Table 2.
Treatment outcomes
| N, (%) | Total |
|---|---|
| Study completion | |
| Cycle 3 | 25/32 (78.1) |
| Cycle 8 | 7/32 (21.9) |
| Reasons for no completing the study | |
| Progression | 19/25 (76.0) |
| Death | 2/25 (8.0) |
| Others | 4/25 (16.0) |
| Consent withdrawal | 1 |
| For additional treatment | 3 |
| Best response during the study | |
| sCR + CR | 11/31 (35.5) |
| VGPR | 3/31 (9.7) |
| PR | 7/31 (22.6) |
| SD | 7/31 (22.6) |
| PD | 3/31 (9.7) |
| ORR (sCR + CR + VGPR + PR) | 21/31 (67.7) |
| NE | 1 |
| DCEP dose reductions | |
| Cycle 1 (N = 32) | Full dose 9/32 (28.1%); planned 30% DR 23/32 (71.9%) |
| Cycle 2 (N = 29) | Same dose as Cycle 1 25/29 (86.2%); dose reduction from Cycle 1 2/29 (6.9%)*; dose escalation from Cycle 1 2/29 (6.9%) |
| Cycle 3 (N = 25) | Same dose as Cycle 2 25/25 (100%) |
| DCEP dose delays | |
| Cycle 2 (N = 29) | 4 (13.8) |
| Cycle 3 (N = 25) | 3 (12.0) |
| ASCT during clinical trial | 2/32 (6.3) |
| History of prior ASCT | 1 |
| Infused CD34 cells, × 106/kg, median (range) | 4.53 (3.3.41–5.65) |
| Conditioning regimen | |
| Melphalan 200 mg/m2 | 2 |
sCR stringent complete response; CR complete response; VGPR very good partial response; PR partial response; SD stable disease; PD progressive disease; NE not evaluable; DCEP dexamethasone–cyclophosphamide–etoposide–cisplatin; ASCT autologous stem cell transplantation
*2 patients underwent additional dose reduction from Cycle 1