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Therapeutic effect of recombinant human epidermal growth factor (rhEGF) on mucositis in patients undergoing radiotherapy, with or without chemotherapy, for head and neck cancer
Author(s) -
Wu Hong Gyun,
Song Si Yeol,
Kim Yeon Sil,
Oh Young Taek,
Lee Chang Geol,
Keum Ki Chang,
Ahn Yong Chan,
Lee Sangwook
Publication year - 2009
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.24414
Subject(s) - mucositis , medicine , placebo , head and neck cancer , radiation therapy , chemotherapy , chemoradiotherapy , cancer , gastroenterology , surgery , oncology , pathology , alternative medicine
BACKGROUND: We evaluated the efficacy of topically applied human recombinant epidermal growth factor (rhEGF) for the treatment of oral mucositis induced by radiotherapy (RT), with or without chemotherapy, in patients with head and neck cancer. METHODS: Patients receiving definitive chemoradiotherapy, definitive RT, or postoperative RT to the oral cavity or oropharynx were recruited from 6 institutions and enrolled in a randomized, double‐blind, placebo‐controlled phase 2 trial. Patients were assigned to a placebo group or to 1 of 3 EGF‐treatment groups (10, 50, or 100 μg/mL doses, delivered in a spray, twice daily). The grade of mucositis was evaluated using the Radiation Therapy Oncology Group (RTOG) scoring criteria. Responders to EGF were defined as having an RTOG grade of 2 or lower at the fourth‐ or fifth‐week examinations during RT, but an enduring RTOG grade 2 for 2 weeks was an exception. RESULTS: Of the 113 patients included in the study, 28 received placebo and 29 received EGF at 10 μg/mL, 29 at 50 μg/mL, and 27 at 100 μg/mL. EGF significantly reduced the incidence of severe oral mucositis at the primary endpoint (a 64% response was observed with 50 μg/mL EGF vs a 37% response in the control group; P = .0246). CONCLUSIONS: The EGF oral spray may have potential benefit for oral mucositis in patients undergoing RT for head and neck cancer. Phase 3 studies are ongoing to confirm these results. Cancer 2009. © 2009 American Cancer Society.