Table 3.
Relative dose intensity and reasons for dose reduction of NFF.
| Starting dose | Nal-IRI | Fluorouracil | |
|---|---|---|---|
| Full dose | n (%) | 104 (65) | 123 (76) |
| Reduction level −1* | n (%) | 51 (32) | 30 (19) |
| Reduction level −2** | n (%) | 6 (4) | 8 (5) |
| Relative dose intensity | Median (range) | 81.6 (53.0–105.7) | 90.7 (40.8–108.3) |
| Treatment cycle | Median (range) | 5 (1–38) | |
| Reasons for dose reduction during treatment, n (%) | |||
| No reduction | 94 (58) | 99 (61) | |
| Neutropenia | 25 (16) | 23 (14) | |
| Anorexia | 17 (11) | 14 (9) | |
| Nausea/vomiting | 7 (4) | 5 (3) | |
| Diarrhea | 3 (2) | 5 (3) | |
| Fatigue | 2 (1) | 2 (1) | |
| Malaise | 2 (1) | 2 (1) | |
| Others | 10 (6) | 10 (6) | |
*Reduction level −1: Nal-IRI 50 mg/m2, fluorouracil 1800 mg/m2.
**Reduction level −2: Nal-IRI 43 mg/m2, fluorouracil 1,350 mg/m2.
For patients homozygous of UGT1A1*6 or UGT1A1*28 or heterozygous of UGT1A1*6 and UGT1A1*28, the reduction level −1 for Nal-IRI is 43 mg/m2, and the reduction level −2 is 35 mg/m2.
Abbreviations: NFF Nanoliposomal irinotecan and fluorouracil with folinic acid, Nal-IRI nanoliposomal irinotecan, UGT1A1 Uridine diphosphate glucuronosyltransferase Family 1 Member A1.