Evidence map›Paper›PMID 37269194›Full record

Trial reportCancer medicine2023

Prophylactic treatment of dacomitinib-induced skin toxicities in epidermal growth factor receptor-mutated non-small-cell lung cancer: A multicenter, Phase II trial.

Masahiro Iwasaku, Junji Uchino, Kenji Chibana, Shigeru Tanzawa, Takahiro Yamada, Kazunori Tobino, Yasuki Uchida, Takashi Kijima, Katsumi Nakatomi, Miiru Izumi and 9 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer medicine, 2023. 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
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.

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, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Kinase Inhibitors FDA Approved 2018-2023: Drug Targets, Metabolic Pathways, and Drug-Induced Toxicities.Drug metabolism and disposition: the biological fate of chemicals · 2024
    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

19 authors at 13 institutions in 1 country.

Masahiro IwasakuDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.ORCID 0000-0001-7269-5129
Junji UchinoDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.ORCID 0000-0003-0651-7767
Kenji ChibanaDepartment of Respiratory Medicine, National Hospital Organization Okinawa National Hospital, Okinawa, Japan.
Shigeru TanzawaDivision of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan.
Takahiro YamadaDepartment of Pulmonary Medicine, Matsushita Memorial Hospital, Osaka, Japan.
Kazunori TobinoDepartment of Respiratory Medicine, Iizuka Hospital, Iizuka, Japan.
Yasuki UchidaDivision of Respiratory Medicine, Department of Internal Medicine, Shiga University of Medical Science, Japan.ORCID 0000-0002-1999-4709
Takashi KijimaDepartment of Respiratory Medicine and Hematology, Hyogo Medical University, School of Medicine, Hyogo, Japan.
Katsumi NakatomiDepartment of Respiratory Medicine, National Hospital Organization Ureshino Medical Center, Ureshino, Japan.
Miiru IzumiDepartment of Respiratory Medicine, National Hospital Organization, Omuta National Hospital, Fukuoka, Japan.
Nobuyo TamiyaDepartment of Pulmonary Medicine, Rakuwakai Otowa Hospital, Kyoto, Japan.
Hideharu KimuraDepartment of Respiratory Medicine, Kanazawa University Hospital, Ishikawa, Japan.
Masaki FujitaDepartment of Respiratory Medicine, Fukuoka University Hospital, Fukuoka, Japan.
Ryoichi HondaDepartment of Respiratory Medicine, Asahi General Hospital, Asahi, Japan.
Chieko TakumiDepartment of Respiratory Medicine, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan.
Tadaaki YamadaDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.ORCID 0000-0002-6945-281X
Yoshiko KanekoDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Fumiaki KiyomiStatistics and Data Center, Clinical Research Support Center Kyushu, Fukuoka, Japan.
Koichi TakayamaDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.ORCID 0000-0002-7723-8960
Kyoto Prefectural University of Medicine · JPNational Hospital Organization · JPAsahi General Hospital · JPAso Iizuka Hospital · JPFukuoka University Hospital · JPHyogo University · JPKanazawa University Hospital · JPKyoto first Red Cross hospital · JPKyushu Economic Research Center · JPOmuta hospital · JPRakuwakai Otowa Hospital · JPShiga University of Medical Science · JPTeikyo University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDacomitinib significantly improves progression-free survival and overall survival (OS) compared with gefitinib in patients with non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR)-activating mutations. However, dacomitinib often causes skin toxicities, resulting in treatment discontinuation. We aimed to evaluate a prophylactic strategy for skin toxicity induced by dacomitinib.

methodsWe performed a single-arm, prospective, open-label, multi-institutional phase II trial for comprehensive skin toxicity prophylaxis. Patients with NSCLC harboring EGFR-activating mutations were enrolled and received dacomitinib with comprehensive prophylaxis. The primary endpoint was the incidence of skin toxicity (Grade ≥2) in the initial 8 weeks.

resultsIn total, 41 Japanese patients participated between May 2019 and April 2021 from 14 institutions (median age 70 years; range: 32-83 years), 20 were male, and 36 had a performance status of 0-1. Nineteen patients had exon 19 deletions and L858R mutation. More than 90% of patients were perfectly compliant with prophylactic minocycline administration. Skin toxicities (Grade ≥2) occurred in 43.9% of patients (90% confidence interval [CI], 31.2%-56.7%). The most frequent skin toxicity was acneiform rash in 11 patients (26.8%), followed by paronychia in five patients (12.2%). Due to skin toxicities, eight patients (19.5%) received reduced doses of dacomitinib. The median progression-free survival was 6.8 months (95% CI, 4.0-8.6 months) and median OS was 21.6 months (95% CI, 17.0 months-not reached).

conclusionAlthough the prophylactic strategy was ineffective, the adherence to prophylactic medication was quite good. Patient education regarding prophylaxis is important and can lead to improved treatment continuity.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAgedErbB ReceptorsFemaleHumansMaleMutationProspective StudiesProtein Kinase InhibitorsQuinazolinonesdacomitinibErbB ReceptorsProtein Kinase InhibitorsQuinazolinonesdacomitinibdermatitisnon-small-cell lung cancersteroidssunscreen

Identifiers

PMID37269194
PMCPMC10417098
OpenAlexW4379197721

What OpenQuestion holds

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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.