Table 4 Haematologic toxicities
Number of patients (cycles) with toxicity | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Leukopenia | Neutropenia | Anemia | Thrombocytopenia | ||||||||||
Dose level | No. Pts a (cycles) | Mean nadir (Range: μ l−1) | Grade 2 | Grade 3 | Grade 4 | Mean nadir (Range: μ l−1) | Grade 2 | Grade 3 | Grade 4 | Mean nadir (Range: g dl−1) | Grade 3–4 | Mean nadir (Range: × 104 μ l−1) | Grade 3–4 |
Phase I | |||||||||||||
60N | 7 (13) | 2806 (1000–4160) | 3 (5) | 3 (3) | 0 | 1276 (324–2288) | 2 (5) | 1 (2) | 2 (2) | 10.7 (8.0–12.7) | 0 | 18.3 (11.3–25.1) | 0 |
60P | 5 (8) | 2123 (1300–3560) | 3 (4) | 1 (3) | 0 | 877 (312–1940) | 1 (1) | 2 (5) | 1 (1) | 9.8 (8.7–13.3) | 0 | 14.8 (8.0–18.8) | 0 |
65P | 5 (14) | 3055 (2100–4700) | 4 (8) | 0 | 0 | 1204 (483–1998) | 2 (3) | 2 (6) | 1 (1) | 10.7 (8.5–13.5) | 0 | 15.9 (9.4–26.8) | 0 |
70P | 4 (9) | 3167 (2000–4050) | 1 (1) | 0 | 0 | 1367 (860–1789) | 1 (4) | 3 (3) | 0 | 11.4 (9.5–13.7) | 0 | 23.4 (16.9–35.6) | 0 |
75P | 6 (15) | 2825 (1800–4080) | 4 (9) | 1 (1) | 0 | 1303 (378–2489) | 3 (4) | 2 (5) | 1 (1) | 9.8 (8.0–12.1) | 0 | 20.6 (8.7–33.6) | 0 |
80P | 2 (2) | 1235 (400–2070) | 1 (1) | 0 | 1 (1) | 446 (200–691) | 0 | 1 (1) | 1 (1) | 11.7 (10.8–12.5) | 0 | 12.6 (9.4–15.8) | 0 |
Phase II | 48 (140) | 2926 (510–7290) | 21 (64) | 15 (22) | 1 (2) | 1303 (112–3612) | 11 (49) | 24 (42) | 7 (10) | 9.8 (5.7–13.6) | 9 (14) | 19.2 (4.9–45.5) | 1 (1) |