PMID: 9166489Nov 1, 1995Paper

Paclitaxel administered by a 1-hour infusion: A phase I-II trial comparing two schedules

The Cancer Journal From Scientific American
J D HainsworthF A Greco

Abstract

Paclitaxel is currently administered by prolonged intravenous infusion primarily because of severe hypersensitivity reactions that occurred with rapid infusions during early clinical trails. This phase I-II study evaluates the feasibility of 1-hour paclitaxel administration and compares the toxicity and efficacy of two different 1-hour infusion schedules. One hundred sixty-four patients with advanced, refractory cancer were randomized to receive one of two paclitaxel schedules: a 1-hour infusion or a 3-day, divided dose schedule, each daily dose administered by 1-hour infusion. The first 60 patients received a total paclitaxel dose of 135 mg/m2, and the remaining 104 patients received 200 mg/m2. All patients were premedicated with dexamethasone, diphenhydramine, and cimetidine. Cytokines were not routinely used. No serious hypersensitivity reactions occurred in 620 courses of paclitaxel. Both doses were well tolerated; grade 3 or 4 leukopenia was produced in 22% of courses at 135 mg/m2 and 23% of courses at 200 mg/m2. Both schedules were well tolerated, but grade 3 and 4 leukopenia was more common with the 3-day schedule when paclitaxel 200 mg/m2 was administered. Myalagias were more common with the 1-day schedule. Major respon...Continue Reading

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