Table 3.

Efficacy results

Median (95% CI)
EndpointSunitinib (n = 243)Placebo (n = 118)HR (95% CI)P
TTP, wk26.6 (16.0–32.1)6.4 (4.4–10.0)0.339 (0.244–0.472)<0.001
PFS, wk22.9 (10.9–28.0)6.0 (4.4–9.7)0.347 (0.253–0.475)<0.001
Best overall response, n (%)
 Partial response16 (7)0
 Stable disease128 (53)50 (42)
 Progressive disease45 (19)44 (37)
 Missing/unevaluable54 (22)24 (20)
Overall ORR, % (range)7 (4–11)07 (3–10)a0.004
OS, wk
 Conventional methods72.7 (61.3–83.0)64.9 (45.7–96.0)0.876 (0.679–1.129)0.306
 RPSFT method72.7 (61.3–83.0)39.0 (28.0–54.1)0.505 (0.262–1.134)b0.306c
  • aDifference between overall ORRs in sunitinib and placebo arms,% (95% CI of difference).

  • bEmpirical 95% CI was obtained using 100,000 bootstrap samples.

  • cThe RPSFT method does not alter the P value obtained using the conventional ITT method.