Table 2.
Patient Characteristics and Outcomes
| All Patients | Poor Risk Patients | |||||
|---|---|---|---|---|---|---|
| Demographics | CPX-351 | Salvage | CPX-351 | Salvage | ||
| n (%) | n (%) | n (%) | n (%) | |||
| n=81 | n=44 | n=56 | n=29 | |||
| Gender | Male | 38 (46.9) | 19 (43.2) | 25 (44.6) | 11 (37.9) | |
| Age Group | 18 – 60 yr | 68 (84.0) | 35 (79.5) | 44 (78.6) | 21 (72.4) | |
| 61 – 65 yr | 13 (16.0) | 9 (20.5) | 12 (21.4) | 8 (27.6) | ||
| Median (yr) | 52 | 56 | 56 | 58 | ||
| Race | Caucasian | 70 (86.4) | 36 (81.8) | 50 (89.3) | 26 (89.7) | |
| AML Type | De novo AML | 71 (87.7) | 41 (93.2) | 47 (83.9) | 28 (96.6) | |
| Secondary AML | 10 (12.3) | 3 (6.8) | 9 (16.1) | 1(3.4) | ||
| WBC at Baseline | < 20 × 109/L | 65 (80.2) | 38 (86.4) | 45 (80.4) | 23 (11.5) | |
| 20 – 100×109/L | 16 (19.8) | 5 (11.4) | 11 (19.6) | 5 (17.2) | ||
| > 100×109/L | 0 (0.0) | 1 (2.3) | 0 (0.0) | 1 (3.4) | ||
| European Prognostic Index Factors | Points | |||||
| Risk Group | Favorable | 1–6 | 9 (11.1) | 6 (13.6) | -- | -- |
| Intermediate | 7–9 | 16 (19.8) | 9 (20.5) | -- | -- | |
| Poor | 8–14 | 56 (69.1) | 29 (65.9) | 56 (100) | 29 (100) | |
| Relapse-free Interval from CR1 (months) | > 18 | 0 | 11 (13.6) | 8 (18.2) | 0 (0.0) | 1 (3.4) |
| 6–18 | 3 | 43 (53.1) | 20 (45.5) | 30 (53.6) | 12 (41.4) | |
| ≤ 6 | 5 | 27 (33.3) | 16 (36.4) | 26 (46.4) | 16 (55.2) | |
| Cytogenetics at Diagnosis | Inv(16) or t(16;16) | 0 | 7 (8.6) | 4 (9.1) | 0 (0.0) | 0 (0.0) |
| t(8;21) | 3 | 2 (2.5) | 1 (2.3) | 0 (0.0) | 0 (0.0) | |
| Other | 5 | 72 (88.9) | 39 (88.6) | 56 (100) | 29 (100) | |
| Age at First Relapse (years) | ≤ 35 | 0 | 10 (12.3) | 4 (9.1) | 4 (7.1) | 2 (6.9) |
| 36 – 45 | 1 | 14 (17.3) | 7 (15.9) | 5 (8.9) | 1 (3.4) | |
| > 45 | 2 | 57 (70.4) | 33 (75.0) | 47 (83.9) | 26 (89.7) | |
| HSCT before Relapse | No | 0 | 59 (72.8) | 37 (84.1) | 39 (69.6) | 24 (82.8) |
| Yes | 2 | 22 (27.2) | 7 (15.9) | 17 (30.6) | 5 (17.2) | |
| Outcomes | ||||||
| Response (CR+CRi) | MLFS* | 58/75* (77.3) | 25/42* (59.5) | 37/56 (66.1) | 13/29 (44.8) | |
| CR+CRi | 40 (49.4) | 18 (40.9) | 22 (39.3) | 8 (27.6) | ||
| CR | 30 (37.0) | 14 (31.8) | 16 (28.6) | 6 (20.7) | ||
| CRi | 10 (12.3) | 4 (9.1) | 6 (10.7) | 2 (6.9) | ||
| Favorable | 7 (8.6) | 5 (11.4) | -- | -- | ||
| Intermediate | 11 (13.6) | 5 (11.4) | -- | -- | ||
| Poor | 22 (27.2) | 8 (18.2) | 22 (39.3) | 8 (27.6) | ||
| Early Mortality | 30 days | 6 (7.4) | 2 (4.5) | 5 (8.9) | 2 (6.9) | |
| 60 days | 12 (14.8) | 7 (15.9) | 9 (16.1) | 7 (24.1) | ||
| 90 days | 15 (18.5) | 13 (29.5) | 12 (21.4) | 11 (37.9) | ||
| EFS (median, mos.) | -- | 4.0 | 1.5 | 2.0 | 1.2 | |
| OS (median, mos.) | -- | 8.5 | 6.3 | 6.6 | 4.2 | |
| Post Induction HSCT | ALL | 38 (46.9) | 21 (47.7) | 23 (41.1) | 11 (37.9) | |
| CR | 22 (27.2) | 12 (27.3) | 10 (17.6) | 5 (17.2) | ||
| CRi | 6 (7.4) | 4 (9.1) | 4 (7.1) | 2 (6.9) | ||
| NR | 10 (12.3) | 5 (11.4) | 9 (16.1) | 4 (13.8) | ||
*
SixCPX-351 patients and two Control patients did not have a Day 14-21 bone marrow. MLFS= morphologic leukemia-free state: bone marrow blasts <5% absence of Auer rods and extramedullary disease on or after Day 14