Title
|
Efficacy |
Number of Patients Screened
|
29 |
Number of Patients Enrolled
|
23 |
Number of Patients Evaluable for Toxicity
|
23 |
Number of Patients Evaluated for Efficacy
|
23 |
Evaluation Method
|
RECIST 1.1 |
Response Assessment CR
|
n = 0 (0%) |
Response Assessment PR
|
n = 0 (0%) |
Response Assessment SD
|
n = 12 (52%) |
Response Assessment PD
|
n = 6 (26%) |
Response Assessment Nonevaluable
|
n = 5 (22%) |
(Median) Duration Assessments PFS
|
3.3 months, 95% CI: 1.6–4.4 |
(Median) Duration Assessments OS
|
8.9 months, 95% CI: 3.5–12.7 |
Outcome Notes
|
|
Five patients (22%) were nonevaluable for response, because of either lack of postbaseline tumor assessment (4 patients) or discontinuation due to nonradiographic progression. The overall disease control (DC) rate was 52% (95% CI: 31–73). The median duration of DC was 5.5 months (95% CI: 2.9–6.7). Figure 2 summarizes the best percentage change from baseline in tumor size for each patient. Five patients experienced tumor shrinkage and no patient experienced tumor shrinkage ≥30%. |