Table 2

Best overall responses (n = 257*)

All patients (n = 257)Patients with unfavorable cytogenetic/FISH markers (n = 71)
Response category, n (%)   
    Complete response 1 (0.4) 0 (0) 
    Very good partial response 13 (5.1) 3 (4.2) 
    Partial response 47 (18.3) 18 (25.4) 
    Minimal response 34 (13.2) 3 (4.2) 
    Stable disease 81 (31.5) 28 (39.4) 
    Progressive disease 69 (26.8) 15 (21.1) 
    Not evaluable 12 (4.7) 4 (5.6) 
Overall response, n (%) 61 (23.7) 21 (29.6) 
    95% CI 18.7-29.4 19.3-41.6 
Clinical benefit rate, n (%) 95 (37.0) 24 (33.8) 
    95% CI 31.1-43.2 23.0-46.0 
PFS, median (95% CI), mo 3.7 (2.8-4.6) 3.6 (2.3-4.6) 
Median duration of response, mo (95% CI) 7.8 (5.6-9.2) 6.9 (3.7-8.5) 
Mean treatment duration, mo (range) 3.0 (0.03-16.9) 3.6 (0-11.1) 
All patients (n = 257)Patients with unfavorable cytogenetic/FISH markers (n = 71)
Response category, n (%)   
    Complete response 1 (0.4) 0 (0) 
    Very good partial response 13 (5.1) 3 (4.2) 
    Partial response 47 (18.3) 18 (25.4) 
    Minimal response 34 (13.2) 3 (4.2) 
    Stable disease 81 (31.5) 28 (39.4) 
    Progressive disease 69 (26.8) 15 (21.1) 
    Not evaluable 12 (4.7) 4 (5.6) 
Overall response, n (%) 61 (23.7) 21 (29.6) 
    95% CI 18.7-29.4 19.3-41.6 
Clinical benefit rate, n (%) 95 (37.0) 24 (33.8) 
    95% CI 31.1-43.2 23.0-46.0 
PFS, median (95% CI), mo 3.7 (2.8-4.6) 3.6 (2.3-4.6) 
Median duration of response, mo (95% CI) 7.8 (5.6-9.2) 6.9 (3.7-8.5) 
Mean treatment duration, mo (range) 3.0 (0.03-16.9) 3.6 (0-11.1) 
*

Response-evaluable population.

Calculated for patients with partial response or better.

Before the opening of the extension study (PX-171-010), individual protocol exceptions were granted for 7 patients to continue receiving treatment beyond 12 cycles.

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