Table 1.
VTE group | |||||||
---|---|---|---|---|---|---|---|
No (N = 227) | Yes (N = 114) | Overall (N = 341) | P-value | ||||
N | (%) | N | (%) | N | (%) | ||
Sex (Male) | 142 | (62.6) | 70 | (61.4) | 212 | (62.2) | 0.84 |
Age, continuous (median, IQR) | 24.3 (17.0, 33.3) | 22.3 (17.5, 33.7) | 23.2 (17.2, 33.3) | 0.79 | |||
Age | 0.78 | ||||||
15–29 years | 156 | (68.7) | 80 | (70.2) | 236 | (69.2) | |
30–50 years | 71 | (31.3) | 34 | (29.8) | 105 | (30.8) | |
BMI group (per CDC guidelines)a | 0.048 | ||||||
Normal/Underweight | 137 | (60.4) | 56 | (49.1) | 193 | (56.6) | |
Overweight/Obese | 90 | (39.6) | 58 | (50.9) | 148 | (43.4) | |
WBC at diagnosis (x109/L, median, IQR) | 16.0 (4.0, 55.0) | 14.6 (5.4, 59.0) | 15.6 (4.2, 57.0) | >0.99 | |||
Immunophenotype | 0.18 | ||||||
B-ALL | 167 | (73.6) | 76 | (66.7) | 243 | (71.3) | |
T-ALL | 60 | (26.4) | 38 | (33.3) | 98 | (28.7) | |
CNS involvementb | 0.62 | ||||||
CNS-1 | 180 | (79.3) | 86 | (75.4) | 266 | (78.0) | |
CNS-2 | 24 | (10.6) | 17 | (14.9) | 41 | (12.0) | |
CNS-3 | 6 | (2.6) | 4 | (3.5) | 10 | (2.9) | |
Anterior mediastinal massc | 45 | (19.8) | 30 | (26.3) | 75 | (22.0) | 0.18 |
Cytogenetics | |||||||
Normal | 71 | (31.3) | 31 | (27.2) | 102 | (29.9) | 0.44 |
Complex | 7 | (3.1) | 3 | (2.6) | 10 | (2.9) | >0.99 |
Hyperdiploid | 30 | (13.2) | 4 | (3.5) | 34 | (10.0) | 0.0038 |
KMT2A rearrangements (MLL) | 20 | (8.8) | 4 | (3.5) | 24 | (7.0) | 0.08 |
Treatment type (On trial vs. per protocol) | 181 | (79.7) | 80 | (70.2) | 261 | (76.5) | 0.049 |
Asparaginase typed (PEG vs. non-PEG) | 119 | (52.4) | 68 | (59.6) | 187 | (54.8) | 0.33 |
VTE PPx erae (vs. pre-PPx era) | 70 | (30.8) | 36 | (31.6) | 106 | (31.1) | 0.89 |
AlloHSCT | 34 | (15.0) | 12 | (10.5) | 46 | (13.5) | 0.26 |
VTE venous thromboembolism, IQR interquartile range, BMI body mass index, CDC Centers for Disease Control, WBC white blood cell count, ALL acute lymphoblastic leukemia, CNS central nervous system, MLL mixed-lineage leukemia, PEG pegylated, PPx prophylaxis, AlloHSCT allogeneic hematopoietic stem cell transplantation.
aBMI Cutoff: For patients ≥20 years, normal (including underweight): <24.99, overweight/obese: >30. For patients 15-19, age-adjusted percentiles per CDC were used where overweight/obese ≥85%.
b17 patients had traumatic tap/unknown CNS status.
cThree patients mediastinal mass evaluation was unknown.
dNine patients had unknown type of asparaginase.
eAt 09/2011, after finding high prevalence of VTE events in the 06-254 protocol, any patients on the 06-254 or treated as per 06-254 received thromboprophylaxis during asparaginase treatment and antithrombin repletion when < 30%.