title: Phase II trial of epidermal growth factor ointment for patients with Erlotinib-related skin effects.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01593995.
authors.affiliation: Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
authors.forename: In Gyu
authors.initials: IG
authors.lastname: Hwang
authors.affiliation: Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.
authors.forename: Jung Hun
authors.initials: JH
authors.lastname: Kang
authors.affiliation: Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea. drosy@dau.ac.kr.|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.
authors.forename: Sung Yong
authors.initials: SY
authors.lastname: Oh
authors.affiliation: Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.
authors.forename: Suee
authors.initials: S
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.
authors.forename: Sung-Hyun
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Department of Dermatology, Dong-A University Hospital, Busan, Republic of Korea.
authors.forename: Ki-Hoon
authors.initials: KH
authors.lastname: Song
authors.affiliation: Department of Pulmonology, Dong-A University Hospital, Busan, Republic of Korea.
authors.forename: Choonhee
authors.initials: C
authors.lastname: Son
authors.affiliation: Department of Internal Medicine, Busan University Yangsan Hospital, Busan, Republic of Korea.
authors.forename: Min Jae
authors.initials: MJ
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.
authors.forename: Myung Hee
authors.initials: MH
authors.lastname: Kang
authors.affiliation: Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.
authors.forename: Hoon Gu
authors.initials: HG
authors.lastname: Kim
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Jeeyun
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Young Suk
authors.initials: YS
authors.lastname: Park
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Jong Mu
authors.initials: JM
authors.lastname: Sun
authors.affiliation: Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.
authors.forename: Hyun Jung
authors.initials: HJ
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.
authors.forename: Chan Kyu
authors.initials: CK
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.
authors.forename: Seong Yoon
authors.initials: SY
authors.lastname: Yi
authors.affiliation: Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
authors.forename: Joung-Soon
authors.initials: JS
authors.lastname: Jang
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. kpark@skku.edu.|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.
authors.forename: Keunchil
authors.initials: K
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.
authors.forename: Hyo-Jin
authors.initials: HJ
authors.lastname: Kim
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003879:Dermatologic Agents / Q000008:administration & dosage*; D018450:Disease Progression; D018572:Disease-Free Survival; D003875:Drug Eruptions / Q000188:drug therapy*; D004815:Epidermal Growth Factor / Q000008:administration & dosage*; D000069347:Erlotinib Hydrochloride / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009824:Ointments; D010190:Pancreatic Neoplasms / Q000188:drug therapy; D047428:Protein Kinase Inhibitors / Q000009:adverse effects; D056910:Republic of Korea; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D003879:Dermatologic Agents; D009824:Ointments; D047428:Protein Kinase Inhibitors; D004815:Epidermal Growth Factor; D000069347:Erlotinib Hydrochloride
keywords: Epidermal growth factor; Erlotinib; Ointment; Skin reaction