Table 3.
Description of the treatment in the BuMel group according to the age category (N = 205).
| < 12 years old (n = 65) | 12-17 years old (n = 81) | 18-24 years old (n = 31) | > =25 years old (n = 28) | p(1) | |
|---|---|---|---|---|---|
| ECOG Performance status (MD = 53) | 0.26(2) | ||||
| 0 | 36 (67 %) | 33 (54 %) | 13 (65 %) | 6 (35 %) | |
| 1 | 9 (17 %) | 17 (28 %) | 5 (25 %) | 8 (47 %) | |
| 2 | 8 (15 %) | 5 (8 %) | 0 | 0 | |
| 3 | 1 (2 %) | 6 (10 %) | 2 (10 %) | 3 (18 %) | |
| Tumour status before HDC (MD=5) | 0.55(3) | ||||
| CR | 39 (62 %) | 46 (58 %) | 13 (42 %) | 12 (46 %) | |
| PR | 18 (29 %) | 24 (30 %) | 10 (32 %) | 8 (31 %) | |
| SD | 3 (5 %) | 7 (9 %) | 7 (23 %) | 3 (12 %) | |
| Not evaluable | 1 (2 %) | 1 (1 %) | 0 | 2 (8 %) | |
| Not evaluated | 2 (3 %) | 2 (3 %) | 1 (3 %) | 1 (4 %) | |
| Time interval between last VAI course and HD (MD = 13) | 0.14 | ||||
| Median (range) | 28 (20; 67) | 29 (19; 64) | 31 (21; 58) | 30 (21; 85) | |
| Time interval between last VAI course and HDC>35 days (MD=13) | 0.39 | ||||
| No | 49 (80 %) | 58 (73 %) | 20 (71 %) | 16 (67 %) | |
| Yes | 12 (20 %) | 21 (27 %) | 8 (29 %) | 8 (33 %) | |
| Reported reason for delayed HDC (MD=20) | |||||
| Surgical complications | 1 | 1 | 0 | 0 | |
| Problems in stem cell collection | 3 | 3 | 0 | 1 | |
| Decreased general status | 0 | 1 | 0 | 0 | |
| Other | 3 | 11 | 3 | 2 | |
| Number of CD34 + stem cells infused (106/kg) (MD = 46) | 0.18 | ||||
| Median (range) | 4.4 (1.8; 10) | 4.7 (2.2; 10) | 5.6 (3; 9.8) | 5 (2.3; 9.6) | |
| Number of CD34 + stem cells infused (in categories) | 0.09(4) | ||||
| < 2 106/kg | 1 (1 %) | 0 | 0 | 0 | |
| [2-3[106/kg | 8 (17 %) | 14 (22 %) | 0 | 3 (16 %) | |
| ≥3 106/kg | 39 (81 %) | 51 (78 %) | 27 (100 %) | 16 (84 %) | |
| Duration of grade 4 leukopenia from stem cell rescue (days) (MD=3) | 0.15 | ||||
| Median (range) | 11 (0; 55) | 11.5 (0; 60) | 11 (2; 26) | 11 (0; 97) | |
| Duration of grade 4 neutropenia from stem cell rescue (days) (MD=18) | 0.02 | ||||
| Median (range) | 12 (0; 55) | 12 (0; 378) | 11 (0; 42) | 10 (6; 18) | |
| Dose modification for Busulfan > 20 % (MD = 5) | 0.04 | ||||
| No | 60 (95 %) | 64 (81 %) | 28 (90 %) | 20 (80 %) | |
| Yes | 3 (5 %) | 15 (19 %) | 3 (10 %) | 5 (20 %) | |
| Preventive treatment of SOS (MD=19) | 0.02(5) | ||||
| None | 21 (34 %) | 35 (50 %) | 20 (65 %) | 13 (54 %) | |
| Heparin | 10 (16 %) | 11 (16 %) | 2 (6 %) | 6 (25 %) | |
| Ursodiol | 23 (38 %) | 22 (31 %) | 6 (19 %) | 4 (17 %) | |
| Both | 7 (11 %) | 2 (3 %) | 3 (10 %) | 1 (4 %) |
MD, missing data; CR, Complete response; PR, Partial response; SD, Stable disease; SOS, Sinusoidal occlusive syndrome
(1) P-value of the test comparing < 12 years versus 12-17 years old versus ≥ 18 years (pooling the two groups of patients ≥ 18 years because of the limited number of patients)
(2) P-value of the test comparing ECOG 0 versus ECOG 1,2 or 3
(3) P-value of the test comparing CR versus PR or SD. Patients with tumour status non evaluable or not evaluated are excluded for the comparison
(4) P-value of the test comparing < 3 106/kg versus ≥ 3 106/kg
(5) P-value of the test comparing Preventive treatment of SOS No versus Yes (any type)