Table 4 |
||||
|
Efficacy |
||||
|
Population |
Intent-to-Treat (N = 39) |
Efficacy Evaluable (N = 36) |
||
|
n (%) |
95% CI |
n (%) |
95% CI |
|
|
|
||||
|
Objective Response |
10 (25.6) |
13.0-42.1 |
10 (27.8) |
14.2-45.2 |
|
CR |
1 (2.6) |
0.1-13.5 |
1 (2.8) |
0.1-14.5 |
|
PR |
9 (23.1) |
11.1-39.3 |
9 (25.0) |
12.1-42.2 |
|
SD |
20 (51.3) |
34.8-67.6 |
19 (52.8) |
35.5-69.6 |
|
PD |
8 (20.5) |
9.3-36.5 |
7 (19.4) |
8.2-36.0 |
|
NE* |
1 (2.6) |
---- |
0 |
0 |
|
DSR |
30 (76.9) |
60.7-88.9 |
29 (80.6) |
64.0-91.8 |
|
Patients having SD ≥ 3 months |
19 (48.7) |
19 (52.8) |
||
|
Objective Response by RECIST by Platinum Status (ITT) |
Platinum Refractory or Primary Platinum Resistant N = 15 n (%); [95% CI] |
Secondary Platinum Resistant N = 24 n (%); [95% CI] |
||
|
ORR |
4 (26.7); [7.8-55.1] |
6 (25.0); [9.8-46.7] |
||
|
CR |
1 (6.7); [0.2-31.9] |
0 |
||
|
PR |
3 (20.0); [4.3-48.1] |
6 (25.0); [9.8-46.7] |
||
|
SD |
8 (53.3); [26.6-78.7] |
12 (50.0); [29.1-70.9] |
||
|
PD |
3 (20.0); [4.3-48.1] |
5 (20.8); [7.1-42.2] |
||
|
NE |
0 |
1 (4.2); NA |
||
|
Patients having SD ≥ 3 Months |
7 (46.7) |
12 (50.0) |
||
|
ITT Population n; Median |
ITT Population Q1-Q3 |
|||
|
Duration of Response (Months) |
10; 9.7 |
5.8-NA |
||
|
CR |
1; NA |
NA |
||
|
PR |
9; 9.7 |
5.8-NA |
||
|
Duration of SD |
20; 6.4 |
4.3-13.9 |
||
|
Time to Objective Response |
10; 2.9 |
2.3-3.9 |
||
|
Platinum Refractory or Primary Platinum Resistant N = 15 |
Secondary Platinum Resistant N = 24 |
All N = 39 |
||
|
Median (Q1-Q3) |
Median (Q1-Q3) |
Median (Q1-Q3) |
||
|
Time to Tumor Progression (Months) |
6.4 (4.1-14.0) |
6.0 (2.6-12.0) |
6.2 (3.3-12.0) |
|
|
Progression-free Survival (Months) |
6.4 (4.1-14.0) |
5.8 (2.3-11.6) |
6.0 (2.6-12.0) |
|
|
Overall Survival (Months) |
17.8 (7.0-NA) |
17.4 (8.1-NA) |
17.8 (7.7-NA) |
|
|
|
||||
|
Abbreviations: NE, not evaluable; CI, confidence interval |
||||
|
Kavanagh et al. Journal of Hematology & Oncology 2010 3:9 doi:10.1186/1756-8722-3-9 |
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