Table 1.
Demographics
| CLAG-M ND | CLAG-M R/R | 7 + 3 | Total | |
|---|---|---|---|---|
| n | 195 | 137 | 115 | 447 |
| Age, median (range), y | 62.2 (18.6-84.4) | 57.0 (19.3-82.6) | 57.1 (20.2-78.8) | 59.4 (18.6-84.4) |
| Female, n (%) | 83 (43) | 60 (44) | 50 (43) | 193 (43) |
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 4 (2) | 2 (1) | 4 (3) | 10 (2) |
| Not Hispanic or Latino | 187 (96) | 114 (83) | 39 (34) | 340 (76) |
| Unknown | 4 (2) | 21 (15) | 72 (63) | 97 (22) |
| Race, n (%) | ||||
| White | 162 (83) | 114 (83) | 84 (73) | 360 (81) |
| Black/African American | 9 (5) | 2 (1) | 4 (3) | 15 (3) |
| Asian | 15 (8) | 10 (7) | 8 (7) | 33 (7) |
| American or Alaskan Native/Pacific Islander | 7 (4) | 8 (6) | 13 (11) | 28 (6) |
| Unknown/mixed | 2 (1) | 3 (2) | 6 (5) | 11 (2) |
| Primary disease, n (%) | ||||
| AML | 154 (79) | 109 (80) | 104 (90) | 367 (82) |
| Myelodysplastic syndrome | 29 (15) | 23 (17) | 11 (10) | 63 (14) |
| Other | 12 (6) | 5 (4) | 0 (0) | 17 (4) |
| Secondary disease, n (%) | 71 (36) | 39 (28) | 27 (23) | 137 (31) |
| Performance status, n (%) | ||||
| 0 | 35 (18) | 22 (16) | 2 (2) | 59 (13) |
| 1 | 152 (78) | 94 (69) | 92 (80) | 338 (76) |
| 2 | 6 (3) | 16 (12) | 16 (14) | 38 (9) |
| 3 | 2 (1) | 4 (3) | 3 (3) | 9 (2) |
| Treatment-related mortality score, median (range) | 3.0 (0.0-96.0) | 0.1 (0.0-84.0) | 20.0 (0.0-93.0) | 3.0 (0.0-96.0) |
| No. of prior therapies, n (%) | ||||
| 0 | 137 (100) | 0 | 115 (100) | 252 (56) |
| 1 | 0 | 39 (28) | 0 | 39 (28) |
| 2 | 0 | 57 (42) | 0 | 57 (42) |
| ≥3 | 0 | 41 (30) | 0 | 41 (30) |
| Prior hematopoietic cell transplant, n (%) | 0 | 36 (26) | 0 | 36 (8) |
| Active graft-versus-host disease at baseline, n (%) | 0 | 2 (1) | 0 | 2 (0.4) |
| Baseline absolute neutrophil count, median (range) | 2.0 (0.0-95.1) | 1.7 (0.0-92.0) | 0.8 (0.0-25.8) | 1.6 (0.0-95.1) |
| Baseline peripheral blasts, median (range) | 3.0 (0.0-96.0) | 0.1 (0.0-84.0) | 20.0 (0.0-93.0) | 3.0 (0.0-96.0) |
| Year to initiate therapy, n (%) | ||||
| 2006-2010 | 0 | 0 | 71 (62) | 71 (16) |
| 2011-2014 | 43 (22) | 61 (45) | 41 (36) | 145 (32) |
| 2015-2018 | 152 (78) | 76 (55) | 3 (3) | 231 (52) |
| Cycle 2 chemotherapy, n (%) | 150 (77) [130 FF] | 70 (51) [58 FF] | 88 (77) [77 FF] | 308 (69) [265 FF] |
| 7 + 3 reinduction | 0 | 4 (3) | 11 (10) | 15 (3) |
| CLAG-M reinduction | 35 (18) | 33 (24) | 3 (3) | 71 (16) |
| CLAG consolidation | 97 (50) | 16 (12) | 2 (2) | 115 (26) |
| HiDAC consolidation | 13 (7) | 7 (5) | 64 (56) | 84 (19) |
| Other | 5 (3) | 10 (7) | 8 (6) | 23 (5) |
| Days after cycle 1, median (interquartile range) | 40 (37-47) | 44 (36-56) | 43 (34-49) | 42 (36-49) |
| Cycle 3 chemotherapy, n (%) | 60 (31) [44 FF] | 21 (15) [14 FF] | 64 (56) [47 FF] | 145 (32) [105 FF] |
| 7 + 3 reinduction | 0 | 0 | 4 (3) | 4 (1) |
| CLAG-M reinduction | 2 (1) | 3 (2) | 4 (3) | 9 (2) |
| CLAG consolidation | 13 (7) | 2 (1) | 2 (2) | 17 (4) |
| HiDAC consolidation | 37 (13) | 6 (4) | 46 (40) | 89 (20) |
| Other | 8 (4) | 10 (7) | 8 (6) | 26 (6) |
| Days after cycle 1, median (interquartile range) | 93 (82-111) | 96 (79-117) | 83 (71-94) | 89 (76-104) |
| M-PPX∗, n (%) | ||||
| Cycle 1 | 118 (59) | 69 (50) | 14 (10) | 196 (44) |
| Posaconazole | 111 (57) | 51 (37) | 2 (2) | 164 (37) |
| Voriconazole | 2 (1) | 18 (13) | 10 (9) | 30 (7) |
| Cycle 2∗,† (% of FF cycle 2), n (%) | 87 (67) | 40 (69) | 14 (18) | 141 (53) |
| Posaconazole | 78 (60) | 32(55) | 1 (1) | 111 (42) |
| Voriconazole | 9 (7) | 8 (14) | 12 (16) | 29 (11) |
| Cycle 3∗,† (% of FF cycle 3), n (%) | 25 (57) | 11 (79) | 7 (15) | 43 (41) |
| Posaconazole | 25 (57) | 9 (64) | 2 (4) | 36 (34) |
| Voriconazole | 0 | 2 (14) | 5 (11) | 7 (7) |
FF, fungal free.
∗
Defined as initiation by day 14 of the cycle.
†
Excluding patients with IFD in previous cycles.