Table 3.
Post-induction events by risk group and treatment arm.
| IR (n = 111) | HR (n = 35) | Total (IR + HR) (n = 146) | Arm B (n = 54) | Arm C-DL2 (n = 67) | Total (Arm B + Arm C-DL2) (n = 121) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N | % | N | % | N | % | N | % | N | % | N | % | |
| Treatment failurea | 4 | 4% | 3 | 9% | 7 | 5% | 3 | 6% | 4 | 6% | 7 | 6% |
| Relapseb | 46 | 41% | 19 | 54% | 65 | 45% | 23 | 43% | 32 | 48% | 55 | 45% |
| BM | 38 | 34% | 19 | 54% | 57 | 39% | 20 | 37% | 29 | 43% | 49 | 40% |
| iBM | 30 | 27% | 17 | 49% | 47 | 32% | 17 | 31% | 24 | 36% | 41 | 34% |
| cBM + CNS | 5 | 5% | 2 | 6% | 7 | 5% | 2 | 4% | 4 | 6% | 6 | 5% |
| cBM + Skin | 1 | 1% | – | – | 1 | 1% | – | – | 1 | 1% | 1 | 1% |
| cBM + Test | 2 | 2% | – | – | 2 | 1% | 1 | 2% | – | – | 1 | 1% |
| iEM | 8 | 7% | – | – | 8 | 5% | 3 | 6% | 3 | 4% | 6 | 5% |
| iCNS | 7 | 6% | – | – | 7 | 5% | 3 | 6% | 2 | 3% | 5 | 4% |
| iSkin | 1 | 1% | – | – | 1 | 1% | – | – | 1 | 1% | 1 | 1% |
| Death as the first event | 17 | 15% | 7 | 20% | 24 | 16% | 8 | 15% | 8 | 12% | 16 | 13% |
| Induction (infx) | 4 | 4% | 2 | 6% | 6 | 4% | – | – | – | – | – | – |
| Remission/on protocolc | 5 | 5% | 3 | 9% | 8 | 5% | 3 | 6% | 5 | 7% | 8 | 7% |
| Infx | 4 | 4% | 3 | 9% | 7 | 5% | 3 | 6% | 4 | 6% | 7 | 6% |
| Neuro | 1 | 1% | – | – | 1 | 1% | – | – | 1 | 1% | 1 | 1% |
| Remission/off protocol | 8 | 7% | 2 | 6% | 10 | 7% | 5 | 9% | 3 | 4% | 8 | 7% |
| Infx | 4 | 4% | – | – | 4 | 3% | 4 | 7% | – | – | 4 | 3% |
| TRM | 2 | 2% | 1 | 3% | 3 | 2% | 1 | 2% | 1 | 1% | 2 | 2% |
| Neuro | 1 | 1% | 1 | 3% | 2 | 1% | – | – | 1 | 1% | 1 | 1% |
| Cardiac aneurysm | 1 | 1% | – | – | 1 | 1% | – | – | 1 | 1% | 1 | 1% |
| Any event | 67 | 60% | 29 | 83% | 96 | 66% | 34 | 63% | 44 | 66% | 78 | 64% |
IR intermediate risk, HR high risk, DL2 dose level 2, BM bone marrow, EM extramedullary, i isolated, c combined, CNS central nervous system, Test testicular, infx infection, neuro neurologic (encephalopathy), TRM transplant-related mortality.
a
Treatment failure defined as without morphologic remission (<5% BM blasts, resolution of extramedullary disease) by the end of induction intensification.
b
Combined relapse defined as M2 or M3 marrow at any point after achieving remission with concomitant extramedullary relapse.
c
Includes two patients who died shortly after going off protocol therapy.