Table 3.
Efficacy outcomes in imatinib or dasatinib R/I patients and patients with newly diagnosed disease
| Outcome* | R/I to imatinib or dasatinib (n = 33) | Newly diagnosed (n = 25) |
|---|---|---|
| MMR | ||
| At baseline | 7 (21.2) | 0 |
| Rate at 6 cycles (primary end point in R/I patients) | 13 (39.4)† | 13 (52.0) |
| Rate at 12 cycles | 16 (48.5)† | 15 (60.0) |
| Rate at 24 cycles | 17 (51.5)† | 14 (56.0) |
| Cumulative rate by 12 cycles (coprimary end point in newly diagnosed CML) | 19 (57.6)† | 16 (64.0) |
| Cumulative rate by 24 cycles | 19 (57.6)† | 17 (68.0) |
| Cumulative rate by data cutoff | 20 (60.6)† | 18 (72.0) |
| Median time to first MMR, months (range)‡ | 2.8 (0-38.8) | 5.6 (2.7-33.0) |
| CCyR | ||
| At baseline | 14 (42.4) | 0 |
| Rate at 6 cycles | 24 (72.7)§ | 21 (84.0) |
| Rate at 12 cycles (coprimary end point in newly diagnosed CML) | 23 (69.7)§ | 16 (64.0) |
| Rate at 24 cycles | 21 (63.6)§ | 15 (60.0) |
| Cumulative rate by 12 cycles | 27 (81.8)§ | 21 (84.0) |
| Cumulative rate by 24 cycles | 27 (81.8)§ | 21 (84.0) |
| Estimated EFS at 24 mo, % (95% CI)|| | 96.3 (76.5-99.5) | 91.2 (69.0-97.7) |
| Progression to AP/BC on treatment | 1 (3.0) | 0 |
Data are presented as number (%) unless otherwise specified.
BC, blast crisis; CHR, complete hematologic response; EFS, event-free survival; MCyR, major cytogenetic response; PCyR, partial cytogenetic response.
Patients with missing data were counted as nonresponders.
In the R/I cohort, 6 patients in MMR at 6 and 12 cycles, 7 patients in MMR at 24 cycles, and 7 patients in MMR by 12 cycles, 24 cycles, and the data cutoff were in MMR at baseline.
Median time (range) to first MMR among the patients who achieved MMR by the data cutoff.
In the R/I cohort, 12 patients in CCyR at 6 cycles, 11 patients in CCyR at 12 cycles, 12 patients in CCyR at 24 cycles, and 14 patients in CCyR by 12 and 24 cycles were already in CCyR at baseline.
The following were considered events during treatment: loss of CHR, loss of MCyR (MCyR includes both PCyR and CCyR), progression to AP/BC (from CP) or to BC (from AP), or death from any cause.