Table 5.
2nd/3rd generation TKI in accelerated phase of chronic myeloid leukemia.
| Study | TKI |
Patients n° (R/I) |
Hematologic response | Cytogenetic/molecular response | Survival |
|---|---|---|---|---|---|
| AFTER FAILURE OF IMATINIB AND/OR OTHER TKI | |||||
| Kantarjian et al. (70) | Nilotinib 50–1,200 mg (phase I study) | 56 (100%/0%) |
HR 74% CHR 46% |
MCyR 27% CCyR 14% |
n.a. |
| Giles et al. (71) | Nilotinib 400 mg b.i.d. | 21 (86%/14%) |
HR 29% | MCyR 12% CCyR 0% |
6-mo PFS 57% 1-year OS 80% |
| le Coutre et al. (72) | Nilotinib 400 mg b.i.d. | 137 (80%/20%) |
CHR 31% |
MCyR 32% CCyR 21% |
2-years PFS 33% 2-years OS 70% |
| Nicolini et al. (73) | Nilotinib 400 mg b.i.d. | 181 (82%/18%) |
CHR 22% | MCyR 19% CCyR 11% |
18-mo OS 81% |
| Talpaz et al. (74) | Dasatinib 15–240 mg (phase I study) | 11 (82%/18%) |
HR 82% CHR 45% |
MCyR 27% CCyR 18% |
n.a. |
| Apperley et al. (75) | Dasatinib 70 mg b.i.d. | 174 (93%/7%) |
CHR 50% | MCyR 40% CCyR 33% |
2-years PFS 46% 2-years OS 72% |
| Kantarjian et al. (76) | Dasatinib 70 mg b.i.d. (n = 159) or dasatinib 140 mg daily (n = 158) | 317 (73%/27%) |
CHR 47–52% | MCyR 39–43% CCyR 32–33% |
2-years PFS 51–55% 2-years OS 63–72% |
| Gambacorti-Passerini et al. (77) | Bosutinib 500 mg daily | 79 (86%/14%) |
HR 57% | MCyR 40% | 4-years OS 59% |
| Cortes et al. (78) | Ponatinib 45 mg daily | 83 (92%/8%) |
HR 55% | MCyR 39% CCyR 24% |
1-year PFS 55% 1-year OS 84% |
| AT DIAGNOSIS, TKI-NAÏVE | |||||
| Ohanian et al. (62) | Nilotinib (n = 16) or dasatinib (n = 5) | 21 | CHR 95% | CCyR 90% MMR 76% MR4.5 50% |
3-years PFS 90% 3-years OS 95% |
| Jiang et al. (79) | Nilotinib/dasatinib | 101 | n.r. | EMR 62–65% | 3-years PFS 78–95% 3-years OS 92–97% |
| Balsat et al. (80) | Nilotinib 300–400 mg b.i.d. (n = 39) or dasatinib 100–140 mg daily (n = 27) | 66 | CHR 97% | CCyR 84% MMR 70% DMR 50% |
7-years PFS 83% 7-years OS 87% |
| Masarova et al. (81) | Nilotinib 400 mg b.i.d. | 22 | CHR 73% | CCyR 73% MMR 73% MR4.5 55% |
5-years PFS 91% 5-years OS 84% |
R/I, resistant/intolerant; HR, hematologic response; CHR, complete hematologic response; MCyR, major cytogenetic response; CCyR, complete cytogenetic response; MMR, major molecular response; EMR, early molecular response; DMR, deep molecular response (MR4 or better); OS, overall survival; PFS, progression-free survival.