Table 4.
Engraftment, Mortality, and Toxicity
| Variable | Dose (mg/m2) |
Total (n = 147) |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Contro l0.0 (n = 37) |
Pentostatin |
|||||||||||
| 0.5 (n = 10) |
1.0 (n = 29) |
1.5 (n = 61) |
2.0 (n = 10) |
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| No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | |
| Engraftment | ||||||||||||
| Time to neutrophil engraftment, days* | ||||||||||||
| Median | 13 | 15 | 12 | 12 | 13 | 13 | ||||||
| Range | 8-23 | 10-20 | 10-22 | 8-24 | 11-25 | 8-25 | ||||||
| Time to platelet engraftment, days† | ||||||||||||
| Median | 18 | 21 | 15 | 15 | 22 | 16 | ||||||
| Range | 10-177 | 11-70 | 9-85 | 9-90 | 12-71 | 9-177 | ||||||
| Day-100 mortality | ||||||||||||
| Overall mortality | 5 | 13.5 | 2 | 20 | 4 | 13.8 | 6 | 9.8 | 0 | 17 | 11.6 | |
| Nonrelapse mortality | 3 | 8.1 | 1 | 10 | 3 | 10.3 | 5 | 8.2 | 0 | 12 | 8.2 | |
| Cause of death | ||||||||||||
| GVHD | 3 | 8.1 | 0 | 3 | 10.3 | 3 | 4.9 | 0 | 9 | 6.1 | ||
| Infection | 0 | 1 | 10.0 | 0 | 0 | 0 | 1 | 0.7 | ||||
| Relapse | 2 | 5.4 | 1 | 10.0 | 1 | 3.4 | 1 | 1.6 | 0 | 5 | 3.4 | |
| Other | 0 | 0 | 0 | 2 | 3.3 | 0 | 2 | 1.4 | ||||
| Day-100 relapse rate | 6 | 16.2 | 4 | 40 | 3 | 10.3 | 6 | 9.8 | 1 | 10 | 20 | 13.6 |
| No response to HSCT | 2 | 5.4 | 1 | 10.0 | 1 | 3.4 | 3 | 4.9 | 0 | 7 | 4.8 | |
| Transplantation-related toxicity | ||||||||||||
| Graft failure | 1 | 2.7 | 2 | 20 | 0 | 5* | 8.2 | 0 | 8 | 5.4 | ||
| Prolongation of neutrophil engraftment time beyond 21 days‡ | 4 | 10.8 | 0 | 0.0 | 2 | 6.9 | 2 | 3.3 | 1 | 10.0 | 9 | 6.1 |
| Early death (within 30 days from SCT) | 0 | 0 | 1 | 3.4 | 2 | 3.3 | 0 | 3 | 2.0 | |||
| Renal toxicity ‡ | ||||||||||||
| Creatinine elevation | ||||||||||||
| Grade 1 | 9 | 24.3 | 5 | 50.0 | 3 | 10.3 | 10 | 16.4 | 1 | 10.0 | 28 | 19.0 |
| Grade 2 | 2 | 5.4 | 1 | 10.0 | 1 | 3.4 | 8 | 13.1 | 3 | 30.0 | 15 | 10.2 |
| Grade 3 | 0 | 0 | 0 | 3 | 4.9 | 0 | 3 | 2.0 | ||||
| TTP/HUS | 2 | 5.4 | 0 | 0 | 3 | 4.9 | 2 | 20 | 7 | 4.8 | ||
| Infectious complications | ||||||||||||
| Bacterial | 24 | 64.9 | 6 | 60.0 | 17 | 58.6 | 38 | 62.3 | 7 | 70.0 | 92 | 62.6 |
| Viral | 23 | 62.2 | 4 | 40.0 | 15 | 51.7 | 7 | 70.0 | 89 | |||
| Fungal | 5 | 13.5 | 2 | 20.0 | 7 | 24.1 | 1 | 10.0 | 24 | 16.3 | ||
| Parasite | 0 | 0 | 1 | 3.4 | 0 | 2 | 1.4 | |||||
| CMV | 21 | 56.8 | 3 | 30.0 | 12 | 41.4 | 27 | 44.3 | 5 | 50.0 | 68 | 46.3 |
Abbreviations: GVHD, graft-verus-host disease; HSCT, hematopoietic stem-cell transplantation; SCT, stem-cell transplantation; TTP/HUS, thrombotic thrombocytopenic purpura/hemolytic uremic syndrome; CMV, cytomegalovirus.
The initial two graft failures had a diagnosis of chronic myelomonocytic leukemia and myelodysplastic syndromes with myelofibrosis and subsequently this was made an exclusion criteria. Thereafter, three additional cases of graft failures incurred in the pentostatin 1.5 mg/m2 arm.
Thirteen patients did not engraft platelets: two at control dose 0.0 mg/m2, three at dose 0.5 mg/m2, two at dose 1.0 mg/m2, six at dose 1.5 mg/m2.
In 0.5 mg/m2 dose group, one patient had renal failure in the context of multiple organ failure; in 1.5 mg/m2 dose group, one patient required dialysis.