title: Efficacy and effects of palifermin for the treatment of oral mucositis in patients affected by acute lymphoblastic leukemia.
abstract: This randomized-controlled trial studied the efficacy of palifermin, administered as a dose during hematopoietic stem cell transplant (HSCT) therapy, as primary prophylaxis on pediatric patients with acute lymphoblastic leukemia in order to reduce oral mucositis (OM). Patients in the palifermin group were randomly assigned to receive palifermin, 60 μg/kg, intravenously as a single dose 3 days before and 0, +1, and +2 post autologous HSCT infusion. The patients in the control group received only a placebo treatment. OM-related assessments were the WHO oral-toxicity scale and the patient-reported outcomes. There was a statistically significant reduction in the incidence of OM grade 3 and 4 in the palifermin group compared to the control group. There was also a reduction in the degree of severity of OM in the palifermin group (1.65 grade respect to 2.33 in the control group). Palifermin could prevent the recurrence of severe OM and improve the quality of life in patients with acute lymphoblastic leukemia (ALL).
authors.affiliation: a Department of Orthodontics , Dental School (Dean: Prof. E. Gherlone), Vita-Salute San Raffaele University , Milan , Italy ;|b Research in Dentofacial Orthopedics, Orthodontics and Pediatric Dentistry, Research Area in Oral Pathology and Implantology (Head: Prof. E. Gherlone), IRCCS San Raffaele Hospital , Milan , Italy ;
authors.forename: Alessandra
authors.initials: A
authors.lastname: Lucchese
authors.affiliation: c Department of Specialist Medical-Surgical Experimental Sciences and Odontostomatology (Dean: Prof. G. Cordasco) , AOU Policlinico "G. Martino," University of Messina , Messina , Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Matarese
authors.affiliation: a Department of Orthodontics , Dental School (Dean: Prof. E. Gherlone), Vita-Salute San Raffaele University , Milan , Italy ;
authors.forename: Luis Huanca
authors.initials: LH
authors.lastname: Ghislanzoni
authors.affiliation: a Department of Orthodontics , Dental School (Dean: Prof. E. Gherlone), Vita-Salute San Raffaele University , Milan , Italy ;|b Research in Dentofacial Orthopedics, Orthodontics and Pediatric Dentistry, Research Area in Oral Pathology and Implantology (Head: Prof. E. Gherlone), IRCCS San Raffaele Hospital , Milan , Italy ;
authors.forename: Giorgio
authors.initials: G
authors.lastname: Gastaldi
authors.affiliation: a Department of Orthodontics , Dental School (Dean: Prof. E. Gherlone), Vita-Salute San Raffaele University , Milan , Italy ;|b Research in Dentofacial Orthopedics, Orthodontics and Pediatric Dentistry, Research Area in Oral Pathology and Implantology (Head: Prof. E. Gherlone), IRCCS San Raffaele Hospital , Milan , Italy ;
authors.forename: Maurizio
authors.initials: M
authors.lastname: Manuelli
authors.affiliation: a Department of Orthodontics , Dental School (Dean: Prof. E. Gherlone), Vita-Salute San Raffaele University , Milan , Italy ;|b Research in Dentofacial Orthopedics, Orthodontics and Pediatric Dentistry, Research Area in Oral Pathology and Implantology (Head: Prof. E. Gherlone), IRCCS San Raffaele Hospital , Milan , Italy ;
authors.forename: Enrico
authors.initials: E
authors.lastname: Gherlone
mesh_terms: D000293:Adolescent; D002648:Child; D005260:Female; D051523:Fibroblast Growth Factor 7 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects; D006801:Humans; D008297:Male; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000150:complications* / Q000628:therapy; D020011:Protective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D013280:Stomatitis / Q000188:drug therapy* / Q000209:etiology* / Q000517:prevention & control; D019172:Transplantation Conditioning / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D020011:Protective Agents; D051523:Fibroblast Growth Factor 7
keywords: Acute lymphoblastic leukemia; oral mucositis; palifermin; randomized clinical trial