Table 2.
Treatment characteristics, response, and toxicity.
| Characteristics | n | % |
|---|---|---|
| Follow-up, months (median, range) | 9.3 (0.2–26.1) | |
| No. of induction cycles with CPX (median, range) | 1 (1–2) | |
| ANC recoverya in patients with CR/CRi after CPX-351 induction (n = 83) | ||
| Yes | 79 | 95 |
| No | 4 | 5 |
| Time, days (median, range) | 33 (6–99) | |
| Platelet recoveryb in patients with CR/CRi after CPX-351 induction (n = 83) | ||
| Yes | 76 | 92 |
| No | 7 | 8 |
| Time, days (median, range) | 30 (7–77) | |
| Response after induction (n = 179) | ||
| CR/CRi | 85 | 47 |
| MLFS | 35 | 20 |
| Refractory disease | 53 | 30 |
| Early death (<30 days) without response | 6 | 3 |
| Evaluation | ||
| MRD available in case of CR/CRi | 36 | 42c |
| MRD negative | 23 | 64d |
| Grade III/IV non-hematologic toxicities (n = 188) | ||
| Infection | 41 | 22 |
| GI (mucositis, nausea, vomiting) | 7 | 4 |
| Bleeding | 7 | 4 |
| Renal failure | 5 | 3 |
| Febrile neutropenia | 28 | 15 |
| Pneumonia | 42 | 22 |
| Mortality on d30 after CPX-351 induction (n = 176)e | ||
| Alive | 162 | 92 |
| Dead | 14 | 8 |
ANC absolute neutrophile count, CR complete remission, CRi complete remission with incomplete hematologic recovery, d day, GI gastrointestinal, MLFS morphologic leukemia-free state, MRD minimal residual disease, n number, SD stable disease, PD progressive disease, n.d. not done.
Numbers in parentheses display patients with available information.
aDefined as ANC > 500/µl.
bDefined as platelet count >50,000/µl.
cOf the 85 patients with CR/CRi.
dOf the 36 patients with available MRD results.
ePatients proceeding to allo-HSCT before d30 following CPX-351 induction have been excluded.