Table 1.

Patient characteristics

CharacteristicTwice daily dose
Total (N = 103)
10 mg (n = 51)100 mg (n = 52)
Age, y
    <5511 (22)18 (35)29 (28)
    55-6420 (39)21 (40)41 (40)
    65-7412 (24)10 (19)22 (21)
    75-848 (16)3 (6)11 (11)
Median/mean/range62/61.3/20-8058/58.0/37-7859/59.6/20-80
Sex
    Male31 (61)36 (69)67 (65)
    Female20 (39)16 (31)36 (35)
ECOG performance status
    037 (73)35 (67)72 (70)
    113 (25)16 (31)29 (28)
    20 (0)1 (2)1 (1)
    Unknown1 (2)0 (0)1 (1)
Histology
    Clear cell37 (73)41 (79)78 (76)
    Nonclear cell14 (28)11 (21)25 (24)
Sites of metastasis
    Lung36 (71)30 (58)66 (64)
    Liver12 (24)14 (27)26 (25)
    Bone5 (10)4 (8)9 (9)
No. metastatic sites
    125 (49)23 (44)48 (47)
    215 (29)15 (29)30 (29)
    3 or more11 (22)14 (27)25 (24)
Modified MSKCC risk category*
    Favorable16 (31)18 (35)34 (33)
    Intermediate/poor§34 (67)34 (65)68 (66)
  • * Modified MSKCC risk category criteria were as follows: ECOG score >1, hemoglobin <lower limit of normal, lactate dehydrogenase >1.5 times the upper limit of normal, calcium >10/dL, and <1 y time interval between initial diagnosis and start of study drug. Value in table expressed as n (%).

  • N = 102 because complete baseline-modified MSKCC risk category criteria were not available for one patient.

  • Patients with no risk factors per modified MSKCC risk category criteria.

  • § Patients with at least one risk factor per modified MSKCC risk category criteria.