Table 3.
Summary of patients treated with bortezomib, carboplatin and etoposide every 21 days
| Dose level | Number of patients treated | Number of courses | Bortezomiba (mg m−2 dose−1) | Carboplatin AUC (day 1) | Etoposide (mg m−2 dose−1; days 1, 2, 3) | Dose-limiting toxicities (number of patients) | Other grade 3 or 4 toxicities (n) |
|---|---|---|---|---|---|---|---|
| 1 | 3 | 8 | 1 | AUC 5 | 100 | Grade 4 neutropenia (2) | Grade 4 thrombocytopenia (1), grade 3 thrombocytopenia (1) |
| −1 | 6 | 14 | 0.75 | AUC 4 | 75 | Grade 2 neutropenia (2) | Grade 3 neutropenia (1), grade 3 fatigue (1) |
| 1a | 7 | 22 | 0.75 | AUC 5 | 75 | Grade 4 neutropenia > 5 days (2), grade 3 transaminitis (1), grade 3 thrombocytopenia (2) | Grade 3 anemia (4) |
| 1b | 5 | 15 | 1 | AUC 5 | 75 | Grade 4 neutropenia > 5 days (2), grade 3 neutropenic fever (2) | Grade 4 anemia (1), grade 3 thrombocytopenia (2), grade 3 fatigue (2) |
| 2 | 3 | 5 | 1 | AUC 5 | 100 | Grade 4 neutropenia > 5 days and grade 3 thrombocytopenia (1) | Grade 3 thrombocytopenia (2), grade 3 anemia (2) |
| Total | 24 | 64 |
a
Bortezomib dosed on days 1, 4, 8, and 11 in dose level 1, −1, 1a, and on days 1 and 8 in dose level 1b and 2