Table 1.
Exposure to study treatments and overall dose adjustments in RELAY
| Study treatment exposure and dose adjustments | RAM + ERL (n = 221) | PBO + ERL (n = 225) | ||
|---|---|---|---|---|
| RAM | ERL | PBO | ERL | |
| Duration of therapy (months)a | 12.4 (0.5–33.8) | 15.1 (0.0–33.8) | 10.1 (0.5–35.4) | 11.2 (0.4–35.5) |
| Infusions received per patient | 21.0 (1.0–69.0) | NA | 19.0 (1.0–74.0) | NA |
| Relative dose intensity (%)b | 94.5 (42.9–112.1) | 92.3 (30.2–100) | 97.7 (54.2–106.7) | 96.3 (27.9–100) |
| Patients with at least one dose adjustment | 168 (76.0) | 143 (64.7) | 133 (59.1) | 134 (59.6) |
| Patients with a dose reduction | 23 (10.4) | 99 (44.8) | 4 (1.8) | 96 (42.7) |
| One dose reduction | 14 (6.3) | 64 (29.0) | 3 (1.3) | 71 (31.6) |
| Two dose reductions | 7 (3.2) | 31 (14.0) | 1 (0.4) | 22 (9.8) |
| Three or more dose reductions | 2 (0.9) | 4 (1.8) | 0 | 3 (1.3) |
| Reasons leading to dose reductions | ||||
| AE | 23 (10.4) | 96 (43.4) | 4 (1.8) | 93 (41.3) |
| Others | 0 | 10 (4.5) | 0 | 10 (4.4) |
| Patients with a dose delayc | 147 (66.5) | NA | 121 (53.8) | NA |
| One dose delay | 50 (22.6) | NA | 50 (22.2) | NA |
| Two dose delays | 33 (14.9) | NA | 31 (13.8) | NA |
| Three or more dose delays | 64 (29.0) | NA | 40 (17.8) | NA |
| Reasons leading to dose delays | ||||
| AE | 140 (63.3) | NA | 102 (45.3) | NA |
| Scheduling conflict | 32 (14.5) | NA | 37 (16.4) | NA |
| Patients with a dose omission | 62 (28.1) | 119 (53.8) | 28 (12.4) | 118 (52.4) |
| One dose omission | 50 (22.6) | 51 (23.1) | 18 (8.0) | 54 (24.0) |
| Two dose omissions | 8 (3.6) | 24 (10.9) | 3 (1.3) | 29 (12.9) |
| Three or more dose omissions | 4 (1.8) | 44 (19.9) | 7 (3.1) | 35 (15.6) |
| Reasons leading to dose omissions | ||||
| AE | 48 (21.7) | 116 (52.5) | 20 (8.9) | 113 (50.2) |
| Others | 17 (7.7) | 34 (15.4) | 11 (4.9) | 30 (13.3) |
Data are presented as median (range) or n (%) unless otherwise indicated. The data cutoff date was 23 January 2019
AE treatment-emergent adverse events, ERL erlotinib, N number of patients, n number of patients in the specified category, NA not applicable, PBO placebo, RAM ramucirumab
aData are from a censored analysis in which 64 patients in the RAM +ERL arm and 43 patients in the PBO + ERL arm were censored because of continuing study treatment
bRelative dose intensity was calculated as (actual amount of drug taken / amount of drug planned per protocol) × 100
cDose delays of erlotinib were not captured on the case report form