PMID: 9427267Jan 14, 1998Paper

A phase I trial of radiotherapy and simultaneous 24-hour paclitaxel in patients with locally advanced head and neck squamous cell carcinoma

Seminars in Oncology
L SteinbergM Strauss

Abstract

Preclinical studies have demonstrated that tumor cells exposed to paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) for protracted periods (ie, 24 hours) and then irradiated undergo enhanced radiation-induced cell kill. Importantly, paclitaxel-induced tumor cell mitotic arrest at the time of radiation was associated with the enhanced cell kill. At the Case Western Reserve Cancer Center, we have conducted a phase I trial in 24 patients with either locally advanced or recurrent/metastatic head and neck squamous cell carcinoma to evaluate the clinical and pharmacologic effects of a 24-hour paclitaxel infusion combined with radiotherapy. The maximum tolerated dose was < or =75 mg/m2. Dose-limiting toxicity was febrile granulocytopenia. Mucositis was significant and necessitated the use of enteral feeding tubes in the majority of patients. All patients with locally advanced disease demonstrated either a complete response or major partial response. At a median follow-up of 13.4 months, disease has relapsed in only two of 22 patients with locally advanced disease. Pharmacokinetic studies revealed that a dose of > or =75 mg/m2 achieved near steady-state mean paclitaxel plasma concentrations greatly exceeding the threshold...Continue Reading

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