Table 2.
RAISE overall survival and progression-free survival by ramucirumab exposure quartile
| Quartile, C min,ss | Overall survivala | Progression-free survivalb | ||||
|---|---|---|---|---|---|---|
| Median (mos) | Hazard ratio (95% CI)c | p valued | Median (mos) | Hazard ratio (95% CI)c | p valued | |
| PBO + FOLFIRI | 12.4e | 5.2e | ||||
| RAM + FOLFIRI Q1 | 11.5 | 1.311 (1.024, 1.678) | 0.0314 | 5.4 | 0.932 (0.739, 1.175) | 0.5516 |
| RAM + FOLFIRI Q2 | 12.9 | 0.954 (0.736, 1.238) | 0.7249 | 4.6 | 0.957 (0.763, 1.200) | 0.7013 |
| RAM + FOLFIRI Q3 | 16.4 | 0.604 (0.459, 0.795) | 0.0003 | 6.8 | 0.684 (0.542, 0.864) | 0.0014 |
| RAM + FOLFIRI Q4 | 16.7 | 0.657 (0.500, 0.865) | 0.0027 | 8.5 | 0.546 (0.434, 0.688) | <0.0001 |
C min,ss minimum concentration at steady state, ECOG PS Eastern Oncology Cooperative Group performance status, FOLFIRI folinic acid, 5-fluorouracil, and irinotecan, OS overall survival, PBO placebo, PFS progression-free survival, Q quartile, RAM ramucirumab
aAdjusted for time to progression after beginning first-line therapy, KRAS status, ECOG PS, number of metastatic sites, liver only metastasis, and carcinoembryonic antigen
bAdjusted for ECOG PS, number of metastatic sites, liver only metastasis, carcinoembryonic antigen, and prior bevacizumab use
cAdjusted for significant prognostic factors relative to PBO + FOLFIRI in RAISE
dWald’s test of RAM quartile versus PBO + FOLFIRI
eMedian OS and PFS for PBO + FOLFIRI differ from those reported in Tabernero et al. [9], because patients in the PBO arm who dropped out prior to the third dose were excluded from the exposure–efficacy analyses