Table 4. Toxicity in feasibility phase for four cycles (N= 40 patients).
Adverse event | |||||
---|---|---|---|---|---|
Grade of adverse event | 0 | 1 | 2 | 3 | 4 |
Allergy | 34 | 3 | 3 | 0 | 0 |
Auditory | 37 | 0 | 3 | 0 | 0 |
Blood/bone marrow | |||||
Hemoglobin | 3 | 14 | 17 | 6 | 0 |
Neutrophils | 0 | 1 | 1 | 4 | 34 + |
Platelets | 15 | 17 | 6 | 1 | 1* |
Cardiac | 37 | 2 | 1 | 0 | 0 |
Coagulation | 39 | 1 | 0 | 0 | 0 |
Constitutional | 6 | 17 | 16 | 1@ | 0 |
Dermatologic | 5 | 16 | 19 | 0 | 0 |
Endocrine | 36 | 3 | 1 | 0 | 0 |
Gastrointestinal | 3 | 17 | 15 | 4@ £ † | 1ˆ |
Genitourinary | 31 | 6 | 3 | 0 | 0 |
Hemorrhage | 34 | 6 | 0 | 0 | 0 |
Hepatic | 39 | 0 | 0 | 1# | 0 |
Infection | 20 | 0 | 11 | 9 | 0 |
Febrile Neutropenia | 33 | - | - | 7@ # & | 0 |
Infection with Grade 0 ANC | 39 | 0 | 1 | 0 | 0 |
Infection with Grade 3 or 4 ANC | 28 | - | 10 | 2< | 0 |
Lymphatic | 36 | 4 | 0 | 0 | 0 |
Metabolic | 20 | 11 | 5 | 3 $ | 1& |
Musculoskeletal | 38 | 1 | 1 | 0 | 0 |
Neurologic | 19 | 18 | 2 | 1ˆ | 0 |
Ocular | 31 | 6 | 3 | 0 | 0 |
Pain | 7 | 20 | 13 | 0 | 0 |
Pulmonary | 30 | 7 | 3 | 0 | 0 |
Vascular | 38 | 0 | 0 | 2# = | 0 |
ANC- Absolute neutrophil count
Dose-limiting toxicities include:
2 patients with grade 4 neutropenia prolonged >7 days
1 patient with grade 4 thrombocytopenia
7 patients with neutropenic fever: Of these 7 patients with neutropenic fever, one patient also had grade 3 gastrointestinal/constitutional toxicity
one also had grade 3 hepatic toxicity with prolonged LFT elevation /septic pelvic thrombophlebitis
one also had grade 4 hyponatremia
2 patients with grade 3 port infections and grade 3 neutropenia
1 patient with pulmonary embolism
1 patient with grade 3 oral mucositis
1 patient with grade 4 dehydration
Grade 3 nausea and vomiting
Grade 3 metabolic (hypokalemia) were not DLTs in this study.