Table 1.
Follow-up of patients with SCN and SDS in the SCNIR
| No. | Person-y | Median no. (range) of pre-Rx CBC | Median G-CSF dose at 6 mo, μg/kg/d | Total MDS/AML, no. | Total deaths from sepsis, no. | MDS/AML crude rate, % per y* | Death from sepsis crude rate, % per y | |
|---|---|---|---|---|---|---|---|---|
| SCN | ||||||||
| Group 1 | 374 | 2043 | NA | NA | 44 | 19 | 2.2 | 0.9 |
| Group 2 | 365 | 2007 | NA | 6.0 | 44 | 19 | 2.2 | 0.9 |
| Group 3 | 305 | 1769 | 3 (1-76) | 6.2 | 42 | 17 | 2.4 | 1.0 |
| Group 4 | 307 | 1963 | NA | 6.2 | 41 | 15 | 2.1 | 0.8 |
| Group 5 | 238 | 1583 | 9 (1-80) | 8.0 | 34 | 12 | 2.1 | 0.8 |
| Group 6† | 211 | 1445 | 12 (2-116) | 8.0 | 33 | 10 | 2.3 | 0.7 |
| SDS | ||||||||
| Group 1 | 29 | 161 | NA | NA | 2 | 2 | 1.2 | 1.2 |
| Group 2 | 18 | 67 | NA | 4.3 | 2 | 2 | 3.0 | 3.0 |
| Group 3 | 16 | 57 | 3 (1-19) | 4.3 | 1 | 2 | 1.8 | 3.5 |
| Group 4 | 14 | 65 | NA | 4.3 | 1 | 1 | 1.5 | 1.5 |
| Group 5 | 9 | 38 | 3 (2-11) | 4.2 | 1 | 1 | 2.7 | 2.7 |
| Group 6† | 8 | 28 | 8 (4-25) | 4.3 | 1 | 1 | 3.6 | 3.6 |
Dose data indicates G-CSF dose in μg/kg/d at 6 months; Rx, treatment; and NA, not applicable. The pre-Rx CBCs were obtained from 3 years before treatment through the day that treatment was started. Groups were defined as follows: group 1, enrolled; group 2, enrolled with dose data; group 3, enrolled with dose data and CBC data pre-Rx; group 4, enrolled with dose data and followed beyond 18 months; group 5, enrolled with dose data and followed beyond 18 months with CBC data at 6-18 months; and group 6, enrolled with dose data and followed beyond 18 months with CBC data at 6-18 months and pre-Rx.
Crude rates are defined as the total number of events, divided by the person-years of follow-up, times 100%.
Includes both follow-up intervals.