Phase I/II study of Fluosol-DA and 100% oxygen as an adjuvant to radiation in the treatment of advanced squamous cell tumors of the head and neck.

Fluosol-DA 20% (Fluosol) is an emulsion of perfluorodecalin and perfluorotripropylamine, which has the ability to carry oxygen and has been shown to enhance the ability of radiation to control tumors in animal studies. Since November 1984, patients with unresectable squamous cell carcinomas of the head and neck have been enrolled in a study to evaluate the safety and potential efficacy of this adjuvant therapy. Forty-six patients were entered of which 37 completed radiation and are evaluable. Patients were infused weekly with Fluosol and then breathed 100% oxygen for a minimum of 30 minutes prior to and during radiation. Eleven patients received 5 infusions of 8 mL/Kg, four patients 6 infusions of 8 mL/Kg, five patients 5 infusions of 9 mL/Kg, seven patients 7 infusions of 7 mL/Kg and eight patients 8 infusions of 7 mL/Kg. Nine patients had Stage III disease, 20 patients Stage IV disease and 8 patients had failed previous therapy with chemotherapy and/or surgery. The radiation doses delivered ranged from 6600 cGy to 7500 cGy. The overall complete response rate for this group was 76%. All 9 Stage III patients were complete responders, 13 of 20 Stage IV responded and 6 of 8 with previous therapy were complete responders. The survival rate at 1 year was 67% for absolute and 78% as determinant. Of those patients achieving a complete response, 75% continued free of disease 1 year after therapy. Out of 254 total test doses, 11 patients experienced a reaction to the test dose of Fluosol. Of 235 total infusions 6 patients experienced a reaction during the Fluosol infusion with 7 patients experiencing post infusion reactions. These were readily controlled with diphenhydramine or acetominophen. Elevated liver enzymes were observed in some patients with a mean time to normalization of 102 days for alkaline phosphatase, 39 days for SGOT, and 46 days for SGPT.