TABLE 2.
Baseline and clinical characteristics of patients with or without IAa
| Phase and characteristic | Value(s) according to population |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| aspBIOmics consortium and UHS-GHV-PCRAGA |
CSC-MO and VNH |
aspBIOmics consortium, UHS-GHV-PCRAGA, and CSC-MO |
||||||||||
| Overall (n = 593) | IA patients (n = 113) | Non-IA patients (n = 480) | P value | Overall (n = 188) | IA patients (n = 36) | Non-IA patients (n = 152) | P value | Overall (n = 781) | IA patients (n = 149) | Non-IA patients (n = 632) | P value | |
| Phase 1 | ||||||||||||
| Demographic variables | ||||||||||||
| Age (yr [avg ± SD]) | 51.46 ± 15.08 | 51.70 ± 13.20 | 51.40 ± 15.51 | 0.834 | ||||||||
| Sex ratio (no. male/no. female) | 1.27 (332/261) | 1.90 (74/39) | 1.16 (258/222) | 0.031 | ||||||||
| Hematological disease (no. [%]) | ||||||||||||
| AML | 412 (69.48) | 66 (58.41) | 346 (72.08) | 0.006 | ||||||||
| ALL | 73 (12.31) | 23 (20.35) | 50 (10.42) | 0.006 | ||||||||
| Other | 108 (18.21) | 24 (21.24) | 84 (17.50) | 0.429 | ||||||||
| Allo-HSCT (no. [%]) | 299 (50.42) | 65 (57.52) | 234 (48.75) | 0.116 | ||||||||
| Prophylaxis receivedb (no. [%]) | ||||||||||||
| Posaconazole | 73 (12.31) | 10 (8.85) | 63 (13.13) | 0.277 | ||||||||
| Itraconazole | 49 (8.26) | 13 (11.50) | 36 (7.50) | 0.230 | ||||||||
| Echinocandins | 30 (5.06) | 2 (1.77) | 28 (5.83) | 0.125 | ||||||||
| Voriconazole | 21 (3.54) | 6 (5.31) | 15 (3.13) | 0.397 | ||||||||
| Amphotericin B | 4 (0.67) | 0 (0.00) | 4 (0.83) | 0.738 | ||||||||
| Never received prophylaxis (no. [%]) | 450 (75.89) | 87 (76.99) | 363 (75.63) | 0.855 | ||||||||
| Phase 2 | ||||||||||||
| Demographic variables | ||||||||||||
| Age (yr [avg ± SD]) | 56.93 ± 18.12 | 55.75 ± 19.50 | 57.21 ± 17.84 | 0.665 | ||||||||
| Sex ratio (no. male/no. female) | 1.32 (107/81) | 1.57 (22/14) | 1.27 (85/67) | 0.705 | ||||||||
| Hematological disease (no. [%]) | ||||||||||||
| AML | 173 (92.02) | 34 (94.44) | 139 (91.45) | 0.799 | ||||||||
| ALL | 3 (1.60) | 1 (2.78) | 2 (1.32) | 0.912 | ||||||||
| Other | 12 (6.38) | 1 (2.78) | 11 (7.24) | 0.545 | ||||||||
| Allo-HSCT (no. [%]) | 39 (20.74) | 3 (8.33) | 36 (23.68) | 0.069 | ||||||||
| Prophylaxisc received (no. [%]) | ||||||||||||
| Posaconazole | 40 (40.40) | 3 (11.11) | 37 (51.39) | 0.0007 | ||||||||
| Itraconazole | 7 (7.07) | 3 (11.11) | 4 (5.56) | 0.603 | ||||||||
| Echinocandins | 1 (1.01) | 0 (0.00) | 1 (1.39) | 0.608 | ||||||||
| Voriconazole | 2 (2.02) | 0 (0.00) | 2 (2.78) | 0.942 | ||||||||
| Amphotericin B | 16 (16.16) | 2 (7.41) | 14 (19.44) | 0.253 | ||||||||
| Never received prophylaxis (no. [%]) | 69 (69.70) | 24 (88.89) | 45 (62.50) | 0.022 | ||||||||
| Phases 1 and 2 | ||||||||||||
| Demographic variables | ||||||||||||
| Age (yr [avg ± SD]) | 52.77 ± 16.03 | 52.67 ± 15.00 | 52.79 ± 16.27 | 0.935 | ||||||||
| Sex ratio (no. male/no. female) | 1.28 (439/342) | 1.81 (96/53) | 1.19 (343/289) | 0.031 | ||||||||
| Hematological disease (no. [%]) | ||||||||||||
| AML | 585 (74.90) | 100 (67.11) | 485 (76.74) | 0.020 | ||||||||
| ALL | 76 (09.73) | 24 (16.11) | 52 (08.23) | 0.006 | ||||||||
| Other | 120 (15.36) | 25 (16.78) | 95 (15.03) | 0.685 | ||||||||
| Allo-HSCT (no. [%]) | 338 (43.28) | 68 (45.64) | 270 (42.72) | 0.579 | ||||||||
| Prophylaxis received (no. [%]) | ||||||||||||
| Posaconazole | 113 (16.33) | 13 (9.29) | 100 (18.12) | 0.017 | ||||||||
| Itraconazole | 56 (8.09) | 16 (11.43) | 40 (7.25) | 0.148 | ||||||||
| Echinocandins | 31 (4.48) | 2 (1.43) | 29 (5.25) | 0.085 | ||||||||
| Voriconazole | 23 (3.32) | 6 (4.29) | 17 (3.08) | 0.655 | ||||||||
| Amphotericin B | 20 (2.89) | 2 (1.43) | 18 (3.26) | 0.383 | ||||||||
| Never received prophylaxisd (no. [%]) | 519 (75.00) | 111 (79.29) | 408 (73.91) | 0.229 | ||||||||
Abbreviations: HSCT, hematopoietic stem cell transplantation; AML, acute myeloid leukemia; ALL, acute lymphoid leukemia; UHS, University Hospital of Salamanca (Spain); GHV, General Hospital of Valencia (Spain); PCRAGA, clinical trial (EU clinical trial number 2010-019406-17); CSC, Università Cattolica del S. Cuore, Rome (Italy); MO, University of Modena and Reggio Emilia, Modena (Italy); VNH, Virgen de las Nieves University Hospital. P values of ≤0.05 were considered significant and are shown in boldface.
Some patients received several prophylactic drugs.
Prophylaxis status was available for only 99 subjects (15 IA and 72 non-IA patients).
Percentage calculated according to the number of patients with prophylaxis data available.