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A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor
Young Saing Kim1, Jun Ho Ji2, Sung Yong Oh3
1Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Background:
The efficacy of epidermal growth factor (EGF) receptor (EGFR) inhibitors in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC), or colorectal cancer (CRC) has been demonstrated. However, dermatological reactions to these inhibitors can cause significant physical and psychosocial discomfort. The objective of the present study was to evaluate the efficacy of EGF ointment for EGFR inhibitor-related skin adverse events (ERSEs).
Materials And Methods:
This placebo-controlled, double-blind, multicenter, pilot phase III trial enrolled patients with NSCLC, PC, or CRC treated with EGFR inhibitors. Patients with grade ≥2 ERSEs were included. Patients were randomized to three treatment arms: arm 1, placebo; arm 2, 1 ppm of EGF ointment; and arm 3, 20 ppm of EGF ointment. Patients applied ointment to their skin lesions twice daily.
Results:
Efficacy evaluation was available for 80 patients (9 for PC, 28 for NSCLC, and 43 for CRC). Responses were 44.4% in arm 1, 61.5% in arm 2, and 77.8% in arm 3. There was a linear correlation between EGF concentrations and responses (p = .012). Quality of life (QoL) was assessed for 74 patients. Maximum changes in composite scores by Skindex-16 after treatment were significantly different among arms (mean ± SD: -5.2 ± 8.6 for arm 1, -11.7 ± 14.2 for arm 2, and - 18.6 ± 17.7 for arm 3; p = .008). EGF arms showed significant improvement in emotions (p = .005) and functioning (p = .044) scores over the placebo arm.
Conclusion:
EGF ointment is effective for managing ERSEs. It can also improve patients' QoL compared with placebo. Clinical trial identification number. NCT02284139 IMPLICATIONS FOR PRACTICE: Patients with non-small cell lung cancer, pancreatic cancer, or colorectal cancer who are treated with epidermal growth factor (EGF) receptor (EGFR) inhibitors may experience dermatologic reactions to their treatment. This study investigated the benefit of an EGF ointment in the treatment of these adverse events and observed the ointment to be effective in managing EGFR inhibitor-related skin adverse events.
Insights
EGF ointment effectively manages skin adverse events caused by EGFR inhibitors in cancer patients. This treatment also significantly improves patients' quality of life compared to placebo.
Area of Science:
- Oncology
- Dermatology
- Pharmacology
Background:
- Epidermal growth factor (EGF) receptor (EGFR) inhibitors are crucial in treating non-small cell lung cancer (NSCLC), pancreatic cancer (PC), and colorectal cancer (CRC).
- Dermatological reactions, known as EGFR inhibitor-related skin adverse events (ERSEs), frequently occur, causing significant patient discomfort.
- Effective management strategies for ERSEs are needed to improve patient tolerance and adherence to cancer therapies.
Purpose of the Study:
- To evaluate the efficacy of EGF ointment in managing ERSEs.
- To assess the impact of EGF ointment on the quality of life (QoL) of patients experiencing ERSEs.
Main Methods:
- A placebo-controlled, double-blind, multicenter, pilot phase III trial was conducted.
- Patients with NSCLC, PC, or CRC experiencing grade ≥2 ERSEs were randomized into three groups: placebo, 1 ppm EGF ointment, and 20 ppm EGF ointment.
- Ointments were applied twice daily to affected skin lesions, with efficacy and QoL assessed.
Main Results:
- Efficacy evaluations were completed by 80 patients, showing response rates of 44.4% for placebo, 61.5% for 1 ppm EGF, and 77.8% for 20 ppm EGF.
- A statistically significant linear correlation was observed between EGF concentrations and treatment response (p = .012).
- Quality of life assessments in 74 patients revealed significant improvements in the EGF ointment arms compared to placebo, particularly in emotional and functioning domains (p = .008).
Conclusions:
- EGF ointment demonstrates significant efficacy in managing ERSEs.
- Treatment with EGF ointment leads to a notable improvement in patients' quality of life.
- The findings support the use of EGF ointment as a beneficial therapeutic option for dermatological side effects of EGFR inhibitors.
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