Table 1.
Patient characteristics at baseline
| Characteristics | Subgroup | N (%)a |
Median (5th and 95th percentile) |
|---|---|---|---|
| Sex | Female | 157 (44) | |
| Male | 196 (56) | ||
| Race | Caucasian | 182 (52) | |
| Others | 21 (6) | ||
| East Asian | 150 (42) | ||
| Liver metastasis (for NAPOLI‐1 only) | No | 87 (34) | |
| Yes | 171 (66) | ||
| Study name | NAPOLI‐1 | 258 (73) | |
| Others | 95 (27) | ||
| UGT1A1*28 (for NAPOLI‐1 only) | Non 7/7 | 244 (95) | |
| 7/7 | 14 (5) | ||
| Treatment (for NAPOLI‐1 only) | nal‐IRI+5FU/LV | 116 (45) | |
| nal‐IRI (mono) | 142 (55) | ||
| Tumor type at diagnosis | Colorectal cancer | 18 (5) | |
| Gastric & GEJ cancer | 37 (10) | ||
| Metastatic pancreatic cancer | 258 (73) | ||
| Solid tumor | 40 (11) | ||
| Initial dose, mg/m2 b | 50 (60) | 4 (1) | |
| 70 (80) | 141 (40) | ||
| 80 (90) | 6 (2) | ||
| 90 (100) | 11 (3) | ||
| 100 (120) | 187 (53) | ||
| 150 (180) | 4 (1) | ||
| Age, y | 353 | 63 (39.8, 79.2) | |
| Albumin, g/L | 349 | 40 (29, 47) | |
| ALT, U/L | 352 | 25 (8.9, 96.3) | |
| AST, U/L | 352 | 29 (14.7, 81.9) | |
| Bilirubin (umol/L) | 352 | 7 (3, 19) | |
| BSA, m2 | 353 | 1.7 (1.3, 2.2) | |
| CrCl, 10‐3 L/s | 352 | 1.36 (0.66, 2.53) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BSA, body surface area; GEJ, gastroesophageal junction.
a
Percent only included in baseline characteristics with subcategories.
b
Dose is given based on irinotecan free base with the original protocol dose (based on irinotecan hydrochloride trihydrate is in parentheses.