Table 3.

Efficacy results

Variable	Sunitinib (N = 238)	Capecitabine (N = 244)	Hazard ratio	95% CI	P
Progression-free survival
Events, n (%)	151 (63)	147 (60)
Median, months	2.8	4.2	1.47	1.16–1.87	0.999a 0.002b
95% CI	2.4–4.0	3.8–5.5
Overall survival
Events, n (%)	78 (33)	71 (29)
Median, months	15.3	24.6	1.17	0.84–1.63	0.825a 0.350b
95% CI	11.4–25.3	12.6–26.0
Objective response rate, %	11	16	0.65c	0.4–1.1	0.109d
95% exact CI	8–16	12–22
Duration of response
Events, n (%)	27 (11)	40 (16)
Median, months	6.9	9.3	2.79	1.04–7.46	NA
95% CI	3.1–8.5	5.5–9.7
Clinical benefit rate, %	19	27	0.65c	0.4–1.0	0.045d
95% exact CI	15–25	22–33

Objective response rate: % complete responses and partial responses; NA: not applicable; clinical benefit rate: % complete responses, partial responses, and stable disease ≥6 months

^aOne-sided stratified log-rank test

^bTwo-sided stratified log-rank test

^cOdds ratio

^dPearson χ² test