Baseline characteristics of patients recruited to the TIER trial
| . | Overall . | Thiotepa dose level . | ||
|---|---|---|---|---|
| 30 mg/m2 . | 40 mg/m2 . | 50 mg/m2 . | ||
| No. of patients | 36 | 5 | 4 | 27 |
| Median age, y (range) | 62 (31-76) | 48 (40-74) | 68 (61-74) | 62 (31-76) |
| Female sex | 14 (39) | 1 (20) | 2 (50) | 11 (41) |
| IELSG risk group (score) | ||||
| Low (0-1) | 10 (28) | 2 (40) | 0 | 8 (30) |
| Intermediate (2-3) | 15 (42) | 1 (20) | 2 (50) | 12 (44) |
| High (4-5) | 11 (31) | 2 (40) | 2 (50) | 7 (26) |
| Performance status | ||||
| 0 | 9 (25) | 1 (20) | 1 (25) | 7 (26) |
| 1 | 10 (28) | 0 | 2 (50) | 8 (30) |
| 2 | 11 (31) | 1 (20) | 1 (25) | 9 (33) |
| 3 | 6 (17) | 3 (60) | 0 | 3 (11) |
| CSF involvement by morphology | ||||
| Yes | 1 (3) | 0 | 0 | 1 (4) |
| No | 18 (50) | 3 (60) | 3 (75) | 12 (44) |
| Not assessed | 17 (47) | 2 (40) | 1 (25) | 14 (52) |
| Vitreoretinal involvement | ||||
| Yes | 2 (6) | 1 (20) | 1 (25) | 0 |
| No | 34 (94) | 4 (80) | 3 (75) | 27 (100) |
| No. of previous lines of therapy | ||||
| 1 | 32 (89) | 4 (80) | 4 (100) | 24 (89) |
| 2 | 4 (11) | 1 (20) | 0 | 3 (11) |
| Previous treatments | ||||
| MATRix | 11 (31) | 0 | 0 | 11 (41) |
| Chemotherapy without thiotepa | 25 (69) | 5 (100) | 4 (100) | 16 (59) |
| Consolidation | ||||
| ASCT | 2 (6) | 0 | 0 | 2 (7) |
| WBRT | 11 (31) | 2 (40) | 0 | 9 (33) |
| Median time from start of previous treatment to relapse, mo (IQR) | 17 (2-35) | 25 (22-31) | 12 (3-36) | 12 (2-36) |
| . | Overall . | Thiotepa dose level . | ||
|---|---|---|---|---|
| 30 mg/m2 . | 40 mg/m2 . | 50 mg/m2 . | ||
| No. of patients | 36 | 5 | 4 | 27 |
| Median age, y (range) | 62 (31-76) | 48 (40-74) | 68 (61-74) | 62 (31-76) |
| Female sex | 14 (39) | 1 (20) | 2 (50) | 11 (41) |
| IELSG risk group (score) | ||||
| Low (0-1) | 10 (28) | 2 (40) | 0 | 8 (30) |
| Intermediate (2-3) | 15 (42) | 1 (20) | 2 (50) | 12 (44) |
| High (4-5) | 11 (31) | 2 (40) | 2 (50) | 7 (26) |
| Performance status | ||||
| 0 | 9 (25) | 1 (20) | 1 (25) | 7 (26) |
| 1 | 10 (28) | 0 | 2 (50) | 8 (30) |
| 2 | 11 (31) | 1 (20) | 1 (25) | 9 (33) |
| 3 | 6 (17) | 3 (60) | 0 | 3 (11) |
| CSF involvement by morphology | ||||
| Yes | 1 (3) | 0 | 0 | 1 (4) |
| No | 18 (50) | 3 (60) | 3 (75) | 12 (44) |
| Not assessed | 17 (47) | 2 (40) | 1 (25) | 14 (52) |
| Vitreoretinal involvement | ||||
| Yes | 2 (6) | 1 (20) | 1 (25) | 0 |
| No | 34 (94) | 4 (80) | 3 (75) | 27 (100) |
| No. of previous lines of therapy | ||||
| 1 | 32 (89) | 4 (80) | 4 (100) | 24 (89) |
| 2 | 4 (11) | 1 (20) | 0 | 3 (11) |
| Previous treatments | ||||
| MATRix | 11 (31) | 0 | 0 | 11 (41) |
| Chemotherapy without thiotepa | 25 (69) | 5 (100) | 4 (100) | 16 (59) |
| Consolidation | ||||
| ASCT | 2 (6) | 0 | 0 | 2 (7) |
| WBRT | 11 (31) | 2 (40) | 0 | 9 (33) |
| Median time from start of previous treatment to relapse, mo (IQR) | 17 (2-35) | 25 (22-31) | 12 (3-36) | 12 (2-36) |
All data are n (%) unless otherwise specified.
CSF, cerebrospinal fluid; IELSG, International Extranodal Lymphoma Study Group; IQR, interquartile range; MATRix, methotrexate, cytarabine, thiotepa, rituximab.