Table 3

Best cumulative response to bosutinib

Response, n (%)IM + DAS resistant (n = 37)IM + DAS intolerant (n = 50)IM + NI resistant (n = 27)IM + DAS ± NI (n = 4)*Total (n = 118)
Median follow-up, mo (range) 20.0 (2.7-51.3) 34.5 (0.3-56.2) 23.0 (7.1-54.0) 34.5 (22.8-40.0) 28.5 (0.3-56.2) 
Hematologic response      
    Evaluable patients 37 49 26 116 
    Complete response 23 (62) 39 (80) 20 (77) 3 (75) 85 (73) 
Hematologic response among patients with no baseline CHR      
    Evaluable patients 22 24 20 68 
    Complete response 11 (50) 16 (67) 15 (75) 2 (100) 44 (65) 
Cytogenetic response      
    Evaluable patients 35 43 26 108 
    Major response 11 (31) 13 (30) 9 (35) 2 (50) 35 (32) 
        Complete response 5 (14) 12 (28) 7 (27) 2 (50) 26 (24) 
        Partial response 6 (17) 1 (2) 2 (8) 9 (8) 
        Minor response 4 (9) 2 (8) 6 (6) 
    Molecular response§      
        Evaluable patients 35 48 19 105 
        Major response 1 (3) 12 (25) 2 (11) 1 (33) 16 (15) 
            Complete response 9 (19) 2 (11) 1 (33) 12 (11) 
Response, n (%)IM + DAS resistant (n = 37)IM + DAS intolerant (n = 50)IM + NI resistant (n = 27)IM + DAS ± NI (n = 4)*Total (n = 118)
Median follow-up, mo (range) 20.0 (2.7-51.3) 34.5 (0.3-56.2) 23.0 (7.1-54.0) 34.5 (22.8-40.0) 28.5 (0.3-56.2) 
Hematologic response      
    Evaluable patients 37 49 26 116 
    Complete response 23 (62) 39 (80) 20 (77) 3 (75) 85 (73) 
Hematologic response among patients with no baseline CHR      
    Evaluable patients 22 24 20 68 
    Complete response 11 (50) 16 (67) 15 (75) 2 (100) 44 (65) 
Cytogenetic response      
    Evaluable patients 35 43 26 108 
    Major response 11 (31) 13 (30) 9 (35) 2 (50) 35 (32) 
        Complete response 5 (14) 12 (28) 7 (27) 2 (50) 26 (24) 
        Partial response 6 (17) 1 (2) 2 (8) 9 (8) 
        Minor response 4 (9) 2 (8) 6 (6) 
    Molecular response§      
        Evaluable patients 35 48 19 105 
        Major response 1 (3) 12 (25) 2 (11) 1 (33) 16 (15) 
            Complete response 9 (19) 2 (11) 1 (33) 12 (11) 

IM indicates imatinib; DAS, dasatinib; and NI, nilotinib.

*

Includes 3 patients who previously received all 3 inhibitors and 1 patient with NI intolerance.

Evaluable patients had a baseline disease assessment. Patients with CHR at baseline were evaluable for hematologic response and were considered responders if they maintained their response at 2 consecutive post-baseline assessments ≥ 4 weeks apart.

Evaluable patients had a baseline disease assessment. Patients with CCyR at baseline were considered nonresponders for assessment of cytogenetic response.

§

Because of logistical constraints, patients from sites in China, India, Russia, and South Africa were not assessed for molecular response. MMR indicates ≥ 3 log reduction from standardized baseline Bcr-Abl:Abl ratio; and CMR, undetectable Bcr-Abl, with a sensitivity of ≥ 5 log. Molecular response was not assessed according to the International Scale.

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