Table 1.

Baseline patient characteristics and prior imatinib treatment history

ITT populationBiomarker subset
Sunitinib (n = 243)Placebo (n = 118)Sunitinib (n = 88)Placebo (n = 60)
Median age, y (range)57 (23–84)55 (23–81)57 (28–81)55 (26–81)
Sex, n (%)
 Male152 (63)71 (60)52 (59)41 (68)
 Female91 (37)47 (40)36 (41)19 (32)
ECOG performance status, n (%)
 0109 (45)53 (45)42 (48)30 (50)
 1131 (54)63 (53)45 (51)30 (50)
 23 (1)2 (2)1 (1)0 (0)
Median tumor burdena, mm (range)227 (18–722)240 (29–749)218 (45–707)243 (29–749)
Most common metastatic sites, n (%)
 Liver mass/nodule138 (57)68 (58)67 (76)44 (73)
 Peritoneal mass/nodule100 (41)45 (38)44 (50)29 (48)
 Mesenteric adenopathy26 (11)15 (13)11 (13)11 (18)
Previous imatinib therapy
 Median maximum daily dose, mg (range)800 (300–1,600)800 (400–1,600)800 (300–1,600)800 (400–1,600)
 Median cumulative treatment duration, wk (range)107 (0.3–206)108 (11–231)104 (7–195)105 (12–174)
 Treatment outcome, n (%)
  Progression ≤6 mo42 (17)20 (17)16 (18)10 (17)
  Progression >6 mo188 (77)94 (80)68 (77)47 (78)
  Intolerance13 (5)4 (3)4 (5)3 (5)
 Best response, n (%)
  Complete response9 (4)1 (1)3 (3)0 (0)
  Partial response62 (26)43 (36)20 (23)22 (37)
  Stable disease97 (40)40 (34)44 (51)20 (33)
  Progressive disease68 (28)32 (27)18 (21)17 (28)
  Not applicable/missing7 (3)2 (2)2 (2)1 (2)
Time since diagnosis
 Median, y (range)3.2 (0.2–26.8)3.3 (0.2–16.4)3.2 (0.2–15.7)3.2 (0.5–9.5)
  • aSum of longest diameters of target lesions.