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.