Topical Recombinant Human Epidermal Growth Factor for Oral Mucositis Induced by Intensive Chemotherapy with Hematopoietic Stem Cell Transplantation: Final Analysis of a Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial
| Autor: | Ji Hyun Kwon, Jung Mi Oh, Seonyang Park, Hyun Jung Lee, Sung-Soo Yoon, Myeong Gyu Kim, Youngil Koh, Byoung Kook Kim, Inho Kim, Kyung Im Kim, Ji Won Kim |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Male Cell Transplantation medicine.medical_treatment Administration Topical Cancer Treatment Phases of clinical research lcsh:Medicine Hematopoietic stem cell transplantation Gastroenterology law.invention 0302 clinical medicine Randomized controlled trial law Clinical endpoint Medicine and Health Sciences Blood and Lymphatic System Procedures lcsh:Science Analgesics Multidisciplinary Cumulative dose Pharmaceutics Incidence Hematopoietic Stem Cell Transplantation Drugs Middle Aged Recombinant Proteins Analgesics Opioid Oncology Research Design 030220 oncology & carcinogenesis Anesthesia Hematologic Neoplasms Female Research Article Adult Clinical Oncology medicine.medical_specialty Adolescent Clinical Research Design Antineoplastic Agents Surgical and Invasive Medical Procedures Placebo Research and Analysis Methods 03 medical and health sciences Young Adult Cancer Chemotherapy Double-Blind Method Drug Therapy Internal medicine medicine Mucositis Humans Pain Management Chemotherapy Adverse effect Aged Pharmacology Stomatitis Transplantation Epidermal Growth Factor business.industry lcsh:R High-Dose Chemotherapy medicine.disease Opioids 030104 developmental biology Quality of Life lcsh:Q Adverse Events Clinical Medicine business Stem Cell Transplantation |
| Zdroj: | PLoS ONE PLoS ONE, Vol 12, Iss 1, p e0168854 (2017) PLOS ONE(12): 1 |
| ISSN: | 1932-6203 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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