ATLANTA, Jun 01 (Reuters Health) - Intralesional injections of a gel containing cisplatin and epinephrine are an efficacious means of delivering intensive chemotherapy to solid tumors, a New York University researcher told attendees at the 35th annual meeting of the American Society of Clinical Oncology held recently here.
Dr. Ruth Oratz of New York University presented phase III data on 102 patients with either breast cancer, melanoma, esophageal cancer or other solid tumors who received IntraDose (cisplatin/epinephrine) Injectable Gel weekly for up to six treatments in an 8-week trial.
All patients had advanced disease and 96% had a history of chemotherapy, with 76% receiving two or more courses of chemotherapy prior to enrollment.
Treatment reduced tumor size by more than 50% in 45% of patients. Response rates were comparable across all tumor types. Mean duration of response was about 36 days for esophageal cancer and 78 days for recurrent breast cancer.
Use of gel injections was associated with a lower incidence of toxic effects compared with systemic delivery of the same drugs and Dr. Oratz reported a "...strong correlation between reduced tumor size and improved quality of life."
Dr. Oratz noted in an interview with Reuters Health that intralesional therapy is ideal for local disease that is superficial and easily accessible, and for tumors that are a few millimeters to 2 to 3 cm in diameter.
For tumors less than 1 cm in size, Dr. Oratz saw a response in 1 to 2 weeks. For larger tumors, additional weeks of therapy were required, but without a significant increase in toxicity, she noted.
"My feeling is that we really have demonstrated a great deal of efficacy [with IntraDose]...I don't need a comparison study or more phase III studies to know it works," she declared.
Just prior to the presentation at ASCO, FDA granted Matrix Pharmaceutical, Inc. of Fremont, California fast track status for IntraDose in treatment of head and neck cancers.