Single Vial Docetaxel Injection - ION Solutions

Table 3 - Non-Hematologic Adverse Reactions in Breast Cancer Patients Previously Treated with
Chemotherapy Treated at Docetaxel 100 mg/m 2 with Normal or Elevated Liver Function Tests or
60 mg/m 2 with Normal Liver Function Tests
Docetaxel
Docetaxel
100 mg/m 2 60 mg/m 2
Adverse Reaction
Acute Hypersensitivity Reaction
Regardless of Premedication
Any
Severe
Fluid Retention***
Regardless of Premedication
Any
Severe
Neurosensory
Any
Severe
Normal LFTs* Elevated LFTs** Normal LFTs*
n=730
n=18 n=174
% % %
13
1
56
8
57
6
50
0
20
0
Myalgia 23 33 3
Cutaneous
Any 45 61 31
Severe 5 17 0
Asthenia
Any 65 44 66
Severe 17 22 0
Diarrhea
Any 42 28 NA
Severe 6 11
Stomatitis
Any 53 67 19
Severe 8 39 1
NA = not available
*Normal Baseline LFTs: Transaminases ≤1.5 times ULN or alkaline phosphatase ≤2.5 times ULN or
isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN
**Elevated Baseline Liver Function: AST and/or ALT >1.5 times ULN concurrent with alkaline
phosphatase >2.5 times ULN
***Fluid Retention includes (by COSTART): edema (peripheral, localized, generalized, lymphedema,
pulmonary edema, and edema otherwise not specified) and effusion (pleural, pericardial, and ascites); no
premedication given with the 60 mg/m 2 dose
In the three-arm monotherapy trial, TAX313, which compared docetaxel 60 mg/m 2 , 75 mg/m 2 and
100 mg/m 2 in advanced breast cancer, grade 3/4 or severe adverse reactions occurred in 49.0% of patients
treated with docetaxel 60 mg/m 2 compared to 55.3% and 65.9% treated with 75 mg/m 2 and 100 mg/m 2
respectively. Discontinuation due to adverse reactions was reported in 5.3% of patients treated with
6
0
61
17
1
0
13
0
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