A simplified premedication protocol for one-hour paclitaxel infusion in various combinations.

BACKGROUND: Many investigations have focused on optimal doses/schedules since regulatory agency approval of paclitaxel (Taxol). Paclitaxel is generally administered at doses of 175-225 mg/m2 over 3 hours or 135-175 mg/m2 over 24 hours, every 3 weeks. The purpose of this study was to simplify administration and render it suitable and practical in the outpatient setting. Using this rationale, the duration of administration was decreased to one hour, with a minimized premedication regimen.

MATERIAL/METHODS: One hundred patients who were to receive paclitaxel-based chemotherapy combinations entered the study. Tumor types were non-small-cell lung cancer (NSCLC, n=40), small-cell lung cancer (SCLC, n=18), breast cancer (n=12), head and neck cancer (n=16), and ovarian cancer (n=14). Sixty patients received paclitaxel at 175 mg/m2 and the remaining 40 at 225 mg/m2. The premedication regimen consisted of a single dose of dexamethasone 20 mg, dimethindene maleate (Fenistil) 4 mg, and ranitidine (Zantac) 50 mg, followed by the standard antiemetic therapy. Paclitaxel was always administered before other chemotherapeutic agents, i.e. ifosfamide and/or platinum compounds, except for breast cancer, where epirubicin preceded paclitaxel administration.

RESULTS: Hypersensitivity reactions were recorded in 7 patients (7.0%) and were not influenced by age, gender, disease, dose schedule, or cycles of therapy. No serious adverse events were observed.

CONCLUSIONS: The simplified administration dose schedule for paclitaxel is safe and accommodates its combination with other cytostatic agents.