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Table 4 Efficacy end points

From: Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma, or leukemia

End point

Safety population (n = 50)

Efficacy population (n = 27)

Best RR (CR + PR), No. (%, 95% CI)

4 (8.0, 2.2–19.2)

4 (14.8, 4.2–33.7)

Best ORR (CR + PR + SD), No. (%, 95% CI)

6 (12.0, 4.5–24.3)

6 (22.2, 8.6–42.3)

Median response duration, months

19.1

19.1

Median PFS, months (95% CI)

4.6 (3.7–5.3)

5.3 (4.6–5.9)

Median OS, months (95% CI)

6.1 (4.0–10.4)

22.4 (6.3 - --)

  1. RR, response rate; CR, complete response (not observed); PR, partial response; SD, stable disease; ORR, overall response rate; PFS, progression free survival; OS, overall survival