DOCETAXEL (Page 9 of 20)
Combination therapy with docetaxel in chemotherapy-naive advanced unresectable or metastatic NSCLC
Table 8presents safety data from two arms of an open label, randomized controlled trial (TAX326) that enrolled patients with unresectable stage IIIB or IV non-small cell lung cancer and no history of prior chemotherapy. Adverse reactions were described using the NCI Common Toxicity Criteria except where otherwise noted.
Adverse Reaction | Docetaxel 75 mg/m 2 + Cisplatin 75 mg/m 2 n=406 % | Vinorelbine 25 mg/m 2 + Cisplatin 100 mg/m 2 n=396 % |
---|---|---|
Neutropenia | ||
Any | 91 | 90 |
Grade 3/4 | 74 | 78 |
Febrile Neutropenia | 5 | 5 |
Thrombocytopenia | ||
Any | 15 | 15 |
Grade 3/4 | 3 | 4 |
Anemia | ||
Any | 89 | 94 |
Grade 3/4 | 7 | 25 |
Infection | ||
Any | 35 | 37 |
Grade 3/4 | 8 | 8 |
Fever in absence of infection | ||
Any | 33 | 29 |
Grade 3/4 | < 1 | 1 |
Hypersensitivity Reaction * | ||
Any | 12 | 4 |
Grade 3/4 | 3 | < 1 |
Fluid Retention † | ||
Any | 54 | 42 |
All severe or life-threatening events | 2 | 2 |
Pleural effusion | ||
Any | 23 | 22 |
All severe or life-threatening events | 2 | 2 |
Peripheral edema | ||
Any | 34 | 18 |
All severe or life-threatening events | <1 | <1 |
Weight gain | ||
Any | 15 | 9 |
All severe or life-threatening events | <1 | <1 |
Neurosensory | ||
Any | 47 | 42 |
Grade 3/4 | 4 | 4 |
Neuromotor | ||
Any | 19 | 17 |
Grade 3/4 | 3 | 6 |
Skin | ||
Any | 16 | 14 |
Grade 3/4 | <1 | 1 |
Nausea | ||
Any | 72 | 76 |
Grade 3/4 | 10 | 17 |
Vomiting | ||
Any | 55 | 61 |
Grade 3/4 | 8 | 16 |
Diarrhea | ||
Any | 47 | 25 |
Grade 3/4 | 7 | 3 |
Anorexia † | ||
Any | 42 | 40 |
All severe or life-threatening events | 5 | 5 |
Stomatitis | ||
Any | 24 | 21 |
Grade 3/4 | 2 | 1 |
Alopecia | ||
Any | 75 | 42 |
Grade 3 | <1 | 0 |
Asthenia † | ||
Any | 74 | 75 |
All severe or life-threatening events | 12 | 14 |
Nail Disorder † | ||
Any | 14 | <1 |
All severe events | <1 | 0 |
Myalgia † | ||
Any | 18 | 12 |
All severe events | <1 | <1 |
Deaths within 30 days of last study treatment occurred in 31 patients (7.6%) in the docetaxel+cisplatin arm and 37 patients (9.3%) in the vinorelbine+cisplatin arm. Deaths within 30 days of last study treatment attributed to study drug occurred in 9 patients (2.2%) in the docetaxel+cisplatin arm and 8 patients (2.0%) in the vinorelbine+cisplatin arm.
The second comparison in the study, vinorelbine+cisplatin versus docetaxel+carboplatin (which did not demonstrate a superior survival associated with docetaxel [see Clinical Studies (14.3)] ) demonstrated a higher incidence of thrombocytopenia, diarrhea, fluid retention, hypersensitivity reactions, skin toxicity, alopecia and nail changes on the docetaxel+carboplatin arm, while a higher incidence of anemia, neurosensory toxicity, nausea, vomiting, anorexia and asthenia was observed on the vinorelbine+cisplatin arm.
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