Table 1.
Patient demographics of studies in subjects ≥60 years old (100103) and patients <60 years old (19808 and 10503).
| CALGB Study | 19808 | 10503 | 19808+10503 | 100103 |
|---|---|---|---|---|
|
| ||||
| Number of patients | 56 | 100 | 156 | 32 |
|
| ||||
| Useable pharmacokinetic data | 56 | 100 | 156 | 29 |
|
| ||||
| Median age (range) | 50.3 (19.3–59.6) | 49.6 (17.8–60.0) | 49.8 (17.8–60.0) | 66.3 (60.3–74.3) |
|
| ||||
| Sex | ||||
| Male (%) | 21 (37.5) | 50 (50) | 71 (45.5) | 20 (69) |
|
| ||||
| Race | ||||
| White n (%) | 46 (82) | 85 (85) | 131 (84) | 27 (93) |
| African n (%) | 6 (11) | 4 (4) | 10 (6) | 0 |
| Asian n (%) | 1 (2) | 1 (1) | 2 (1) | 0 |
|
| ||||
| ECOG Performance Status* | ||||
| 0 (%) | 26 (46) | 32 (32) | 58 (37) | 15 (52) |
| 1 (%) | 24 (43) | 62 (62) | 86 (55) | 10 (34) |
| 2 (%) | 5 (9) | 6 (6) | 11 (7) | 4 (14) |
| 3 (%) | 1 (2) | 0 | 1 (0.6) | 0 |
|
| ||||
| Phenytoin use (%) | 49 (88) | 55 (55) | 104 (67) | 13 (45) |
|
| ||||
| Weight (kg) | 76.1(49–172) | 82.3(46.6–171) | 79,8(46.6–172)** | 84(54.1–124)** |
|
| ||||
| BMI (kg/m2) | 27(18.9–57.9) | 29.4(17–54.4) | 28.4(17–57.9)*** | 27.1(19.8–35.4)*** |
*
Performance status was recorded at the time of diagnosis for patients on the 2 studies with younger patients, but only at the time of transplantation in the older patient study.
**
P-value by wilcox rank test: 0.7307
***
P-value by two-sided Fisher’s Exact test: 0.024