Table 2.
Incidence of Dose-Limiting Toxicities and Dose Modifications
| Dose level | DLT during Cycle 1 | DLT after Cycle 1 | Dose reduction for DLT | Discontinuation due to DLT | Average daily dose a |
|---|---|---|---|---|---|
| (mg/m2/d) | Patients with DLT/Evaluable patients(%) | Number of DLT events/Evaluable patients (%) | Patients having dose reduction/Evaluable patients (%) | Patients discontinuing/Evaluable Patients (%) | mg/m2/d (SD) |
| 30 | 0/6 (0) | 2/5 (40) | 0/6 (0) | 1/6 (17) | 30.8 (3.6) |
|
| |||||
| 40 | 5/19 (26) | 8/16 (50) | 5/19b (26) | 0/19 (0) | 31.5 (10.3) |
|
| |||||
| 55 | 3/11 (27) | 5/9 (56) | 4/11c (36) | 2/11 (18) | 46.0 (11.1) |
Abbreviations in table: DLT=dose limiting toxicity; SD=standard deviation
a
Average daily dose for each patient over all cycles was calculated as total dose in mg received per cycle divided by body surface area and cycle length.
b
Three patients had one dose reduction, two patients had two dose reductions
c
Two patients had one dose reduction, two patients had two dose reductions