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 Link

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.