Evidence map›Paper›PMID 36853016›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2023

Phase II Study of Palbociclib (PD-0332991) in CCND1, 2, or 3 Amplification: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1B.

Amy S Clark, Fangxin Hong, Richard S Finn, Angela M DeMichele, Edith P Mitchell, James Zwiebel, Fernanda I Arnaldez, Robert J Gray, Victoria Wang, Lisa M McShane and 13 more

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

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
4.4field-weighted citation impact, top 5% 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

17 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Article
  8. 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
  9. Article
  10. Review
  11. Cancer takes many paths through G1/S.Trends in cell biology · 2024
    Review
  12. Article
  13. Review
  14. Review
  15. MYCN in human development and diseases.Frontiers in oncology · 2024
    Review
  16. Heterogeneity in precision oncology.Cambridge prisms. Precision medicine · 2024
    Review
  17. 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

23 authors at 14 institutions in 1 country.

Amy S ClarkUniversity of Pennsylvania, Philadelphia, Pennsylvania.ORCID 0000-0002-3685-6535
Fangxin HongDana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, Massachusetts.ORCID 0000-0001-8049-0086
Richard S FinnUniversity of California, Los Angeles, Los Angeles, California.ORCID 0000-0003-2494-2126
Angela M DeMicheleUniversity of Pennsylvania, Philadelphia, Pennsylvania.ORCID 0000-0003-1297-4251
Edith P MitchellSidney Kimmel Cancer Center at Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.ORCID 0000-0002-6788-7086
James ZwiebelInvestigational Drug Branch, Division of Cancer Treatment and Diagnosis, NCI, Bethesda, Maryland.ORCID 0000-0003-4455-8789
Fernanda I ArnaldezCancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, NCI, Bethesda, Maryland.ORCID 0000-0003-1185-2498
Robert J GrayDana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, Massachusetts.ORCID 0000-0002-5724-4917
Victoria WangDana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, Massachusetts.ORCID 0000-0003-4079-5576
Lisa M McShaneBiometric Research Program, Division of Cancer Treatment and Diagnosis, NCI, Bethesda, Maryland.ORCID 0000-0001-8195-3206
Larry V RubinsteinBiometric Research Program, Division of Cancer Treatment and Diagnosis, NCI, Bethesda, Maryland.ORCID 0000-0002-9720-9737
David PattonCenter for Biomedical Informatics and Information Technology, NCI, Bethesda, Maryland.ORCID 0000-0003-3855-0166
P Mickey WilliamsFrederick National Laboratory for Cancer Research, Frederick, Maryland.ORCID 0000-0002-3309-5988
Stanley R HamiltonCity of Hope National Medical Center, Duarte, California.ORCID 0000-0002-8331-1052
Mehmet S CopurCatholic Health Initiatives NCORP, Grand Island, Nebraska.ORCID 0000-0003-0797-8389
Samer S KasbariSoutheast COR NCORP, Goldsboro, North Carolina.ORCID 0000-0002-4329-8578
Ravneet ThindUniversity of Kentucky, Lexington, Kentucky.ORCID 0000-0003-3915-0367
Barbara A ConleyDivision of Cancer Treatment and Diagnosis, NCI, Bethesda, Maryland.ORCID 0000-0002-1445-1684
Carlos L ArteagaUT Southwestern Simmons Comprehensive Cancer Center, Dallas, Texas.ORCID 0000-0003-0870-9586
Peter J O'DwyerUniversity of Pennsylvania, Philadelphia, Pennsylvania.ORCID 0000-0002-9302-4073
Lyndsay N HarrisDivision of Cancer Treatment and Diagnosis, NCI, Bethesda, Maryland.ORCID 0000-0002-9774-6719
Alice P ChenEarly Clinical Trials Development Program, Division of Cancer Treatment and Diagnosis, NCI, Bethesda, Maryland.ORCID 0000-0002-1426-853X
Keith T FlahertyMassachusetts General Hospital Cancer Center, Boston, Massachusetts.ORCID 0000-0002-3402-0478
Center for Cancer Research · USECOG-ACRIN Cancer Research Group · USUniversity of Pennsylvania · USCatholic Health Initiatives · USCenter for Information Technology · USCity Of Hope National Medical Center · USFrederick National Laboratory for Cancer Research · USMassachusetts General Hospital · USNorth Central Cancer Treatment Group · USSidney Kimmel Cancer Center · USSouthwestern Medical Center · USUniversity of California, Los Angeles · USUniversity of Kentucky · USWayne Community College · US

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
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
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
CIRI Oncology Research Alliance (CORA)UG1CA189809 · NCI · COMMONSPIRIT HEALTH RESEARCH INSTITUTE · PI Loretta Jo Nastoupil · 2014 to 2026
$12.1M
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
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 U10 CA180888NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA189809NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA233180NCI NIH HHS UG1 CA233302NCI NIH HHS UG1 CA233341
6 · The paper itself

Abstract

purposeCyclin D/CDK4/6 is critical in controlling the G1 to S checkpoint. CCND, the gene encoding cyclin D, is known to be amplified in a variety of solid tumors. Palbociclib is an oral CDK4/6 inhibitor, approved in advanced breast cancer in combination with endocrine therapy. We explored the efficacy of palbociclib in patients with nonbreast solid tumors containing an amplification in CCND1, 2, or 3. PATIENTS AND

methodsPatients with tumors containing a CCND1, 2, or 3 amplification and expression of the retinoblastoma protein were assigned to subprotocol Z1B and received palbociclib 125 mg once daily for 21 days of a 28-day cycle. Tumor response was assessed every two cycles.

resultsForty patients were assigned to subprotocol Z1B; 4 patients had outside assays identifying the CCND1, 2, or 3 amplification and were not confirmed centrally; 3 were ineligible and 2 were not treated (1 untreated patient was also ineligible), leaving 32 evaluable patients for this analysis. There were no partial responses; 12 patients (37.5%) had stable disease as best response. There were seven deaths on study, all during cycle 1 and attributable to disease progression. Median progression-free survival was 1.8 months. The most common toxicities were leukopenia (n = 21, 55%) and neutropenia (n = 19, 50%); neutropenia was the most common grade 3/4 event (n = 12, 32%).

conclusionsPalbociclib was not effective at treating nonbreast solid tumors with a CCND1, 2, or 3 amplification in this cohort. These data do not support further investigation of single-agent palbociclib in tumors with CCND1, 2, or 3 amplification.

Indexed as

Breast NeoplasmsNeutropeniaAntineoplastic Combined Chemotherapy ProtocolsCyclin D1FemaleHumansPiperazinesPyridinesCCND1 protein, humanCyclin D1palbociclibPiperazinesPyridines

Identifiers

PMID36853016
PMCPMC10102836
OpenAlexW4322617534

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.