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. 2020 Jul 2;25(12):e1825–e1836. doi: 10.1634/theoncologist.2020-0521
Title Enzalutamide efficacy (part 1)
Number of Patients Enrolled 16
Number of Patients Evaluable for Toxicity 16
Number of Patients Evaluated for Efficacy 15
Evaluation Method RECIST 1.1
Response Assessment CR n = 0 (0%)
Response Assessment PR n = 0 (0%)
Response Assessment SD n = 7 (44%)
Response Assessment PD n = 8 (50%)
Response Assessment OTHER n = 1 (6%)
(Median) Duration Assessments PFS 1.76 months, CI: 1.61–3.55
(Median) Duration Assessments OS 7.03 months, CI: 3.55–NR
Outcome Notes One patient did not complete 80% of dosing in cycle 1 and was replaced for DLT per protocol. The patient clinically deteriorated on study and was evaluable for toxicity and survival but not for response.