Aug. 16, 2002 CHICAGO – An injectable gel combining cisplatin, a chemotherapy drug, and epinephrine is effective in treating cancers of the head and neck, according to a new study published in The Archives of Otolaryngology and Head and Neck Surgery, one of the JAMA/Archives journals.
Squamous cell carcinoma is a type of cancer that originates in a particular type of cell found in many different parts of the body. Head and neck squamous cell carcinoma (HNSCC) refers to this type of cancer in the head or neck.
According to background information, HNSCC is diagnosed in about 40,000 Americans each year and more than 600,000 people worldwide. Barry L. Wenig, M.D., M.P.H., of Northwestern Medical School, Evanston, Ill., and colleagues investigated the use of cisplatin/epinephrine gel injected directly into the tumor in patients with HNSCC. Cisplatin given intravenously (by vein) has been shown to be a potent agent for treating HNSCC, but because it affects the entire body when given intravenously, it can have serious adverse effects.
The authors write "Therapeutic options for advanced HNSCC are limited. These patients generally have undergone extensive surgery, have received near-maximum tolerated doses of radiation, and are often poor candidates for aggressive combination therapy. Therefore, for more effective local and regional control of HNSCC and to minimize systemic exposure and toxicity, locally injectable therapies have been investigated."
The researchers conducted two placebo-controlled phase III trials of identical design. One hundred seventy patients previously treated for their cancers were enrolled (one patient was later excluded). Eighty- nine percent of the patients were treated with more than one treatment including surgery, chemotherapy and radiotherapy. One hundred nineteen patients received the cisplatin/epinephrine gel, and 59 patients received a placebo gel. Patients' tumors were injected up to 6 times per week over 8 weeks with weekly evaluations for four weeks after treatment and monthly evaluations thereafter. Patients with nonresponsive tumors after three weeks of treatment could switch from placebo group to treatment group.
Tumors responded in 35 of 119 patients receiving the cisplatin/epinephrine gel (29 percent). Twenty-three (19 percent) had complete responses with the cisplatin/epinephrine gel vs. 2 percent for those in the placebo gel groups (1 in 59 patients). Patients in the treatment group also met more of their treatment goals (27 percent vs. 12 percent in the placebo group). Treatment goals included improved pain control, improved wound care, relief of symptoms and better physical appearance.
"In these two randomized, double-blind, placebo-controlled phase II trials, cisplatin/epinephrine gel was shown to be effective in producing clinically meaningful response and palliative benefit in a group of patients with advanced HNSCC who had few, if any, remaining therapeutic options. Moreover, the strong association between response and patient benefit clearly demonstrated the advantage of treatment over placebo," the authors write.
Editor's Note: This study was supported by a clinical grant from Matrix Pharmaceutical Inc., Fremont, Calif.
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