Table 1.
Baseline demographics and characteristics of the enrolled participants.
| Positive n = 10 |
Negative n = 52 |
Determinate
#
n = 62 |
Indeterminate n = 27 |
p-value | Total n = 89 |
|
|---|---|---|---|---|---|---|
| Age, years | 71.0 (39.0, 83.0) | 58.0 (20.0, 81.0) | 59.0 (20.0, 83.0) | 56.0 (20.0, 82.0) | 0.324 | 58.0 (20.0, 83.0) |
| Male gender (%) | 9 (90.0) | 26 (50.0) | 35 (56.5) | 12 (44.4) | 0.417 | 47 (52.8) |
| BCG vaccinated (%) | 10 (100) | 50 (96.2) | 60 (96.8) | 25 (92.6) | 0.582 | 85 (95.5) |
| Tumour type | 0.044* | |||||
| Leukaemia (%) | 2 (20.0) | 18 (34.6) | 20 (32.3) | 17 (63.0) | 37 (41.6) | |
| AML § (%) | 1 (10.0) | 14 (26.9) | 15 (24.2) | 13 (48.1) | 28 (31.5) | |
| Precursor B-cell ALL (%) | 0 (0.0) | 2 (3.8) | 2 (3.2) | 3 (11.1) | 5 (5.6) | |
| CML (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 1 (3.7) | 2 (2.2) | |
| Blast crisis (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 0 (0.0) | 1 (1.1) | |
| Chronic phase (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.7) | 1 (1.1) | |
| CLL (%) | 1 (10.0) | 1 (1.9) | 2 (3.2) | 0 (0.0) | 2 (2.2) | |
| Rai stage III (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 0 (0.0) | 1 (1.1) | |
| Rai stage IV (%) | 1 (10.0) | 0 (0.0) | 1 (1.6) | 0 (0.0) | 1 (1.1) | |
| Lymphoma (%) | 5 (50.0) | 28 (53.8) | 33 (53.2) | 7 (25.9) | 40 (44.9) | |
| Ann Arbor stage I (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 0 (0.0) | 1 (1.1) | |
| Ann Arbor stage II (%) | 1 (10.0) | 3 (5.8) | 4 (6.5) | 1 (3.7) | 5 (5.6) | |
| Ann Arbor stage III (%) | 1 (10.0) | 4 (7.7) | 5 (8.1) | 2 (7.4) | 7 (7.9) | |
| Ann Arbor stage IV (%) | 3 (30.0) | 20 (38.5) | 23 (37.1) | 4 (14.8) | 27 (30.3) | |
| Multiple myeloma (%) | 3 (30.0) | 6 (11.5) | 9 (14.5) | 3 (11.1) | 12 (13.5) | |
| Durie–Salmon stage IA (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 0 (0.0) | 1 (1.1) | |
| Durie–Salmon stage IB (%) | 1 (10.0) | 0 (0.0) | 1 (1.6) | 0 (0.0) | 1 (1.1) | |
| Durie–Salmon stage IIA (%) | 1 (10.0) | 1 (1.9) | 2 (3.2) | 0 (0.0) | 2 (2.2) | |
| Durie–Salmon stage IIIA (%) | 1 (10.0) | 3 (5.8) | 4 (6.5) | 3 (11.1) | 7 (7.9) | |
| Durie–Salmon stage IIIB (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 0 (0.0) | 1 (1.1) | |
| Treatment received previously | 0.197 | |||||
| None (%) | 4 (40.0) | 10 (19.2) | 14 (22.6) | 3 (11.1) | 17 (19.1) | |
| Leukaemia (%) | 0 (0.0) | 2 (3.8) | 2 (3.2) | 2 (7.4) | 4 (4.5) | |
| AML § (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 2 (7.4) | 3 (3.4) | |
| CLL | ||||||
| Rai stage III (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 0 (0.0) | 1 (1.1) | |
| Lymphoma (%) | 2 (20.0) | 7 (13.5) | 9 (14.5) | 1 (3.7) | 10 (11.2) | |
| Ann Arbor stage III (%) | 1 (10.0) | 1 (1.9) | 2 (3.2) | 0 (0.0) | 2 (2.2) | |
| Ann Arbor stage IV (%) | 1 (10.0) | 6 (11.5) | 7 (11.3) | 1 (3.7) | 8 (9.0) | |
| Multiple myeloma (%) | 2 (20.0) | 1 (1.9) | 3 (4.8) | 0 (0.0) | 3 (3.4) | |
| Durie-Salmon stage IB (%) | 1 (10.0) | 0 (0.0) | 1 (1.6) | 0 (0.0) | 1 (1.1) | |
| Durie-Salmon stage IIA (%) | 1 (10.0) | 1 (1.9) | 2 (3.2) | 0 (0.0) | 2 (2.2) | |
| Chemotherapy only (%) | 6 (60.0) | 41 (78.8) | 47 (75.8) | 22 (81.5) | 69 (77.5) | |
| Leukaemia (%) | 2 (20.0) | 15 (28.8) | 17 (27.4) | 14 (51.9) | 31 (34.8) | |
| AML § (%) | 1 (10.0) | 12 (23.1) | 13 (21.0) | 10 (37.0) | 23 (25.8) | |
| Precursor B-cell ALL (%) | 0 (0.0) | 2 (3.8) | 2 (3.2) | 3 (11.1) | 5 (5.6) | |
| CML (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 1 (3.7) | 2 (2.2) | |
| Blast crisis (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 0 (0.0) | 1 (1.1) | |
| Chronic phase (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.7) | 1 (1.1) | |
| CLL | ||||||
| Rai stage IV (%) | 1 (10.0) | 0 (0.0) | 1 (1.6) | 0 (0.0) | 1 (1.1) | |
| Lymphoma (%) | 3 (30.0) | 21 (40.4) | 24 (38.7) | 6 (22.2) | 30 (33.7) | |
| Ann Arbor stage I (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 0 (0.0) | 1 (1.1) | |
| Ann Arbor stage II (%) | 1 (10.0) | 3 (5.8) | 4 (6.5) | 1 (3.7) | 5 (5.6) | |
| Ann Arbor stage III (%) | 0 (0.0) | 3 (5.8) | 3 (4.8) | 2 (7.4) | 5 (5.6) | |
| Ann Arbor stage IV (%) | 2 (20.0) | 14 (26.9) | 16 (25.8) | 3 (11.1) | 19 (21.3) | |
| Multiple myeloma (%) | 1 (10.0) | 5 (9.6) | 6 (9.7) | 2 (7.4) | 8 (9.0) | |
| Durie–Salmon stage IA (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 0 (0.0) | 1 (1.1) | |
| Durie–Salmon stage IIIA (%) | 1 (10.0) | 3 (5.8) | 4 (6.5) | 2 (7.4) | 6 (6.7) | |
| Durie–Salmon stage IIIB (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 0 (0.0) | 1 (1.1) | |
| Chemotherapy + radiotherapy (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 2 (7.4) | 3 (3.4) | |
| Leukaemia | ||||||
| AML § (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 1 (3.7) | 2 (2.2) | |
| Multiple myeloma | ||||||
| Durie–Salmon stage IIIA (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.7) | 1 (1.1) | |
| Chest X-ray | 0.508 | |||||
| Normal (%) | 1 (10.0) | 27 (51.9) | 28 (45.2) | 13 (48.1) | 41 (46.1) | |
| Abnormal but not related to previous or current TB infection (%) | 8 (80.0) | 23 (44.2) | 31 (50.0) | 14 (51.9) | 45 (50.6) | |
| Presence of bronchiectasis (%) | 1 (10.0) | 2 (3.8) | 3 (4.8) | 0 (0.0) | 3 (3.4) | |
| Laboratory finding | ||||||
| WBC, ×109/l | 7.1 (4.3, 14.4) | 7.2 (0.6, 114.4) | 7.2 (0.6, 114.4) | 3.0 (0.2, 161.7) | 0.001* | 6.7 (0.2, 161.7) |
| Normal reference range$ (%) | 9 (90.0) | 44 (84.6) | 53 (85.5) | 3 (11.1) | 56 (62.9) | |
| Abnormal reference range (%) | 1 (10.0) | 8 (15.4) | 9 (14.5) | 24 (88.9) | 33 (37.1) | |
| Lymphocyte (%) | 32.0 (7.0, 54.0) | 31.5 (6.8, 60.0) | 32.0 (6.8, 60.0) | 14.0 (2.0, 65.5) | 0.001* | 29.5 (2.0, 65.5) |
| Normal reference range & (%) | 8 (80.0) | 45 (86.5) | 53 (85.5) | 5 (18.5) | 58 (65.2) | |
| Abnormal reference range (%) | 2 (20.0) | 7 (13.5) | 9 (14.5) | 22 (81.5) | 31 (34.8) | |
| Lymphocyte, ×109/l (%) | 2.2 (1.0, 3.7) | 2.3 (0.1, 49.2) | 2.2 (0.1, 49.2) | 0.5 (0.0, 66.3) | 0.000* | 2.0 (0.0, 66.3) |
| QFT-GIT, IU/ml | ||||||
| Nil, negative control | 0.1 (0.0, 0.2) | 0.1 (0.0, 1.7) | 0.1 (0.0, 1.7) | 0.1 (0.0, 1.2) | 0.932 | 0.1 (0.0, 1.7) |
| TB antigen minus nil | 1.9 (0.4, 10.0) | 0.0 (−0.2, 0.2) | 0.0 (−0.2, 10.0) | 0.0 (−0.6, 0.1) | 0.072 | 0.0 (−0.6, 10.0) |
| Mitogen minus nil, positive control | 10.0 (0.4, 10.0) | 7.0 (0.6, 10.0) | 8.3 (0.4, 10.0) | 0.1 (−0.4, 0.5) | 0.000* | 2.4 (−0.4, 10.0) |
| Co-morbidity | ||||||
| Diabetes mellitus (%) | 0 (0.0) | 4 (7.7) | 4 (6.5) | 3 (11.1) | 0.429 | 7 (7.9) |
| Autoimmune disorder (%) | 1 (10.0) | 5 (9.6) | 6 (9.7) | 2 (7.4) | 1.000 | 8 (9.0) |
| COPD (%) | 2 (20.0) | 4 (7.7) | 6 (9.7) | 2 (7.4) | 1.000 | 8 (9.0) |
| Asthma (%) | 0 (0.0) | 2 (3.8) | 2 (3.2) | 1 (3.7) | 1.000 | 3 (3.4) |
| Chronic renal failure (%) | 0 (0.0) | 1 (1.9) | 1 (1.6) | 2 (7.4) | 0.217 | 3 (3.4) |
Data are presented as median (min–max) or number (%).
#
Determinate = positive + negative.
*
p < 0.05.
$
The reference range of the study institute: male, 3900–10600/μl; female, 3500–11000/μl.
&
The reference range of the study institute: 19–48%.
§
The European LeukemiaNet risk stratification by genetics did not performed for patients with AML because of the unavailability of the assays for genetic testing in the study period.
ALL, acute lymphocytic leukaemia; AML, acute myeloid leukaemia; BCG, Bacillus Calmette–Guérin; CLL, chronic lymphocytic leukaemia; CML, chronic myeloid leukaemia; COPD, chronic obstructive pulmonary disease; QFT-GIT, QuantiFERON-TB Gold in-Tube; TB, tuberculosis; WBC, white blood count.