Table 2.
Dose level | DLT criteria | No. of cases | Other grade 3/4 toxicities (non–dose limiting) |
---|---|---|---|
90 mg/m2 | Grade 4 neutropenia† | 0 | Lymphocytopenia: 1 grade 4, 2 grade 3 Neutropenia: 1 grade 3 Leukopenia: 1 grade 3 |
Platelets <10 000/mm3‡ | 0 | ||
Other grade 4 hematologic toxicity§ | 0 | ||
Grade ≥3 non‐hematologic toxicity | 0 | ||
120 mg/m2 | Grade 4 neutropenia† | 0 | Lymphocytopenia: 3 each grades 3 and 4 Neutropenia: 1 each grades 3 and 4 Leukopenia: 3 grade 3 |
Platelets <10 000/mm3‡ | 0 | ||
Other grade 4 hematologic toxicity§ | 0 | ||
Grade ≥3 non‐hematologic toxicity | 0 |
†Grade 4 neutropenia lasting >1 week and accompanied by fever (38°C or higher). ‡Grade 4 thrombocytopenia or hemorrhage requiring platelet transfusion. §Any other grade 4 hematological toxicity excluding lymphopenia and differential white blood cell count (%).