Table 5

DOR, TTP, and time to response

Cohort 1, 20 mg/m2 (n = 59)Cohort 2, 20/27 mg/m2 (n = 67)Total (N = 126)
DOR, mo* 
    N 25 35 60 
    Median, mo (95% CI) 13.1 (7.2-NR) NR (NR-NR) NR (13.1-NR) 
Duration of CBR, mo 
    N 35 43 78 
    Median, (95% CI) 11.5 (6.2-NR) NR (NR-NR) NR (11.5-NR) 
TTP, mo 
    N 59 67 126 
    Median (95% CI) 8.3 (6.0-12.3) NR (11.3-NR) 12.0 (8.2-NR) 
Time to response, mo 
    N 25 35 60 
    Median, (min, max) 1.0 (0.5, 3.7) 1.9 (0.5, 3.7) 1.7 (0.5-3.7) 
Time to CBR, mo 
    N 35 43 78 
    Median, (min, max) 0.5 (0.5, 6.5) 0.5 (0.5, 5.9) 0.5 (0.5-6.5) 
Cohort 1, 20 mg/m2 (n = 59)Cohort 2, 20/27 mg/m2 (n = 67)Total (N = 126)
DOR, mo* 
    N 25 35 60 
    Median, mo (95% CI) 13.1 (7.2-NR) NR (NR-NR) NR (13.1-NR) 
Duration of CBR, mo 
    N 35 43 78 
    Median, (95% CI) 11.5 (6.2-NR) NR (NR-NR) NR (11.5-NR) 
TTP, mo 
    N 59 67 126 
    Median (95% CI) 8.3 (6.0-12.3) NR (11.3-NR) 12.0 (8.2-NR) 
Time to response, mo 
    N 25 35 60 
    Median, (min, max) 1.0 (0.5, 3.7) 1.9 (0.5, 3.7) 1.7 (0.5-3.7) 
Time to CBR, mo 
    N 35 43 78 
    Median, (min, max) 0.5 (0.5, 6.5) 0.5 (0.5, 5.9) 0.5 (0.5-6.5) 

The table is based on a response-evaluable population.

CBR indicates clinical benefit response; DOR, duration of response; NR, not reached; and TTP, time to progression.

*

Calculated for ORR.

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