ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(十)
omized Metastatic Breast Cancer Study on an Every-3-Weeks Schedule a Based on worst grade by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.
b Paclitaxel injection patients received premedication.
c Includes treatment-related events related to hypersensitivity (e.g., flushing, dyspnea, chest pain, hypotension) that began on a day of dosing.
d Severe events are defined as at least grade 3 toxicity.
Percent of Patients
ABRAXANE
260 mg/m2 over 30 min
(n=229) Paclitaxel Injection
175 mg/m2 over 3 hb
(n=225)
Bone Marrow
Neutropenia
< 2.0 x 109/L 80 82
< 0.5 x 109/L 9 22
Thrombocytopenia
< 100 x 109/L 2 3
< 50 x 109/L <1 <1
Anemia
< 11 g/dL 33 25
< 8 g/dL 1 <1
Infections 24 20
Febrile Neutropenia 2 1
Neutropenic Sepsis <1 <1
Bleeding 2 2
Hypersensitivity Reactionc
All 4 12
Severed 0 2
Cardiovascular
Vital Sign Changes During Administration
Bradycardia <1 <1
Hypotension 5 5
Severe Cardiovascular Eventsd 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 Symptomsd 10 2
Myalgia / Arthralgia
Any Symptoms 44 49
Severe Symptomsd 8 4
Asthenia
Any Symptoms 47 39
Severe Symptomsd 8 3
Fluid Retention/Edema
Any Symptoms 10 8
Severe Symptomsd 0 <1
Gastrointestinal
Nausea
Any Symptoms 30 22
Severe Symptomsd 3 <1
Vomiting
Any Symptoms 18 10
Severe Symptomsd 4 1
Diarrhea
Any Symptoms 27 15
Severe Symptomsd <1 1
Mucositis
Any Symptoms 7 6
Severe Symptomsd <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
Adverse Event Experiences by Body System
Hematologic Disorders
Neutropenia 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. Pancytopenia has been observed in clinical trials.
Infections
Infectious episodes were reported in 24% of the patients treated with ABRAXANE. Oral candidiasis, respiratory tract infections and pneumonia were |
