Table 3.
Weighted KM survival estimate, months, median (95% CI) | p valuea | Parametric modeling survival estimate, months, b median (95% CI) | |
---|---|---|---|
Primary analysis | |||
OS | |||
Cabozantinib (ESS = 63) | 10.6 (9.5, 17.3) | 0.104 | 12.0 (9.6, 14.5) |
Ramucirumab (N = 197) | 8.7 (7.3, 10.8) | 9.6 (8.4, 10.8) | |
PFS | |||
Cabozantinib (ESS = 63) | 5.5 (4.6, 7.4) | 0.016 | 5.2 (4.1, 6.4) |
Ramucirumab (N = 197) | 2.8 (2.7, 4.1) | 3.2 (2.8, 3.6) | |
Sensitivity analysis | |||
OS | |||
Cabozantinib (ESS = 73) | 10.6 (9.5, 17.3) | 0.133 | 11.7 (9.2, 14.2) |
Ramucirumab (N = 197) | 8.7 (7.3, 10.8) | 9.6 (8.4, 10.8) | |
PFS | |||
Cabozantinib (ESS = 73) | 5.5 (4.6, 7.4) | 0.023 | 5.2 (4.1, 6.4) |
Ramucirumab (N = 197) | 2.8 (2.7, 4.1) | 3.2 (2.8, 3.6) | |
Validation analysis | |||
OS | |||
Cabozantinib (ESS = 80) | 9.7 (8.1, 12.4) | 0.409 | 10.6 (8.6, 12.4) |
Ramucirumab (N = 197) | 8.7 (7.3, 10.7) | 9.6 (8.4, 10.8) | |
PFS | |||
Cabozantinib (ESS = 80) | 5.4 (4.0, 6. 9) | 0.031 | 4.9 (4.0, 5.8) |
Ramucirumab (N = 197) | 2.8 (2.7, 4.1) | 3.2 (2.8, 3.6) |
CI confidence interval, ESS effective sample size, KM Kaplan-Meier, OS overall survival, PFS progression-free survival
aLog-rank test
bBest-fit models: OS, Weibull (for primary, sensitivity and validation analyses); PFS, log-logistic (for primary, sensitivity and validation analyses)