Title
|
Enzalutamide and sorafenib efficacy (part 2) |
Number of Patients Enrolled
|
12 |
Number of Patients Evaluable for Toxicity
|
12 |
Number of Patients Evaluated for Efficacy
|
10 |
Evaluation Method
|
RECIST 1.1 |
Response Assessment CR
|
n = 0 (0%) |
Response Assessment PR
|
n = 1 (6%) |
Response Assessment SD
|
n = 5 (42%) |
Response Assessment PD
|
n = 4 (33%) |
Response Assessment OTHER
|
n = 2 (17%) |
(Median) Duration Assessments PFS
|
2.89 months, CI: 1.61–NR |
(Median) Duration Assessments OS
|
6.69 months, CI: 4.60–NR |
Outcome Notes
|
Two of 12 patients were not included in the efficacy analysis. One could not swallow enzalutamide and hence never received combination treatment, and the other had an adverse event related to sorafenib during the sorafenib run‐in and never received combination treatment. These two were not included in the efficacy end points of ORR, PFS, and OS but were assessed for safety. |