Recombinant Epidermal Growth Factor (RhEGF)

Evaluate the wound healing effects of RhEGF in patients with radiation-induced oral mucositis.

RhEGF 25 mcg/day was applied topically to the oral cavity twice daily for seven days.

The study was comprised of 11 patients, with an age range of 34-70 years.

Females: 2, Males: 9

Diagnosis Information: Nine patients with head and neck cancer, two patients with lymphoma

Other Key Characteristics: Concurrent chemo/RT five patients. Patients had severe mucositis at the point of study entry.

Single site: Seoul, Korea

Prospective trial--pilot study

Unaided oral and soft palate evaluation was done on day seven.

Oral mucositis was scored according to RTOG criteria.

All patients showed improvements in oral mucositis, with decreased mean RTOG grades. Two patients with grade 4 improved to grade 3; two patients with grade 4 improved to grade 2; five patients with grade 3 improved to grade 2; and two patients with grade 3 improved to grade 1. None of the patients had to interrupt RT because of acute mucositis.

Topical treatment with RhEGF has a therapeutic effect on RT-induced oral mucositis.

Small sample size (pilot study). Mucositis evaluated by unaided eye and restricted or oral and soft palate-may have not been consistent grading if done by different individuals. Sample was too varied, including nasopharyngeal tumors, oropharynx tumors, and hypopharynx tumors and lymphoma. These all differ greatly in the treatment techniques, amount of radiation given, and severity of reaction.

More data are needed to determine effectiveness. Topical applications have limitations as far as adherence to the intended amount of drug and effective coverage of mucosa with medication. Topical application may be easier to apply, but not for everyone, and depending on the taste, an aversion to the taste may occur over time.

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.

To evaluate the efficacy and safety of recombinant human epidermal growth factor (rhEGF) oral spray for the prevention of oral mucositis

Patients were randomly assigned to rhEGF or placebo oral spray. The spray was applied to the entire oral mucosa twice daily from the first day of conditioning chemotherapy until neutrophil recovery. The spray was used six times for each application. Patients were not to eat or drink for 30 minutes after application. The severity of oral mucositis was recorded daily.

• N = 136   
• MEAN AGE = 52 years
• AGE RANGE = 18–65 years
• MALES: 51.5%, FEMALES: 48.5%
• CURRENT TREATMENT: Combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Patients undergoing hematopoietic cell transplantation (HCT). Most had lymphoma or multiple myeloma. Ninety-six percent had autologous HCT.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Republic of Korea

PHASE OF CARE: Active antitumor treatment

Double-blind, placebo-controlled, randomized, controlled trial

• Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
• Oral Mucositis Daily Questionnaire

No significant difference existed between groups in the incidence of mucositis grade 2 or higher. Subgroup analysis by specific chemotherapy used also did not show any difference. Patients in the study group received less cumulative dose of opioids (p = 0.046) and for a shorter duration (p = 0.036) than those in the control group. No differences between groups in adverse events were reported.

rhEGF oral spray did not reduce the incidence of grade 2 or higher mucositis. This might have a beneficial effect in terms of the reduction of pain associated with oral mucositis.

rhEGF was not shown to have a preventive effect for oral mucositis among patients receiving high-dose chemotherapy prior to HCT. The oral spray examined here may have some positive effect for pain reduction. Additional research is needed to evaluate this potential use.