Table 3.
Grade 3/4 laboratory abnormalities and treatment-related (or relationship unknown) adverse events (or in ≥10% of patients)
| PM01183 (n =52) |
Topotecan (n =29)a |
|||||||
|---|---|---|---|---|---|---|---|---|
| NCI-CTCAE grade |
NCI-CTCAE grade |
|||||||
| 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | |
| n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |
| Hematological laboratory abnormalities | ||||||||
| Anemia | 14 (27%) | 18 (35%) | 19 (37%) | - | 5 (17%) | 12 (41%) | 11 (38%) | - |
| Leukopenia | - | 12 (23%) | 19 (37%) | 15 (29%) | 6 (21%) | 8 (28%) | 9 (31%) | 2 (7%) |
| Lymphopenia | 13 (25%) | 24 (46% | 8 (15%) | 5 (10%) | 6 (21%) | 11 (38%) | 5 (17%) | 1 (3%) |
| Neutropenia | 1 (2%) | 1 (2%) | 11 (21%) | 33 (64%) | 5 (17%) | 7 (24%) | 3 (10%) | 8 (28%) |
| Thrombocytopenia | 16 (31%) | 4 (8%) | 5 (10%) | 12 (23%) | 11 (38%) | 4 (14%) | 4 (14%) | 3 (10%) |
| Biochemical laboratory abnormalities | ||||||||
| ALP increase | 25 (48%) | 4 (8%) | 2 (4%) | - | 13 (48%) | 4 (15%) | - | - |
| ALT increase | 23 (44%) | 13 (25%) | 8 (15%) | 1 (2%) | 14 (48%) | 1 (3%) | - | - |
| AST increase | 29 (56%) | 2 (4%) | 6 (12%) | - | 8 (28%) | 1 (3%) | - | - |
| Creatinine increase | 40 (77%) | 6 (12%) | 2 (4%) | - | 23 (79%) | 2 (7%) | - | - |
| GGT increase | 16 (31%) | 14 (27%) | 12 (23%) | 1 (2%) | 10 (37%) | 7 (26%) | 3 (11%) | - |
| Treatment-related adverse events | ||||||||
| Abdominal pain | 5 (10%) | 1 (2%) | - | - | - | 1 (3%) | - | - |
| Alopecia | 4 (8%) | - | - | - | 2 (7%) | 3 (10%) | - | - |
| Constipation | 11 (21%) | 4 (8%) | - | - | 1 (3%) | 1 (3%) | - | - |
| Decreased appetite | 7 (14%) | 1 (2%) | 2 (4%) | - | 2 (7%) | 1 (3%) | 1 (3%) | - |
| Diarrhea | 4 (8%) | 3 (6%) | - | - | 5 (17%) | 2 (7%) | - | - |
| Fatigue | 10 (19%) | 12 (23%) | 18 (35%) | - | 5 (17%) | 8 (28%) | - | - |
| Febrile neutropenia | - | - | 8 (15%) | 3 (6%) | - | - | 3 (10%) | - |
| Gastrointestinal toxicity | - | - | 1 (2%) | - | - | - | - | - |
| Nausea | 14 (27%) | 15 (29%) | 6 (12%) | - | 6 (21%) | 5 (17%) | - | - |
| Rhabdomyolysis | - | - | 1 (2%) | - | - | - | - | - |
| Vomiting | 15 (29%) | 8 (15%) | 5 (10%) | - | 4 (14%) | - | - | |
a
Weekly (n = 21): 4.0–2.4 mg/m2 days 1, 8, and 15 q4wk; standard (n = 8): 1.50–0.75 mg/m2 days 1–5 q3wk.
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CPK, creatine transferase; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.