Tags

Type your tag names separated by a space and hit enter

Therapeutic effect of recombinant human epidermal growth factor (RhEGF) on mucositis in patients undergoing radiotherapy, with or without chemotherapy, for head and neck cancer: a double-blind placebo-controlled prospective phase 2 multi-institutional clinical trial.
Cancer. 2009 Aug 15; 115(16):3699-708.C

Abstract

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 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.

RESULTS

Of 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).

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.

Authors+Show Affiliations

Department of Radiation Oncology and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19514089

Citation

Wu, Hong Gyun, et al. "Therapeutic Effect of Recombinant Human Epidermal Growth Factor (RhEGF) On Mucositis in Patients Undergoing Radiotherapy, With or Without Chemotherapy, for Head and Neck Cancer: a Double-blind Placebo-controlled Prospective Phase 2 Multi-institutional Clinical Trial." Cancer, vol. 115, no. 16, 2009, pp. 3699-708.
Wu HG, Song SY, Kim YS, et al. Therapeutic effect of recombinant human epidermal growth factor (RhEGF) on mucositis in patients undergoing radiotherapy, with or without chemotherapy, for head and neck cancer: a double-blind placebo-controlled prospective phase 2 multi-institutional clinical trial. Cancer. 2009;115(16):3699-708.
Wu, H. G., Song, S. Y., Kim, Y. S., Oh, Y. T., Lee, C. G., Keum, K. C., Ahn, Y. C., & Lee, S. W. (2009). Therapeutic effect of recombinant human epidermal growth factor (RhEGF) on mucositis in patients undergoing radiotherapy, with or without chemotherapy, for head and neck cancer: a double-blind placebo-controlled prospective phase 2 multi-institutional clinical trial. Cancer, 115(16), 3699-708. https://doi.org/10.1002/cncr.24414
Wu HG, et al. Therapeutic Effect of Recombinant Human Epidermal Growth Factor (RhEGF) On Mucositis in Patients Undergoing Radiotherapy, With or Without Chemotherapy, for Head and Neck Cancer: a Double-blind Placebo-controlled Prospective Phase 2 Multi-institutional Clinical Trial. Cancer. 2009 Aug 15;115(16):3699-708. PubMed PMID: 19514089.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Therapeutic effect of recombinant human epidermal growth factor (RhEGF) on mucositis in patients undergoing radiotherapy, with or without chemotherapy, for head and neck cancer: a double-blind placebo-controlled prospective phase 2 multi-institutional clinical trial. AU - Wu,Hong Gyun, AU - Song,Si Yeol, AU - Kim,Yeon Sil, AU - Oh,Young Taek, AU - Lee,Chang Geol, AU - Keum,Ki Chang, AU - Ahn,Yong Chan, AU - Lee,Sang-wook, PY - 2009/6/11/entrez PY - 2009/6/11/pubmed PY - 2009/9/18/medline SP - 3699 EP - 708 JF - Cancer JO - Cancer VL - 115 IS - 16 N2 - 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 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. RESULTS: Of 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). 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. SN - 0008-543X UR - https://www.unboundmedicine.com/medline/citation/19514089/Therapeutic_effect_of_recombinant_human_epidermal_growth_factor__RhEGF__on_mucositis_in_patients_undergoing_radiotherapy_with_or_without_chemotherapy_for_head_and_neck_cancer:_a_double_blind_placebo_controlled_prospective_phase_2_multi_institutional_clinical_trial_ L2 - https://doi.org/10.1002/cncr.24414 DB - PRIME DP - Unbound Medicine ER -