Table 1.
Response rates of 1L and 2L TKI therapiesa
| Study | Number of patients, n | Arms | Response | Response rate, n (%) | Patients remaining on study at data cutoff, n (%) |
|---|---|---|---|---|---|
| 1L | |||||
| Hochhaus A, et al. Leukemia. 2016 [16] | 283 | Imatinib 400 mg QD |
MMR by 5 y MR4 MR4.5 |
171 (60.4) 118 (41.7) 89 (31.4) |
141 (49.8)b |
| 282 | Nilotinib 300 mg BID |
MMR MR4 MR4.5 |
217 (77.0) 185 (65.6) 151 (53.5) |
169 (59.9) | |
| 281 | Nilotinib 400 mg BID |
MMR MR4 MR4.5 |
217 (77.2) 177 (63.0) 147 (52.3) |
174 (61.9) | |
| Cortes J, et al. J Clin Oncol. 2016 [17] | 260 | Imatinib 400 mg QD |
MMR by 5 y MR4.5 |
(64) (33) |
162 (63) |
| 259 | Dasatinib 100 mg QD |
MMR MR4.5 |
(76) (42) |
158 (61) | |
| Cortes J, et al. J Clin Oncol. 2018 [14] | 241c | Imatinib 400 mg QD |
MMR at 2 y MR4 |
(50.7) (25.7) |
|
| 246 | Bosutinib 400 mg QD |
MR4.5 MMR MR4 MR4.5 |
(10.8) (61.2) (32.8) (13.1) |
||
| 2L | |||||
| Kantarjian H, et al. Blood. 2011 [24] | 321d | Nilotinib 400 mg BID |
MCyR by 2 y MMR |
(59)e,f 82 (28)g |
124 (39) |
| Shah N, et al. Haematologica. 2010 [25]h | 167 | Dasatinib mg 140 QD |
MCyR by 2 y CCyR MMRi |
105 (63) 84 (50) 55 (38) |
|
| 167 | Dasatinib 100 mg QD |
MCyR CCyR MMR |
106 (63) 83 (50) 57 (37) |
||
| 168 | Dasatinib 70 mg BID |
MCyR CCyR MMR |
103 (61) 90 (54) 56 (38) |
||
| 168 | Dasatinib 50 mg QD |
MCyR CCyR MMR |
103 (61) 84 (50) 59 (38) |
||
| Gambacorti-Passerini C, et al. Am J Hematol. 2014 [131] | 200 | Bosutinib (imatinib resistant) |
MCyRj CCyRj MMRk |
108 (58) 85 (46) 45 (34) |
92 (46) |
| 88 | Bosutinib (imatinib intolerant) |
MCyRl CCyRl MMRm |
49 (61) 43 (54) 24 (35) |
37 (42) | |
1L first line, 2L second line, BID twice a day, CCyR complete cytogenetic response, MCyR major cytogenetic response, MMR major molecular response, MR4 4.0-log molecular response (BCR-ABL1IS ≤ 0.01%), MR4.5 4.5-log molecular response (BCR-ABL1IS ≤ 0.0032%), QD once a day, TKI tyrosine kinase inhibitor
aThese are selected studies focusing on pivotal trials
bPatients remaining on core study treatment at 5 years
c268 patients were randomized to each arm; however, 54 failed screening; 3 patients randomly assigned to imatinib arm were not treated
dPatients were resistant or intolerant to imatinib
e45% if measured only by metaphase analysis and excluding fluorescence in situ hybridization analysis and also excluding MCyR responders who had an MCyR at baseline or who had a missing cytogenetic analysis at baseline
f56% for imatinib-resistant patients and 66% for imatinib-intolerant patients
gMolecular response was assessed in 294 of the 321 patients
hPatients remaining on study at data cutoff were not included in the publication
i600 patients were assessed for molecular response
j186 evaluable patients
k132 evaluable patients
l80 evaluable patients
m68 evaluable patients