Patient baseline demographic and clinical characteristics
| Parameter . | CP2L . | CP3L . | ADV (n = 166) . | Total (n = 570) . | |||||
|---|---|---|---|---|---|---|---|---|---|
| IM-R (n = 196) . | IM-I (n = 90)* . | Total (n = 286) . | IM-R/I + D-R (n = 38) . | IM-R/I + D-I (n = 50)* . | IM-R/I + N-R (n = 26) . | Total† (n = 118) . | |||
| Median age (range), y | 51 (18-86) | 55 (23-91) | 53 (18-91) | 56 (23-76) | 57 (25-79) | 53 (20-73) | 56 (20-79) | 50 (18-84) | 53 (18-91) |
| Male sex, n (%) | 114 (58) | 36 (40) | 150 (52) | 18 (47) | 19 (38) | 14 (54) | 53 (45) | 97 (58) | 300 (53) |
| Race, n (%) | |||||||||
| White | 131 (67) | 55 (61) | 186 (65) | 28 (74) | 38 (76) | 17 (65) | 86 (73) | 103 (62) | 375 (66) |
| Asian | 42 (21) | 22 (24) | 64 (22) | 4 (11) | 9 (18) | 2 (8) | 15 (13) | 35 (21) | 114 (20) |
| Black | 11 (6) | 5 (6) | 16 (6) | 1 (3) | 1 (2) | 3 (12) | 6 (5) | 19 (11) | 41 (7) |
| Other | 12 (6) | 8 (9) | 20 (7) | 5 (13) | 2 (4) | 4 (15) | 11 (9) | 9 (5) | 40 (7) |
| Median time since CML diagnosis(range), y | 4.1 (0.6-15.1) | 2.6 (0.1-13.6) | 3.7 (0.1-15.1) | 7.0 (1.2-17.6) | 5.8 (0.6-18.3) | 5.9 (1.2-16.3) | 6.6 (0.6-18.3) | 3.9 (0.1-22.1) | 4.2 (0.1-22.1) |
| ECOG performance status, n (%)‡ | |||||||||
| 0 | 152 (78) | 67 (74) | 219 (77) | 28 (74) | 31 (62) | 24 (92) | 85 (72) | 74 (45) | 378 (66) |
| 1 | 44 (22) | 21 (23) | 65 (23) | 10 (26) | 18 (36) | 2 (8) | 32 (27) | 72 (43) | 169 (30) |
| 2 | 0 | 1 (1) | 1 (<1) | 0 | 0 | 0 | 0 | 20 (12) | 21 (4) |
| No. of prior therapies, n (%) | |||||||||
| 1 | 119 (61) | 67 (74) | 186 (65) | 0 | 0 | 0 | 0 | 72 (43) | 258 (45) |
| 2 | 77 (39) | 23 (26) | 100 (35) | 12 (32) | 26 (52) | 13 (50) | 52 (44) | 50 (30) | 202 (35) |
| 3 | 0 | 0 | 0 | 26 (68) | 24 (48) | 13 (50) | 64 (54) | 36 (22) | 100 (18) |
| 4 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (2) | 8 (5) | 10 (2) |
| Prior TKI therapy, n (%) | |||||||||
| Imatinib only | 196 (100) | 90 (100) | 286 (100) | 0 | 0 | 0 | 0 | 98 (59) | 384 (67) |
| Imatinib + dasatinib | 0 | 0 | 0 | 38 (100) | 50 (100) | 0 | 88 (75) | 40 (24) | 128 (22) |
| Imatinib + nilotinib | 0 | 0 | 0 | 0 | 0 | 26 (100) | 27 (23) | 12 (7) | 39 (7) |
| Imatinib + dasatinib + nilotinib | 0 | 0 | 0 | 0 | 0 | 0 | 3 (3) | 16 (10) | 19 (3) |
| Other prior therapies, n (%) | |||||||||
| Interferon | 77 (39) | 23 (26) | 100 (35) | 26 (68) | 24 (48) | 13 (50) | 65 (55) | 62 (37) | 227 (40) |
| Stem cell transplant | 6 (3) | 2 (2) | 8 (3) | 2 (5) | 5 (10) | 0 | 9 (8) | 14 (8) | 31 (5) |
| Parameter . | CP2L . | CP3L . | ADV (n = 166) . | Total (n = 570) . | |||||
|---|---|---|---|---|---|---|---|---|---|
| IM-R (n = 196) . | IM-I (n = 90)* . | Total (n = 286) . | IM-R/I + D-R (n = 38) . | IM-R/I + D-I (n = 50)* . | IM-R/I + N-R (n = 26) . | Total† (n = 118) . | |||
| Median age (range), y | 51 (18-86) | 55 (23-91) | 53 (18-91) | 56 (23-76) | 57 (25-79) | 53 (20-73) | 56 (20-79) | 50 (18-84) | 53 (18-91) |
| Male sex, n (%) | 114 (58) | 36 (40) | 150 (52) | 18 (47) | 19 (38) | 14 (54) | 53 (45) | 97 (58) | 300 (53) |
| Race, n (%) | |||||||||
| White | 131 (67) | 55 (61) | 186 (65) | 28 (74) | 38 (76) | 17 (65) | 86 (73) | 103 (62) | 375 (66) |
| Asian | 42 (21) | 22 (24) | 64 (22) | 4 (11) | 9 (18) | 2 (8) | 15 (13) | 35 (21) | 114 (20) |
| Black | 11 (6) | 5 (6) | 16 (6) | 1 (3) | 1 (2) | 3 (12) | 6 (5) | 19 (11) | 41 (7) |
| Other | 12 (6) | 8 (9) | 20 (7) | 5 (13) | 2 (4) | 4 (15) | 11 (9) | 9 (5) | 40 (7) |
| Median time since CML diagnosis(range), y | 4.1 (0.6-15.1) | 2.6 (0.1-13.6) | 3.7 (0.1-15.1) | 7.0 (1.2-17.6) | 5.8 (0.6-18.3) | 5.9 (1.2-16.3) | 6.6 (0.6-18.3) | 3.9 (0.1-22.1) | 4.2 (0.1-22.1) |
| ECOG performance status, n (%)‡ | |||||||||
| 0 | 152 (78) | 67 (74) | 219 (77) | 28 (74) | 31 (62) | 24 (92) | 85 (72) | 74 (45) | 378 (66) |
| 1 | 44 (22) | 21 (23) | 65 (23) | 10 (26) | 18 (36) | 2 (8) | 32 (27) | 72 (43) | 169 (30) |
| 2 | 0 | 1 (1) | 1 (<1) | 0 | 0 | 0 | 0 | 20 (12) | 21 (4) |
| No. of prior therapies, n (%) | |||||||||
| 1 | 119 (61) | 67 (74) | 186 (65) | 0 | 0 | 0 | 0 | 72 (43) | 258 (45) |
| 2 | 77 (39) | 23 (26) | 100 (35) | 12 (32) | 26 (52) | 13 (50) | 52 (44) | 50 (30) | 202 (35) |
| 3 | 0 | 0 | 0 | 26 (68) | 24 (48) | 13 (50) | 64 (54) | 36 (22) | 100 (18) |
| 4 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (2) | 8 (5) | 10 (2) |
| Prior TKI therapy, n (%) | |||||||||
| Imatinib only | 196 (100) | 90 (100) | 286 (100) | 0 | 0 | 0 | 0 | 98 (59) | 384 (67) |
| Imatinib + dasatinib | 0 | 0 | 0 | 38 (100) | 50 (100) | 0 | 88 (75) | 40 (24) | 128 (22) |
| Imatinib + nilotinib | 0 | 0 | 0 | 0 | 0 | 26 (100) | 27 (23) | 12 (7) | 39 (7) |
| Imatinib + dasatinib + nilotinib | 0 | 0 | 0 | 0 | 0 | 0 | 3 (3) | 16 (10) | 19 (3) |
| Other prior therapies, n (%) | |||||||||
| Interferon | 77 (39) | 23 (26) | 100 (35) | 26 (68) | 24 (48) | 13 (50) | 65 (55) | 62 (37) | 227 (40) |
| Stem cell transplant | 6 (3) | 2 (2) | 8 (3) | 2 (5) | 5 (10) | 0 | 9 (8) | 14 (8) | 31 (5) |
CP, chronic-phase CML; 2L, second-line setting; 3L, third-/fourth-line setting; IM-R, imatinib resistant; IM-I, imatinib intolerant; IM-R/I, imatinib resistant/intolerant; D-R, dasatinib resistant; D-I, dasatinib intolerant; N-R, nilotinib resistant; ADV, advanced leukemia (accelerated-/blast-phase CML and acute lymphoblastic leukemia); ECOG, Eastern Cooperative Oncology Group.
The subgroups of patients with intolerance to prior TKI therapy.
Includes patients (n = 4) in whom prior imatinib therapy failed and who were intolerant to prior nilotinib or resistant or intolerant to prior nilotinib and dasatinib therapy (because of low n, data not shown separately).
ECOG performance status at baseline was missing for 1 patient each in the CP2L and CP3L cohorts.