Table 3.
Treatment outcomes of 111 patients with CML-CP according to molecular response at 3 months
| IM400
|
IM800
|
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ≥10% (N=19) | <10% (N=36) | ≥10% (N=11) | <10% (N=45) | |||||||||||
|
| ||||||||||||||
| Pts | % | 95% CI | Pts | % | 95% CI | P* | Pts | % | 95% CI | Pts | % | 95% CI | P* | |
| CHR** | 18 | 95% | 74–100% | 33 | 92% | 76–98% | 0.83 | 9 | 82% | 48–98% | 44 | 98% | 88–100% | 0.095 |
| Not evaluable | 0 | 3 | 1 | 1 | ||||||||||
|
| ||||||||||||||
| N=15 | N=27 | N=6 | N=28 | |||||||||||
| CCyR*** | 6 | 40% | 16–68% | 23 | 85% | 66–96% | 0.0038 | 3 | 50% | 12–88% | 25 | 93% | 76–99% | 0.031 |
|
| ||||||||||||||
| MR at 1 year**** | N=10 | N=27 | N=9 | N=35 | ||||||||||
| 3-log (MMR) | 1 | 10% | 0–45% | 11 | 41% | 22–61% | 0.080 | 0 | 0% | 0–34% | 26 | 74% | 57–86% | 0.0001 |
| 4-log (MR4.0) | 0 | 0% | 0–31% | 3 | 11% | 2–29% | 0.38 | 0 | 0% | 0–34% | 14 | 40% | 24–58% | 0.020 |
| 4.5-log (MR4.5) | 0 | 0% | 0–31% | 3 | 11% | 2–29% | 0.38 | 0 | 0% | 0–34% | 10 | 29% | 15–46% | 0.074 |
*
One-sided p-value for poorer outcome in patients with <10% reduction in transcript at 3 months, based on Fisher’s exact test.
**
Includes 84 CHRs (40 IM400, 44 IM800) achieved on or before collection of 3-month specimen.
***
All CCyRs were achieved after day 90 specimen collection, except one IM400 patient 4 with ≥10% Reduction.
****
Based on blood specimens collected 295–406 days after randomization (if a patient’s molecular response was tested more than once during that interval, only the result obtained closest to day 365 was included in this analysis).