Evaluation of the efficacy of natural human interferon alpha lozenges on the clinical course of childhood neoplasia and in chronic hepatitis B virus infection in patients who were successfully treated for pediatric malignancies.

The immunostimulating and anti-cancer action of interferons (IFNs) has been known for many years. However, IFNs have not been introduced widely into the schemes of oncological treatment because of serious side effects potentiating untoward effects of chemotherapy. In addition using high doses of IFNs by parental routes the cost of such therapy is prohibitively high. Natural human interferon alpha lozenges produced from lymphoblastoid cell line by the Hayashibara Biochemical Lab. Okayama Japan (nHuIFN-alpha, HBL) is used in small doses delivered on oral mucosa. Thus, it might be expected not to cause severe side effects, and is less expensive. Children given antineoplastic and immunostimulatory treatment for cancer were also given nHuIFN-alpha--HBL lozenges containing 50-200 units of IFN per lozenge. Children treated age varied from 3-14 years. The average time of observation was 188 days. In 6 patients nHuIFN-alpha therapy was introduced at the time of the intensive oncological treatment during break periods. Those children had advanced malignant solid tumors. For the other children the IFN therapy was used after the successfully completed oncological treatment. The reason of using nHuIFN-alpha in this group was a long lasting hepatitis B virus antigenemia. The drug was well tolerated by children from both groups and a positive immunostimulating effect was observed. One prominent effect of the nHuIFN-alpha--HBL in children was a reduction of frequency of infections, improvement of appetite and psychological feeling of well being. It seems to us that IFN oral therapy may improve the tolerance of chemotherapy and radiotherapy.