Evidence map›Paper›PMID 33025213›Full record

Trial reportTargeted oncology2020

Phase II Trial of Palbociclib in Recurrent Retinoblastoma-Positive Anaplastic Oligodendroglioma: A Study from the Spanish Group for Research in Neuro-Oncology (GEINO).

Juan Manuel Sepúlveda-Sánchez, Miguel Gil-Gil, Miriam Alonso-García, María Ángeles Vaz Salgado, Elena Vicente, Carlos Mesía Barroso, Ángel Rodríguez Sánchez, Gema Durán, Ramón De Las Peñas, José Muñoz-Langa and 13 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Targeted oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.7field-weighted citation impact, top 14% 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

13 citing papers in PubMed, 20 citations in OpenAlex.

  1. Trial
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  6. Glioblastoma: An Update in Pathology, Molecular Mechanisms and Biomarkers.International journal of molecular sciences · 2024
    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

23 authors at 13 institutions in 1 country.

Juan Manuel Sepúlveda-SánchezMedical Oncology Department, Hospital Universitario, 12 de Octubre, Avda. Andalucía s/n, 28041, Madrid, Spain. sepulvedasanchez@seom.org.ORCID 0000-0003-3548-9961
Miguel Gil-GilMedical Oncology Department, Institut Català d'Oncologia L'Hospitalet, L'Hospitalet de Llobregat, Barcelona, Spain.
Miriam Alonso-GarcíaMedical Oncology Department, Hospital Universitario Virgen del Rocío, Seville, Spain.
María Ángeles Vaz SalgadoMedical Oncology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Elena VicenteMedical Oncology Department, Hospital Universitario Insular de Gran Canaria, Las Palmas, Spain.
Carlos Mesía BarrosoMedical Oncology Department, Institut Català d'Oncologia L'Hospitalet, L'Hospitalet de Llobregat, Barcelona, Spain.
Ángel Rodríguez SánchezMedical Oncology Department, Hospital Universitario de León, León, Spain.
Gema DuránUnidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen de la Victoria, IBIMA, Málaga, Spain.
Ramón De Las PeñasMedical Oncology Department, Consorcio Hospitalario Provincial de Castellón, Castellón, Spain.
José Muñoz-LangaMedical Oncology Department, Hospital Universitario y Policlínico La Fe, Valencia, Spain.
Guillermo VelascoChemical Sciences Faculty, Universidad Complutense de Madrid, Madrid, Spain.
Aurelio Hernández-LaínDepartment of Pathology (Neuropathology), Instituto de Investigaciones Biomédicas I+12, Hospital Universitario, 12 de Octubre, Madrid, Spain.
Amaya HilarioRadiology Department, Universitary Hospital, 12 de Octubre, Madrid, Spain.
Miguel Navarro MartínMedical Oncology Department, Hospital Universitario de Salamanca, Salamanca, Spain.
Manuel BenavidesUnidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen de la Victoria, IBIMA, Málaga, Spain.
Laura OleagaRadiology Department, Hospital Clínic Barcelona, Barcelona, Spain.
Diana Cantero MontenegroNeurooncology (Molecular Biology) Department, Hospital Universitario, 12 de Octubre, Madrid, Spain.
Yolanda RuanoMolecular Pathology Unit, Hospital Universitario 12 de Octubre Research Institute, Madrid, Spain.
Pilar Sánchez-GómezNeurooncology Unit, Instituto de Salud Carlos III-UFIEC, Madrid, Spain.
María Cruz Martín-SoberónMedical Oncology Department, Hospital Universitario, 12 de Octubre, Avda. Andalucía s/n, 28041, Madrid, Spain.
Robert Morales-LlombartMFAR Clinical Research, Barcelona, Spain.
Vanessa PachónMedical Oncology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Estela PinedaTranslational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.
Hospital Universitario 12 De Octubre · ESHospital Clínic de Barcelona · ESHospital Clínico Universitario Virgen de la Victoria · ESHospital Universitario Ramón y Cajal · ESInstitut Català d'Oncologia · ESComplejo Hospitalario de Salamanca · ESConsorcio Hospitalario Provincial de Castellón · ESHospital de León · ESHospital Universitari i Politècnic La Fe · ESHospital Universitario Insular de Gran Canaria · ESHospital Universitario Virgen del Rocío · ESInstituto de Salud Carlos III · ESUniversidad Complutense de Madrid · ES

Funding

Pfizer WI174842
6 · The paper itself

Abstract

backgroundThe cell cycle checkpoint G1/S, dependent on cyclin-dependent kinase (CDK) 4 amplification/overexpression and retinoblastoma phosphorylation, is altered in most anaplastic oligodendrogliomas (AOs).

objectiveWe aimed to evaluate the efficacy of palbociclib, an oral inhibitor of CDK4/6 with proven efficacy in breast cancer, in patients with AO. The primary endpoint was progression-free survival at 6 months. PATIENTS AND

methodsWe conducted a multicenter, open-label, phase II trial evaluating the efficacy and safety of palbociclib in patients with AO who progressed on radiotherapy and chemotherapy with histologically and molecularly confirmed grade 3 oligodendroglioma and conserved retinoblastoma protein (pRb) expression by immunohistochemistry. Patients were treated with palbociclib (125 mg/day) for 3/1 weeks on/off.

resultsOverall, 34 patients were enrolled across 10 hospitals in the Spanish Group of Neuro-Oncology (GEINO) study. The study was stopped early owing to the lack of efficacy, with 74% of evaluable patients progressing within 6 months, which was insufficient to consider palbociclib as an active drug in this population. Within the median follow-up of 12 months, the median progression-free survival was 2.8 months [95% confidence interval (CI) 2.6-3.1] and the median overall survival was 32.1 months (95% CI 5.1-59.2). There were no partial or complete responses; only 13 patients (38%) achieved stable disease as the best response. Palbociclib was well tolerated, with neutropenia (grade 3 or higher: 58.8%) and thrombocytopenia (grade 3 or higher: 14.7%) as the most common adverse events (AEs). Both AEs had no significant impact.

conclusionDespite the good tolerance, palbociclib monotherapy did not show favorable efficacy against recurrent AO.

trial registrationThis study is registered with ClinicalTrials.gov, identifier NCT0253032 (retrospectively registered on 21 August 2015).

Indexed as

AdultAgedFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalOligodendrogliomaPiperazinesProtein Kinase InhibitorsPyridinesRetinoblastomaTreatment OutcomepalbociclibPiperazinesProtein Kinase InhibitorsPyridines

Identifiers

PMID33025213
OpenAlexW3092471679

What OpenQuestion holds

Textmetadata
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.