Table 3.
Exposure to ramucirumab plus erlotinib or placebo plus erlotinib and relative dose intensity in the Taiwanese subgroup (n = 56) and the overall RELAY safety population (n = 446)
| Taiwanese subgroup | Overall RELAY safety populationa | |||
|---|---|---|---|---|
| RAM+ERL (n = 26) | PBO+ERL (n = 30) | RAM+ERL (n = 221) | PBO+ERL (n = 225) | |
| RAM or PBO | ||||
| Duration of therapy, months | ||||
| Median (IQR) (descriptive analysis) | 9.0 (4.2–17.4) | 11.2 (3.7–13.8) | 11.0 (4.2–15.6) | 9.7 (3.7–15.6) |
| Median [95% CI] (KM analysis) | 9.7 [5.5–19.5] | 11.4 [7.3–13.6] | 12.4 [9.7–13.8] | 10.1 [8.3–11.4] |
| Restricted meanb [95% CI] | 12.8 [8.9–16.6] | 11.7 [8.7–14.6] | 13.7 [12.2–15.2] | 12.5 [11.1–13.9] |
| Median relative dose intensityc (IQR) | 94.8 (87.6–100.0) | 98.5 (96.2–100.0) | 94.9 (86.7–99.9) | 97.7 (91.1–100.3) |
| Patients requiring dose modification, n (%)d | 21 (80.8) | 16 (53.3) | 168 (76.0) | 134 (59.1) |
| ERL | ||||
| Median duration of therapy, months (IQR) | 13.7 (7.4–19.8) | 12.4 (7.4–19.4) | 14.1 (6.5–20.3) | 11.2 (5.8–17.9) |
| Median relative dose intensityc (IQR) | 95.6 (80.2–100.0) | 100 (96.43–100.0) | 92.3 (67.5–100.0) | 96.3 (70.6–100.0) |
| Patients requiring dose modification, n (%) | 11 (42.3) | 9 (30.0) | 168 (76.0) | 143 (64.7) |
aData published in Nakagawa et al. 2019 [20]
bRestriction time is defined by the latest time where the standard error of the survival estimates is ≤0.075 (restriction time = 27.93 months for the Taiwanese subgroup and 33.81 months for the overall RELAY safety population)
cCalculated as (actual amount of drug taken/amount of drug prescribed)*100%
dData published in Chiu et al. [21]
CI confidence interval, ERL erlotinib, IQR interquartile range, KM Kaplan–Meier, PBO placebo, RAM ramucirumab