Evidence map›Paper›PMID 39754986›Full record

Observational studyESMO open2025

Drug-drug interactions between palbociclib and proton pump inhibitors in early breast cancer: an exploratory analysis of PALLAS (ABCSG-42/AFT-05/BIG-14-13/PrE0109).

E Agostinetto, G Pfeiler, D Hlauschek, E L Mayer, M Lambertini, E de Azambuja, M Bellet-Ezquerra, J L Meisel, G Rubovszky, N Zdenkowski and 10 more

Abstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. 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.

E AgostinettoInstitut Jules Bordet and l'Université Libre de Bruxelles (U.L.B.), Hôpital Universitaire de Bruxelles (H.U.B.), Brussels, Belgium. Electronic address: elisa.agostinetto@hubruxelles.be.
G PfeilerDepartment of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna, Austria.
D HlauschekAustrian Breast and Colorectal Cancer Study Group (ABCSG), Vienna, Austria.
E L MayerDana-Farber Cancer Institute, Boston, USA.
M LambertiniDepartment of Medical Oncology, Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Genoa, Italy; Department of Internal Medicine and Medical Specialties (DIMI), School of Medicine, University of Genova, Genoa, Italy.
E de AzambujaInstitut Jules Bordet and l'Université Libre de Bruxelles (U.L.B.), Hôpital Universitaire de Bruxelles (H.U.B.), Brussels, Belgium.
M Bellet-EzquerraVall d'Hebron Institute of Oncology, Barcelona, Spain.
J L MeiselWinship Cancer Institute, Emory University, Atlanta, USA.
G RubovszkyNational Institute of Oncology, Budapest, Hungary.
N ZdenkowskiUniversity of Newcastle, Newcastle, Australia.
Y NovikNew York University, New York, USA.
M Ruiz-BorregoHospital Universitario Virgen del Rocío, Seville, Spain; GEICAM, Spanish Breast Cancer Group, Madrid, Spain.
K A GelmonBC Cancer, Vancouver, Canada.
E P MamounasAdventHealth Cancer Institute, Orlando, USA.
H IwataNagoya City University, Nagoya, Japan.
D R LuPfizer, New York, USA.
L SoelknerAustrian Breast and Colorectal Cancer Study Group (ABCSG), Vienna, Austria.
C FeslAustrian Breast and Colorectal Cancer Study Group (ABCSG), Vienna, Austria.
M GnantAustrian Breast and Colorectal Cancer Study Group (ABCSG), Vienna, Austria; Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
A DeMicheleAbramson Cancer Center, University of Pennsylvania, Philadelphia, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundConcomitant intake of proton pump inhibitors (PPIs) may create drug-drug interactions, potentially impacting efficacy of anticancer agents. In the phase III PALLAS trial, the addition of palbociclib capsules to standard adjuvant endocrine therapy in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer did not improve invasive disease-free survival (iDFS). We explored whether concomitant use of PPIs affected survival outcomes in patients treated with palbociclib in PALLAS.

methodsThis is an exploratory analysis of PALLAS including patients who received at least one dose of palbociclib capsules. We aimed to determine the association of concomitant PPI use with iDFS, distant relapse-free survival and overall survival. Uni- and multivariable Cox models with time-dependent PPI were used. The association between PPI use and neutropenia was also investigated.

resultsOf 2840 patients treated with palbociclib + endocrine therapy, 525 (18.5%) had concomitant PPI and palbociclib intake. PPI intake was significantly associated with older age, post-menopausal status, use of aromatase inhibitors, higher body mass index, and worse Eastern Cooperative Oncology Group status (all P < 0.001). Concomitant PPI intake was not significantly associated with survival outcomes (iDFS, distant relapse-free survival, overall survival). All-grade neutropenia rates were numerically lower in patients who initiated a PPI before study start compared with patients never initiating PPIs (adjusted odds ratio 0.81, 95% confidence interval 0.60-1.09).

conclusionsOur exploratory analysis did not demonstrate worse survival outcomes in patients receiving concomitant palbociclib and PPIs in PALLAS. Nonetheless, careful consideration of possible drug-drug interactions is important, especially when studying novel agents in the early breast cancer setting.

Indexed as

Antineoplastic AgentsBreast NeoplasmsPiperazinesProton Pump InhibitorsPyridinesAdultAgedAntineoplastic Combined Chemotherapy ProtocolsClinical Trials, Phase III as TopicDrug InteractionsFemaleHumansMiddle AgedRandomized Controlled Trials as TopicAntineoplastic AgentspalbociclibPiperazinesProton Pump InhibitorsPyridinesbreast cancerpalbociclibPALLASproton pump inhibitors

Identifiers

PMID39754986
PMCPMC11758119

What OpenQuestion holds

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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.