Table 6.
Simulation analysis for haematological toxicity
| Simulated cohort | Paclitaxel dose, mg m−2 | Nadir, 103 cells µl−1 | Time to nadir, h | Time below threshold*, h | DLT†, % |
|---|---|---|---|---|---|
| III | |||||
| 175 | |||||
| ANC | 0.2 (0.04–0.5) | 170 (135–215) | 119 (0–173) | 27.5 | |
| Thrombocytes | 79 (41–123) | 124 (113–137) | 39 (0–65) | 6.5 | |
| 115 | |||||
| ANC | 0.92 (0.39–1.69) | 147 (113–193) | 35 (0–51) | 4.2 | |
| Thrombocytes | 139 (95–185) | 117 (105–132) | 0 | 0 | |
| IV | |||||
| 135 | |||||
| ANC | 0.32 (0.08–0.82) | 163 (128–208) | 91 (0–145) | 18.0 | |
| Thrombocytes | 75 (38–120) | 125 (113–138) | 42 (0–76) | 7.5 | |
| 100 | |||||
| ANC | 0.91 (0.38–1.68) | 148 (114–194) | 36 (0–55) | 4.9 | |
| Thrombocytes | 119 (76–166) | 120 (108–134) | 0 | 0 | |
| V | |||||
| 110 | |||||
| ANC | 0.18 (0.03–0.59) | 173 (136–220) | 125 (0–185) | 30.8 | |
| Thrombocytes | 33 (10–73) | 134 (121–150) | 102 (0–173) | 26.8 | |
| 70 | |||||
| ANC | 0.96 (0.39–1.81) | 149 (114–196) | 37 (0–52) | 4.4 | |
| Thrombocytes | 93 (50–142) | 124 (112–138) | 0 | 0 | |
Results given as median with 25% and 75% percentiles.
*
500 µl−1absolute neutrophil count (ANC) and 50 ×103 µl−1 thrombocytes.
†
Frequency of dose-limiting toxicity, defined as ANC <500 µl−1ANC or 50 × 103 µl−1thrombocytes for >7 days.