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FDA Approves Docetaxel

On September 28, 2007, the U. S. Food and Drug Administration (FDA) approved docetaxel (Taxotere Injection Concentrate, Sanofi-Aventis) for use in combination with cisplatin and fluorouracil (5-FU) for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).

The safety and efficacy of Taxotere for the above indication were evaluated in a multi-center, open-label, randomized trial.  In this study, 501 patients with previously untreated locally advanced SCCHN, and performance status 0 or 1, received either Taxotere 75 mg/m2  followed by cisplatin 100 mg/m2 on day 1, followed by 5-FU 1000 mg/m2/day as a continuous infusion on days 1-4 (TPF) or cisplatin 100 mg/m2 on day 1, followed by 5-FU 1000 mg/m2/day as a continuous infusion on days 1-5 (PF).  These regimens were administered every 3 weeks for 3 cycles.  All patients in both treatment arms who did not have progressive disease following induction chemotherapy received 7 weeks of chemoradiotherapy (CRT).  During radiotherapy, carboplatin (AUC 1.5) was administered weekly as a 1-hour infusion for a maximum of 7 doses.  Surgery could be considered at anytime following completion of CRT.

Overall survival was significantly prolonged with the Taxotere-containing regimen compared to the PF regimen (log‑rank test, p=0.0058).  The median survival was 70.6 months in the TPF group compared to 30.1 months in the PF group (hazard ratio = 0.70, 95% confidence interval:  0.54, 0.90).

The most frequent adverse events (>40%, any grade) on the TPF arm were neutropenia, anemia, nausea, alopecia, stomatitis, lethargy, vomiting, diarrhea, and anorexia.  Neutropenic fever with or without infection occurred in greater than 5% of patients on the TPF arm.  Grade 3 or 4 adverse events with a greater than 5% frequency in patients on the TPF arm were neutropenia, infection, stomatitis, nausea, esophagitis/dysphagia/odynophagia, anorexia, vomiting, and anemia.  Neutropenia, alopecia, diarrhea, and anorexia were more frequently seen in the TPF arm.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at Drugs@FDA 


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Date created: October 2, 2007


Page Last Updated: 02/24/2016
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