Table 2. Patients with DLTs (any treatment course).
| Schedule | Dose (mg) | Coursea | DLT |
|---|---|---|---|
| A |
250 |
1 |
Neutropenia (grade 4 for ⩾7 days) |
| |
|
|
Thrombocytopenia (grade 4) |
| |
300 |
5 |
Febrile neutropenia (grade 3) |
| |
300 |
1b |
Febrile neutropenia (grade 4) |
| |
|
|
Neutropenia (grade 4 for ⩾7 days) |
| |
|
|
Thrombocytopenia (grade 4) |
| |
300 |
1b |
Neutropenia (grade 4 for ⩾7 days) |
| |
300 |
1b |
Neutropenia (grade 4 for ⩾7 days) |
| |
300 |
1b |
Thrombocytopenia (grade 4) |
| |
350 |
1 |
Febrile neutropenia (grade 3) |
| |
|
|
Neutropenia (grade 4 for ⩾7 days) |
| |
|
|
Thrombocytopenia (grade 4) |
| |
350 |
1 |
Thrombocytopenia (grade 4) |
| |
350 |
1 |
Neutropenia (grade 4 for ⩾7 days) |
| B |
150 |
2 |
Neutropenia (grade 3 on day 8 before second administration) |
| |
150 |
5 |
Tinnitus (grade 2 on day 8 of the course) |
| |
150 |
14 |
Alanine aminotransferase increased (grade 3 on day 8 of the course) |
| |
200 |
1 |
Febrile neutropenia (grade 3) |
| 200 | 1 | Neutropenia (grade 4 for ⩾7 days) |
Abbreviation: DLT=dose-limiting toxicity.
a
At first occurrence.
b
Patients who were enrolled after maximum tolerated dose (MTD) had been determined.