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.
Highlights
Chemotherapy-induced oral mucositis (OM), a condition characterized by erythema, edema, and ulceration of the oral cavity, is one of the most common and debilitating adverse effects in patients undergoing intensive chemotherapy and hematopoietic stem cell transplantation (HSCT) [1,2,3]
We present the final analysis of this trial to evaluate the efficacy and safety of recombinant human Epidermal growth factor (EGF) (rhEGF) oral spray for chemotherapy-induced OM
The final analysis of this randomized phase 2 study found no evidence to suggest that rhEGF oral spray reduced the incidence of OM after intensive chemotherapy followed by HSCT
Summary
Chemotherapy-induced oral mucositis (OM), a condition characterized by erythema, edema, and ulceration of the oral cavity, is one of the most common and debilitating adverse effects in patients undergoing intensive chemotherapy and hematopoietic stem cell transplantation (HSCT) [1,2,3]. Epidermal growth factor (EGF) is a single-chain polypeptide composed of 53 amino acids, and exists in a number of tissues and fluids in the body [5, 6]. It can stimulate the proliferation and differentiation of epithelial tissue and facilitate skin regeneration and wound healing [7, 8], suggesting that it might be effective for treatment of chemotherapy- or radiotherapyinduced OM. A previous animal study revealed that recombinant human EGF (rhEGF) enhanced the mucosal wound-healing process [7, 9, 10], while topical application of rhEGF showed promising therapeutic efficacy and minimal toxicity on radiation-induced OM in patients with head and neck cancer [11, 12]
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