Kim, K. I., Kim, J. W., Lee, H. J., Kim, B. S., Bang, S. M., Kim, I., et al. (2013). Recombinant human epidermal growth factor on oral mucositis induced by intensive chemotherapy with stem cell transplantation. American Journal of Hematology, 88(2), 107-112.

Evaluate the effect of topical rhEGF spray for the prevention and treatment of OM in patients receiving intensive chemotherapy followed by HSCT for hematoplogic malignancies.

Patients were randomly assigned to spray either 50 µg/ml rhEGF or placebo over entire oral mucosa twice daily. Investigators evaluated adherence by examining residual volume of the spray on a daily basis.

The study was comprised of 58 patients, with a median age of 56.5 years and a range of 18-63.
MALES 53.6%, FEMALES 46.4%
KEY DISEASE CHARACTERISTICS: multiple myeloma, non-Hodgkin lymphoma, ALL, MDS
OTHER KEY SAMPLE CHARACTERISTICS: intensive chemotherapy followed by autologous or allogeneic HSCT

SITE: Single site

SETTING TYPE: Inpatient

LOCATION: South Korea

PHASE OF CARE: Active antitumor treatment

Phase II randomized, double-blind placebo-controlled

NCI Common terminology Criteria for Adverse Events (CTCAE), WHO scale, ECOG, modified Oral Mucositis Daily Questionaire  (OMDQ)

Incidence of NCI grade ≥2 OM 78.6% rhEGF group, 50% in placebo group (p = 0.0496); time to NCI grade 2, 11 days rhEGF; day 10 placebo (p = 0.843), median duration NCI grade ≥2 8.5 days rhEGF and 14.5 days placebo (p = 0.262).

NCI grade ≥3 OM 39.3% in rhEFG group, 32.1% in placebo group (p = 0.577) with median duration eight days rhEGF  versus 16 days placebo group (p = 0.381; QMDQ questionnaire showed reduced limitations in swallowing and drinking in rhEGF group.

rhEGF did not reduce incidence of NCI grade ≥2 OM. Severe OM with WHO grade ≥3 in rhEGF group had shorter duration of TPN use and opioid analgesic use.

Small sample (<100)

OM is debilitating for patients receiving intensive chemotherapy for hematologic malignancies and can lead to resource intensive episodes. To date, IV palifermin is the only available treatment modality for prevention or treatment of OM. Further research is needed to identify other modalities and to continue to explore the effects of rhEGF on prevention and treatment of chemotherapy-induced OM.