Follow-up of the 120 patients randomized
| Characteristics . | Randomized to GO, N = 59, n (%) . | Randomized to no further therapy, N = 61, n (%) . |
|---|---|---|
| Treated with GO | ||
| No | 5 (8) | 60 (98) |
| 1 course | 1 (2) | 0 |
| 2 courses | 53 (90) | 1 (2) |
| Events | ||
| No event | 33 (56) | 35 (57) |
| Death in CR1 | 0 (0) | 1 (2) |
| MDS | 2 (3) | 0 (0) |
| Relapse | 24 (41) | 25 (41) |
| Median time from diagnosis to relapse, mo | 16 | 11 |
| Median follow-up for patients alive, y | 4.3 | 4.1 |
| HSCT in CR2 | ||
| Yes | 23* | 21 |
| Median days from last consolidation to SCT | 458 | 286 |
| Survival | ||
| 5-year EFS, % | 55 | 51 |
| 95% confidence interval, % | 51-59 | 42-59 |
| 5-year OS, % | 74 | 80 |
| 95% confidence interval, % | 70-78 | 72-86 |
| Characteristics . | Randomized to GO, N = 59, n (%) . | Randomized to no further therapy, N = 61, n (%) . |
|---|---|---|
| Treated with GO | ||
| No | 5 (8) | 60 (98) |
| 1 course | 1 (2) | 0 |
| 2 courses | 53 (90) | 1 (2) |
| Events | ||
| No event | 33 (56) | 35 (57) |
| Death in CR1 | 0 (0) | 1 (2) |
| MDS | 2 (3) | 0 (0) |
| Relapse | 24 (41) | 25 (41) |
| Median time from diagnosis to relapse, mo | 16 | 11 |
| Median follow-up for patients alive, y | 4.3 | 4.1 |
| HSCT in CR2 | ||
| Yes | 23* | 21 |
| Median days from last consolidation to SCT | 458 | 286 |
| Survival | ||
| 5-year EFS, % | 55 | 51 |
| 95% confidence interval, % | 51-59 | 42-59 |
| 5-year OS, % | 74 | 80 |
| 95% confidence interval, % | 70-78 | 72-86 |
GO indicates gemtuzumab ozogamicin; CR1, first complete remission; MDS, myelodysplastic syndrome; HSCT, hematopoietic stem cell transplantation; EFS, event-free survival; and OS, overall survival.
Including 2 patients with therapy-related MDS.