Single Vial Docetaxel Injection - ION Solutions
Single Vial Docetaxel Injection - ION Solutions
Single Vial Docetaxel Injection - ION Solutions
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<strong>Docetaxel</strong><br />
75 mg/m 2<br />
n=176<br />
%<br />
Best Supportive Care<br />
n=49<br />
%<br />
Vinorelbine/Ifosfamide<br />
n=119<br />
%<br />
Adverse Reaction<br />
Asthenia<br />
Any 53 57 54<br />
Severe*** 18 39 23<br />
Stomatitis<br />
Any 26 6 8<br />
Grade 3/4 2 0 1<br />
Pulmonary<br />
Any 41 49 45<br />
Grade 3/4 21 29 19<br />
Nail Disorder<br />
Any 11 0 2<br />
Severe*** 1 0 0<br />
Myalgia<br />
Any 6 0 3<br />
Severe*** 0 0 0<br />
Arthralgia<br />
Any 3 2 2<br />
Severe*** 0 0 1<br />
Taste Perversion<br />
Any 6 0 0<br />
Severe*** 1 0 0<br />
*Normal Baseline LFTs: Transaminases ≤1.5 times ULN or alkaline phosphatase ≤2.5 times ULN or<br />
isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN<br />
**Febrile Neutropenia: ANC grade 4 with fever >38°C with intravenous antibiotics and/or hospitalization<br />
† Not Applicable<br />
†† Not Done<br />
***COSTART term and grading system<br />
Combination therapy with docetaxel in chemotherapy-naïve advanced unresectable or metastatic<br />
NSCLC<br />
Table 6 presents safety data from two arms of an open label, randomized controlled trial<br />
(TAX326) that enrolled patients with unresectable stage IIIB or IV non-small cell lung cancer and no<br />
history of prior chemotherapy. Adverse reactions were described using the NCI Common Toxicity<br />
Criteria except where otherwise noted.<br />
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