Evidence map›Paper›PMID 32918131›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2021

Results of the non-small cell lung cancer part of a phase III, open-label, randomized trial evaluating topical corticosteroid therapy for facial acneiform dermatitis induced by EGFR inhibitors: stepwise rank down from potent corticosteroid (FAEISS study, NCCH-1512).

Kazumi Nishino, Yutaka Fujiwara, Yuichiro Ohe, Ryota Saito, Eisaku Miyauchi, Tetsu Kobayashi, Yasuo Nakai, Toshiaki Takahashi, Taro Shibata, Tetsuya Hamaguchi and 5 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 30% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Efficacy and safety of EGFR-TKI for EGFR-mutated NSCLC: systematic review and network meta-analysis.International journal of clinical and experimental pathology · 2025
    Review
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

15 authors at 8 institutions in 1 country.

Kazumi NishinoDepartment of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan. kazumi.nishino@oici.jp.ORCID https://orcid.org/0000-0003-2000-7472
Yutaka FujiwaraDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Yuichiro OheDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Ryota SaitoDepartment of Respiratory Medicine, Tohoku University Hospital, Miyagi, Japan.
Eisaku MiyauchiDepartment of Respiratory Medicine, Tohoku University Hospital, Miyagi, Japan.
Tetsu KobayashiDepartment of Pulmonary and Critical Care Medicine, Mie University Graduate School of Medicine, Mie, Japan.
Yasuo NakaiDepartment of Dermatology, Mie University Graduate School of Medicine, Mie, Japan.
Toshiaki TakahashiDivision of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Taro ShibataBiostatistics Division, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan.
Tetsuya HamaguchiDepartment of Gastroenterological Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Katsuko KikuchiDepartment of Dermatology, Tohoku University Graduate School of Medicine, Miyagi, Japan.
Naoya YamazakiDepartment of Dermatological Oncology, National Cancer Center Hospital, Tokyo, Japan.
Haruhiko FukudaData Management Division, National Cancer Center Hospital, Tokyo, Japan.
Keiko NozawaAppearance Support Center, National Cancer Center Hospital, Tokyo, Japan.
Yoshio KiyoharaDepartment of Dermatology, Shizuoka Cancer Center, Shizuoka, Japan.
Mie University · JPShizuoka Cancer Center · JPTohoku University Hospital · JPMitsui Memorial Hospital · JPOsaka International Cancer Institute · JPSaitama Medical University · JPTohoku University · JPTokyo National Hospital · JP

Funding

Japan Agency for Medical Research and Development (AMED) JP17ck0106326
6 · The paper itself

Abstract

purposeThis FAEISS study was designed to confirm the superior efficacy of reactive topical corticosteroid strategies employing serially ranking-DOWN from very strong steroid levels for the treatment of facial acneiform rash induced by epidermal growth factor receptor (EGFR) inhibitors (EGFRIs), in comparison with strategies employing serially ranking-UP from weak steroid levels. This article reports the primary results of the non-small cell lung cancer (NSCLC) part of the trial.

methodsPatients with EGFR-mutated advanced NSCLC treated with erlotinib or afatinib were enrolled in the first registration. All patients received preemptive therapy with oral minocycline and heparinoid moisturizer from the initiation of an EGFR inhibitor. Enrolled patients who developed facial acneiform rash within 2 weeks were randomized at second registration to either a ranking-UP (WEAK) group or a ranking-DOWN group. The primary endpoint was incidence of grade ≥ 2 facial acneiform rash over 8 weeks.

resultsFifty-one patients were enrolled at the first registration and received EGFRIs (n = 30 for afatinib, n = 21 for erlotinib). However, 35 patients did not develop facial acneiform rash within 2 weeks; one patient discontinued preemptive treatment. Fifteen patients (29.4%) were enrolled in the second registration; nine were assigned to the WEAK group and six to the DOWN group. There was no significant difference in the incidence of grade ≥ 2 facial acneiform rash between the WEAK group (one patient, twice) and the DOWN group (one patient, twice; p = 0.8417). No patients developed severe facial acneiform rash within 10 weeks.

conclusionIn NSCLC patients who received EGFRIs, preemptive therapy of oral minocycline and heparinoid moisturizer reduced facial acneiform rash incidence.

trial registrationUMIN000024113.

Indexed as

Administration, TopicalAdrenal Cortex HormonesAdultAgedCarcinoma, Non-Small-Cell LungDermatitisFemaleHumansLung NeoplasmsMaleMiddle AgedProtein Kinase InhibitorsAdrenal Cortex HormonesProtein Kinase InhibitorsEpidermal growth factor receptorFacial acneiform rashHeparinoid moisturizerMinocyclineNon-small cell lung cancerTopical corticosteroid

Identifiers

PMID32918131
PMCPMC7981297
OpenAlexW3086158931

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.