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. 2020 Jan 29;21(3):858. doi: 10.3390/ijms21030858

Table 1.

Baseline clinical and demographic characteristics. Patients at our institution who received allogeneic hematopoietic stem cell transplant between January 11, 2011 and May 31, 2016 were consented, and enrolled in this tacrolimus pharmacogenetics study (n = 252). Associations with p < 0.05 are considered significant and are bolded below.

Patient Characteristics Total
(n = 252)
CYP3A5*1/*1
(n = 13)
CYP3A5*1/*3
(n = 64)
CYP3A5*3/*3
(n = 175)
p-Value
Age 52 (19–76) 55 (27–68) 50 (22–69) 54 (19–76) 0.09
Sex
 Male 145 (57.5%) 7 (53.8%) 32 (50%) 106 (60.6%) 0.39
 Female 107 (42.5%) 6 (46.2%) 32 (50%) 69 (39.4%) 0.39
Primary diagnosis
 Aplastic Anemia 5 (2%) 1 (7.7%) 1 (1.6%) 3 (1.7%) 0.32
 Acute Leukemia 139 (55.2%) 7 (53.8%) 31 (48.4%) 101 (57.7%) 0.44
 Chronic Leukemia 16 (6.3%) 0 (0%) 7 (10.9%) 9 (5.1%) 0.17
 Lymphoma 33 (13.1%) 2(15.4%) 10 (15.6%) 21 (12%) 0.74
 MDS/MPS 56 (22.2%) 2 (15.4%) 14 (21.9%) 40 (22.9%) 0.82
 Myeloma 3 (1.2%) 0 (0) 1 (1.6%) 2 (1.1%) 0.89
Donor
 MUD 165 (65.4%) 8 (61.5%) 23 (35.9%) 56 (32%) 0.09
 MRD 87 (34.6%) 5 (38.5%) 41 (64.1%) 119 (68%) 0.09
Stem cell source
 PBSC 237 (94%) 11 (84.6%) 61 (95.3%) 165 (94.3%) 0.32
 BM 14 (5.6%) 1 (15.4%) 3 (4.7%) 10 (5.7%) 0.90
 Cord Blood 1 (0.4%) 1 (100%) 0 (0%) 0 (0%) -
Conditioning regimen
 MAC 131 (52%) 4 (30.8%) 38 (59.4%) 89 (50.9%) 0.15
 RIC 121 (48%) 9 (69.2%) 26 (40.6%) 86 (49.1%) 0.15
Race
 White 211 (83.7%) 4 (1.9%) 39 (18.5%) 168 (79.6%) <0.001
 Black 30 (11.9%) 7 (53.8%) 19 (29.7%) 4 (2.3%) <0.001
 Other 11 (4.4%) 2 (18.2%) 6 (54.5%) 3 (27.3%) 0.01
Drug-drug Interactions
 No interaction 19 (7.5%) 3 (23.1%) 4 (6.3%) 12 (6.9%) 0.09
 Minimal risk interaction 41 (16.3%) 1 (7.7%) 11 (17.2%) 29 (16.6%) 0.69
 Moderate risk interaction 183 (72.6%) 9 (69.2) 46 (71.9%) 128 (73.1%) 0.94
 Severe risk interaction 9 (3.6%) 0 (0%) 3 (4.7%) 6 (3.4%) 0.70
 Median IBW, kg (range) 85.1
(42.8–166.6)
80.8
(60.2–109.2)
86.6
(52.7–144.1)
85.4
(42.8–166.6)
0.15
 Median tacrolimus starting daily dose, mg/dose (range) 4.0 (1.0–8.0) 4.0 (1.0–6.0) 4.0 (2.0–8.0) 5.0 (1.5–7.0) 0.55
 Median tacrolimus trough concentration, ng/mL (range) 5.05 (0.6–27.1) 2.8 (0.6–11.2) 3.0 (0.8–14.4) 6.2 (1.3–27.1) <0.001
 Median time to tacrolimus goal trough, days (range) 6 (3–31) 11 (3–31) 8 (4–25) 5 (3–16) <0.001
Liver function tests at admission
 AST (U/L) 33.0 (5–206) 33.0 (12–128) 25.5 (10–127) 26.0 (5–206) 0.46
 ALT (U/L) 51 (12–209) 42 (20–103) 34.5 (14–177) 39 (11–209) 0.40
 Tbili (mg/dL) 0.58 (0.1–2.5) 0.5 (0.1–1.4) 0.6 (0.2–2.5) 0.5 (0.1–2.1) 0.73
 SCr (mg/dL) at admission 0.79 (0.34–1.58) 0.80 (0.4–2.0) 0.80 (0.3–1.8) 0.70 (0.3–1.6) 0.57

Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; BM, bone marrow; IDW, ideal body weight; MAC, myeloablative conditioning; MDS, myelodysplastic syndrome; MPS, mucopolysaccharidosis; MRD, match related donor; MUD, match unrelated donor; PBSC, peripheral blood stem cell; RIC, reduced-intensity conditioning; SCr, serum creatinine; Tbili, total bilirubin.