• Hong Gyun Wu, Si Yeol Song, Yeon Sil Kim, Young Taek Oh, Chang Geol Lee, Ki Chang Keum, Yong Chan Ahn, and Sang-wook Lee.
• Department of Radiation Oncology and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
• Cancer. 2009 Aug 15; 115 (16): 3699-708.

BackgroundWe 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.MethodsPatients 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 microg/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.ResultsOf the 113 patients included in the study, 28 received placebo and 29 received EGF at 10 microg/mL, 29 at 50 microg/mL, and 27 at 100 microg/mL. EGF significantly reduced the incidence of severe oral mucositis at the primary endpoint (a 64% response was observed with 50 microg/mL EGF vs a 37% response in the control group; P = .0246).ConclusionsThe 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.

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