Table 3.
aGVHD Incidence and Distribution
| Variable | No. of Patients | Dose (mg/m2) |
All (n = 139) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control 0.0 (n = 36) |
Pentostatin |
||||||||||||||||
| 0.5 (n = 8) |
1.0 (n = 29) |
1.5 (n = 56) |
2.0 (n = 10) |
||||||||||||||
| No.* | % | No.* | % | P | No.* | % | P | No.* | % | P | No.* | % | P | No.* | % | ||
| Grades 2 to 4 aGVHD | 20 | 55.6 | 4 | 50.0 | .999 | 12 | 41.4 | .321 | 20 | 35.7 | .085 | 5 | 50 | .999 | 61 | 43.9 | |
| HLA 10/10 | 100 | 15/27 | 55.6 | 2/4 | 50 | 3/18 | 16.7 | 16/45 | 35.6 | 4/7 | 57.1 | 40/100 | 40.0 | ||||
| HLA < 10/10 | 39 | 5/9 | 55.6 | 2/5 | 40 | 9/11 | 81.8 | 4/11 | 36.4 | 1/3 | 33.3 | 21 | 53.8 | ||||
| Grades 3 to 4 aGVHD | 7 | 19.4 | 3 | 37.5 | .355 | 5 | 17.2 | .999 | 6 | 10.7 | .358 | 1 | 10 | .664 | 22 | 15.8 | |
| HLA 10/10 | 100 | 6/27 | 22.2 | 1/3 | 33.3 | 0/18 | 0 | 6/45 | 13.3 | 1/7 | 14.3 | 14 | 14.0 | ||||
| HLA < 10/10 | 39 | 1/9 | 11.1 | 2/5 | 40 | 5/11 | 45.5 | 0/11 | 0 | 0/3 | 0 | 8 | 20.5 | ||||
| Organs affected by grades 2 to 4 aGVHD | |||||||||||||||||
| Skin | 17 | 47.2 | 4 | 50 | 11 | 37.9 | 18 | 32.1 | 5 | 50 | 55 | 39.5 | |||||
| GI tract | 11 | 30.5 | 3 | 37.5 | 5 | 17.2 | 13 | 23.2 | 2 | 20 | 34 | 24.4 | |||||
| Liver | 4 | 11.1 | 2 | 25 | 5 | 17.2 | 0 | 0 | 11 | 7.9 | |||||||
| Time to grades 2 to 4 aGVHD, days | |||||||||||||||||
| Median | 33.5 | 21 | 20 | 23 | 27 | 25 | |||||||||||
| Range | 8-52 | 11-27 | 11-73 | 9-69 | 11-49 | 8-73 | |||||||||||
| Use of steroids on day 100 | 11/33 | 33.3 | 2/8 | 25 | .999 | 7/26 | 26.9 | .777 | 21/55 | 36.0 | .819 | 6/10 | 60.0 | .158 | 47/132 | 35.6 | |
| Response to steroids used for GVHD treatment | 9/22 | 40.9 | 1/4 | 25 | .999 | 14/17 | 82.4 | .020 | 31/40 | 77.5 | .006 | 4/9 | 44.4 | .999 | 59/92 | 64.1 | |
NOTE. P values are from Fisher's exact test for comparison with control arm.
Abbreviation: aGVHD, acute graft-versus-host disease.
*
Indicates number of events/patients at risk.