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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

Arch Otolaryngol Head Neck Surg. 2002;128:880-885.

Objective  To determine the safety and efficacy of targeted antitumor therapy with cisplatin/epinephrine injectable gel in patients with advanced squamous cell carcinoma of the head and neck.

Design  Two prospective, double-blind, placebo-controlled phase III trials of identical design. Crossover from blinded to open-label phase was permitted for patients with disease progression.

Setting  Tertiary referral centers in North America and Europe.

Patients  One hundred seventy-nine intensively pretreated patients with recurrent or refractory squamous cell carcinoma of the head and neck.

Intervention  Cisplatin/epinephrine injectable or placebo gel was administered by direct intratumoral injection; up to 6 weekly treatments. Dose was 0.25 mL of active or placebo gel per cubic centimeter of tumor up to 10 mL total. Patient benefit after local tumor control of the most symptomatic tumor was assessed by patients and physicians using the Treatment Goals Questionnaire.

Main Outcome Measures  Local tumor response and patient benefit attributable to improvements in tumor-related symptoms.

Results  Combined results for the 178 patients with evaluable data in the 2 trials confirmed objective tumor responses in 35 (29%) of 119 patients, including 23 (19%) complete responses achieved with cisplatin/epinephrine gel, vs 1 (2%) of 59 for placebo (P<.001). Tumor response and patient benefit were significantly correlated (P = .006): 47% (17/36) of patients with target tumor responses achieved a rigorously defined benefit based on a prospectively selected treatment goal vs 15% (22/142) of nonresponders.

Conclusion  Cisplatin/epinephrine injectable gel reduces tumor burden, ameliorates tumor symptoms, and provides a new therapeutic option for treating patients with squamous cell carcinoma of the head and neck.

From the Department of Otolaryngology–Head and Neck Surgery, Northwestern University Medical School, Evanston, Ill (Dr Wenig); Department of Otolaryngology–Head and Neck Surgery, University of Marburg, Marburg, Germany (Dr Werner); Division of Head and Neck Surgery, UCLA School of Medicine, Los Angeles, Calif (Dr Castro); Department of Medicine, University of Miami School of Medicine, Miami, Fla (Dr Sridhar); Department of Internal Medicine, Hematology and Oncology, University of Arizona, Tucson (Dr Garewal); Ear, Nose, and Throat Department, University Hospital Eppendorf, Hamburg, Germany (Dr Kehrl); Department of Oncology and Chemotherapy Clinic, Medical University, ód, Poland (Dr Pluzanska); Department of Otolaryngology, Head and Neck Surgery, University of Regensburg, Regensburg, Germany (Dr Arndt); Department of Otolaryngology and Neurosurgery, The Mount Sinai School of Medicine, New York, NY (Dr Costantino); Department of Medicine, Hematology/Oncology Section, Louisiana State University Medical Center, Shreveport (Dr Mills); Division of Bone Marrow Transplantation, Medical Oncology and Hematology, Department of Internal Medicine, St Louis University Health Sciences Center, St Louis, Mo (Dr Dunphy); and Matrix Pharmaceutical Inc, Fremont, Calif (Drs Orenberg and Leavitt). Dr Costantino is now with St Luke's–Roosevelt Medical Center, Columbia University College of Physicians and Surgeons, New York, NY, and Dr Dunphy is now with the Oncology Division, Department of Medicine, Duke University, Durham, NC.
Dr Sridhar is deceased.

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