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. 2020 Jul 2;25(12):e1825–e1836. doi: 10.1634/theoncologist.2020-0521
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.