TABLE 1.
Patient demographics, medical history, primary disease and primary disease therapy for mITT and per protocol populations
| Patient population demographics, medical history, and primary disease history (mITT) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Parameter | Chemotherapy | HCT myeloablative | HCT non‐ablative + RIC | Total | PRPC‐CPC | ||||
| Cohort | PRPC | CPC | PRPC | CPC | PRPC | CPC | PRPC | CPC | |
| Patients in cohort (n) | 524 | 717 | 405 | 374 | 139 | 132 | 1068 | 1223 | |
| Mean age ± SD (years) | 57.1 ± 18.7 | 50.5 ± 23.8 | 56.1 ± 13.4 | 51.4 ± 17.9 | 58.8 ± 14.7 | 53.2 ± 18.3 | 57.0 ± 16.4 | 50.8 ± 21.6 | <0.001* |
| Male sex: (%) | 58.6 | 55.2 | 59.5 | 61.0 | 64.7 | 58.3 | 59.7 | 57.3 | 0.310 |
| medical history | |||||||||
| Prior pulmonary disease | 257 (49.0) | 316 (44.1) | 159 (39.3) | 124 (33.2) | 69 (49.6) | 59 (44.7) | 485 (45.4) | 499 (40.8) | 0.009* |
| Prior cardiac disease | 336 (64.1) | 411 (57.3) | 247 (61.0) | 195 (52.1) | 91 (65.5) | 81 (61.4) | 674 (63.1) | 687 (56.2) | <0.001* |
| Prior transfusion reaction | 114 (21.8) | 111 (15.5) | 18 (4.4) | 12 (3.2) | 16 (11.5) | 17 (12.9) | 148 (13.9) | 140 (11.4) | 0.008* |
| primary disease prior to study | |||||||||
| Leukemia | 306 (58.4) | 429 (59.8) | 35 (8.6) | 46 (12.3) | 42 (30.2) | 39 (29.5) | 383 (35.9) | 514 (42.0) | <0.001* |
| Lymphoma | 87 (16.6) | 83 (11.6) | 120 (29.6) | 95 (25.4) | 24 (17.3) | 14 (18.2) | 231 (21.6) | 202 (16.5) | |
| Myeloma | 27 (5.2) | 35 (4.9) | 218 (53.8) | 192 (51.3) | 26 (18.7) | 31 (23.5) | 271 (25.4) | 258 (21.1) | |
| MDS/myeloproliferative | 4 (0.8) | 18 (2.5) | 3 (0.7) | 6 (1.6) | 7 (5.0) | 13 (9.8) | 14 (1.3) | 37 (3.0) | |
| Myelodysplastic | 47 (9.0) | 49 (6.8) | 5 (1.2) | 3 (0.8) | 26 (18.7) | 11 (8.3) | 78 (7.3) | 63 (5.2) | |
| Other disease | 53 (10.1) | 103 (14.4) | 24 (5.9) | 32 (8.6) | 14 (10.1) | 14 (10.6) | 91 (8.5) | 149 (12.2) | |
| Recurrent disease | 169 (32.3) | 227 (31.7) | 105 (25.9) | 109 (29.1) | 43 (30.9) | 44 (33.3) | 317 (29.7) | 380 (31.1) | 0.622 |
| Refractory disease | 147 (28.1) | 187 (26.1) | 58 (14.3) | 75 (20.1) | 26 (18.7) | 38 (28.8) | 231 (21.6) | 300 (24.5) | 0.124 |
| Primary therapy on study | |||||||||
| Any HCT 1 | 58 (11.1) | 97 (13.5) | 405 (100) | 374 (100) | 139 (100) | 132 (100) | 602 (56.4) | 603 (49.3) | 0.056 |
| Autologous | 26 (5.0) | 31 (4.3) | 351 (86.7) | 300 (80.2 | 38 (27.3) | 40 (30.3) | 415 (38.9) | 371 (30.2) | |
| Allogeneic | 32 (6.1) | 66 (9.2) | 54 (13.3) | 74 (19.8) | 101 (72.7) | 92 (69.7) | 187 (17.5) | 232 (19.0) | |
| Chemotherapy no HCT | 466 (88.9) | 620 (86.5) | 0 | 0 | 0 | 0 | 466 (43.6) | 624 (50.7) | |
| Local radiation | 68 (13.0) | 86 (12.0) | 74 (18.3) | 57 (15.2) | 17 (12.2) | 14 (10.6) | 159 (14.9)) | 157 (12.8) | 0.010* |
| No local radiation | 453 (86.5) | 626 (87.3) | 329 (81.2) | 306 (81.8) | 122 (87.8) | 114 (86.4) | 904 (84.6) | 1046 (85.5) | |
| Total body radiation | 7 (1.3) | 21 (2.9) | 8 (2.0) | 7 (1.9) | 10 (7.2) | 10 (7.6) | 25 (2.3) | 38 (3.1) | 0.038* |
| No total body Radiation | 512 (97.7) | 690 (96.2) | 396 (97.8) | 357 (95.5) | 129 (92.8) | 119 (90.2) | 1037 (97.1) | 1166 (95.3) | |
*p < 0.05 level of significance.
1HCT = hematopoietic cell transplant.