Hwang, I.G., Kang, J.H., Oh, S.Y., Lee, S., Kim, S.H., Song, K.H., . . . Kim, H.J. (2016). Phase II trial of epidermal growth factor ointment for patients with erlotinib-related skin effects. Supportive Care in Cancer, 24, 301–309.

DOI Link

Study Purpose

To evaluate the effect of epidermal growth factor (EGF) ointment on quality of life (QOL) and erlotinib-related skin effects (ERSEs) in patients with non-small cell lung cancer and pancreatic cancer

Intervention Characteristics/Basic Study Process

EGF ointment containing 1 ppm of nepidermin was applied evenly to skin lesions twice daily for patients with grade 2 or greater lesions.

Sample Characteristics

  • N = 46  
  • MEDIAN AGE = 61 years (40–83); 20 aged younger than 60 years (43%), 26 aged older than 60 years (57%)
  • MALES: 30 (65%), FEMALES: 16 (35%)
  • CURRENT TREATMENT: Targeted therapy (erlotinib)
  • KEY DISEASE CHARACTERISTICS: Non-small cell lung cancer or pancreatic cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) score, number of previous chemotherapy sessions

Setting

  • SITE: Multicenter   
  • SETTING TYPE: Institutes    
  • LOCATION: Korea

Phase of Care and Clinical Applications

PHASE OF CARE: Active treatment

Study Design

Phase II, open-label, noncomparative, multicentered trial

Measurement Instruments/Methods

  • Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, for ERSE grading
  • Skindex-16 for QOL

Results

ERSEs (n = 46): EGF ointment was effective in 36 (69.2%) intention-to-treat patients for treatment of ERSEs. The grading for average CTCAE rating of rash/acne and itching improved:
  • 2.02 (SD = 0.83) to 1.13 (SD = 0.89) (rash/acne) (p < 0.001)
  • 1.52 (SD = 0.84) to 0.67 (SD = 0.9) (itching) (p < 0.001)
QOL (n = 25 patients from two institutions):
  • Medial overall score of 41.25 (SIQR = 14.38)
  • Highest scores were emotion demain (median = 42.86, SIQR = 15.71).
    • Higher than functioning and symptoms domain
  • Medial overall score after treatment was 8.75.
    • Significantly lower than initial median score of 41.25 (p = 0.0019)

Conclusions

EGF ointment was effective for ERSEs regardless of patient gender, age, type of tumor, and dosage of erlotinib and seems to improve all kinds of ERSEs.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Findings not generalizable
  • No discussion of nursing education of patients
  • No discussion of training on grading

Nursing Implications

Nursing education, interventions, and additional randomized, controlled studies are needed to elucidate the effectiveness of EGF ointment on ERSEs and QOL in patients with non-small cell lung cancer and pancreatic cancer.