Evidence map›Paper›PMID 29191595›Full record

Trial reportLung cancer (Amsterdam, Netherlands)2017

Phase 2 study of intermittent pulse dacomitinib in patients with advanced non-small cell lung cancers.

Helena A Yu, Myung-Ju Ahn, Byoung Chul Cho, David E Gerber, Ronald B Natale, Mark A Socinski, Nagdeep Giri, Susan Quinn, Eric Sbar, Hui Zhang and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Lung cancer (Amsterdam, Netherlands), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01858389 (Phase 2 Open Label Trial Of Oral Intermittent Dacomitinib In Patients With Advanced Nsclc), which is 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
–field-weighted citation impact
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.

NCT01858389 phase2completednot on this map

Phase 2 Open Label Trial Of Oral Intermittent Dacomitinib In Patients With Advanced Nsclc

TypeinterventionalSponsorPfizerRan2013 to 2015Enrolled41ConditionsNon-small Cell Lung CancerArmsDacomitinib
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Updated Insights on EGFR Signaling Pathways in Glioma.International journal of molecular sciences · 2021
    Review
  5. Review
  6. Overcoming EGFRNature communications · 2018
    Article
  7. 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

11 authors.

Helena A YuMemorial Sloan Kettering Cancer Center, 300 East 66th, Street, New York, NY 10065, USA. Electronic address: YuH@mskcc.org.
Myung-Ju AhnSamsung Medical Center, 50 Ilweon-Dong, Seoul 135-230, South Korea. Electronic address: silkahn@skku.edu.
Byoung Chul ChoSeverance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea. Electronic address: CBC1971@yuhs.ac.
David E GerberHarold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Mail Code 8852, Dallas, TX 75390-8852, USA. Electronic address: david.gerber@utsouthwestern.edu.
Ronald B NataleSamuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, 8700 Beverly Blvd. Ste. AC1042 B Los Angeles, CA 90048-1804, USA. Electronic address: ronald.natale@cshs.org.
Mark A SocinskiUniversity of Pittsburgh Medical Center, UPMC Cancer Pavilion, 5150 Centre Avenue, Fifth Floor, Pittsburgh, PA, 15232, USA. Electronic address: mark.socinski.md@flhosp.org.
Nagdeep GiriPfizer Global Product Development, 10646 Science Center Drive, San Diego, CA 92121, USA. Electronic address: nagdeep.giri@pfizer.com.
Susan QuinnPfizer Global Product Development Oncology, 300 Technology Square Suite 302, Cambridge, MA 02139, USA. Electronic address: susan.quinn@pfizer.com.
Eric SbarPfizer Global Product Development Oncology, 500 Arcola Road, Collegeville, PA 19426, USA. Electronic address: eric.sbar@pfizer.com.
Hui ZhangPfizer(China) Research & Development Co., Ltd., 3/F, Building 3, Ascendas Lotus Business Park, Lane 60, Naxian Road, Pudong ZhangJiang Hi-tech. Park, Shanghai, 201203, China. Electronic address: Hui.Zhang2@pfizer.com.
Giuseppe GiacconeLombardi Comprehensive Cancer Center, Georgetown University, 3970 Reservoir Road Washington DC 20007, USA. Electronic address: gg496@georgetown.edu.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundDacomitinib is a second-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). Pre-clinical data suggest that intermittent pulsatile dosing of dacomitinib may result in inhibition of EGFR T790M.

methodsWe evaluated safety, pharmacokinetics and efficacy of intermittent pulsatile dacomitinib in both molecularly unselected patients and patients with lung cancers harboring EGFR T790M (Clinical Trial Registration Number NCT01858389).

resultsThirty-eight patients were treated on study with pulse dacomitinib; sixteen with EGFR T790M in Cohort A and 22 who were not molecularly selected in Cohort B. One patient out of 16 patients in Cohort A had a partial response to study therapy (ORR 6.3%, 95% CI 0.2-30.2%). The median progression-free survival (PFS) in Cohort A was 2.3 months and median PFS in Cohort B was 1.6 months. The adverse event profile was similar to standard daily dose dacomitinib with the most frequent treatment-related toxicities occurring in >20% of patients being diarrhea, rash, stomatitis, nausea, dry skin, paronychia, fatigue, and decreased appetite.

conclusionIntermittent pulsatile dacomitinib is safe and relatively well tolerated but is not effective in patients that harbor EGFR T790M or in unselected patients with non-small cell lung cancer.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, Non-Small-Cell LungFemaleHumansLung NeoplasmsMaleMiddle AgedProtein Kinase InhibitorsPulse Therapy, DrugQuinazolinonesAntineoplastic AgentsdacomitinibProtein Kinase InhibitorsQuinazolinonesDacomitinibEgfrNon-small-cell lung cancerPulsatile dosingT790MTyrosine kinase inhibitors

Identifiers

PMID29191595
PMCPMC8788626

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.