Evidence map›Paper›PMID 39437014›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025

Phase II Study of Palbociclib in Patients with Tumors with CDK4 or CDK6 Amplification: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1C.

Mark H O'Hara, Opeyemi Jegede, Mark A Dickson, Angela M DeMichele, Richard Piekarz, Robert J Gray, Victoria Wang, Lisa M McShane, Lawrence V Rubinstein, David R Patton and 10 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. 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

20 authors.

Mark H O'Hara *Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania.ORCID 0000-0003-2751-6122
Opeyemi JegedeDana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, Massachusetts.ORCID 0000-0003-1763-8214
Mark A Dickson *Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.ORCID 0000-0003-2764-751X
Angela M DeMicheleAbramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania.ORCID 0000-0003-1297-4251
Richard PiekarzDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0002-3591-7893
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, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0001-8195-3206
Lawrence V RubinsteinBiometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0002-9720-9737
David R PattonCenter for Biomedical Informatics and Information Technology, National Cancer Institute, 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
Adedayo OnitiloMarshfield Medical Center - Weston, Weston, Wisconsin.ORCID 0000-0001-9185-0606
James V TricoliDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0003-3975-8516
Barbara A ConleyDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0002-1445-1684
Carlos L ArteagaUT Southwestern Simmons Cancer Center, Dallas, Texas.ORCID 0000-0003-0870-9586
Lyndsay N HarrisDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0002-9774-6719
Peter J O'DwyerAbramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania.ORCID 0000-0002-9302-4073
Alice P ChenDivision of Cancer Treatment and Diagnosis, Developmental Therapeutics Clinic, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0002-1426-853X
Keith T FlahertyMassachusetts General Hospital Cancer Center, Boston, Massachusetts.ORCID 0000-0002-3402-0478

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
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
Wisconsin NCI Community Oncology Research Program (WiNCORP)UG1CA189956 · NCI · MARSHFIELD CLINIC RESEARCH FOUNDATION · PI ADEDAYO A ONITILO, Kurt Oettel · 2014 to 2026
$32.3M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
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
National Cancer Institute (NCI) U10CA180794National Cancer Institute (NCI) U10CA180820National Cancer Institute (NCI) UG1CA233180National Cancer Institute (NCI) UG1CA233302NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA189956NCI NIH HHS UG1 CA233180NCI NIH HHS UG1 CA233290NCI NIH HHS UG1 CA233302NCI NIH HHS UG1 CA233341
6 · The paper itself

Abstract

purposeAmplification of cyclin-dependent kinase 4 (CDK4) and CDK6 is a feature of a variety of malignancies, and preclinical evidence suggests that inhibition of CDK4/6 is a plausible treatment strategy in these tumors. Subprotocol Z1C of the NCI-Molecular Analysis for Therapy Choice trial was designed to evaluate the CDK4/6 inhibitor palbociclib in CDK4- or CDK6-amplified tumors. PATIENTS AND

methodsPatients had a solid malignancy or lymphoma with progression on at least one systemic therapy for advanced disease or with no standard-of-care therapy available. Tumors with ≥7 copies of CDK4 or CDK6 were considered amplified and molecularly eligible. Enrolled patients were treated with palbociclib 125 mg daily on days 1 to 21 of a 28-day cycle. The primary endpoint was objective response rate.

resultsForty-three patients were enrolled on subprotocol Z1C, and 38 patients were deemed eligible, treated, and included in analyses; 25 patients were eligible, treated, and centrally confirmed to have CDK4 or CDK6 amplification and comprised the primary analysis cohort for objective response rate endpoint. Among the 25 patients in the primary cohort, one patient had a partial response, 4 patients had stable disease, and 16 patients had progressive disease as best response. Four patients were not evaluable due to lack of follow-up scans. Among the 38 evaluable patients, one patient had a partial response, 10 patients had stable disease, and 21 patients had progressive disease as best response. Partial response and stable disease were seen only in patients with CDK4 amplification. Median progression-free survival was 2.0 months, and median overall survival was 8.8 months.

conclusionsPalbociclib showed limited activity in histology-agnostic CDK4- or CDK6-amplified tumors, although central nervous system tumors may be worthy of future investigation.

Indexed as

Cyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Gene AmplificationNeoplasmsPiperazinesProtein Kinase InhibitorsAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedPyridinesTreatment OutcomeCDK4 protein, humanCDK6 protein, humanCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6palbociclibPiperazinesProtein Kinase InhibitorsPyridines

Identifiers

PMID39437014
PMCPMC11721435

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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.