Evidence map›Paper›PMID 35939768›Full record

Trial reportJCO precision oncology2022

Phase II Study of Afatinib in Patients With Tumors With Human Epidermal Growth Factor Receptor 2-Activating Mutations: Results From the National Cancer Institute-Molecular Analysis for Therapy Choice ECOG-ACRIN Trial (EAY131) Subprotocol EAY131-B.

Philippe L Bedard, Shuli Li, Kari B Wisinski, Eddy S Yang, Sewanti A Limaye, Edith P Mitchell, James A Zwiebel, Jeffrey A Moscow, Robert J Gray, Victoria Wang and 11 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in JCO precision oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
2.6field-weighted citation impact, top 8% 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

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Review
  6. Concordance between Tumor Tissue and Plasma DNA Genotyping in the NCI-MATCH Trial (EAY131).Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Tumor-Specific Activity of Precision Medicines in the NCI-MATCH Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Article
  12. Heterogeneity in precision oncology.Cambridge prisms. Precision medicine · 2024
    Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. 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

21 authors at 13 institutions in 3 countries.

Philippe L BedardPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.ORCID 0000-0002-6771-2999
Shuli LiE-A Biostatistical Center, Boston, MA.
Kari B WisinskiUniversity of Wisconsin Carbone Cancer Center, Madison, WI.ORCID 0000-0003-3535-0652
Eddy S YangUniversity of Alabama-Birmingham, Birmingham, AL.ORCID 0000-0002-6450-2638
Sewanti A LimayeKokilaben Dhirubhai Ambani Hospital, Mumbai, India (Current).ORCID 0000-0002-2170-5187
Edith P MitchellThomas Jefferson University Hospital, Philadelphia, PA.
James A ZwiebelInvestigational Drug Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.ORCID 0000-0003-4455-8789
Jeffrey A MoscowCancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Robert J GrayDana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.ORCID 0000-0002-5724-4917
Victoria WangDana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.
Lisa M McShaneBiometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.ORCID 0000-0001-8195-3206
Larry V RubinsteinBiometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.ORCID 0000-0002-9720-9737
David R PattonCenter for Biomedical Informatics & Information Technology, National Cancer Institute, Bethesda, MD.ORCID 0000-0003-3855-0166
P Mickey WilliamsFrederick National Laboratory for Cancer Research, Frederick, MD.ORCID 0000-0002-3309-5988
Stanley R HamiltonCity of Hope National Medical Center, Duarte, CA.ORCID 0000-0002-8331-1052
Barbara A ConleyCancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.ORCID 0000-0002-1445-1684
Carlos L ArteagaUT Southwestern Simmons Cancer Cancer Center, Dallas, TX.
Lyndsay N HarrisCancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Peter J O'DwyerUniversity of Pennsylvania, Philadelphia, PA.
Alice P ChenDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.ORCID 0000-0002-2919-4326
Keith T FlahertyMassachusetts General Hospital, Boston, MA.ORCID 0000-0002-3402-0478
National Cancer Institute · USDana-Farber Cancer Institute · USBiostatistical Consulting (United States) · USCity Of Hope National Medical Center · USFrederick National Laboratory for Cancer Research · USKokilaben Dhirubhai Ambani Hospital · INMassachusetts General Hospital · USPrincess Margaret Cancer Centre · CAThe University of Texas Southwestern Medical Center · USThomas Jefferson University Hospital · USUniversity of Alabama at Birmingham · USUniversity of Pennsylvania · USUniversity of Wisconsin Carbone Cancer Center · US

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
Princess Margaret Phase I Consorium (PMP1C)UM1CA186644 · NCI · UNIVERSITY HEALTH NETWORK · PI Philippe Bedard, Kevin D Courtney · 2014 to 2026
$16.6M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareUG1CA233180 · NCI · DANA-FARBER CANCER INST · PI Harold John Burstein · 2019 to 2026
$8.6M
UT Southwestern NCI National Clinical Trials Network (NCTN) LAPS - Supplemental Funds YR4UG1CA233302 · NCI · UT SOUTHWESTERN MEDICAL CENTER · PI David Eric Gerber · 2019 to 2026
$6.4M
National Clinical Trials Network Research at the University of WisconsinUG1CA233277 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI Lisa M Barroilhet, Andrew M. Baschnagel · 2019 to 2026
$4.9M
NCTN Deep South Research ConsortiumUG1CA233330 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Charles A. Leath, Andrew M McDonald · 2019 to 2026
$3.7M
Sidney Kimmel Cancer Center LAPS Institutional CollaborationUG1CA233341 · NCI · THOMAS JEFFERSON UNIVERSITY · PI Steven Cohen, Mitchell Edelson · 2019 to 2026
$3.5M
NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA233180NCI NIH HHS UG1 CA233277NCI NIH HHS UG1 CA233302NCI NIH HHS UG1 CA233330NCI NIH HHS UG1 CA233341NCI NIH HHS UM1 CA186644
6 · The paper itself

Abstract

purposeNational Cancer Institute-Molecular Analysis for Therapy Choice is a multicohort trial that assigns patients with advanced cancers to targeted therapies on the basis of central tumor genomic testing. Arm B evaluated afatinib, an ErbB family tyrosine kinase inhibitor, in patients with

methodsEligible patients had selected

resultsA total of 59 patients were assigned and 40 were enrolled. The median age was 62 years, 78% were female, 68% had performance status = 1, and 58% had received > 3 prior therapies. The confirmed ORR was 2.7% (n = 1 of 37; 90% CI, 0.14 to 12.2), and 6-month progression-free survival was 12.0% (90% CI, 5.6 to 25.8). A confirmed partial response occurred in a patient with adenocarcinoma of extra-mammary Paget disease of skin who progressed after cycle 6. Two unconfirmed partial responses were observed (low-grade serous gynecological tract and estrogen receptor-positive/HER2-negative immunohistochemistry breast ductal carcinoma). Of 12 patients with breast cancer, 1 additional patient with lobular carcinoma (estrogen receptor-positive/HER2 fluorescent in situ hybridization) had a 51% reduction in target lesions but progressed because of a new lesion at cycle 6. The most common (> 20%) treatment-related adverse events were diarrhea (68%), mucositis (43%), fatigue (40%), acneiform rash (30%), dehydration (27%), vomiting (27%), nausea (27%), anemia (27%), and anorexia (22%). Four patients (11%) discontinued because of adverse events.

conclusionAlthough afatinib did not meet the prespecified threshold for antitumor activity in this heavily pretreated cohort, the response in a rare tumor type is notable. The safety profile of afatinib was consistent with prior studies.

Indexed as

Breast NeoplasmsQuinazolinesAfatinibDiarrheaErb-b2 Receptor Tyrosine KinasesFemaleHumansIn Situ Hybridization, FluorescenceMaleMiddle AgedMutationNational Cancer Institute (U.S.)Receptors, EstrogenStroke VolumeUnited StatesVentricular Function, LeftAfatinibERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesQuinazolinesReceptors, Estrogen

Identifiers

PMID35939768
PMCPMC9384949
OpenAlexW4290719500

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.