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. 2020 Jul 17;25(11):e1628–e1639. doi: 10.1634/theoncologist.2020-0520
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%.