Table 1.
Baseline characteristics of patients on Continuous and Intermittent Androgen Deprivation Therapy, S9346
| Current Medicare Study | p- value1 |
S9346 Parent Population |
|||
|---|---|---|---|---|---|
| Continuous | Intermittent | All | |||
| n=311 | n=325 | n=636 | n=1,535 | ||
| Age, yr | .56 | ||||
| Mean | 71.5 | 71.1 | 71.3 | 70 | |
| Median | 71.2 | 71 | 71.1 | 70.4 | |
| <65 | 70 (23%) | 80 (25%) | 151 (24%) | 476 (31%) | |
| 65+ | 241 (77%) | 245 (75%) | 490 (76%) | 1057 (69%) | |
| Weight, kg | .46 | ||||
| Mean | 88 | 90.3 | 89.1 | 89.6 | |
| Median | 87.4 | 85 | 86.6 | 85 | |
| BMI, kg/m2 | .96 | ||||
| Mean | 30.7 | 30.6 | 30.6 | 29.6 | |
| Median | 27.8 | 27.8 | 27.8 | 27.6 | |
| <25 | 69 (24%) | 72 (24%) | 143 (24%) | 371 (27%) | |
| 25+ | 218 (76%) | 232 (76%) | 453 (76%) | 995 (73%) | |
| Performance Status | .70 | ||||
| 0–1 | 305 (98%) | 320 (98%) | 630 (98%) | 1474 (96%) | |
| 2 | 6 (2%) | 5 (2%) | 11 (2%) | 59 (4%) | |
| Severity of Disease | .30 | ||||
| Minimal | 175 (56%) | 170 (52%) | 345 (54%) | 791 (52%) | |
| Extensive | 135 (44%) | 155 (48%) | 296 (46%) | 742 (48%) | |
| Prior Hormone Therapy | .40 | ||||
| Finasteride | 3 (<1%) | 2 (<1%) | 5 (1%) | 10 (1%) | |
| Neoadjuvant | 34 (11%) | 47 (14%) | 85 (13%) | 176 (11%) | |
| Neither | 274 (88%) | 276 (85%) | 551 (86%) | 1347 (88%) | |
| Race | .68 | ||||
| White | 253 (81%) | 262 (81%) | 520 (81%) | 1024 (67%) | |
| Black | 51 (16%) | 52 (16%) | 103 (16%) | 189 (12%) | |
| Asian/PI | 4 (1%) | 3 (1%) | 7 (1%) | 16 (1%) | |
| Native | 1 (1%) | 3 (1%) | 4 (1%) | 6 (1%) | |
| Unknown | 2 (1%) | 5 (1%) | 7 (1%) | 298 (19%)3 | |
| Prior comorbidities2 | |||||
| Diabetes | 44 (14%) | 43 (14%) | 87 (14%) | .73 | |
| Hypercholesterolemia | 66 (21%) | 75 (24%) | 141 (22%) | .59 | |
| Osteoperosis | 40 (13%) | 39 (12%) | 79 (12%) | .73 | |
| All Bone | 97 (31%) | 85 (26%) | 182 (28%) | .15 | |
| Organic Sexual Dysfunction |
13 (4%) | 15 (5%) | 28 (4%) | .79 | |
| Depression | 14 (4%) | 12 (4%) | 26 (4%) | .60 | |
T-tests were conducted to compare continuous measures between treatment arms, and chi-square tests to compare categorical variables between treatment arms.
Based on claims prior to enrollment. Selected conditions are shown. In addition to the conditions listed in the table, there was no difference by arm in the proportion of patients with acute MI (p=.93; overall baseline rate = 2%), ischemic heart disease (p=.74; overall baseline rate = 3%), severe thrombosis (p=.95; overall baseline rate = 1%), obesity (p=.59; overall baseline rate = 2%), fracture (p=.11; overall baseline rate = 4%), dementia (p=.69; overall baseline rate <1%), and acute kidney injury (p=.15; overall baseline rate = 2%). Diabetes with sequelae was somewhat higher on the continuous arm (p=.02; overall baseline rate = 3%).
The large number of patients reporting unknown race from the parent trial was due to the absence of race reporting from international collaborators.