Table 3.
Treatment duration and exposure in the nal‐IRI+5‐FU/LV and 5‐FU/LV treatment groups (safety population)
| Asia region safety population | Overall safety population | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Combination therapy | Monotherapy | Combination therapy | Monotherapy | ||||||
|
nal‐IRI+ 5‐FU/LV n = 33 |
5‐FU/LV n = 29 |
nal‐IRI n = 50 |
5‐FU/LV n = 42 |
nal‐IRI+ 5‐FU/LV n = 117 |
5‐FU/LV n = 105 |
nal‐IRI n = 147 |
5‐FU/LV n = 134 |
||
| No. of treatment cycles received | |||||||||
| Mean (SD) | 5.9 (5.9) | 1.8 (1.5) | 4.0 (3.0) | 1.8 (1.6) | 6.6 (6.3) | 2.0 (2.0) | 3.7 (2.7) | 2.0 (2.1) | |
| Median (1st and 3rd quartiles) | 3.0 (2, 8) | 1.0 (1, 2) | 3.0 (2, 6) | 1.0 (1, 2) | 3.0 (2, 9) | 1.0 (2, 9) | 2.5 (2, 5) | 1.0 (1, 2) | |
| Minimum time on treatment, n (%) | |||||||||
| ≥6 wk | 22 (66.7) | 20 (69.0) | 40 (80.0) | 30 (71.4) | 82 (72.6) | 77 (72.6) | 119 (80.4) | 101 (74.8) | |
| ≥12 wk | 13 (39.4) | 7 (24.1) | 21 (42.0) | 10 (23.8) | 47 (40.9) | 31 (29.2) | 58 (39.2) | 40 (29.6) | |
| ≥18 wk | 11 (33.3) | 4 (13.8) | 13 (26.0) | 6 (14.3) | 40 (34.8) | 17 (16.0) | 33 (22.3) | 22 (16.3) | |
| Relative dose intensity (%), mean (SD)a | |||||||||
| nal‐IRI | 74.9 (20.1) | n/a | 90.2 (11.5) | n/a | 83.2 (17.7) | n/a | 90.2 (11.8) | 95.1% (−)b | |
| 5‐FU | 75.5 (20.6) | 94.9 (13.3) | n/a | 95.1 (12.3) | 83.9 (18.1) | 95.7 (11.2) | n/a | 95.6 (11.1) | |
| Duration of exposure (weeks), mean (SD)c | |||||||||
| nal‐IRI | 14.7 (13.8) | n/a | 12.8 (9.7) | n/a | 15.0 (13.7) | n/a | 11.9 (9.0) |
n/a |
|
| 5‐FU | 14.7 (13.8) | 9.4 (9.3) | n/a | 9.7 (9.9) | 15.0 (13.7) | 10.0 (10.8) | n/a | 10.4 (11.3)b | |
Cycle lengths differ for each regimen: nal‐IRI+5‐FU/LV, 2 wk; nal‐IRI monotherapy, 3 wk; 5‐FU/LV, 6 wk.
Abbreviations: 5‐FU, 5‐fluorouracil; LV, leucovorin (folinic acid); nal‐IRI, liposomal irinotecan; n/a, not applicable; SD, standard deviation.
Relative dose intensity is a function of both amount of study drug received and the time frame over which it was received expressed as a percentage of that planned study drug in the protocol‐defined schedule.
One patient randomized to the 5‐FU/LV arm of the overall population erroneously received 6 wk of nal‐IRI+5‐FU/LV.
Duration of exposure is the time from (the date of the last dose of study administration + projected days to next dose of study drug administration – date first study drug administration)/7.