title: Recombinant human epidermal growth factor on oral mucositis induced by intensive chemotherapy with stem cell transplantation.
abstract: Oral mucositis (OM) is one of the most common and debilitating complications in patients undergoing intensive chemotherapy followed by hematopoietic stem cell transplantation (HSCT). The aim of this study was to evaluate the efficacy and safety of recombinant human epidermal growth factor (rhEGF) oral spray for OM induced by intensive chemotherapy followed by HSCT. Patients were randomly assigned to either the rhEGF group or placebo group. The severity of OM and self-reported quality of life (QOL) were assessed daily. A total of 58 patients were analyzed. Baseline characteristics were similar between the two groups. The incidence of NCI grade ≥ 2 OM was higher in the rhEGF group (78.6% vs. 50%, P = 0.0496). However, the duration of OM in patients with NCI grade ≥ 2 tended to be shorter in the rhEGF group (8.5 days vs. 14.5 days, P = 0.262). The QOL analysis in patients with World Health Organization (WHO) grade ≥ 3 OM showed that rhEGF significantly reduced limitations in swallowing (P = 0.039) and drinking (P = 0.042). The duration of hospitalization (P = 0.047), administration of total parenteral nutrition (P = 0.012), and the usage of opioid analgesics (P = 0.018) were significantly shorter in the rhEGF group with WHO grade ≥ 3 OM. Adverse events were mild and similar between the two groups. In conclusion, this analysis showed that rhEGF did not reduce the incidence of NCI grade ≥ 2 OM. However, the patients with WHO grade ≥ 3 OM in the rhEGF group showed better results compared to the placebo group for several secondary endpoints.
authors.affiliation: College of Pharmacy, Seoul National University, Seoul, Republic of Korea.
authors.forename: Kyung Im
authors.initials: KI
authors.lastname: Kim
authors.forename: Ji-Won
authors.initials: JW
authors.lastname: Kim
authors.forename: Hyun Jung
authors.initials: HJ
authors.lastname: Lee
authors.forename: Byung-Su
authors.initials: BS
authors.lastname: Kim
authors.forename: Soo-Mee
authors.initials: SM
authors.lastname: Bang
authors.forename: Inho
authors.initials: I
authors.lastname: Kim
authors.forename: Jung Mi
authors.initials: JM
authors.lastname: Oh
authors.forename: Sung-Soo
authors.initials: SS
authors.lastname: Yoon
authors.forename: Jong Seok
authors.initials: JS
authors.lastname: Lee
authors.forename: Seonyang
authors.initials: S
authors.lastname: Park
authors.forename: Byoung Kook
authors.initials: BK
authors.lastname: Kim
mesh_terms: D000293:Adolescent; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000627:therapeutic use; D003680:Deglutition Disorders / Q000209:etiology / Q000517:prevention & control; D004311:Double-Blind Method; D004815:Epidermal Growth Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D019337:Hematologic Neoplasms / Q000628:therapy*; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D058993:Oral Sprays; D010288:Parenteral Nutrition; D011788:Quality of Life; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012720:Severity of Illness Index; D013280:Stomatitis / Q000139:chemically induced / Q000188:drug therapy* / Q000503:physiopathology / Q000517:prevention & control; D019172:Transplantation Conditioning / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D058993:Oral Sprays; D011994:Recombinant Proteins; D004815:Epidermal Growth Factor