Evidence map›Paper›PMID 38561577›Full record

Observational studyBreast cancer research and treatment2024

First-line therapy with palbociclib in patients with advanced HR

N Martínez-Jañez, M Bellet Ezquerra, L M Manso Sanchez, F Henao Carrasco, A Anton Torres, S Morales, P Tolosa Ortega, V L Obadia Gil, T Sampedro, R Andrés Conejero and 10 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Breast cancer research and treatment, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04874025 (Observational Analysis of Treatment With Palbociclib in Patients With Locally Advanced and / or Metastatic RH + / HER 2- Breast Cancer in the First Line of Treatment Within Routine Clinical Practice.), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 6% 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.

NCT04874025 completednot on this map

Observational Analysis of Treatment With Palbociclib in Patients With Locally Advanced and / or Metastatic RH + / HER 2- Breast Cancer in the First Line of Treatment Within Routine Clinical Practice.

TypeobservationalSponsorHospital San Carlos, MadridRan2021 to 2022Enrolled815ConditionsBreast CancerArmsIbrance
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Observational
  3. Article
  4. Review
  5. CDK4/6 inhibitors for metastatic breast cancer in routine clinical practice in Spain: survey of patterns of use and oncologists' perceptions.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Article
  6. Observational
  7. p57International journal of molecular sciences · 2024
    Article
  8. CDKN2A somatic copy number amplification in normal tissues surrounding gastric carcinoma reduces cancer metastasis risk in droplet digital PCR analysis.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2024
    Article
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 at 18 institutions in 1 country.

N Martínez-JañezMedical Oncology Department, Ramon y Cajal University Hospital, Hospital Ramón y Cajal, Ctra. de Colmenar Viejo km. 9,100, Madrid, 28034, Spain.ORCID http://orcid.org/0000-0002-0436-0906
M Bellet EzquerraOncology Department, Vall d'Hebron Institute of Oncology (VHIO)-Cellex Center, Barcelona, Spain.ORCID http://orcid.org/0000-0001-8859-8307
L M Manso SanchezMedical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.ORCID http://orcid.org/0000-0002-1683-550X
F Henao CarrascoOncology, Hospital Universitario Virgen Macarena, Seville, Spain.ORCID http://orcid.org/0000-0003-3819-9572
A Anton TorresMedical Oncology Department, Hospital Universitario Miguel Servet, Zaragoza, Spain.ORCID http://orcid.org/0000-0002-9159-4988
S MoralesMedical Oncology Department, Hospital Arnau de Vilanova - Lleida, Alpicat, Spain.ORCID http://orcid.org/0000-0001-7445-4193
P Tolosa OrtegaMedical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.ORCID http://orcid.org/0000-0002-3747-4766
V L Obadia GilBreast Cancer Unit, ICO - Institut Català d'Oncologia l'Hospitalet (Hospital Duran i Reynals) L'Hospitalet De, Llobregat, Spain.ORCID http://orcid.org/0000-0001-9886-2626
T SampedroMedical Oncology Department, Hospital Universitario de Cabuenes, Gijón, Spain.
R Andrés ConejeroMedical Oncology Department, Hospital Clinico Universitario Lozano Blesa, Zaragoza, Spain.ORCID http://orcid.org/0000-0003-4315-415X
L Calvo-MartinezMedical Oncology Department, CHUAC - Complexo Hospitalario Universitario A Coruña, A Coruña, Spain.
E Galve-CalvoMedical Oncology Department, Hospital Universitario de Basurto, Bilbao, Spain.ORCID http://orcid.org/0000-0003-4204-5736
R LópezServicio de Oncología Médica y Grupo de Oncología Médica Traslacional, Hospital Clínico Universitario e Instituto de Investigación Sanitaria-CIBERONC, Santiago de Compostela, Spain.ORCID http://orcid.org/0000-0003-1315-655X
F Ayala de la PenaMedical Oncology Department, Hospital General Universitario Morales Meseguer, Murcia, Spain.ORCID http://orcid.org/0000-0001-6311-920X
S Lopez-TarruellaMedical Oncology Service, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), CIBERONC, Geicam, Universidad Complutense, Madrid, Spain.ORCID http://orcid.org/0000-0002-2606-9538
B A Hernando Fernandez de AraguizMedical Oncology Department, Complejo Hospitalario de Burgos -Hospital General Yagüe, Burgos, Spain.ORCID http://orcid.org/0000-0001-5650-3502
L Boronat RuizOncology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
T Martos CardenasMedical Oncology Department, Hospital del Mar - Parc de Salut Mar, Barcelona, Spain.
J I ChaconMedical Oncology Department, Hospital Virgen de la Salud, Toledo, Spain.
F Moreno AntónMedical Oncology Department, Hospital Clínico Universitario San Carlos, Madrid, Spain. fermor03@ucm.es.ORCID http://orcid.org/0000-0001-8933-0687
Hospital Universitario 12 De Octubre · ESCIBBIM-Nanomedicine · ESComplexo Hospitalario Universitario A Coruña · ESHospital Arnau de Vilanova · ESHospital Clínico San Carlos · ESHospital Clínico Universitario Lozano Blesa · ESHospital de Basurto · ESHospital de Sant Pau · ESHospital General Universitario Gregorio Marañón · ESHospital General Universitario Morales Meseguer · ESHospital General Yagüe · ESHospital Universitario De Cabueñes · ESHospital Universitario Miguel Servet · ESHospital Universitario Virgen Macarena · ESHospital Virgen de la Salud · ESInstitut Català d'Oncologia · ESInstituto de Investigación Sanitaria de Santiago · ESParc de Salut · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the efficacy and safety of first-line therapy with palbociclib in a Spanish cohort treated after palbociclib approval.

methodsPALBOSPAIN is an observational, retrospective, multicenter study evaluating real-world patterns and outcomes with 1 L palbociclib in men and women (any menopausal status) with advanced HR

resultsA total of 762 patients were included. The median rw-PFS and OS were 24 months (95% CI 21-27) and 42 months (40-not estimable [NE]) in the whole population, respectively. By cohort, the median rw-PFS and OS were as follows: 28 (95% CI 23-39) and 44 (95% CI 38-NE) months in patients with de novo metastatic disease, 13 (95% CI 11-17) and 36 months (95% CI 31-41) in patients who experienced relapse < 12 months after the end of ET, and 31 months (95% CI 26-37) and not reached (NR) in patients who experienced relapse > 12 months after the end of ET. rw-PFS and OS were longer in patients with oligometastasis and only one metastatic site and those with non-visceral disease. The most frequent hematologic toxicity was neutropenia (72%; grade ≥ 3: 52.5%), and the most common non-hematologic adverse event was asthenia (38%).

conclusionThese findings, consistent with those from clinical trials, support use of palbociclib plus ET as 1 L for advanced BC in the real-world setting, including pre-menopausal women and men. TRIAL REGISTRATION NUMBER: NCT04874025 (PALBOSPAIN). Date of registration: 04/30/2021 retrospectively registered.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesPiperazinesPyridinesAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedProgression-Free SurvivalProtein Kinase InhibitorsReceptors, EstrogenReceptors, ProgesteroneRetrospective StudiesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespalbociclibPiperazinesProtein Kinase InhibitorsPyridinesReceptors, EstrogenReceptors, ProgesteroneAdvanced breast cancerFirst-line treatmentHR+/HER2−Overall survivalPalbociclibProgression-free survival

Identifiers

PMID38561577
PMCPMC11182794
OpenAlexW4393373053

What OpenQuestion holds

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Registered trials

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.