On November 27, 2002, the FDA approved docetaxel (Taxotere®, a trademark of Aventis Pharmaceuticals, Inc.) for use in combination with cisplatin for the treatment of patients with unresectable (not removable by surgery), locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received chemotherapy for this condition.

Docetaxel was assessed in a single, open-label randomized multicenter international trial. A total of 1,218 patients with unresectable stage IIIB or IV NSCLC and no prior chemotherapy were randomized to receive one of three treatments: docetaxel 75 mg/m2 as a one hour infusion immediately followed by cisplatin 75 mg/m2 over 30-60 minutes every three weeks; vinorelbine 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every four weeks; or a combination of docetaxel and carboplatin.

The primary endpoint was overall survival. There was no statistically significant difference in overall survival between patients receiving docetaxel + cisplatin compared to patients receiving vinorelbine + cisplatin (median survival 10.9 months versus 10.0 months, p = 0.12). The efficacy of Taxotere in this combination was established by a non-inferiority analysis.

Efficacy of docetaxel when used in combination with carboplatin was not established. There was no statistically significant difference in survival between patients receiving docetacel + carboplatin versus patients receiving vinorelbine + cisplatin (median survival 9.1 months versus 10.0 months, p = 0.66). The docetaxel + carboplatin arm did not demonstrate non-inferiority when compared to vinorelbine + cisplatin.

The most common adverse events (> 50 percent of patients) were neutropenia, anemia, nausea, vomiting, fluid retention, asthenia, pain and alopecia. Other common adverse events (20-50 percent of patients) were diarrhea, weight loss, stomatitis, infection, hemoptysis, constipation, and neurosensory events.

Febrile neutropenia and grade 3 / 4 infection occurred in 5 percent and 8 percent of patients in the cisplatin-containing regimens, respectively. Less common adverse events (< 20 percent of patients) were thrombocytopenia, hypersensitivity reactions, neuro-hearing cerebellar or motor adverse events, myalgia, arthralgia, dehydration, and nail disorders. The toxic death rate (deaths within 30 days of drug administration) was 2.2 percent in the docetaxel + cisplatin arm and 2 percent in the cisplatin + vinorelbine arm.

For chemotherapy-naïve patients, the recommended dose of docetaxel is 75 mg/m2 administered intravenously over one hour immediately followed by cisplatin 75 mg/m2 over 30-60 minutes every three weeks.

Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

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