209P Real-world effectiveness of palbociclib + endocrine therapy in HR+/HER2- advanced breast cancer patients: Interim results of the PERFORM study
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Le résumé fourni par la source
Endocrine therapy (ET) + CDK4/6 inhibitors are first-line (1L) standard in patients (pts) with HR+/HER2- advanced breast cancer (ABC). High efficacy and good tolerability have been shown in randomized clinical trials. To support these findings and to obtain insights in the CDK4/6i usage in the real-world further studies are important. The prospective, non-interventional PERFORM study aims to enroll 1, 900 pts from 320 sites across Germany and Austria to gain insights on effectiveness, tolerability, patient-reported outcomes. Here, we show results of the third interim analysis (IA3) on effectiveness in the total analysis population and chosen subgroups. Between 10/2020 and 09/2023, 1211 pts were enrolled, 1110 pts had a follow-up of >6 months and 990 pts were evaluable for analysis. The median age was 68.5 years (range 33-96), 29.1% of pts were ≥75 years old, 11.7% had ECOG ≥2 at inclusion. 99.2% of pts are female and 1% (n=8) male. The rate of de novo ABC was 39.5%. Regarding the sites of metastases, 45.9% had visceral, 34.7% bone only, 11.1% non-visceral metastases and 8.3% no metastases present at inclusion. Median progression-free survival (PFS) was 29.6 months in the total population. 12-month-PFS rate was 71.0%; overall response rate (ORR) and clinical benefit rate (CBR) were 34.1% and 63.4%, respectively. Notably, 12-month-PFS rate, ORR and CBR were similar across age subgroups: 12-month-PFS rate was 70.5% for pts <75 years vs. 72.2% for pts ≥75 years, ORR 33.9% vs. 34.7% and CBR 64.4 % vs. 61.1%, respectively. De novo disease was associated with higher ORR compared to non-de novo disease. Pts with no metastasis [LMP1] [SW2] at inclusion showed higher PFS rates compared to pts with bone-only metastases or non-visceral disease. Visceral involvement was associated with lowest PFS rates at 6 and 12 months. The IA3 of PERFORM shows results regarding PFS, ORR and CBR of 1L treatment with palbociclib + ET in a broad real world patient population and chosen subgroup. The obtained results are in line with the data of clinical trials and support use of palbociclib-based treatment independent of e.g. age.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- 209P Real-world effectiveness of palbociclib + endocrine therapy in HR+/HER2- advanced breast cancer patients: Interim results of the PERFORM study
- Date Crossref
- 01/05/2024
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Johanna-Etienne-Krankenhaus pays non établi dans la noticeÉtablissement de santé
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Klinik für Frauenheilkunde pays non établi dans la noticeÉtablissement de santé
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Praxis für Hämatologie und Onkologie pays non établi dans la noticeÉtablissement de santé
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cts CaritasKlinikum Saarbrücken pays non établi dans la noticeÉtablissement de santé
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Fischer (Germany) pays non établi dans la noticeEntreprise
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Klinikum Fichtelgebirge pays non établi dans la noticeÉtablissement de santé
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Fraunhofer Project Centre Wolfsburg pays non établi dans la noticeStructure de recherche
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Pfizer (Germany) pays non établi dans la noticeEntreprise
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Pfizer (Austria) pays non établi dans la noticeEntreprise
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Iomedico (Germany) pays non établi dans la noticeEntreprise
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Olgahospital pays non établi dans la noticeÉtablissement de santé
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Medical University of Vienna pays non établi dans la noticeUniversité ou école supérieure
Johanna-Etienne-Krankenhaus, Klinik für Frauenheilkunde et Praxis für Hämatologie und Onkologie, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.