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Docetaxel is a chemotherapy drug that is used to treat several forms of cancer. On March 22nd 2006, the United States Food and Drug Administration (FDA) approved the use of docetaxel in combination with cisplatin and flourouracil for the treatment of patients with advanced gastric adenocarcinoma who had not yet received chemotherapy for advanced disease.
The use of the drug in this context was based on a multicenter trial of 455 patients with this cancer who had not previously received chemotherapy treatment for the condition. The patients were randomly assigned to either receive an infusion of docetaxel 75 mg/m2 plus cisplatin 75 mg/m2 as well as a five-day infusion of flourouracil 750 mg/m² (TCF arm) or cisplatin 100 mg/m2 and a five-day infusion of flourouracil 1000 mg/m2 (CF arm). The TCF regimen was administered every three weeks and the CF regimen every four weeks.
The results of the study showed that time to disease progression (TTP) was significantly longer among those who received TCF than among those who received CF, at a median of 5.6 versus 3.7 months. The overall survival was also significantly longer with TFC than with CF, at a median of 9.2 versus 8.6 months.
However, more side effects were reported with TCF than with CF and more of those in the TCF group also discontinued there medication regimen. Those who received TCF had increased rates of infection, fever, neutropenia, allergic reaction, fluid retention, edema, dizziness, hair loss, diarrhea, cramping and dysphagia, compared with those who took CF.
The recommended dosing regimen for TCF in the treatment of gastric cancer is docetaxel 75 mg/m2 infused over one hour, followed by a one to three hour infusion of cisplatin 75 mg/m2, followed by fluorouracil 750 mg/m2 as a continuous infusion for five days after cisplatin infusion ends. This treatment is given every three weeks.