Table 1.
Overall (n=66) | Ibrutinib-untreated CLL (n=34) | Ibrutinib-treated CLL (n=32) | P value* | ||||
---|---|---|---|---|---|---|---|
Sex: | |||||||
Male | 43 | (65%) | 21 | (62%) | 22 | (69%) | 0.61 |
Female | 23 | (35%) | 13 | (38%) | 10 | (31%) | |
Age (years) | 72 | (45-86) | 72.5 | (45-86) | 71 | (55-82) | 0.93 |
17p deletion | |||||||
Positive | 5 | (8%) | 0 | (0%) | 5 | (16%) | 0.02 |
Negative | 61 | (92%) | 34 | (100%) | 27 | (84%) | |
Trisomy 12 | |||||||
Positive | 0 | (0%) | 0 | (0%) | 0 | (0%) | >0.99 |
Negative | 66 | (100%) | 34 | (100%) | 32 | (100%) | |
11q deletion | |||||||
Positive | 7 | (11%) | 1 | (3%) | 6 | (19%) | 0.05** |
Negative | 59 | (89%) | 33 | (97%) | 26 | (81%) | |
13q deletion | |||||||
Positive | 14 | (21%) | 0 | (0%) | 14 | (44%) | <0.001 ** |
Negative | 52 | (79%) | 34 | (100%) | 18 | (56%) | |
β2 microglobulin | 2.45 | (1.4-6.5) | 2.3 | (1.4-6.5) | 2.5 | (1.5-6.3) | 0.27 |
IgG at Diagnosis (g/L) | 8.9 | (3.1-22) | 9.15 | (3.1-21.5) | 8.8 | (5.2-22) | 0.97 |
CD38 | |||||||
Positive | 20 | (30%) | 9 | (26%) | 11 | (34%) | 0.59 |
Negative | 46 | (70%) | 25 | (74%) | 21 | (66%) | |
Binet stage# | |||||||
A | 49 | (74%) | 23 | (68%) | 26 | (81%) | 0.12 |
B | 4 | (6%) | 4 | (12%) | 0 | (0%) | |
C | 11 | (17%) | 6 | (18%) | 5 | (16% | |
Time from Diagnosis (years) | 4 | (0.1-23.4) | 1.95 | (0.1-13.9) | 8.1 | (1-23.4) | <0.001 ** |
Time on Ibrutinib (years) | - | - | 1.35 | (0.1-3.4) | - | ||
Number of Medications excluding ibrutinib | 4 | (0-9) | 3 | (0-9) | 4 | (1-8) | – |
Hb (g/L) | 133 | (88-163) | 129 | (87-152) | 139.5 | (95-163) | 0.57 |
WCC (x109/L) | 20 | (2-379) | 38 | (3-379) | 11.65 | (2-319) | 0.009 ** |
Lymphocyte (x109/L)## | 16 | (0.6-372) | 40 | (1.9-372) | 3 | (0.6-279) | <0.001 ** |
Platelet Count (x109/L) | 152 | (39-378) | 166 | (39-378) | 147 | (75-253) | 0.05** |
Hb, hemoglobin; WCC, white blood cell count. #For Binet staging, untreated patients are n=33, and treated patients are n = 31. ##For lymphocyte counts, untreated patients were n = 13, and treated patients were n = 16. *Significant difference (p ≤ 0.05).
Data is shown as number (%) or median (range) as appropriate. Cytogenetic tests, CD38 positivity test, and IgG and β2 microglobulin levels are at time of diagnosis; the rest of measurements are at time of blood sample collection. All p values are for comparisons between ibrutinib-untreated and ibrutinib-treated CLL groups. P values for continuous variables were evaluated using Student t-test or Mann-Whitney test, for parametric and non-parametric data, respectively. For categorical variables, p values were calculated using the chi-square test or Fisher’s exact test. P ≤ 0.05 was considered significant. See Supplementary Information for normal hematological and serum immunoglobulin reference ranges, and Supplementary Tables 1 , 2 for information on patients’ concurrent medications.