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. Author manuscript; available in PMC: 2016 Sep 22.
Published in final edited form as: Breast Cancer Res Treat. 2015 Nov 23;154(3):591–608. doi: 10.1007/s10549-015-3643-5

Table 4.

Summary of sensitivity analysis on the base case results

Sensitivity analysis Sample size Model coefficient, 95 % CI and p value Model R2
HR for OS and PFS
 Base case 75 0.18 (0.009 to 0.35); p = 0.04 0.31
 Year of publication ≥2004 40 0.12 (−0.22 to 0.48); p = 0.48 0.31
 First-line trials only 48 0.01 (−0.19 to 0.22); p = 0.90 0.30
 Trials in 2nd line and beyond 27 0.40 (0.21 to 0.58); p < 0.001 0.55
 Trials meeting the modern FDA definition of PFS 38 0.26 (0.05 to 0.42); p = 0.015 0.38
 Trials with censored data 47 0.18 (−0.05 to 0.42); p = 0.12 0.35
 Trials allowing cross over 20 0.24 (0.14 to 0.33); p < 0.001 0.49
 Only globally conducted trials 34 0.031 (−0.27 to 0.33); p = 0.83 0.10
Δ in OS and Δ in PFS
 Base case 79 0.79 (0.32 to 1.26); p = 0.001 0.44
 Year of publication C2004 41 0.68 (0.08 to 1.28); p = 0.027 0.51
 First-line trials only 51 0.77 (0.26 to 1.28); p = 0.004 0.47
 Trials in 2nd line and beyond 28 1.1 (0.38 to 1.74); p = 0.004 0.49
 Trials meeting the modern FDA definition of PFS 39 0.74 (0.10 to 1.37); p = 0.25 0.50
 Trials with censored data 49 0.81 (0.25 to 1.36); p = 0.006 0.54
 Trials allowing cross over 20 1.57 (0.66 to 2.48); p = 0.002 0.75
 Globally conducted trials only 36 0.82 (0.14 to 1.51); p = 0.02 0.51

HR hazard ratio, OS overall survival, PFS progression-free survival, Δ change, FDA Food and Drug Administration