Pharmacokinetics and Toxicity of Inhaled Human Interferon-α in Patients with Lung Cancer

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Abstract
Eight patients with advanced, previously treated non-small cell lung cancer inhaled natural leukocyte interferon-.alpha. (IFN-.alpha.) from a dosimeter-equipped jet nebulizer. Single doses of IFN ranged from 1 .times. 106 to 120 .times. 106 IU. Serum IFN was undetectable after single doses of 1 .times. 106 to 18 .times. 106 IU, but 60 .times. 106 IU resulted in measurable levels of circulating IFN in 3 out of 6 patients. All 5 patients who inhaled 120 .times. 106 IU had between 11 and 35 IU of IFN per milliliter of serum for at least 12 h. No systemic or local side effects were observed after 1 .times. 106 to 18 .times. 106 IU, but doses of 60 .times. 106 to 120 .times. 106 IU resulted in temperature rise, headache, and malaise. All symptoms started within 3-6 h, reached their peak by 8-10 h, and lasted until 12-24 h after inhalation. A decrease (> 20%) in peak expiratory flow following inhalation was temporarily found in 2 patients. We conclude that IFN, given by inhalation, penetrates into the blood stream, thus causing systemic side effects similar to those described after systemic IFN administration and, in addition, occasionally reversible airflow obstruction.