Epithelial Growth Factor

Epithelial Growth Factor

PEP Topic 
Radiodermatitis
Description 

Epithelial growth factor (EGF) regulates epithelial cell proliferation, growth, and migration. In addition, it has an effect on angiogenesis for the nutritional support of tissues. Thus, EGF may have an effect on wound healing and tissue generation. EGF has been examined for effectiveness in prevention and treatment of radiodermatitis.

Effectiveness Not Established

Research Evidence Summaries

Kang, H.C., Ahn, S.D., Choi, D.H., Kang, M.K., Chung, W.K., & Wu, H.G. (2014). The safety and efficacy of EGF-based cream for the prevention of radiotherapy-induced skin injury: Results from a multicenter observational study. Radiation Oncology Journal, 32, 156–162.

doi: 10.3857/roj.2014.32.3.156
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Study Purpose:

To evaluate the efficacy and safety of topically applied recombinant human epidermal growth factor (rhEGF) for the prevention of radiation-induced dermatitis in patients with cancer

Intervention Characteristics/Basic Study Process:

EasyDew CR cream (0.005% rhEGF, ceramide, hyaluronic acid, Inca omega oil, portulaca oleracea extract, mango butter, and meadowfoam oil) was applied to the radiation portal skin twice per day from day 1 to the last day of radiation treatment (RT). Patients were advised to wash the cream off prior to RT. No other prophylactic creams or lotions were allowed, and additional applications were ceased if an adverse reaction occurred because of the rhEGF-based cream. Compliance in applying the cream was evaluated weekly by the treating radiation oncologist.

Sample Characteristics:

  • N = 1,138
  • MEAN AGE = 51 years (range = 18–90 years)
  • MALES: 17.6%, FEMALES: 82.4%
  • KEY DISEASE CHARACTERISTICS: Histologically-confirmed breast (73%), head & neck (13%), others combined (14%; cervical, soft tissue, esophagus, lung, rectum, and thymus)
  • OTHER KEY SAMPLE CHARACTERISTICS: All participants received > 50 Gy of external radiotherapy, but the mode varied (photons [51.8%], electrons [4.6%], and photons with electrons [43.6%]).

Setting:

  • SITE: Multi-site
  • SETTING TYPE: Outpatient
  • LOCATION: Twenty-one cancer centers in Korea

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment

Study Design:

Multi-site, prospective, observational study of the efficacy and safety of rhEGF cream to prevent radiodermatitis (in patients receiving more than 50 Gy of external radiotherapy)

Measurement Instruments/Methods:

  • Modified Radiation Therapy Oncology Group (RTOG) Acute Skin Toxicity Scale
    • The authors commented, “This scale of radiation dermatitis was modified with a representative sign to reduce interobserver variations.” The presence of edema, dry skin, and pruritus also were measured. The status of pruritus was scored using the following criteria: grade 0, no pruritus; grade 1, mild or localized, relieved spontaneously; grade 2, mild or localized, relieved by local measures; grade 3, intense or widespread, relieved by systemic measures; and grade 4, intense or widespread and poorly controlled despite treatment.

Results:

SAFETY of CREAM: Adverse events related to the rhEGF-based cream developed in 49 patients (4%) with mild erythema being the most common side effect. Skin toxicity grades > 2 were observed in 5% of patients. Edema, dry skin, and pruritus grades ≥ 3 developed in 9%, 9%, and 1% of the patients, respectively. Safety was categorized in 99.2% of patients.
 
EFFICACY of CREAM: The percentage of radiation dermatitis with maximum grades of 0 and 1 was 19% and 58%, respectively, at the time of 50 Gy.

Conclusions:

This study showed that the intervention used was not associated with any severe adverse reactions, but it provides no real evidence regarding the efficacy of the rhEGF cream.

Limitations:

  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Risk of bias (sample characteristics)
  • Other limitations/explanation: There were 21 centers and no mention of the number of raters used, how the raters were trained, or measurement of inter-rater reliability. The standard RTOG scale was modified. Skin toxicities had Common Terminology Criteria for Adverse Events (CTCAE) variations. RT doses were not surveyed using a method. The objective radiation dermatitis assessment tool needed improvement.

Nursing Implications:

Additional studies of this cream are needed before considering the use of this cream in practice. The authors addressed pruritus and radiation toxicity as being potential adverse events; however, they do not stress the importance. Pruritus has been demonstrated to negatively impact quality of life.

Kong, M., & Hong, S.E. (2013). Topical use of recombinant human epidermal growth factor (EGF)-based cream to prevent radiation dermatitis in breast cancer patients: A single-blind randomized preliminary study. Asian Pacific Journal of Cancer Prevention, 14, 4859–4864.

doi: 10.7314/APJCP.2013.14.8.4859
Print

Study Purpose:

To determine if the use of a human epidermal growth factor (EGF)-based cream can prevent radiation dermatitis in patients with breast cancer treated with radiation

Intervention Characteristics/Basic Study Process:

Patients with breast cancer needing post-operative radiation randomly were assigned to use human recombinant EGF-based cream (intervention) or general supportive skin care (control). The intervention group applied study cream three times daily to the radiated area from start of treatment through two weeks post-completion of treatment. The control group washed gently with or without mild soap, patting to dry. No cosmetics, perfumes, creams, or lotions were allowed on the treated area in the control arm.

Sample Characteristics:

  • N = 40
  • MEAN AGE: Intervention group: 57.3 years (40.2–74.0 years); control group: 51.8 years (36.5–76.1 years)
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Unilateral breast cancer, no skin invasion by tumor, breast-conserving surgery, presence or absence of adjuvant chemotherapy, radiation to minimum dose of 45 cGy without use of bolus
  • OTHER KEY SAMPLE CHARACTERISTICS: No concurrent chemotherapy, rashes, or unhealed wounds in treatment area. No history of previous radiation therapy (RT) to chest wall, connective tissue disorder.

Setting:

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: Department of Radiation Oncology, Kyung Hee University Medical Center, Seoul, Republic of Korea

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment

Study Design:

  • Single-blind, randomized preliminary study

Measurement Instruments/Methods:

Examination of site was completed prior to RT, weekly during RT, and six weeks post-RT. Skin changes were scored using the Radiation Therapy Oncology Group (RTOG) criteria by a radiation oncologist blinded to group assignment. Pain was evaluated with a 10-point visual analog scale. Intervention patients completed a questionnaire regarding ease of cream application at the end of the study.

Results:

There was no statistical difference between the intervention and control groups for dermatitis and pain scores. For the total population, maximal dermatitis was 27.5% grade 3, 52.5% grade 2, and 20% grade 1. In the intervention group, maximal dermatitis was 15% grade 3, 55% grade 2, and 30% grade 1. In the control group, maximal dermatitis was 40% grade 3, 50% grade 2, and 10% grade 1. For the total population, mean maximal pain score was 3.13 with a range of 0–7. In the intervention group, mean maximal pain score was 2.80 with a range of 0–6. In the control group, mean maximal pain score was 3.13 with a range of 0–7.

Conclusions:

Although there was a difference in the intervention and control groups in terms of grade 3 dermatitis, (15% compared to 40%), there was no statistical difference between the intervention of human recombinant EGF-based cream and the control of supportive skin care. As with previous studies, total RT dose and lymph node radiation were prognostic factors for grade 3 radiation dermatitis. This study did not look at patient-related prognostic factors that potentially contribute to increased radiation dermatitis.

Limitations:

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Measurement validity/reliability questionable
  • Other limitations/explanation: As with other studies, the RTOG skin toxicity scoring, although utilized by many practices and clinical trials, has not been tested for validity and reliability.

Nursing Implications:

There continues to be no “best practice” for prevention and treatment of radiation dermatitis. Practice varies worldwide. Further studies with a large sample size and inclusion of a double-blinding would be useful for this product as several studies have shown with EGF for wound healing.


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