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Support Care Cancer. 2016 Jan;24(1):301-309. doi: 10.1007/s00520-015-2783-9. Epub 2015 Jun 4.

Phase II trial of epidermal growth factor ointment for patients with Erlotinib-related skin effects.

Author information

1
Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
2
Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.
3
Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea. drosy@dau.ac.kr.
4
Department of Internal Medicine, Dong-A University College of Medicine, Daeshin Park road 26, Seo-gu, Busan, 602-715, Republic of Korea. drosy@dau.ac.kr.
5
Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.
6
Department of Dermatology, Dong-A University Hospital, Busan, Republic of Korea.
7
Department of Pulmonology, Dong-A University Hospital, Busan, Republic of Korea.
8
Department of Internal Medicine, Busan University Yangsan Hospital, Busan, Republic of Korea.
9
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
10
Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.
11
Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.
12
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. kpark@skku.edu.
13
Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 135-710, Republic of Korea. kpark@skku.edu.

Abstract

PURPOSE:

The efficacy of erlotinib, the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, has been demonstrated in patients with non-small cell lung cancer (NSCLC) and pancreatic cancer (PC). In the present study, we evaluated the effect of epidermal growth factor (EGF) ointment on erlotinib-related skin effects (ERSEs).

METHODS:

This was an open-label, non-comparative, multicenter, phase II trial. The patients included those diagnosed with NSCLC or PC who were treated with erlotinib. The effectiveness of the 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 persisted for at least 2 weeks.

RESULTS:

Fifty-two patients from seven institutes in Korea were enrolled with informed consent. The final assessment included 46 patients (30 males, 16 females). According to the definition of effectiveness, the EGF ointment was effective in 36 (69.2%) intention to treat patients. There were no statistically significant differences in the effectiveness of the EGF ointment by gender (p = 0.465), age (p = 0.547), tumor type (p = 0.085), erlotinib dosage (p = 0.117), and number of prior chemotherapy sessions (p = 0.547). The grading for the average National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) rating of rash/acne and itching improved from 2.02 ± 0.83 to 1.13 ± 0.89 and 1.52 ± 0.84 to 0.67 ± 0.90, respectively (p < 0.001). The most common reason for discontinuing the study was progression of cancer (37%).

CONCLUSIONS:

Based on the results, the EGF ointment is effective for ERSEs, regardless of gender, age, type of tumor, and dosage of erlotinib. The EGF ointment evenly improved all kinds of symptoms of ERSEs.

CLINICAL TRIAL REGISTRATION NO:

ClinicalTrials.gov identifier: NCT01593995.

KEYWORDS:

Epidermal growth factor; Erlotinib; Ointment; Skin reaction

PMID:
26041481
DOI:
10.1007/s00520-015-2783-9
[Indexed for MEDLINE]

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