Evidence map›Paper›PMID 39707595›Full record

Observational studyInternational journal of cancer2025

Head-to-head comparison of palbociclib and ribociclib in first-line treatment of HR-positive/HER2-negative metastatic breast cancer with real-world data from the OPAL registry.

Marc Thill, Mark-Oliver Zahn, Anja Welt, Arnd Nusch, Matthias Zaiss, Kathrin Engelken, Gabriele Kaltenecker, Kai Ringwald, Katja Gratzke, Stephanie Dille and 9 more

Registry-linked trialAbstract readMulticenter StudyObservational StudyComparative Study
In one paragraph

Observational study in International journal of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03417115 (Treatment and Outcome of Patients With Breast Cancer), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–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.

NCT03417115 recruitingnot on this map

Treatment and Outcome of Patients With Breast Cancer: Clinical Research Platform for Real World Data

Typeobservational_patient_registrySponsoriOMEDICO AGRan2017 to 2032Enrolled6,150ConditionsBreast Cancer
3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. Observational
  7. Observational
  8. Article
  9. Observational
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Observational
  19. 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

19 authors.

Marc ThillAgaplesion Markus Krankenhaus, Klinik für Gynäkologie und Gynäkologische Onkologie, Brustzentrum, Frankfurt am Main, Germany.
Mark-Oliver ZahnMVZ Onkologische Kooperation Harz, Goslar, Germany.
Anja WeltInnere Klinik, Tumorforschung, Universitätsklinikum Essen, Essen, Germany.ORCID 0000-0002-0948-4385
Arnd NuschPraxis für Hämatologie und internistische Onkologie, Ratingen, Germany.
Matthias ZaissPraxis für interdisziplinäre Onkologie und Hämatologie, Freiburg, Germany.
Kathrin EngelkenKlinik Dr. Hancken, Mammazentrum, Stade, Germany.
Gabriele KalteneckerStädtisches Klinikum Karlsruhe, Frauenklinik, Karlsruhe, Germany.
Kai RingwaldBioinformatics, iOMEDICO, Freiburg, Germany.
Katja GratzkeMedical Department, iOMEDICO, Freiburg, Germany.
Stephanie DilleMedical Department, iOMEDICO, Freiburg, Germany.
Lisa KruggelClinical Epidemiology and Health Economics, iOMEDICO, Freiburg, Germany.
Martina JänickeClinical Epidemiology and Health Economics, iOMEDICO, Freiburg, Germany.
Holger SchulzPraxis internistischer Onkologie und Hämatologie PIOH, Köln, Germany.
Volker HagenSt.-Johannes-Hospital, Innere Medizin II, Dortmund, Germany.
Roland FrickerKlinikum Hanau, Gynäkologisches Krebszentrum, Hanau, Germany.
Elmar StickelerUniklinik RWTH Aachen Gynäkologie und Geburtsmedizin, Aachen, Germany.
Nadia HarbeckBrustzentrum, Frauenklinik und CCC München, LMU Klinikum, München, Germany.
Achim WöckelUniversitätsklinikum Würzburg, Frauenklinik und Poliklinik, Würzburg, Germany.
Thomas DeckerStudienzentrum Onkologie, Ravensburg, Germany.ORCID 0000-0003-3814-8775

Funding

Daiichi Sankyo Deutschland GmbHDaiichi Sankyo Europe GmbHEisai GmbHGilead Sciences GmbHLilly Deutschland GmbHMundipharma GmbHMylan Germany GmbHOnkovis GmbHPfizer GmbHRoche Pharma AG
6 · The paper itself

Abstract

Cyclin-dependent kinase 4/6 inhibitors (CDKIs) in combination with endocrine therapy (ET) are the standard-of-care in the first-line treatment of HR-positive, HER2-negative metastatic breast cancer. In the absence of direct head-to-head trials comparing the efficacy and safety of the different CDKIs, the individual choice of treatment in everyday practice is complex. Inverse probability of treatment weighting was used to emulate a head-to-head comparison of palbociclib +ET (PALBO) and ribociclib +ET (RIBO) in patients recruited into the prospective, observational, multicenter registry platform OPAL (NCT03417115). Progression-free survival (PFS), overall survival (OS) and quality of life surveys were analyzed, also for subgroups stratified by treatment-free interval (TFI). A total of 623 patients with HR-positive, HER2-negative metastatic breast cancer received PALBO (n = 388) or RIBO (n = 235) in their first line of treatment. No difference between PALBO and RIBO was found for PFS (median 26.7 months [23.6, 30.7] vs. 27.0 months [21.1, 30.4], HR 1.01 [0.80, 1.27]) and OS (median 42.4 months [38.8, 50.3] vs. 49.3 months [36.9, NA], HR 0.96 [0.71, 1.28]). There was a trend for longer PFS and OS in patients with TFI <12 months receiving RIBO. Patients reported comparable side effects for both CDKIs. This head-to-head comparison revealed no difference in PFS and OS between PALBO and RIBO, however, a trend to longer PFS and OS with RIBO was observed in the subgroup of patients with TFI <12 months. Side effects experienced with PALBO and RIBO highlight the important toxicities to be addressed during treatment decision.

Indexed as

AminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsPiperazinesPurinesPyridinesAdultAgedAged, 80 and overErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedProgression-Free SurvivalProspective StudiesQuality of LifeAminopyridinesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespalbociclibPiperazinesPurinesPyridinesReceptors, EstrogenReceptors, Progesteroneribociclibbreast neoplasmspalbociclibregistriesribociclib

Identifiers

PMID39707595
PMCPMC11887017

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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.