Evidence map›Paper›PMID 36165912›Full record

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

Palbociclib Rechallenge for Hormone Receptor-Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial.

Joan Albanell, José Manuel Pérez-García, Miguel Gil-Gil, Giuseppe Curigliano, Manuel Ruíz-Borrego, Laura Comerma, Joan Gibert, Meritxell Bellet, Begoña Bermejo, Lourdes Calvo and 14 more

Open access · hybridAbstract readMulticenter StudyClinical 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 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
5.3field-weighted citation impact, top 3% 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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

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  14. CDK4/6 inhibitors: The Devil is in the Detail.Current oncology reports · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 16 institutions in 5 countries.

Joan Albanell *Medical Oncology Department, Hospital del Mar, Barcelona, Spain.ORCID 0000-0003-1239-4580
José Manuel Pérez-García *International Breast Cancer Center (IBCC), Quironsalud Group, Barcelona, Spain.ORCID 0000-0003-4238-2046
Miguel Gil-GilGEICAM, Spain.ORCID 0000-0003-1380-2718
Giuseppe CuriglianoIstituto Europeo di Oncologia, IRCCS, Milano, Italy.ORCID 0000-0003-1781-2518
Manuel Ruíz-BorregoGEICAM, Spain.ORCID 0000-0002-1181-5622
Laura ComermaCancer Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.ORCID 0000-0002-0249-4636
Joan GibertCancer Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.ORCID 0000-0002-0742-0759
Meritxell BelletVall d´Hebrón University Hospital, Barcelona, Spain.ORCID 0000-0001-8859-8307
Begoña BermejoCentro de Investigación Biomédica en Red de Oncología (CIBERONC-ISCIII), Madrid, Spain.ORCID 0000-0001-7773-5994
Lourdes CalvoGEICAM, Spain.ORCID 0000-0001-8314-0241
Juan de la HabaHospital Universitario Reina Sofía, Córdoba, Spain.ORCID 0000-0001-5111-1702
Enrique EspinosaHospital Universitario La Paz, Madrid, Spain.ORCID 0000-0001-6562-7902
Alessandro Marco MinisiniDepartment of Oncology, Azienda Sanitaria Universitaria del Friuli Centrale, Udine, Italy.ORCID 0000-0001-7712-7286
Vanesa QuirogaBadalona-Applied Research Group in Oncology (B-ARGO Group), Catalan Institute of Oncology, Badalona, Barcelona, Spain.ORCID 0000-0002-7852-474X
Ana Santaballa BertranHospital Universitari i Politècnic La Fe, Valencia, Spain.ORCID 0000-0001-7763-320X
Leonardo MinaMedica Scientia Innovation Research (MEDSIR), Barcelona, Spain and Ridgewood, New Jersey.ORCID 0000-0002-2289-4936
Beatriz BellosilloCancer Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.ORCID 0000-0002-5335-2726
Federico RojoCentro de Investigación Biomédica en Red de Oncología (CIBERONC-ISCIII), Madrid, Spain.ORCID 0000-0001-9989-0290
Silvia MenéndezCancer Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.ORCID 0000-0002-9116-8743
Miguel Sampayo-CorderoMedica Scientia Innovation Research (MEDSIR), Barcelona, Spain and Ridgewood, New Jersey.ORCID 0000-0003-1469-3410
Crina PopaMedica Scientia Innovation Research (MEDSIR), Barcelona, Spain and Ridgewood, New Jersey.ORCID 0000-0002-4294-9949
Andrea MalfettoneMedica Scientia Innovation Research (MEDSIR), Barcelona, Spain and Ridgewood, New Jersey.ORCID 0000-0003-3467-2334
Javier Cortés *International Breast Cancer Center (IBCC), Quironsalud Group, Barcelona, Spain.ORCID 0000-0001-7623-1583
Antonio Llombart-Cussac *Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain and Ridgewood, New Jersey.ORCID 0000-0003-4515-8293
MedSIR (Spain) · ESHospital Del Mar · ESUniversitat Pompeu Fabra · ESBreast Cancer Research Foundation · USComplexo Hospitalario Universitario A Coruña · ESHebron University · PSHospital Municipal de Badalona · ESHospital Universitari i Politècnic La Fe · ESHospital Universitario Fundación Jiménez Díaz · ESHospital Universitario La Paz · ESHospital Universitario Reina Sofía · ESHospital Universitario Virgen del Rocío · ESOspedale Santa Maria della Misericordia di Udine · ITUniversitat de València · ESUniversity of Milan · ITValencia Catholic University Saint Vincent Martyr · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess the efficacy and exploratory biomarkers of continuing palbociclib plus endocrine therapy (ET) beyond progression on prior palbociclib-based regimen in patients with hormone receptor-positive/HER2-negative (HR+/HER2-) advanced breast cancer (ABC). PATIENTS AND

methodsThe multicenter, open-label, phase II BioPER trial included women who had experienced a progressive disease (PD) after having achieved clinical benefit on the immediately prior palbociclib plus ET regimen. Palbociclib (125 mg, 100 mg, or 75 mg daily orally for 3 weeks and 1 week off as per prior palbociclib-based regimen) plus ET of physician's choice were administered in 4-week cycles until PD or unacceptable toxicity. Coprimary endpoints were clinical benefit rate (CBR) and percentage of tumors with baseline loss of retinoblastoma (Rb) protein expression. Additional endpoints included safety and biomarker analysis.

resultsAmong 33 patients enrolled, CBR was 34.4% [95% confidence interval (CI), 18.6-53.2; P < 0.001] and 13.0% of tumors (95% CI, 5.2-27.5) showed loss of Rb protein expression, meeting both coprimary endpoints. Median progression-free survival was 2.6 months (95% CI, 1.8-6.7). No new safety signals were reported. A signature that included baseline mediators of therapeutic resistance to palbociclib and ET (low Rb score, high cyclin E1 score, ESR1 mutation) was independently associated with shorter median progression-free survival (HR, 22.0; 95% CI, 1.71-282.9; P = 0.018).

conclusionsMaintaining palbociclib after progression on prior palbociclib-based regimen seems to be a reasonable, investigational approach for selected patients. A composite biomarker signature predicts a subset of patients who may not derive a greater benefit from palbociclib rechallenge, warranting further validation in larger randomized controlled trials.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsFemaleHumansPiperazinesPyridinespalbociclibPiperazinesPyridines

Identifiers

PMID36165912
PMCPMC9811162
OpenAlexW4297261413

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.