Table 2.
Randomized patients | Transplant recipients | |||||||
---|---|---|---|---|---|---|---|---|
Auto-SCT n = 54 | Allo-SCT n = 49 | Auto-SCT* n = 41 | Allo-SCT n = 26 | |||||
n/group (%) | 95% CI | n/group (%) | 95% CI | n/group (%) | 95% CI | n/group (%) | 95% CI | |
Treatment response | ||||||||
CR/CRu | 21/54 (39) | 26-53 | 25/49 (51) | 36-66 | 26/41 (63) | 47-78 | 19/26 (73) | 52-88 |
CR/CRu/untreated PR | 30/54 (56) | 41-69 | 28/49 (57) | 42-71 | 36/41 (88) | 74-96 | 21/26 (81) | 61-93 |
Relapse after CR/CRu | 7/21 (33) | 15-57 | 3/25 (12) | 3-31 | 10/26 (38) | 20-59 | 0/19 (0) | 0-18 |
Relapse after CR/CRu/untreated PR | 9/30 (30) | 15-49 | 4/28 (14) | 4-33 | 13/36 (36) | 21-54 | 0/21 (0) | 0-16 |
EFS events | ||||||||
PD at the end of therapy | 19/54 (35) | 16/49 (33) | 5/41 (12) | 1/26 (4) | ||||
Relapse after CR, CRu | 7/54 (13) | 3/49 (6) | 10/41 (24) | 0/26 (0) | ||||
Relapse after untreated PR | 2/54 (4) | 1/49 (2) | 3/41 (7) | 0/26 (0) | ||||
Treated PR | 0/54 (0) | 1/49 (2)† | 0/41 (0) | 0/26 (0) | ||||
SD | 2/54 (4)‡ | 0/49 (0) | 0/41 (0) | 0/26 (0) | ||||
Unknown | 3/54 (6)† | 0/49 (0) | 0/41 (0) | 0/26 (0) | ||||
Death after CR, CRu, untreated PR | 1/54 (2) | 8/49 (16) | 1/41 (2) | 8/26 (31) | ||||
EFS, PFS, OS rates with 95 CI | ||||||||
3-y EFS | 38 | 25-52 | 43 | 29-57 | 57 | 42-73 | 65 | 47-84 |
3-y PFS | 39 | 26-52 | 43 | 29-57 | 57 | 42-73 | 65 | 47-84 |
3-y OS | 70 | 57-82 | 57 | 43-71 | 81 | 68-93 | 65 | 47-84 |
Treatment response rates patients in subgroup/total patients (percentage of total group), with the 95% CI in the adjacent column.
Seven patients randomized to allo-SCT are included.
Patients with no PTCL.
Death after salvage treatment.