Table 3.

Summary of tumor responses overall, and by prior systemic anticancer therapy strata.

Stratum 1Stratum 2Total
Parameter(n = 66)(n = 101)(N = 167)
ORRa, n (%)17 (25.8)22 (21.8)39 (23.4)
 95% CIb15.8–38.014.2–31.117.2–30.5
  CR, n (%)5 (7.6)3 (3.0)8 (4.8)
  PR, n (%)12 (18.2)19 (18.8)31 (18.6)
  SD, n (%)24 (36.4)29 (28.7)53 (31.7)
mOS, months17.415.516.1
 95% CIc13.2–21.012.5–18.713.3–18.5
mPFS, months4.24.14.1
 95% CIc3.5–5.52.3–4.43.5–4.2
mDORc,d, months9.08.68.3
 95% CI6.2–22.26.2–25.16.5–22.2
  • Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; m, median; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; SD, stable disease.

  • aORR = CR + PR.

  • b95% CIs were calculated by Clopper–Pearson method.

  • cMedians for PFS, OS, and DOR were estimated using the Kaplan–Meier method and their corresponding 95% CIs were calculated using a generalized Brookmeyer and Crowley method.

  • dIn patients with confirmed CR or PR.