Evidence map›Paper›PMID 31492766›Full record

Trial reportThe oncologist2020

A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor Inhibitor-Induced Skin Toxicities.

Young Saing Kim, Jun Ho Ji, Sung Yong Oh, Suee Lee, Seok Jae Huh, Ji Hyun Lee, Ki-Hoon Song, Choon Hee Son, Mee Sook Roh, Gyeong Won Lee and 13 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in The oncologist, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.0field-weighted citation impact, top 21% 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.

NCT02284139 phase2 / phase3completednot on this map

Pilot Trial of Epidermal Growth Factor (EGF) Ointment for the Patients With Epidermal Growth Factor Receptor (EGFR) Inhibitor Related Skin Side Effects

TypeinterventionalSponsorDong-A University HospitalRan2015 to 2017Enrolled90ConditionsNon-small Cell Lung Cancer, Pancreatic Cancer, Colorectal CancerArmsArm EGF ointment 1ppm, Arm EGF ointment 20 ppm, Arm Placebos
NCT06118047 phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

Efficacy and Safety of Crisaborole Ointment, a Phosphodiesterase 4 (PDE4) Inhibitor, for the Topical Treatment of Cetuximab-Related Skin Toxicity Among Metastatic Colorectal Cancer Patients:A Prospective, Single-arm, Phase II Clinical Trial

TypeinterventionalSponsorSun Yat-sen UniversityRan2023 to 2025Enrolled33ConditionsMetastatic Colorectal Cancer, Cetuximab, Skin ToxicityArmsCrisaborole Ointment, Cetuximab
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 16 citations in OpenAlex.

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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

23 authors at 13 institutions in 1 country.

Young Saing KimDepartment of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Jun Ho JiDivision of Hematology-Oncology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.
Sung Yong OhDepartment of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.ORCID 0000-0002-8321-4113
Suee LeeDepartment of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.
Seok Jae HuhDepartment of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.
Ji Hyun LeeDepartment of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.
Ki-Hoon SongDepartment of Dermatology, National Cancer Center, Goyang, Republic of Korea.
Choon Hee SonDepartment of Pulmonology, Dong-A University Hospital, Busan, Republic of Korea.
Mee Sook RohDepartment of Pathology, Dong-A University College of Medicine, Busan, Republic of Korea.
Gyeong Won LeeDepartment of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.
Jeeyun LeeDepartment of Medicine, Samsung Medical Center, Seoul, Republic of Korea.
Seung Tae KimDepartment of Medicine, Samsung Medical Center, Seoul, Republic of Korea.
Chan Kyu KimDepartment of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.
Joung Soon JangDepartment of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
In Gyu HwangDepartment of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
Hee Kyung AhnDepartment of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Lee Chun ParkDivision of Hematology-Oncology, Department of Medicine, Kosin University College of Medicine, Busan, Republic of Korea.
So Yeon OhDepartment of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.
Seong-Geun KimDepartment of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.
Sang-Cheol LeeDepartment of Internal Medicine, Soonchunhyang University Hospital Cheonan, Cheonan, Republic of Korea.
Do-Hyoung LimDepartment of Internal Medicine, Dankook University College of Medicine, Cheonan, Republic of Korea.
Soon Il LeeDepartment of Internal Medicine, Dankook University College of Medicine, Cheonan, Republic of Korea.
Jung Hun KangDepartment of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.
Dong-A University Hospital · KRDankook University · KRChung-Ang University · KRGachon University Gil Medical Center · KRGyeongsang National University Hospital · KRDong-A University · KRKosin University · KRNational Cancer Center · KRPusan National University Yangsan Hospital · KRSamsung Medical Center · KRSamsung (South Korea) · KRSoonchunhyang University · KRSoonchunhyang University Hospital Seoul · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy of epidermal growth factor (EGF) receptor (EGFR) inhibitors in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC), or colorectal cancer (CRC) has been demonstrated. However, dermatological reactions to these inhibitors can cause significant physical and psychosocial discomfort. The objective of the present study was to evaluate the efficacy of EGF ointment for EGFR inhibitor-related skin adverse events (ERSEs). MATERIALS AND

methodsThis placebo-controlled, double-blind, multicenter, pilot phase III trial enrolled patients with NSCLC, PC, or CRC treated with EGFR inhibitors. Patients with grade ≥2 ERSEs were included. Patients were randomized to three treatment arms: arm 1, placebo; arm 2, 1 ppm of EGF ointment; and arm 3, 20 ppm of EGF ointment. Patients applied ointment to their skin lesions twice daily.

resultsEfficacy evaluation was available for 80 patients (9 for PC, 28 for NSCLC, and 43 for CRC). Responses were 44.4% in arm 1, 61.5% in arm 2, and 77.8% in arm 3. There was a linear correlation between EGF concentrations and responses (p = .012). Quality of life (QoL) was assessed for 74 patients. Maximum changes in composite scores by Skindex-16 after treatment were significantly different among arms (mean ± SD: -5.2 ± 8.6 for arm 1, -11.7 ± 14.2 for arm 2, and - 18.6 ± 17.7 for arm 3; p = .008). EGF arms showed significant improvement in emotions (p = .005) and functioning (p = .044) scores over the placebo arm.

conclusionEGF ointment is effective for managing ERSEs. It can also improve patients' QoL compared with placebo. Clinical trial identification number. NCT02284139 IMPLICATIONS FOR PRACTICE: Patients with non-small cell lung cancer, pancreatic cancer, or colorectal cancer who are treated with epidermal growth factor (EGF) receptor (EGFR) inhibitors may experience dermatologic reactions to their treatment. This study investigated the benefit of an EGF ointment in the treatment of these adverse events and observed the ointment to be effective in managing EGFR inhibitor-related skin adverse events.

Indexed as

AdultAgedAged, 80 and overDouble-Blind MethodErbB ReceptorsFemaleHumansMaleMiddle AgedOintmentsPilot ProjectsSkin DiseasesEGFR protein, humanErbB ReceptorsOintmentsAdverse eventEpidermal growth factor ointmentEpidermal growth factor receptorQuality of lifeSkin

Identifiers

PMID31492766
PMCPMC6964120
OpenAlexW2972121962

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.