Table 3. Treatment-related severe toxicities.
| PP (n=244) | ||||
|---|---|---|---|---|
| Standard chemotherapy (n=122) | Sensitivity-directed chemotherapy (n=122) | |||
| DTIC (n=122) | Total (n=122) | Treo + Gem/AraC (n=58) | Cis + Tax (n=64) | |
| Treatment-related adverse events grade 3 or 4 | ||||
| Any | 15 (12.3%) | 49 (40.2%) | 26 (44.8%) | 23 (35.9%) |
| Anemia | 2 (1.6%) | 7 (5.7%) | 4 (6.9%) | 3 (4.7%) |
| Neutropenia | 4 (3.3%) | 21 (17.2%) | 12 (9.8%) | 9 (14.1%) |
| Thrombocytopenia | 2 (1.6%) | 3 (2.5%) | 3 (2.5%) | - |
| Pyrexia | 1 (<1%) | 1 (<1%) | 1 (1.7%) | - |
| Nausea/vomiting | - | 1 (<1%) | - | 1 (1.6%) |
| Decreased appetite/weight loss | - | 2 (1.6%) | 1 (1.7%) | 1 (1.6%) |
| Digestive disorder | - | 1 (<1%) | - | 1 (1.6%) |
| Increase in liver enzymes | 4 (3.3%) | 6 (4.9%) | 4 (6.9%) | 2 (3.1%) |
| Increase in creatinine | 1 (<1%) | - | - | - |
| Drug hypersensitivity reaction | 1 (<1%) | 3 (2.5%) | - | 3 (4.7%) |
| Neuropathy | 1 (<1%) | 6 (4.9%) | 2 (3.4%) | 4 (6.3%) |
| Infection | 1 (<1%) | - | - | - |
| Hemorrhagia | 1 (<1%) | 1 (<1%) | - | 1 (1.6%) |
| Dyspnoe | - | 2 (1.6%) | 2 (3.4%) | - |
| Endocrinopathy | - | 1 (<1%) | - | 1 (1.6%) |
| Embolism/ischemic event | 1 (<1%) | 1 (<1%) | - | 1 (1.6%) |
| Pain | 1 (<1%) | 7 (5.7%) | 4 (6.9%) | 3 (4.7%) |
| Fatigue | 1 (<1%) | 4 (3.3%) | - | 4 (6.3%) |
| Treatment-related adverse events leading to change in therapy schedule | ||||
| Dose reduction | 9 (7.4%) | 22 (18.0%) | 9 (15.5%) | 13 (20.3%) |
| Cycle delay | 15 (12.3%) | 15 (12.3%) | 5 (8.6%) | 10 (15.6%) |
| Treatment discontinuation | 2 (1.6%) | 4 (3.3%) | - | 4 (6.3%) |
Toxicity was classified and graded according to CTC 3.0 (http://ctep.cancer.gov/reporting/ctc.html). Data represent the worst CTC grade experienced by each patient.