Patient characteristics in the ENHANCE-2 trial
| Characteristic . | Eligible for nonintensive therapy . | Eligible for intensive therapy . | ||
|---|---|---|---|---|
| Magro/Aza (n = 101) . | Ven/Aza (n = 104) . | Magro/Aza (n = 27) . | 7+3 chemotherapy∗ (n = 25) . | |
| Age, median (range), y | 71 (27-87) | 72 (54-88) | 57 (27-73) | 64 (41-74) |
| Age group, n (%) | ||||
| <75 y | 66 (65.3) | 68 (65.4) | 27 (100) | 25 (100) |
| ≥75 y | 35 (34.7) | 36 (34.6) | 0 | 0 |
| Sex, n (%) | ||||
| Male | 58 (57.4) | 61 (58.7) | 22 (81.5) | 14 (56.0) |
| Female | 43 (42.6) | 43 (41.3) | 5 (18.5) | 11 (44.0) |
| Geographical region, n (%) | ||||
| United States | 31 (30.7) | 33 (31.7) | 1 (3.7) | 0 |
| Outside United States | 70 (69.3) | 71 (68.3) | 26 (96.3) | 25 (100) |
| ECOG PS, n (%) | ||||
| 0 | 26 (25.7) | 33 (31.7) | 14 (51.9) | 13 (52.0) |
| 1 | 50 (49.5) | 43 (41.3) | 9 (33.3) | 9 (36.0) |
| 2 | 19 (18.8) | 20 (19.2) | 3 (11.1) | 0 |
| 3 | 1 (1.0) | 1 (1.0) | 0 | 0 |
| Missing | 5 (5.0) | 7 (6.7) | 1 (3.7) | 3 (12.0) |
| AML subtype, n (%) | ||||
| Myelodysplasia related | 45 (44.6) | 42 (40.4) | 13 (48.1) | 11 (44.0) |
| Therapy related | 19 (18.8) | 26 (25.0) | 5 (18.5) | 3 (12.0) |
| Cytogenetic risk assessment, n (%) | ||||
| Intermediate | 12 (11.9) | 8 (7.7) | 2 (7.4) | 3 (12.0) |
| Adverse | 66 (65.3) | 67 (64.4) | 22 (81.5) | 16 (64.0) |
| Unknown/missing | 21 (20.8) | 28 (26.9) | 3 (11.1) | 6 (24.0) |
| TP53 mutations,† n (%) | ||||
| Monoallelic | 13 (12.9) | 15 (14.4) | 2 (7.4) | 2 (8.0) |
| Biallelic‡ | 77 (76.2) | 74 (71.1) | 22 (81.5) | 20 (80.0) |
| Missing data§ | 11 (10.9) | 15 (14.4) | 3 (11.1) | 3 (12.0) |
| Cytogenetics detected,|| n (%) | ||||
| Monosomal | 8 (7.9) | 11 (10.6) | 6 (22.2) | 4 (16.0) |
| Complex karyotype | 14 (13.9) | 22 (21.2) | 5 (18.5) | 3 (12.0) |
| −17/17p | 8 (7.9) | 8 (7.7) | 2 (7.4) | 1 (4.0) |
| Other | 62 (61.4) | 56 (53.8) | 16 (59.3) | 12 (48.0) |
| Unknown/missing | 12 (11.9) | 14 (13.5) | 1 (3.7) | 4 (16.0) |
| BM blast, n (%) | ||||
| <30% | 57 (56.4) | 63 (60.6) | 18 (66.7) | 13 (52.0) |
| ≥30% to <50% | 23 (22.8) | 15 (14.4) | 3 (11.1) | 6 (24.0) |
| ≥50% | 16 (15.8) | 18 (17.3) | 5 (18.5) | 4 (16.0) |
| Missing | 5 (5.0) | 8 (7.7) | 1 (3.7) | 2 (8.0) |
| Characteristic . | Eligible for nonintensive therapy . | Eligible for intensive therapy . | ||
|---|---|---|---|---|
| Magro/Aza (n = 101) . | Ven/Aza (n = 104) . | Magro/Aza (n = 27) . | 7+3 chemotherapy∗ (n = 25) . | |
| Age, median (range), y | 71 (27-87) | 72 (54-88) | 57 (27-73) | 64 (41-74) |
| Age group, n (%) | ||||
| <75 y | 66 (65.3) | 68 (65.4) | 27 (100) | 25 (100) |
| ≥75 y | 35 (34.7) | 36 (34.6) | 0 | 0 |
| Sex, n (%) | ||||
| Male | 58 (57.4) | 61 (58.7) | 22 (81.5) | 14 (56.0) |
| Female | 43 (42.6) | 43 (41.3) | 5 (18.5) | 11 (44.0) |
| Geographical region, n (%) | ||||
| United States | 31 (30.7) | 33 (31.7) | 1 (3.7) | 0 |
| Outside United States | 70 (69.3) | 71 (68.3) | 26 (96.3) | 25 (100) |
| ECOG PS, n (%) | ||||
| 0 | 26 (25.7) | 33 (31.7) | 14 (51.9) | 13 (52.0) |
| 1 | 50 (49.5) | 43 (41.3) | 9 (33.3) | 9 (36.0) |
| 2 | 19 (18.8) | 20 (19.2) | 3 (11.1) | 0 |
| 3 | 1 (1.0) | 1 (1.0) | 0 | 0 |
| Missing | 5 (5.0) | 7 (6.7) | 1 (3.7) | 3 (12.0) |
| AML subtype, n (%) | ||||
| Myelodysplasia related | 45 (44.6) | 42 (40.4) | 13 (48.1) | 11 (44.0) |
| Therapy related | 19 (18.8) | 26 (25.0) | 5 (18.5) | 3 (12.0) |
| Cytogenetic risk assessment, n (%) | ||||
| Intermediate | 12 (11.9) | 8 (7.7) | 2 (7.4) | 3 (12.0) |
| Adverse | 66 (65.3) | 67 (64.4) | 22 (81.5) | 16 (64.0) |
| Unknown/missing | 21 (20.8) | 28 (26.9) | 3 (11.1) | 6 (24.0) |
| TP53 mutations,† n (%) | ||||
| Monoallelic | 13 (12.9) | 15 (14.4) | 2 (7.4) | 2 (8.0) |
| Biallelic‡ | 77 (76.2) | 74 (71.1) | 22 (81.5) | 20 (80.0) |
| Missing data§ | 11 (10.9) | 15 (14.4) | 3 (11.1) | 3 (12.0) |
| Cytogenetics detected,|| n (%) | ||||
| Monosomal | 8 (7.9) | 11 (10.6) | 6 (22.2) | 4 (16.0) |
| Complex karyotype | 14 (13.9) | 22 (21.2) | 5 (18.5) | 3 (12.0) |
| −17/17p | 8 (7.9) | 8 (7.7) | 2 (7.4) | 1 (4.0) |
| Other | 62 (61.4) | 56 (53.8) | 16 (59.3) | 12 (48.0) |
| Unknown/missing | 12 (11.9) | 14 (13.5) | 1 (3.7) | 4 (16.0) |
| BM blast, n (%) | ||||
| <30% | 57 (56.4) | 63 (60.6) | 18 (66.7) | 13 (52.0) |
| ≥30% to <50% | 23 (22.8) | 15 (14.4) | 3 (11.1) | 6 (24.0) |
| ≥50% | 16 (15.8) | 18 (17.3) | 5 (18.5) | 4 (16.0) |
| Missing | 5 (5.0) | 8 (7.7) | 1 (3.7) | 2 (8.0) |
NGS, next-generation sequencing.
Seven days of continuous IV cytarabine (100 or 200 mg/m2 daily) and 3 days of IV daunorubicin (60 mg/m2 daily) or idarubicin (12 mg/m2 daily) on days 1 through 3.
Based on targeted NGS.
One patient had both NGS and biallelic 17p deletion results.
Refers to missing NGS data; these patients were enrolled based on 17p deletion testing.
Cytogenetics were locally collected and not centrally reviewed.