Table 1.

Patient and disease characteristics at baseline

CharacteristicPatients with a confirmed diagnosisAll enrolled patients
(n = 260)
Total
(n = 229)
Previously untreated
(n = 148)
Previously treated
(n = 81)
Median age, y (range) 56  (19-81) 57  (19-81) 52  (20-73) 56  (19-81) 
Sex: M/F 128/101 81/67 47/34 136/124 
ECOG score (no. [%] of patients)     
 0-1 135  (59) 90  (61) 45  (56) 150  (58)  
 2 85  (37) 52  (35) 33  (41) 97  (37)  
 3 2  (1) 1  (1) 1  (1) 4  (2) 
Median y since initial diagnosis of CML (25th-75th percentile) 3.4  (1.4-5.8) 3.1  (1.2-6.0) 3.5  (1.7-5.7) 3.4  (1.5-5.8)  
Median mo since diagnosis of blast crisis (25th-75th percentile) 0.6  (0.2-2.3) 0.4  (0.2-0.9) 2.8  (0.8-5.6) 0.6  (0.3-2.5)  
Extramedullary involvement (no. [%] of patients) 160  (70) 108  (73) 52  (64) 179  (69)  
 Splenomegaly ≥ 10 cm below costal margin 61  (27) 42  (28) 19  (23) 65  (25) 
 Lymph node 24  (10) 20  (14) 4  (5) 24  (9) 
 Other (chloroma) 7  (3) 4  (3) 3  (4) 7  (3) 
Median hemoglobin, g/L (25th-75th percentile) 93  (85-104) 94  (86-107) 92  (85-99) 92  (85-103)  
Median WBC count, × 109/L (25th-75th percentile) 31  (13-67) 27  (11-56) 42  (13-80) 29  (10-66)  
Median platelet count, × 109/L (25th-75th percentile) 66  (29-194) 80  (30-204) 63  (28-168) 75  (29-208)  
Median blasts in bone marrow, % (25th-75th percentile) 50  (35-70) 48  (33-70) 57  (39-71) 46  (32-70)  
Median blasts in peripheral blood, % (25th-75th percentile) 35  (13-61) 34  (11-57) 37  (14-68) 30  (10-56)  
Initial dose of imatinib (no. [%] of patients)     
 400 mg 32  (14) 10  (7) 22  (27) 37  (14)  
 600 mg 197  (86) 138  (93) 59  (73) 223  (86) 
CharacteristicPatients with a confirmed diagnosisAll enrolled patients
(n = 260)
Total
(n = 229)
Previously untreated
(n = 148)
Previously treated
(n = 81)
Median age, y (range) 56  (19-81) 57  (19-81) 52  (20-73) 56  (19-81) 
Sex: M/F 128/101 81/67 47/34 136/124 
ECOG score (no. [%] of patients)     
 0-1 135  (59) 90  (61) 45  (56) 150  (58)  
 2 85  (37) 52  (35) 33  (41) 97  (37)  
 3 2  (1) 1  (1) 1  (1) 4  (2) 
Median y since initial diagnosis of CML (25th-75th percentile) 3.4  (1.4-5.8) 3.1  (1.2-6.0) 3.5  (1.7-5.7) 3.4  (1.5-5.8)  
Median mo since diagnosis of blast crisis (25th-75th percentile) 0.6  (0.2-2.3) 0.4  (0.2-0.9) 2.8  (0.8-5.6) 0.6  (0.3-2.5)  
Extramedullary involvement (no. [%] of patients) 160  (70) 108  (73) 52  (64) 179  (69)  
 Splenomegaly ≥ 10 cm below costal margin 61  (27) 42  (28) 19  (23) 65  (25) 
 Lymph node 24  (10) 20  (14) 4  (5) 24  (9) 
 Other (chloroma) 7  (3) 4  (3) 3  (4) 7  (3) 
Median hemoglobin, g/L (25th-75th percentile) 93  (85-104) 94  (86-107) 92  (85-99) 92  (85-103)  
Median WBC count, × 109/L (25th-75th percentile) 31  (13-67) 27  (11-56) 42  (13-80) 29  (10-66)  
Median platelet count, × 109/L (25th-75th percentile) 66  (29-194) 80  (30-204) 63  (28-168) 75  (29-208)  
Median blasts in bone marrow, % (25th-75th percentile) 50  (35-70) 48  (33-70) 57  (39-71) 46  (32-70)  
Median blasts in peripheral blood, % (25th-75th percentile) 35  (13-61) 34  (11-57) 37  (14-68) 30  (10-56)  
Initial dose of imatinib (no. [%] of patients)     
 400 mg 32  (14) 10  (7) 22  (27) 37  (14)  
 600 mg 197  (86) 138  (93) 59  (73) 223  (86) 

ECOG indicates Eastern Cooperative Oncology Group; CML, chronic myelogenous leukemia; and WBC, white blood cell.

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