	106	1.08 (0.70–1.66)	0.98 (0.62–1.56)
>56	317	143	1.34 (0.87–2.05)	1.41 (0.94–2.10)
Males
≤56	689	297	1.26 (0.88–1.82)	1.36 (0.94–1.97)
>56	620	338	0.97 (0.60–1.58)	0.98 (0.55–1.77)
(B) OSc
Females
≤56	317	58	0.96 (0.51–1.81)	1.21 (0.64–2.29)
>56	317	85	1.62 (0.89–2.95)	2.21 (1.29–3.80)
Males
≤56	689	147	1.10 (0.65–1.87)	1.44 (0.86–2.42)
>56	620	183	0.78 (0.41–1.49)	0.69 (0.32–1.47)

^aDFS event is the first of recurrence, development of second primary cancer, or death from any cause.

^bStratified Cox regression models assessed the joint effect on DFS and OS by sex, age, treatment and their interactions, while adjusting for race (white, black, or other), time from surgery to treatment start (number of weeks), and history of cardiovascular disease and thromboembolic events, and stratifying on the four stratification factors used for randomization in ASSURE (ECOG 2805): histology (clear cell vs not clear-cell), modified UCLA Integrated Staging System (UISS) risk group (intermediate high risk vs very high risk), ECOG performance status (0 vs 1), and surgical approach (laparoscopic vs open). Intermediate high risk is defined as T1b, Grade 3–4, any ECOG PS; T2, Grade 1–4, any ECOG PS; T3, Grade 1–4, ECOG PS 0 or Grade 1, ECOG PS ≥1. Very high risk is defined as T3, Grade 2–4, ECOG PS ≥1; T4, any Grade, any ECOG PS; N+, any T, any Grade, any ECOG PS.

^cP value of interaction by age and sex on mortality with sorafenib=0.10; with sunitinib=0.01.