Evidence map›Paper›PMID 37875500›Full record

Trial reportSignal transduction and targeted therapy2023

Phase II trial of CDK4/6 inhibitor palbociclib in advanced sarcoma based on mRNA expression of CDK4/ CDKN2A.

Javier Martin-Broto, Jeronimo Martinez-Garcia, David S Moura, Andres Redondo, Antonio Gutierrez, Antonio Lopez-Pousa, Javier Martinez-Trufero, Isabel Sevilla, Roberto Diaz-Beveridge, Maria Pilar Solis-Hernandez and 9 more

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

Trial report in Signal transduction and targeted therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
8.8field-weighted citation impact, top 2% 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

33 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
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  14. Choosing the right animal model for sarcoma research.Cellular and molecular life sciences : CMLS · 2026
    Review
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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 14 institutions in 1 country.

Javier Martin-BrotoHealth Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28040, Madrid, Spain. jmartin@atbsarc.org.
Jeronimo Martinez-GarciaMedical Oncology Department, University Hospital Virgen de la Arrixaca, 30120, Murcia, Spain.
David S MouraHealth Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28040, Madrid, Spain.
Andres RedondoDepartment of Medical Oncology, Hospital Universitario La Paz-IdiPAZ, P. Castellana, 261, 28046, Madrid, Spain.
Antonio GutierrezHematology Department, University Hospital Son Espases, 07120, Mallorca, Spain.
Antonio Lopez-PousaMedical Oncology Department, Sant Pau Hospital, 08025, Barcelona, Spain.
Javier Martinez-TruferoMedical Oncology Department, University Hospital Miguel Servet, 50009, Zaragoza, Spain.ORCID http://orcid.org/0000-0002-0997-2573
Isabel SevillaInvestigación Clínica y Traslacional en Cáncer/ Instituto de Investigaciones Biomédicas de Malaga (IBIMA)/ Hospitales Universitarios Regional y Virgen de la Victoria de Malaga, Malaga, Spain.
Roberto Diaz-BeveridgeMedical Oncology Department, Hospital Universitari i Politècnic La Fe, 46026, Valencia, Spain.
Maria Pilar Solis-HernandezMedical Oncology Department, Central University Hospital of Asturias, 33011, Oviedo, Spain.
Amancio CarneroInstituto de Biomedicina de Sevilla (IBiS; HUVR, CSIC, US), 41013, Sevilla, Spain.ORCID http://orcid.org/0000-0003-4357-3979
Marco PerezInstituto de Biomedicina de Sevilla (IBiS; HUVR, CSIC, US), 41013, Sevilla, Spain.
David MarcillaPathology Department, Virgen del Rocio University Hospital, 41013, Sevilla, Spain.
Jesus Garcia-FoncillasHealth Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28040, Madrid, Spain.
Pablo RomeroHealth Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28040, Madrid, Spain.
Javier Fernandez-JaraRadiology Department, Fundación Jimenez Diaz University Hospital, 28040, Madrid, Spain.
Daniel Lopez-LopezInstituto de Biomedicina de Sevilla (IBiS; HUVR, CSIC, US), 41013, Sevilla, Spain.ORCID http://orcid.org/0000-0001-7672-7335
Ivan ArribasUniversitat de València - ERI-CES, 46010, Valencia, Spain.
Nadia HindiHealth Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28040, Madrid, Spain.ORCID http://orcid.org/0000-0002-5864-762X
Hospital Universitario Fundación Jiménez Díaz · ESInstituto de Biomedicina de Sevilla · ESFundación Progreso y Salud · ESHospital de Sant Pau · ESHospital Universitari i Politècnic La Fe · ESHospital Universitario Central de Asturias · ESHospital Universitario La Paz · ESHospital Universitario Miguel Servet · ESHospital Universitario Son Espases · ESHospital Universitario Virgen de la Arrixaca · ESHospital Universitario Virgen del Rocío · ESInstituto de Investigación Biomédica de Málaga · ESPharmaMar (Spain) · ESUniversitat de València · ES

Funding

Cancer Research UK 29363Cancer Research UK C56167/A29363
6 · The paper itself

Abstract

Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors demonstrated activity in terms of progression-free survival (PFS) in advanced dedifferentiated liposarcoma (DD-LPS), a sarcoma with CDK4 amplification. CDK4 overexpression is by far more common than amplification in sarcomas and it might be a rational target for CDK inhibitors. Preclinical investigators of this study found that CDK4 overexpression, while not of CDKN2A, was the most consistent predictive factor for palbociclib efficacy in sarcomas. Advanced adult-type soft-tissue sarcoma, excluding DD-LPS, or bone sarcoma patients, progressing after at least one systemic line, whose tumors overexpressed CDK4, but not CDKN2A at baseline biopsy, were accrued in this single-arm phase II trial (EudraCT number: 2016-004039-19). With the main endpoint of a 6-month PFS rate, 40% was considered promising in this population. Palbociclib was administered orally at 125 mg/day for 21 days in 28-day cycles. A total of 214 patients with 236 CDK4/CDKN2A determinations were assessed for prescreening, archival material (141), and screening, baseline biopsy (95). There were 28 (29%) with favorable mRNA profiles from 95 screened patients at baseline. From 23 enrolled patients, 21 evaluable, the 6-month PFS rate was 29% (95% CI 9-48), and there were 6 patients out of 21 with a PFS longer than 6 months. The median PFS and overall survival were 4.2 (95% CI 3.6-4.8) and 12 (95% CI 8.7-15.4) months, respectively. Translational research showed a significant correlation between CDK4 mRNA and protein expression. Palbociclib was active in a variety of sarcoma subtypes, selected by CDK4/CDKN2A, and deserves further investigation in the sarcoma context.

Indexed as

LipopolysaccharidesSarcomaAdultCyclin-Dependent Kinase 4Cyclin-Dependent Kinase Inhibitor p16HumansPiperazinesPyridinesRNA, MessengerCDK4 protein, humanCDKN2A protein, humanCyclin-Dependent Kinase 4Cyclin-Dependent Kinase Inhibitor p16LipopolysaccharidespalbociclibPiperazinesPyridinesRNA, Messenger

Identifiers

PMID37875500
PMCPMC10598203
OpenAlexW4387898983

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.