Table 3.
Treatment exposure in patients in Canada and the treated population
| Treatment exposure and dose modification | Patients in Canada | All treated patients [9] | ||
|---|---|---|---|---|
| nab-P + Gem (n = 32) | Gem (n = 30) | nab-P + Gem (n = 421) | Gem (n = 402) | |
| Treatment duration, median (range), months | 4.1 (0.3–20.7) | 3.1 (0.6–16.6) | 3.9 (0.1–21.9) | 2.8 (0.1–21.5) |
| No. of treatment cycles administered, median (range) | 4.0 (1–20) | 2.5 (1–17) | 3.0 (1–23) | 2.0 (1–23) |
| Cumulative nab-P dose, median, mg/m2 | 1412.5 | – | 1425.0 | – |
| Cumulative Gem dose, median, mg/m2 | 12,000.0 | 9800.0 | 11,400.0a | 9000.0 |
| Average nab-P dose intensity, median (range), mg/m2/week | 68.4 (15.6–95.5) | – | 74.13 (15.6–96.0) | – |
| Average Gem dose intensity, median (range), mg/m2/week | 627.8 (125.0–763.6) | 667.3 (125.0–875.0) | 597.3 (125.0–768.3) | 674.9 (123.6–907.4) |
| Percentage of protocol nab-P dose, median (range) | 75.0 (16.7–100.0) | – | 80.6 (16.7–100.0) | – |
| Percentage of protocol Gem dose, median (range) | 81.2 (14.3–96.8) | 85.0 (14.3–100.0) | 75.3 (14.3–97.7) | 84.6 (14.1–100.0) |
| Patients with ≥1 nab-P dose reduction, n (%) | 16 (50) | – | 172 (41) | – |
| Patients with ≥1 Gem dose reduction, n (%) | 12 (38) | 12 (40) | 198 (47) | 132 (33) |
| Patients with ≥1 nab-P dose delay/not given, n (%) | 25 (78) | – | 300 (71) | – |
| Patients with ≥1 Gem dose delay/not given, n (%) | 23 (72) | 20 (67) | 295 (70) | 230 (57) |
Gem Gemcitabine, nab-P nab-paclitaxel
aTotal evaluable patients in the population = 420