The efficacy of the epidermal growth factor receptor (EGFR) inhibitors have been demonstrated in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC) and colorectal cancer (CRC). Dermatological reactions can cause significant physical and psycho-social discomfort to patients. In the present study, the investigators evaluated the effect of epidermal growth factor (EGF) ointment on EGFR inhibitor-related skin side effects (ERSEs).
The current study includes patients diagnosed with advanced NSCLC or PC or CRC, with pathological confirmation. The inclusion criteria were NSCLC treated with erlotinib alone and PC treated with gemcitabine and erlotinib combination chemotherapy and CRC treated with cetuximab and5-Fluorouracil (5-FU)+Irinotecan+leucovorin(LV) (FOLFIRI), 5-FU+Oxaliplatin+LV (FOLFOX) and sufficient liver, kidney, and bone marrow function to undergo treatment. All the patients had Grade ≥2 ERSEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 4.03. The patients will be randomized 3 groups; Placebo group, Arm 1, and Arm 2. Arm 1 will be treated with 1ppm concentration EGF ointment. Arm 2 will be treated with 20ppm concentration EGF ointment. And placebo group will be treated with 0ppm concentration EGF ointment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
EGF Ointment 1ppm evenly apply to skin lesion every 12 hr/ day
EGF Ointment 20 evenly apply to skin lesion every 12 hr/ day
EGF Ointment 0ppm evenly apply to skin lesion every 12 hr/ day
Sung Yong Oh
Busan, South Korea
To estimate the response rate of EGF ointment
The effectiveness of the EGF ointment was defined as follows: 1. Grade 2, 3, or 4 ERSEs downgraded to ≤Grade 1 or 2. Grade 3 or 4 ERSEs downgraded to Grade 2 and persisting for at least two weeks.
Time frame: 1 year
Quality of Life
To evaluate the patients' Quality of Life (QoL) by Skin evaluation method (SKINDEX-16)
Time frame: 1 year
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