Patient characteristics
Characteristic . | DL1 . | DL2 . | Total . |
|---|---|---|---|
| Sex, male/female | 31/8 | 39/32 | 70/40 |
| Age, y (median; range) | 45 (24;60) | 43 (18;60) | 44 (18;60) |
| LDH level above UNL, no. (%) | 39 (100) | 71 (100) | 110 (100) |
| LDH level above 2 times UNL, no. (%) | 9 (23) | 18 (25) | 27 (25) |
| Stage III/IV, no. (%) | 23 (59) | 44 (62) | 67 (61) |
| Performance status (ECOG) greater than 1, no. (%) | 10 (26) | 21 (30) | 31 (28) |
| Age-adjusted IPI, no. (%) | |||
| 1 | 13 (33) | 21 (30) | 34 (31) |
| 2 | 19 (49) | 35 (49) | 54 (49) |
| 3 | 7 (18) | 15 (21) | 22 (20) |
| B symptoms, no. (%) | 27 (69) | 44 (62) | 71 (65) |
| Extranodal disease*, no. (%) | 28 (72) | 49 (69) | 77 (70) |
| Extranodal disease at more than one site*, no. (%) | 7 (18)† | 29 (41) | 36 (33) |
| Bulky disease (> 7.5 cm), no. (%) | 25 (66)† | 45 (63) | 70 (64) |
Characteristic . | DL1 . | DL2 . | Total . |
|---|---|---|---|
| Sex, male/female | 31/8 | 39/32 | 70/40 |
| Age, y (median; range) | 45 (24;60) | 43 (18;60) | 44 (18;60) |
| LDH level above UNL, no. (%) | 39 (100) | 71 (100) | 110 (100) |
| LDH level above 2 times UNL, no. (%) | 9 (23) | 18 (25) | 27 (25) |
| Stage III/IV, no. (%) | 23 (59) | 44 (62) | 67 (61) |
| Performance status (ECOG) greater than 1, no. (%) | 10 (26) | 21 (30) | 31 (28) |
| Age-adjusted IPI, no. (%) | |||
| 1 | 13 (33) | 21 (30) | 34 (31) |
| 2 | 19 (49) | 35 (49) | 54 (49) |
| 3 | 7 (18) | 15 (21) | 22 (20) |
| B symptoms, no. (%) | 27 (69) | 44 (62) | 71 (65) |
| Extranodal disease*, no. (%) | 28 (72) | 49 (69) | 77 (70) |
| Extranodal disease at more than one site*, no. (%) | 7 (18)† | 29 (41) | 36 (33) |
| Bulky disease (> 7.5 cm), no. (%) | 25 (66)† | 45 (63) | 70 (64) |
Characteristics of all patients included in analysis. For DL1, n = 39; for DL2, n = 71 (total, n = 110). Significant differences between dose levels were seen in sex (P = .010) and extranodal disease at more than one site (P = .018).
Bone marrow involvement is defined as extranodal disease.
One missing value.