Table 4. Worst all-cycle toxicities during the phase II stage.
|
Plitidepsin (n=20) |
Plitidepsin/DTIC (n=36)a |
|||||
|---|---|---|---|---|---|---|
| Grade 1/4 | Grade 3 | Grade 4 | Grade 1/4 | Grade 3 | Grade 4 | |
|
Nonhaematological | ||||||
| ALT increase | 18 (90%) | 2 (10%) | 33 (92%) | 9 (25%) | 1 (3%) | |
| Anorexia | 2 (10%) | 6 (17%) | ||||
| AP increase | 11 (55%) | 14 (39%) | ||||
| AST increase | 15 (75%) | 25 (69%) | 2 (6%) | |||
| Constipation | 3 (15%) | 4 (11%) | ||||
| CPK increase | 7 (35%) | 2 (10%) | 1 (5%) | 7 (19%) | 1 (3%) | |
| Creatinine increase | 4 (20%) | 5 (14%) | ||||
| Diarrhoea | 3 (15%) | 7 (19%) | 1 (3%) | |||
| Electrocardiogram T wave abnormalb | 4 (11%) | |||||
| Fatigue | 8 (40%) | 1 (5%) | 15 (42%) | 4 (11%) | ||
| Hypersensitivity | 3 (15%) | 1 (5%) | 9 (25%) | 3 (8%) | ||
| Muscle cramps | 2 (10%) | 3 (8%) | 1 (3%) | |||
| Muscle weakness | 1 (5%) | 1 (5%) | 5 (14%) | 2 (6%) | ||
| Myalgia | 4 (20%) | 4 (11%) | ||||
| Nausea | 9 (45%) | 2 (10%) | 25 (69%) | 1 (3%) | ||
| Total bilirubin increased | 5 (25%) | 19 (53%) | ||||
| Vomiting | 6 (30%) | 1 (5%) | 13 (36%) | 2 (6%) | ||
| Weight decrease |
|
|
|
4 (11%) |
|
|
|
Haematological | ||||||
| Anaemia | 11 (55%) | 1 (5%) | 23 (64%) | 1 (3%) | ||
| Leukopenia | 9 (25%) | 1 (3%) | ||||
| Lymphopenia | 11 (55%) | 1 (5%) | 19 (53%) | 1 (3%) | ||
| Neutropenia | 10 (28%) | 2 (6%) | ||||
| Thrombocytopenia | 5 (25%) | 5 (14%) | 2 (6%) | |||
Abbreviations: ALT=alanine aminotransferase; AP=alkaline phosphatase; AST=aspartate aminotransferase; CPK=creatine phosphokinase; DTIC=dacarbazine; n=number of patients evaluable for safety.
Data shown are number (%) of patients.
Only toxicities found in ⩾10% of patients with either treatment are included. Haematological and laboratory abnormalities are shown regardless of their relationship to treatment.
a
Two patients enrolled into this cohort were withdrawn before receiving the first infusion and thus were not evaluable for safety.
b
These comprised grade 2 electrocardiogram T wave inversion (n=2), grade 2 electrocardiogram T wave abnormal, and grade 1 electrocardiogram T wave amplitude decreased (n=1 each).