Evidence map›Paper›PMID 26041481›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016

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 and 9 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01593995 (Phase II Trial of Epidermal Growth Factor Ointment for Patients With Erlotinib Related Skin Effects), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.7field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01593995 phase2completednot on this map

Phase II Trial of Epidermal Growth Factor Ointment for Patients With Erlotinib Related Skin Effects

TypeinterventionalSponsorDong-A University HospitalRan2012 to 2014Enrolled52ConditionsNon-small Cell Lung Cancer, Pancreatic CancerArmsEpidermal growth factor (EGF) ointment
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Phase II trial of epidermal growth factor ointment for patients with Erlotinib-related skin effects.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 8 institutions in 1 country.

In Gyu HwangDepartment of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
Jung Hun KangDepartment of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.
Sung Yong OhDepartment of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea. drosy@dau.ac.kr.
Suee LeeDepartment of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.
Sung-Hyun KimDepartment of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.
Ki-Hoon SongDepartment of Dermatology, Dong-A University Hospital, Busan, Republic of Korea.
Choonhee SonDepartment of Pulmonology, Dong-A University Hospital, Busan, Republic of Korea.
Min Jae ParkDepartment of Internal Medicine, Busan University Yangsan Hospital, Busan, Republic of Korea.
Myung Hee KangDepartment of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.
Hoon Gu KimDepartment of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.
Jeeyun LeeDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Young Suk ParkDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Jong Mu SunDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Hyun Jung KimDepartment of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.
Chan Kyu KimDepartment of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.
Seong Yoon YiDepartment of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.
Joung-Soon JangDepartment of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
Keunchil ParkDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. kpark@skku.edu.
Hyo-Jin KimDepartment of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.
Dong-A University Hospital · KRGyeongsang National University Hospital · KRSamsung Medical Center · KRChung-Ang University · KRSoonchunhyang University · KRBucheon University · KRInje University Ilsan Paik Hospital · KRSungkyunkwan University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe 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).

methodsThis 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.

resultsFifty-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%).

conclusionsBased 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.

Indexed as

AgedAntineoplastic AgentsCarcinoma, Non-Small-Cell LungDermatologic AgentsDisease-Free SurvivalDisease ProgressionDrug EruptionsEpidermal Growth FactorErlotinib HydrochlorideFemaleHumansLung NeoplasmsMaleMiddle AgedOintmentsPancreatic NeoplasmsAntineoplastic AgentsDermatologic AgentsEpidermal Growth FactorErlotinib HydrochlorideOintmentsProtein Kinase InhibitorsEpidermal growth factorErlotinibOintmentSkin reaction

Identifiers

PMID26041481
OpenAlexW657013396

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.