Topical Recombinant Human Epidermal Growth Factor for Oral MucositisInduced by Intensive Chemotherapy with Hematopoietic Stem CellTransplantation: Final Analysis of a Randomized, Double-Blind,Placebo-Controlled, Phase 2 Trial

Collection with item attached
2017
Item details URL
http://open-repository.kisti.re.kr/cube/handle/open_repository/486339.do
DOI
10.1371/journal.pone.0168854
Title
Topical Recombinant Human Epidermal Growth Factor for Oral MucositisInduced by Intensive Chemotherapy with Hematopoietic Stem CellTransplantation: Final Analysis of a Randomized, Double-Blind,Placebo-Controlled, Phase 2 Trial
Description
This study was supported by grant No. 04-2012-0130 from the SNUHResearch Fund (http://www.snuh.org/), grant No. HI14C2399 from the KoreaHealth Technology R&D Project through the Korea Health IndustryDevelopment Institute (https://www.khidi.or.kr/eps), funded by theMinistry of Health and Welfare, Republic of Korea, and Brain Korea (BK)21 Plus Program in 2016. The funders had no role in study design, datacollection and analysis, decision to publish, or preparation of themanuscript.
abstract
The aim of this study was to evaluate the efficacy and safety of recombinant human epidermal growth factor (rhEGF) oral spray for oral mucositis (OM) induced by intensive chemotherapy with hematopoietic stem cell transplantation. In this phase 2 study, patients were randomized to either rhEGF (50 microg/ mL) or placebo in a 1:1 ratio. The primary endpoint was incidence of National Cancer Institute (NCI) grade >= 2 OM. A total of 138 patients were enrolled in this study. In the intention-to-treat analysis, rhEGF did not reduce the incidence of NCI grade >= 2 OM (p = 0.717) nor reduce its duration (p = 0.725). Secondary endpoints including the day of onset and duration of NCI grade >= 2 OM, the incidence of NCI grade >= 3 OM and its duration, and patient-reported quality of life were also similar between the two groups. In the per-protocol analysis, however, the duration of opioid analgesic use was shorter in the rhEGF group (p = 0.036), and recipients in the rhEGF group required a lower cumulative dose of opioid analgesics than those in the placebo group (p = 0.046), among patients with NCI grade >= 2 OM. Adverse events were mild and transient. This study found no evidence to suggest that rhEGF oral spray reduces the incidence of OM. However, further studies are needed to investigate the effect of rhEGF on OM-induced pain reduction after intensive chemotherapy.
provenance
Made available in Cube on 2018-09-28T16:04:57Z (GMT). No. of bitstreams: 0
language
English
author
Kim, Ji-Won
Kim, Myeong Gyu
Lee, Hyun Jung
Koh, Youngil
Kwon, Ji-Hyun
Kim, Inho
Park, Seonyang
Kim, Byoung Kook
Oh, Jung Mi
Kim, Kyung Im
Yoon, Sung-Soo
accessioned
2018-09-28T16:04:57Z
available
2018-09-28T16:04:57Z
issued
2017
citation
PLOS ONE(12): 1
issn
1932-6203
uri
http://open-repository.kisti.re.kr/cube/handle/open_repository/486339.do
Funder
보건복지부
Funding Program
질환극복기술개발
Project ID
1465021344
Jurisdiction
Rep.of Korea
Project Name
Discovering genomic landscape of multiple myeloma using FACS-based NGS analysis : Step-forward to targeted therapy in multiple myeloma
rights
openAccess
type
article


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