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. 2021 Feb 22;26(5):362–e724. doi: 10.1002/onco.13689
Title Response assessment
Number of Patients Screened 77
Number of Patients Enrolled 42
Number of Patients Evaluable for Toxicity 42
Number of Patients Evaluated for Efficacy 42
Evaluation Method RECIST version 1.1
Response Assessment CR n = 0 (0%)
Response Assessment PR n = 2.4 (1%)
Response Assessment SD n = 52.4 (22%)
Response Assessment PD n = 33.3 (14%)
Response Assessment OTHER n = 11.9 (5%)
(Median) Duration Assessments PFS 6.2 months, CI: 4.3–7.9
(Median) Duration Assessments OS 8.8 months, CI: 4.3–12.2
Outcome Notes
Patients received a median of 3.5 cycles (range, 1–39 cycles) of SorCape. The median PFS was 6.2 months (95% CI, 4.3–7.9; Fig. 1A), which was longer when compared with historical controls (3 months; p = .0004). The median OS for this study cohort was 8.8 months (95% CI, 4.3–12.2; Fig. 1B). The 3‐month PFS rate was 83.3% (95% CI, 68.2%–91.7%), 6‐month PFS was 52.4% (95% CI, 36.4%–66.1%), 3‐month OS was also 83.3% (95% CI, 68.2%–91.7%), and 6‐month OS was 64.3% (95% CI, 47.9%–76.7%). One patient had PR (2.4%), and 22 patients had SD (52.4%) per RECIST version 1.1, achieving an overall response rate of 2.4% (95% CI, 0.1%–12.6%) and clinical benefit rate of 54.8% (95% CI, 38.7%–70.2%).