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Recombinant human epidermal growth factor on oral mucositis induced by intensive chemotherapy with stem cell transplantation
Author(s) -
Kim Kyung Im,
Kim JiWon,
Lee Hyun Jung,
Kim ByungSu,
Bang SooMee,
Kim Inho,
Oh Jung Mi,
Yoon SungSoo,
Lee Jong Seok,
Park Seonyang,
Kim Byoung Kook
Publication year - 2013
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.23359
Subject(s) - mucositis , medicine , hematopoietic stem cell transplantation , placebo , chemotherapy , adverse effect , incidence (geometry) , transplantation , gastroenterology , parenteral nutrition , quality of life (healthcare) , surgery , pathology , physics , alternative medicine , nursing , optics
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. Am. J. Hematol. 88:107–112, 2013. © 2012 Wiley Periodicals, Inc.