ORIGINAL ARTICLE The Role of Intratumoral Therapy With Cisplatin/Epinephrine Injectable Gel in the Management of Advanced Squamous Cell Carcinoma of the Head and Neck Barry L. Wenig, MD, MPH; Jochen A. Werner, MD; Dan J. Castro, MD; Kasi S. Sridhar, MD†; Harinder S. Garewal, MD, PhD; Wolfgang Kehrl, MD; Anna Pluzanska, MD; Olaf Arndt, MD; Peter D. Costantino, MD; Glenn M. Mills, MD; Frank R. Dunphy II, MD; Elaine K. Orenberg, PhD; Richard D. Leavitt, MD Objective: To determine the safety and efficacy of patients and physicians using the Treatment Goals targeted antitumor therapy with cisplatin/epinephrine Questionnaire. injectable gel in patients with advanced squamous cell carcinoma of the head and neck. Main Outcome Measures: Local tumor response and patient benefit attributable to improvements in tumor- Design: Two prospective, double-blind, placebo- related symptoms. controlled phase III trials of identical design. Crossover from blinded to open-label phase was permitted for pa- Results: Combined results for the 178 patients with evalu- tients with disease progression. able data in the 2 trials confirmed objective tumor re- sponses in 35 (29%) of 119 patients, including 23 (19%) Setting: Tertiary referral centers in North America and complete responses achieved with cisplatin/epinephrine gel, Europe. vs 1
JAMA Otolaryngology - Head & Neck Surgery – American Medical Association
Published: Aug 1, 2002
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