Bleomycin, a
chemotherapy agent that inhibits synthesis of
DNA, has been increasingly utilized in
sclerotherapy for patients with
vascular malformations. A serious long-term risk of intravenous
bleomycin is dose-dependent
interstitial pneumonitis. Little is known about absorption and circulating levels of
bleomycin when used in
sclerotherapy for patients with
vascular malformations. This is an Institutional Review Board (IRB)-approved prospective study on patients receiving
bleomycin sclerotherapy in the management of
vascular malformations. Depending on the type of
vascular malformation,
bleomycin was administered either in the lumen or interstitial space of the involved lesion. A
bleomycin assay measured serum
bleomycin plasma concentrations versus time at seven intervals following treatment. Pharmacokinetic parameters were obtained for each participant and included peak plasma concentration (Cmax ), time to reach peak plasma concentration (Tmax ), volume of distribution (Vd ), elimination half-life (t1/2 ), the volume of plasma cleared of the drug per unit time (CL), and total systemic exposure area under the curve (AUC). Fifteen patients were enrolled (5: lymphatic, 4: venous, 6:
arteriovenous malformations).
Bleomycin was administered interstitially (IS) in 11 patients and intraluminal (IL) in four; median age of 13 years (range: 2-67). Pharmacokinetic analysis revealed terminal elimination half-life (t1/2λz ) of 88.51 (±23.09) and 111.61 (±37.75) minutes for the IS and IL groups, respectively. Vd was 4.86 L (±6.74) and 1.55 L (±0.54) for the IS and IL groups, respectively. AUC was 53.9 (±23.45) and 129.17 (±93.57) mg min/L for the IS and IL groups, respectively. There were no statistically significant differences in t1/2λz , Vd , or AUC parameters between groups.
Bleomycin is absorbed systemically when used as a
sclerosant for
vascular malformations when injected either IS or IL.