Patient characteristics and study throughput, induction, and consolidation treatments
| . | All patients . | High-risk* patients . | sAML patients . | |||
|---|---|---|---|---|---|---|
| CPX-351, n = 85 . | 7+3, n = 41 . | CPX-351, n = 61 . | 7+3, n = 29 . | CPX-351, n = 33 . | 7+3, n = 19 . | |
| Gender | ||||||
| % Male | 53 (62.4) | 25 (61.0) | 35 (57.4) | 16 (55.2) | 21 (63.6) | 9 (47.4) |
| Age (y) | ||||||
| 60-69 | 51 (60.0) | 26 (63.4) | 27 (44.3) | 14 (48.3) | 20 (60.6) | 11 (57.9) |
| 70-75 | 34 (40.0) | 15 (36.6) | 34 (55.7) | 15 (51.7) | 13 (39.4) | 8 (42.1) |
| Range | 60-77 | 61-77 | 60-77 | 61-77 | 60-75 | 61-75 |
| Median | 68 | 68 | 70 | 71 | 68 | 68 |
| Race | ||||||
| White | 79 (92.9) | 39 (95.1) | 58 (95.1) | 27 (93.1) | 31 (93.9) | 18 (94.7) |
| Performance status | ||||||
| 0 | 22 (25.9) | 12 (29.3) | 15 (24.6) | 10 (34.5) | 8 (24.2) | 6 (31.6) |
| 1 | 48 (56.5) | 24 (58.5) | 36 (59.0) | 15 (51.7) | 18 (54.5) | 9 (47.4) |
| 2 | 15 (17.6) | 5 (12.2) | 10 (16.4) | 4 (13.8) | 7 (21.2) | 4 (21.1) |
| AML type | ||||||
| de novo AML | 52 (61.2) | 22 (53.7) | 28 (45.9) | 10 (34.5) | — | — |
| Secondary AML | 33 (38.8) | 19 (46.3) | 33 (54.1) | 19 (65.5) | 33 (100) | 19 (100) |
| Cytogenetic risk | ||||||
| Intermediate/favorable | 55 (64.7) | 26 (63.4) | 33 (54.1) | 16 (55.2) | 20 (60.6) | 13 (68.4) |
| Adverse | 23 (27.1) | 13 (31.7) | 23 (37.7) | 13 (44.8) | 10 (30.3) | 6 (31.6) |
| Unknown | 7 (8.2) | 2 (4.9) | 5 (8.2) | 0 | 3 (9.1) | 0 |
| Stratification group | ||||||
| Standard risk | 33 (38.8) | 16 (39.0) | 10 (16.4) | 5 (17.2) | — | — |
| High risk | 52 (61.2) | 25 (61.0) | 51 (83.6) | 24 (82.8) | 30 (90.9) | 17 (89.5) |
| WBC count at entry | ||||||
| ≤20 × 109/L | 65 (76.5) | 32 (78.0) | 48 (78.7) | 22 (75.9) | 28 (84.8) | 15 (78.9) |
| >20-100 × 109/L | 19 (22.4) | 9 (22.0) | 12 (19.7) | 7 (24.1) | 5 (15.2) | 4 (21.1) |
| >100 × 109/L | 1 (1.2) | 0 | 1 (1.6) | 0 | 0 | 0 |
| Induction treatment | ||||||
| 1 course | 68 (80.0) | 29 (70.7) | 47 (77.0) | 21 (72.4) | 23 (69.7) | 15 (78.9) |
| 2 courses | 17 (20.0) | 12 (29.3) | 14 (23.0) | 8 (27.6) | 10 (30.3) | 4 (21.1) |
| Persistent AML/not assessed | ||||||
| After 1 or 2 inductions | 29 (34.1) | 20 (48.8) | 23 (37.7) | 15 (51.7) | 14 (42.4) | 13 (68.4) |
| Complete response CR + CRi† | ||||||
| After first course | 46 (54.8) | 13 (31.7) | 29 (48.3) | 9 (31.0) | 13 (39.4) | 4 (21.1) |
| After second course | 10 (11.9) | 8 (19.5) | 9 (15.0) | 5 (17.2) | 6 (18.2) | 2 (10.5) |
| Consolidation therapy (responders only) | ||||||
| None | 15 (26.8) | 3 (14.3) | 10 (26.3) | 2 (14.3) | 5 (26.3) | 0 |
| Chemotherapy only: 1 course | 15 (26.8) | 5 (23.8) | 12 (31.6) | 4 (28.6) | 6 (31.6) | 1 (16.7) |
| Chemotherapy only: 2 courses | 13 (23.2) | 8 (38.1) | 7 (18.4) | 5 (35.7) | 2 (10.5) | 3 (50.0) |
| Transplantation only | 4 (7.1) | 3 (14.3) | 4 (10.5) | 1 (7.1) | 2 (10.5) | 1 (16.7) |
| Chemotherapy followed by transplantation | 9 (16.1) | 2 (9.5) | 5 (13.2) | 2 (14.3) | 4 (21.1) | 1 (16.7) |
| Salvage therapy | ||||||
| Any chemotherapy | 39 (45.9) | 20 (48.8) | 23 (37.7) | 12 (41.4) | 10 (30.3) | 7 (36.8) |
| Patient crossover | — | 10 (24.4) | — | 6 (20.7) | — | 6 (31.5) |
| Transplant | 1 | 5‡ | 1 | 3§ | 1 | 2¶ |
| . | All patients . | High-risk* patients . | sAML patients . | |||
|---|---|---|---|---|---|---|
| CPX-351, n = 85 . | 7+3, n = 41 . | CPX-351, n = 61 . | 7+3, n = 29 . | CPX-351, n = 33 . | 7+3, n = 19 . | |
| Gender | ||||||
| % Male | 53 (62.4) | 25 (61.0) | 35 (57.4) | 16 (55.2) | 21 (63.6) | 9 (47.4) |
| Age (y) | ||||||
| 60-69 | 51 (60.0) | 26 (63.4) | 27 (44.3) | 14 (48.3) | 20 (60.6) | 11 (57.9) |
| 70-75 | 34 (40.0) | 15 (36.6) | 34 (55.7) | 15 (51.7) | 13 (39.4) | 8 (42.1) |
| Range | 60-77 | 61-77 | 60-77 | 61-77 | 60-75 | 61-75 |
| Median | 68 | 68 | 70 | 71 | 68 | 68 |
| Race | ||||||
| White | 79 (92.9) | 39 (95.1) | 58 (95.1) | 27 (93.1) | 31 (93.9) | 18 (94.7) |
| Performance status | ||||||
| 0 | 22 (25.9) | 12 (29.3) | 15 (24.6) | 10 (34.5) | 8 (24.2) | 6 (31.6) |
| 1 | 48 (56.5) | 24 (58.5) | 36 (59.0) | 15 (51.7) | 18 (54.5) | 9 (47.4) |
| 2 | 15 (17.6) | 5 (12.2) | 10 (16.4) | 4 (13.8) | 7 (21.2) | 4 (21.1) |
| AML type | ||||||
| de novo AML | 52 (61.2) | 22 (53.7) | 28 (45.9) | 10 (34.5) | — | — |
| Secondary AML | 33 (38.8) | 19 (46.3) | 33 (54.1) | 19 (65.5) | 33 (100) | 19 (100) |
| Cytogenetic risk | ||||||
| Intermediate/favorable | 55 (64.7) | 26 (63.4) | 33 (54.1) | 16 (55.2) | 20 (60.6) | 13 (68.4) |
| Adverse | 23 (27.1) | 13 (31.7) | 23 (37.7) | 13 (44.8) | 10 (30.3) | 6 (31.6) |
| Unknown | 7 (8.2) | 2 (4.9) | 5 (8.2) | 0 | 3 (9.1) | 0 |
| Stratification group | ||||||
| Standard risk | 33 (38.8) | 16 (39.0) | 10 (16.4) | 5 (17.2) | — | — |
| High risk | 52 (61.2) | 25 (61.0) | 51 (83.6) | 24 (82.8) | 30 (90.9) | 17 (89.5) |
| WBC count at entry | ||||||
| ≤20 × 109/L | 65 (76.5) | 32 (78.0) | 48 (78.7) | 22 (75.9) | 28 (84.8) | 15 (78.9) |
| >20-100 × 109/L | 19 (22.4) | 9 (22.0) | 12 (19.7) | 7 (24.1) | 5 (15.2) | 4 (21.1) |
| >100 × 109/L | 1 (1.2) | 0 | 1 (1.6) | 0 | 0 | 0 |
| Induction treatment | ||||||
| 1 course | 68 (80.0) | 29 (70.7) | 47 (77.0) | 21 (72.4) | 23 (69.7) | 15 (78.9) |
| 2 courses | 17 (20.0) | 12 (29.3) | 14 (23.0) | 8 (27.6) | 10 (30.3) | 4 (21.1) |
| Persistent AML/not assessed | ||||||
| After 1 or 2 inductions | 29 (34.1) | 20 (48.8) | 23 (37.7) | 15 (51.7) | 14 (42.4) | 13 (68.4) |
| Complete response CR + CRi† | ||||||
| After first course | 46 (54.8) | 13 (31.7) | 29 (48.3) | 9 (31.0) | 13 (39.4) | 4 (21.1) |
| After second course | 10 (11.9) | 8 (19.5) | 9 (15.0) | 5 (17.2) | 6 (18.2) | 2 (10.5) |
| Consolidation therapy (responders only) | ||||||
| None | 15 (26.8) | 3 (14.3) | 10 (26.3) | 2 (14.3) | 5 (26.3) | 0 |
| Chemotherapy only: 1 course | 15 (26.8) | 5 (23.8) | 12 (31.6) | 4 (28.6) | 6 (31.6) | 1 (16.7) |
| Chemotherapy only: 2 courses | 13 (23.2) | 8 (38.1) | 7 (18.4) | 5 (35.7) | 2 (10.5) | 3 (50.0) |
| Transplantation only | 4 (7.1) | 3 (14.3) | 4 (10.5) | 1 (7.1) | 2 (10.5) | 1 (16.7) |
| Chemotherapy followed by transplantation | 9 (16.1) | 2 (9.5) | 5 (13.2) | 2 (14.3) | 4 (21.1) | 1 (16.7) |
| Salvage therapy | ||||||
| Any chemotherapy | 39 (45.9) | 20 (48.8) | 23 (37.7) | 12 (41.4) | 10 (30.3) | 7 (36.8) |
| Patient crossover | — | 10 (24.4) | — | 6 (20.7) | — | 6 (31.5) |
| Transplant | 1 | 5‡ | 1 | 3§ | 1 | 2¶ |
Values are n (%). WBC, white blood cell.
High-risk = ≥70 years of age or sAML or adverse cytogenetics.
One patient was removed from the CPX-351 group before response assessment to be treated with imatinib.
Three patients were transplanted after crossover.
Two patients were transplanted after crossover.
Both patients were transplanted after crossover.