Evidence map›Paper›PMID 26499382›Full record

Trial reportInternational journal of clinical oncology2016

Optimal strength and timing of steroids in the management of erlotinib-related skin toxicities in a post-marketing surveillance study (POLARSTAR) of 9909 non-small-cell lung cancer patients.

Naoya Yamazaki, Yoshio Kiyohara, Shoji Kudoh, Akihiro Seki, Masahiro Fukuoka

Open access · hybridAbstract readClinical Trial, Phase IVObservational Study
In one paragraph

Trial report in International journal of clinical oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 25% 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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Trial
  3. The Use ofCase reports in oncology
    Article
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

5 authors at 4 institutions in 2 countries.

Naoya YamazakiDepartment of Dermatologic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-Ku, Tokyo, 104-0045, Japan. nyamazak@ncc.go.jp.
Yoshio KiyoharaDermatology Division, Shizuoka Cancer Center, Shimonagakubo, Nagaizumi-cho, Sunto-Gun, Shizuoka, 411-8777, Japan.
Shoji KudohDouble-Barred Cross Hospital Japan Anti-Tuberculosis Association, Matsuyama, Kiyose-Shi, Tokyo, 204-8522, Japan.
Akihiro SekiChugai Pharmaceutical Co. Ltd, Nihonbashi-Muromachi, Chuo-Ku, Tokyo, 103-8324, Japan.
Masahiro FukuokaIzumi Municipal Hospital, Fuchu-cho, Izumi-Shi, Osaka, 594-0071, Japan.
Izumi City General Hospital · JPJapan Anti Tuberculosis Association · JPNational Cancer Center · USShizuoka Cancer Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSkin toxicities, such as rash, are the most common adverse reactions associated with erlotinib. Steroids are a key treatment option for rash management; however, optimal timing of administration and selection of steroid strength have not been fully established. In this surveillance study of Japanese non-small-cell lung cancer (NSCLC) patients treated with erlotinib, rash management using topical steroids was analyzed in routine clinical practice.

methodsFrom December 2007 to October 2009, all recurrent/advanced NSCLC patients in Japan treated with erlotinib were enrolled into this study (POst-Launch All-patient Registration Surveillance in TARceva). The observation period was 12 months, and data for all adverse events were collected. Erlotinib-related rash, interventions for the symptoms, and outcomes of the interventions were analyzed.

resultsA total of 9909 patients were evaluated. Rash occurred in 67.4 % of patients; grade 1, 2, and 3 rash were observed in 26.8 %, 32.4 %, and 7.2 % of patients, respectively. The most common management strategy was topical steroids in 75.0 % of patients with rash. Regardless of rash grade, earlier initiation of steroids resulted in quicker recovery. In those for whom topical steroids were initiated more than 21 days after rash onset, median recovery time was more than 100 days regardless of rash grade, compared with those treated before rash onset, whose median time to recovery was 35-51 days, depending on rash grade. Median time to recovery of rash in the group initiated on medium-rank steroids then changed to strong-rank steroids was 47, 98, and 103 days for those with grade 1, 2, and 3 rash, respectively, compared with 39, 53, and 73 days median recovery for grade 1, 2, and 3 rash, respectively, in patients initiated on strong-rank steroids.

conclusionEarlier initiation of topical steroids for the management of rash with strong or higher-rank steroids could achieve faster improvement.

Indexed as

AdenocarcinomaAdolescentAdultAgedAged, 80 and overCarcinoma, Non-Small-Cell LungErlotinib HydrochlorideExanthemaFemaleHumansJapanLung NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingErlotinib HydrochlorideProtein Kinase InhibitorsSteroidsErlotinibJapaneseNon-small-cell lung cancerRash managementSteroids

Identifiers

PMID26499382
PMCPMC4824834
OpenAlexW2097576638

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.