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Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
Jan, 2016;24 (1): 301-309.

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

In Gyu Hwang, Jung Hun Kang, Sung Yong Oh, Suee Lee, Sung-Hyun Kim, Ki-Hoon Song, Choonhee Son, Min Jae Park, Myung Hee Kang, Hoon Gu Kim, Jeeyun Lee, Young Suk Park, Jong Mu Sun, Hyun Jung Kim, Chan Kyu Kim, Seong Yoon Yi, Joung-Soon Jang, Keunchil Park, Hyo-Jin Kim
Author Information
  1. In Gyu Hwang: Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
  2. Jung Hun Kang: Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.
  3. Sung Yong Oh: Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea. drosy@dau.ac.kr.
  4. Suee Lee: Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.
  5. Sung-Hyun Kim: Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.
  6. Ki-Hoon Song: Department of Dermatology, Dong-A University Hospital, Busan, Republic of Korea.
  7. Choonhee Son: Department of Pulmonology, Dong-A University Hospital, Busan, Republic of Korea.
  8. Min Jae Park: Department of Internal Medicine, Busan University Yangsan Hospital, Busan, Republic of Korea.
  9. Myung Hee Kang: Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.
  10. Hoon Gu Kim: Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.
  11. Jeeyun Lee: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
  12. Young Suk Park: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
  13. Jong Mu Sun: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
  14. Hyun Jung Kim: Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.
  15. Chan Kyu Kim: Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.
  16. Seong Yoon Yi: Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.
  17. Joung-Soon Jang: Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
  18. Keunchil Park: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. kpark@skku.edu.
  19. Hyo-Jin Kim: Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.
PMID: 26041481 DOI: 10.1007/s00520-015-2783-9

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

Associated Data

ClinicalTrials.gov | NCT01593995

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MeSH Term

Aged
Antineoplastic Agents
Carcinoma, Non-Small-Cell Lung
Dermatologic Agents
Disease Progression
Disease-Free Survival
Drug Eruptions
Epidermal Growth Factor
Erlotinib Hydrochloride
Female
Humans
Lung Neoplasms
Male
Middle Aged
Ointments
Pancreatic Neoplasms
Protein Kinase Inhibitors
Republic of Korea
Treatment Outcome

Chemicals

Antineoplastic Agents
Dermatologic Agents
Ointments
Protein Kinase Inhibitors
Epidermal Growth Factor
Erlotinib Hydrochloride
Clinical Trial, Phase II Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Article has an altmetric score of 3

Word Cloud

Created with Highcharts 10.0.00ointmentpatientspEGFERSEs2=erlotinibgrowthfactor1grade±epidermalcancereffectivenessNSCLCPCstudyskineffectsIItrialincluded34downgradedeffectivegenderage547tumortypedosageimprovedPURPOSE:efficacyreceptorEGFRtyrosinekinaseinhibitordemonstratednon-smallcelllungpancreaticpresentevaluatedeffecterlotinib-relatedMETHODS:open-labelnon-comparativemulticenterphasediagnosedtreateddefinedfollows:≤persistedleastweeksRESULTS:Fifty-twoseveninstitutesKoreaenrolledinformedconsentfinalassessment4630males16femalesAccordingdefinition36692%intentiontreatstatisticallysignificantdifferences465085117numberpriorchemotherapysessionsgradingaverageNationalCancerInstitute'sCommonTerminologyCriteriaAdverseEventsNCI-CTCAEratingrash/acneitching0283138952846790respectively<001commonreasondiscontinuingprogression37%CONCLUSIONS:BasedresultsregardlessevenlykindssymptomsCLINICALTRIALREGISTRATIONNO:ClinicalTrialsgovidentifier:NCT01593995PhaseErlotinib-relatedEpidermalErlotinibOintmentSkinreaction

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