grade 3 toxicity.
Þ
During study drug dosing.
Bone Marrow
Neutropenia
< 2.0 × 109/L 80 82
< 0.5 × 109/L 9 22
Thrombocytopenia
< 100 × 109/L 2 3
< 50 × 109/L <1 <1
Anemia
< 11 g/dL 33 25
< 8 g/dL 1 <1
Infections 24 20
Febrile Neutropenia 2 1
Bleeding 2 2
Hypersensitivity Reaction¶
All 4 12
Severe# 0 2
Cardiovascular
Vital Sign ChangesÞ
Bradycardia <1 <1
Hypotension 5 5
Severe Cardiovascular Events# 3 4
Abnormal ECG
All patients 60 52
Patients with Normal Baseline 35 30
Respiratory
Cough 7 6
Dyspnea 12 9
Sensory Neuropathy
Any Symptoms 71 56
Severe Symptoms# 10 2
Myalgia / Arthralgia
Any Symptoms 44 49
Severe Symptoms# 8 4
Asthenia
Any Symptoms 47 39
Severe Symptoms# 8 3
Fluid Retention/Edema
Any Symptoms 10 8
Severe Symptoms# 0 <1
Gastrointestinal
Nausea
Any symptoms 30 22
Severe symptoms# 3 <1
Vomiting
Any symptoms 18 10
Severe Symptoms# 4 1
Diarrhea
Any Symptoms 27 15
Severe Symptoms# <1 1
Mucositis
Any Symptoms 7 6
Severe Symptoms# <1 0
Alopecia 90 94
Hepatic (Patients with Normal Baseline)
Bilirubin Elevations 7 7
Alkaline Phosphatase Elevations 36 31
AST (SGOT) Elevations 39 32
Injection Site Reaction <1 1
Myelosuppression and sensory neuropathy were dose related.
Adverse Event Experiences by Body System
Unless otherwise noted, the following discussion refers to the primary safety database of 229 patients with metastatic breast cancer treated with single-agent ABRAXANE® in the randomized controlled trial. The frequency and severity of important adverse events for the study are presented above in tabular form. In some instances, rare severe events observed with paclitaxel injection may be expected to occur with ABRAXANE.
Hematologic
Neutropenia, the most important hematologic toxicity, was dose dependent and reversible. Among patients with metastatic breast cancer in the randomized trial, neutrophil counts declined below 500 cells/mm3 (Grade 4) in 9% of the patients treated with a dose of 260 mg/m2 compared to 22% in patients receiving paclitaxel injection at a dose of 175 mg/m2.
In the randomized metastatic breast cancer study, infectious episodes were reported in 24% of the patients treated with a dose of 260 mg/m2 given as a 30-minute infusion. Oral candidiasis, respiratory tract infections and pneumonia were the most frequently reported infec
