Table 1.
Eligible Patient Baseline Demographic and Clinical Characteristics
| Characteristic | AD Plus Cixutumumab (n = 105) |
AD Alone (n = 105) |
||
|---|---|---|---|---|
| No. | % | No. | % | |
| Age, years | ||||
| Median | 65 | 66 | ||
| IQ range | 60-72 | 58-73 | ||
| PSA, ng/mL | ||||
| Median | 31 | 37 | ||
| IQ range | 12-74 | 10-200 | ||
| Weight, kg* | ||||
| Median | 90 | 86 | ||
| IQ range | 60-101 | 77-98 | ||
| BMI, kg/m2 | ||||
| < 18.5 (underweight) | 1 | 0.9 | 2 | 1.9 |
| 18.5 to 24.9 (normal weight) | 21 | 20.0 | 29 | 27.6 |
| 25 to 29.9 (overweight) | 36 | 34.3 | 39 | 37.1 |
| ≥ 30 (obese) | 43 | 40.9 | 33 | 31.4 |
| Unknown | 4 | 3.8 | 2 | 1.9 |
| Gleason score† | ||||
| < 7 | 8 | 7.6 | 6 | 5.7 |
| 7 | 29 | 27.6 | 11 | 10.4 |
| ≥ 7 | 63 | 60.0 | 82 | 78.0 |
| Race | ||||
| Black | 4 | 3.8 | 10 | 9.5 |
| White | 94 | 89.5 | 88 | 83.8 |
| Other | 7 | 6.7 | 7 | 6.7 |
| Zubrod performance score | ||||
| 0 | 62 | 59.0 | 65 | 61.9 |
| 1 | 41 | 39.0 | 38 | 36.1 |
| 2 | 2 | 1.9 | 2 | 1.9 |
| Site of metastasis | ||||
| Lymph node only | 15 | 14.3 | 9 | 8.6 |
| Bone only | 56 | 53.3 | 63 | 60.0 |
| Lymph node and bone | 19 | 18.1 | 17 | 16.2 |
| Visceral | 15 | 14.3 | 16 | 15.2 |
| Bone pain | 28 | 26.6 | 35 | 33.3 |
| Early-induction AD | 59 | 56.1 | 65 | 61.9 |
Abbreviations: AD, androgen deprivation; BMI, body mass index; IQ, interquartile; PSA, prostate-specific antigen.
*
Missing weight, n = 6.
†
Gleason score missing, n = 11.