Treatment and outcomes
| . | . | . | Logistic/Cox regression . | ||||
|---|---|---|---|---|---|---|---|
| . | Control induction therapy . | Clofarabine induction therapy . | OR/HR . | 95% CI . | P . | ||
| Total | 402 (100%) | 393 (100%) | |||||
| Treatments | |||||||
| Remission induction | |||||||
| Cycle I | 401 (100%) | 393 (100%) | |||||
| Cycle II | 360 (90%) | 328 (83%) | |||||
| Consolidation after CR | 301 (75%) | 244 (61%) | |||||
| Consolidation therapy | |||||||
| Cycle III | 97 (24%) | 51 (13%) | |||||
| Autologous SCT | 35 (9%) | 31 (8%) | |||||
| Allogeneic SCT | 169 (42%) | 162 (41%) | |||||
| Outcomes | |||||||
| Complete remission (CR/CRi) | 355 (88%) | 352 (90%) | 1.14 | 0.73-1.77 | .57 | ||
| Early CR/CRi (after cycle I) | 267 (66%) | 293 (75%) | |||||
| Late CR/CRi | 88 (22%) | 59 (15%) | |||||
| Early death | |||||||
| Early death (<30 days) | 18 (4%) | 21 (5%) | |||||
| Death within 60 days | 32 (8%) | 33 (8%) | |||||
| Event-free survival (EFS) at 4 years (actuarial survival, % ± SE) | |||||||
| EFS | 35% (SE = 3%) | 38% (SE = 3%) | 0.90 | 0.75-1.07 | .24 | ||
| No CR | 15% (SE = 2%) | 13% (SE = 2%) | |||||
| Relapse | 38% ± 3 | 30% ± 2 | |||||
| Death | 13% ± 2 | 19% ± 2 | |||||
| Overall survival (OS) at 4 years (numbers, actuarial survival, % ± SE) | |||||||
| OS at 4 years | 43% ± 3 | 44% ± 3 | 0.95 | 0.78-1.15 | .57 | ||
| Relapse free at 4 years (actuarial, % ± SE) | |||||||
| RFS | 41% ± 3 | 44% ± 3 | 0.90 | 0.74-1.10 | .32 | ||
| Relapse | 44% ± 3 | 35% ± 3 | |||||
| Death | 15% ± 2 | 22% ± 3 | |||||
| . | . | . | Logistic/Cox regression . | ||||
|---|---|---|---|---|---|---|---|
| . | Control induction therapy . | Clofarabine induction therapy . | OR/HR . | 95% CI . | P . | ||
| Total | 402 (100%) | 393 (100%) | |||||
| Treatments | |||||||
| Remission induction | |||||||
| Cycle I | 401 (100%) | 393 (100%) | |||||
| Cycle II | 360 (90%) | 328 (83%) | |||||
| Consolidation after CR | 301 (75%) | 244 (61%) | |||||
| Consolidation therapy | |||||||
| Cycle III | 97 (24%) | 51 (13%) | |||||
| Autologous SCT | 35 (9%) | 31 (8%) | |||||
| Allogeneic SCT | 169 (42%) | 162 (41%) | |||||
| Outcomes | |||||||
| Complete remission (CR/CRi) | 355 (88%) | 352 (90%) | 1.14 | 0.73-1.77 | .57 | ||
| Early CR/CRi (after cycle I) | 267 (66%) | 293 (75%) | |||||
| Late CR/CRi | 88 (22%) | 59 (15%) | |||||
| Early death | |||||||
| Early death (<30 days) | 18 (4%) | 21 (5%) | |||||
| Death within 60 days | 32 (8%) | 33 (8%) | |||||
| Event-free survival (EFS) at 4 years (actuarial survival, % ± SE) | |||||||
| EFS | 35% (SE = 3%) | 38% (SE = 3%) | 0.90 | 0.75-1.07 | .24 | ||
| No CR | 15% (SE = 2%) | 13% (SE = 2%) | |||||
| Relapse | 38% ± 3 | 30% ± 2 | |||||
| Death | 13% ± 2 | 19% ± 2 | |||||
| Overall survival (OS) at 4 years (numbers, actuarial survival, % ± SE) | |||||||
| OS at 4 years | 43% ± 3 | 44% ± 3 | 0.95 | 0.78-1.15 | .57 | ||
| Relapse free at 4 years (actuarial, % ± SE) | |||||||
| RFS | 41% ± 3 | 44% ± 3 | 0.90 | 0.74-1.10 | .32 | ||
| Relapse | 44% ± 3 | 35% ± 3 | |||||
| Death | 15% ± 2 | 22% ± 3 | |||||
CI, confidence interval; CR, complete remission on protocol; early CR, complete remission attained after remission induction cycle I; HR, hazard ratio; late CR, complete remission attained after cycle II; OR, odds ratio; RFS, relapse free survival; SCT, hematopoietic stem cell transplantation; SE, standard error.