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