PURPOSE: The combination of chemotherapy and irradiation is considered the standard of care for the treatment of advanced squamous cell carcinoma of head and neck (SCCHN). Paclitaxel has shown a single-agent activity in SCCHN. Besides, this drug is a promising radiosensitizer for some human solid tumors. This is a phase II trial to evaluate the feasibility, efficacy, and toxicity of paclitaxel administered concurrently with split-course radiotherapy in advanced unresectable SCCHN. Methods and Materials Thirty-one patients with advanced SCCHN were enrolled in this trial. Radiotherapy consisted of 66 to 70 Gy delivered over 8 to 10 weeks to the primary tumor and lymphatic drainage, with a fractionation scheme of 1.8 to 2 Gy/field/d. After the initial five patients were treated, a 1-week treatment break was introduced. Paclitaxel was administered weekly in a 1-hour intravenous infusion at a projected dosage of 45 mg/m(2)/wk. RESULTS: The complete and partial response rates, based on a 4-week postradiation evaluation were 43.3% and 40%, respectively, with an overall response rate of 83.3%. Median survival was 49.4 weeks, and 1-year survival was 48%. Freedom from local progression was 65.6% at 1 year. Thirty-six percent and 20% of the patients are alive and disease free at 1 and 2 years, respectively. Grade 3/4 of acute toxicity consisted mostly of mucositis, cutaneous reaction, and weight loss. CONCLUSIONS: Paclitaxel concurrent with radiotherapy seems to be active in squamous cell carcinoma of the head and neck. In the regimen selected for this trial, toxicity was significant and led to a prolongation of treatment time. Copyright 2002 Wiley Periodicals, Inc.
PURPOSE: The combination of chemotherapy and irradiation is considered the standard of care for the treatment of advanced squamous cell carcinoma of head and neck (SCCHN). Paclitaxel has shown a single-agent activity in SCCHN. Besides, this drug is a promising radiosensitizer for some human solid tumors. This is a phase II trial to evaluate the feasibility, efficacy, and toxicity of paclitaxel administered concurrently with split-course radiotherapy in advanced unresectable SCCHN. Methods and Materials Thirty-one patients with advanced SCCHN were enrolled in this trial. Radiotherapy consisted of 66 to 70 Gy delivered over 8 to 10 weeks to the primary tumor and lymphatic drainage, with a fractionation scheme of 1.8 to 2 Gy/field/d. After the initial five patients were treated, a 1-week treatment break was introduced. Paclitaxel was administered weekly in a 1-hour intravenous infusion at a projected dosage of 45 mg/m(2)/wk. RESULTS: The complete and partial response rates, based on a 4-week postradiation evaluation were 43.3% and 40%, respectively, with an overall response rate of 83.3%. Median survival was 49.4 weeks, and 1-year survival was 48%. Freedom from local progression was 65.6% at 1 year. Thirty-six percent and 20% of the patients are alive and disease free at 1 and 2 years, respectively. Grade 3/4 of acute toxicity consisted mostly of mucositis, cutaneous reaction, and weight loss. CONCLUSIONS:Paclitaxel concurrent with radiotherapy seems to be active in squamous cell carcinoma of the head and neck. In the regimen selected for this trial, toxicity was significant and led to a prolongation of treatment time. Copyright 2002 Wiley Periodicals, Inc.
Authors: Deborah Citrin; John Mansueti; Anna Likhacheva; Linda Sciuto; Paul S Albert; Susan F Rudy; Theresa Cooley-Zgela; Ana Cotrim; Beth Solomon; A Dimitrios Colevas; Angelo Russo; John C Morris; Laurie Herscher; Sharon Smith; Carter Van Waes Journal: Int J Radiat Oncol Biol Phys Date: 2008-12-29 Impact factor: 7.038