Table 4.
Combined groups (n=29) |
Augmented BFM (n=13) |
Standard BFM (n=16) |
|
---|---|---|---|
Treatment tolerability | |||
Completed full course of BFM† |
15 (52%) | 5 (38%) | 10 (63%) |
Discontinued BFM early (without relapse) |
6 (21%) | 3 (23%) | 3 (19%) |
Discontinued BFM early (with relapsed or refractory disease) |
7 (24%) | 5 (38%) | 3 (19%) |
Treatment-related mortality |
2 (7%) | 0 (0%) | 2 (13%) |
Responses to induction therapy‡ | |||
Refractory disease | 1 (4%) | 1 (8%) | 0 (0%) |
Complete remission | 27 (93%) | 12 (92%) | 15 (94%) |
Relapses | |||
Relapsed disease | 13 (45%) | 6 (46%) | 7 (44%) |
Relapse during BFM | 7 (24%) | 4 (31%) | 3 (19%) |
Relapse after BFM | 6 (21%) | 2 (15%) | 4 (25%) |
CNS relapses* | 2 (7%) | 0 (0%) | 2 (13%) |
Includes patients completing all phases of BFM including ≥6 cycles of maintenance chemotherapy.
One patient in the standard BFM group died from toxicity during induction and is considered a non-responder.
Nine of 13 relapses with documented lumbar punctures at relapse.