Table 6.
Dose Level | Bortezomiba (mg m−2 dose−1) | Carboplatin AUC (day 1) | Etoposide (mg m−2 dose−1; day 1, 2, 3) | Number of patients (courses) | Fatigue (# of courses) |
Nausea/vomiting (# of courses) |
Anorexia (# of courses) |
Alopecia (# of courses) |
Alk Phos (# of courses) |
|||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | |||||
−1 | 0.75 | AUC 4 | 75 | 6 (14) | 7 | 1 | 3 | - | - | - | 1 | - | 2 | - |
1 | 0.75 | AUC 5 | 100 | 3 (8) | 1 | - | 4 | - | 3 | - | 2 | - | - | - |
1a | 0.75 | AUC 5 | 75 | 7 (22) | 12 | - | 8 | - | 6 | - | 9 | - | 5 | - |
1b | 1 | AUC 5 | 75 | 5 (15) | 9 | 2 | 5 | 1 | 2 | - | 1 | - | 3 | - |
2 | 1 | AUC 5 | 100 | 3 (5) | - | - | 2 | - | 2 | - | - | - | - | - |
Total | 24 (64) | 29 (45%) | 3 (5%) | 22 (34%) | 1 (2%) | 13 (20%) | 0 | 13 (20%) | 0 | 10 (16%) | 0 |
Grade 1–4 represent National Cancer Institute CTC Version 2.0 grades 1–4
Bortezomib dosing on days 1, 4, 8, and 11 in dose levels 1, −1, and 1a, and on days 1 and 8 in dose levels 1b and 2