PMID- 17430488 OWN - NLM STAT- MEDLINE DCOM- 20070919 LR - 20131121 IS - 1397-3142 (Print) IS - 1397-3142 (Linking) VI - 11 IP - 3 DP - 2007 May TI - Oral graft vs. host disease in children--treatment with topical tacrolimus ointment. PG - 306-11 AB - Oral chronic graft vs. host disease (GVHD) frequently presents in patients with sclerotic features of skin GVHD and is often associated with considerable limitations of oral food intake and decreased quality of life. Systemic tacrolimus is efficacious for prophylaxis and treatment of acute and chronic GVHD and topical tacrolimus has shown activity in chronic GVHD skin lesions. We therefore initiated a pilot study to investigate the safety and efficacy of topical tacrolimus ointment in children with oral GVHD. Six patients suffering from oral GVHD (five chronic and one acute) were included in the study. Tacrolimus ointment 0.1% was applied twice daily using sterile gauze. The only side-effects observed were a slight burning discomfort after the first application in one patient and after food intake in another patient. Tacrolimus was absorbed systemically in four of six patients. Of six patients, we observed a complete response in two, a very good partial response (VGPR) in two, and a PR in two patients, respectively. We conclude that topical application of tacrolimus ointment holds promise as a safe and efficacious treatment for oral GVHD in children. The Food and Drug Administration has recently issued a health advisory about a potential cancer risk associated with topical tacrolimus treatment of the skin; therefore, its benefits should be weighed against its potential risks and diligent long-term follow-up should be carried out especially in children. FAU - Albert, Michael H AU - Albert MH AD - Department of Pediatric Hematology/Oncology, Dr von Haunersches Kinderspital, Ludwig Maximilians University, Munich, Germany. mialbert@gmail.com FAU - Becker, B AU - Becker B FAU - Schuster, F R AU - Schuster FR FAU - Klein, B AU - Klein B FAU - Binder, V AU - Binder V FAU - Adam, K AU - Adam K FAU - Nienhoff, C AU - Nienhoff C FAU - Fuhrer, M AU - Fuhrer M FAU - Borkhardt, A AU - Borkhardt A LA - eng PT - Journal Article PL - Denmark TA - Pediatr Transplant JT - Pediatric transplantation JID - 9802574 RN - 0 (Immunosuppressive Agents) RN - 0 (Ointments) RN - WM0HAQ4WNM (Tacrolimus) SB - IM MH - Administration, Topical MH - Adolescent MH - Child MH - Female MH - Graft vs Host Disease/*drug therapy/etiology MH - Hematopoietic Stem Cell Transplantation/adverse effects MH - Humans MH - Immunosuppressive Agents/*therapeutic use MH - Male MH - Mouth Diseases/*drug therapy/etiology MH - Ointments MH - Pilot Projects MH - Tacrolimus/*therapeutic use MH - Treatment Outcome EDAT- 2007/04/14 09:00 MHDA- 2007/09/20 09:00 CRDT- 2007/04/14 09:00 PHST- 2007/04/14 09:00 [pubmed] PHST- 2007/09/20 09:00 [medline] PHST- 2007/04/14 09:00 [entrez] AID - PTR666 [pii] AID - 10.1111/j.1399-3046.2006.00666.x [doi] PST - ppublish SO - Pediatr Transplant. 2007 May;11(3):306-11. doi: 10.1111/j.1399-3046.2006.00666.x.