Regression of infancy hemangiomas with recombinant IFN-alpha 2b

Interferon-alpha (IFN-alpha) has antitumor and antiangiogenic effects. The purpose of this work was to evaluate its efficacy and safety in the treatme nt of infancy hemangioma and to monitor the appearance of anti-IFN antibodi es in these patients. Thirty-nine children (29 girls) aged 1.5-158 months, with 19 younger than 1 year and 9 older than 5, were treated with 3 x 10(6) IU/m(2) IFN-alpha 2b, subcutaneously (s.c.) daily. Inclusion criteria were life-threatening or life-limiting hemangioma and parents' informed consent . Regression was considered if tumor size diminished by 50% or more. Of the 38 patients who completed 6 months of treatment, 27 (71.1%) had regression and 11 (28.9%) had stable disease. No patient experienced progression. Reg ression was more frequent (100%) among patients between 1 and 5 years old, but it was particularly important (68%) among those under 1 year old, when spontaneous regression is rare. The main side effects were the IFN-related flulike syndrome (79%), increase in serum alanine aminotransferase (ALT) (2 8%), anorexia (19%), and mild inflammation at the injection site (19%). The re was no effect on psychomotor or physical development. On the contrary, 1 patient with neurologic symptoms improved remarkably, including seizure di sappearance. Eight patients developed anti-IFN-alpha2 neutralizing antibodi es, and 7 of them responded to IFN treatment, IFN-alpha 2b is a safe and ef ficacious treatment of infancy hemangioma. Further work should look for oth er treatment schedules and ways of administration and carefully monitor ant i-IFN neutralizing antibodies, which does not seem to interfere with respon se.