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http://doi.org/10.25358/openscience-7551
Autoren: | Krajnak, Slavomir Decker, Thomas Schollenberger, Lukas Rosé, Christian Ruckes, Christian Fehm, Tanja Thomssen, Cristoph Harbeck, Nadia Schmidt, Marcus |
Titel: | Phase II study of metronomic treatment with daily oral vinorelbine as first-line chemotherapy in patients with advanced/metastatic HR+/HER2− breast cancer resistant to endocrine therapy : VinoMetro—AGO-B-046 |
Online-Publikationsdatum: | 15-Aug-2022 |
Erscheinungsdatum: | 2021 |
Sprache des Dokuments: | Englisch |
Zusammenfassung/Abstract: | Purpose Metronomic chemotherapy (MCT) is an increasingly used treatment option in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced/metastatic breast cancer (MBC) after failure of endocrine-based therapies. Methods VinoMetro was a multicentre, open-label, single-arm, phase II study of metronomic oral vinorelbine (VRL; 30 mg/day) as a first-line chemotherapy (CT) in patients with HR+/HER2− MBC after endocrine failure. The primary endpoint was the clinical benefit rate (CBR) at 24 weeks. Results Between January 2017 and April 2019, nine patients were enrolled. The CBR was 22.2% (90% confidence interval [CI] 4.1–55.0), p = 0.211. The median progression-free survival (PFS) was 12.0 weeks (95% CI 11.3–12.7). Grade 3–4 adverse events (AEs) occurred in 22.2% of patients. One patient died of febrile neutropenia. Conclusion VinoMetro (AGO-B-046) was closed early after nine patients and occurrence of one grade 5 toxicity in agreement with the lead institutional review board (IRB). Metronomic dosing of oral VRL in HR+/HER2− MBC as first-line CT after failure of endocrine therapies showed only limited benefit in this population. |
DDC-Sachgruppe: | 610 Medizin 610 Medical sciences |
Veröffentlichende Institution: | Johannes Gutenberg-Universität Mainz |
Organisationseinheit: | FB 04 Medizin |
Veröffentlichungsort: | Mainz |
ROR: | https://ror.org/023b0x485 |
DOI: | http://doi.org/10.25358/openscience-7551 |
Version: | Published version |
Publikationstyp: | Zeitschriftenaufsatz |
Nutzungsrechte: | CC BY |
Informationen zu den Nutzungsrechten: | https://creativecommons.org/licenses/by/4.0/ |
Zeitschrift: | Journal of cancer research and clinical oncology 147 |
Seitenzahl oder Artikelnummer: | 3391 3400 |
Verlag: | Springer |
Verlagsort: | Berlin u.a. |
Erscheinungsdatum: | 2021 |
ISSN: | 1432-1335 |
DOI der Originalveröffentlichung: | 10.1007/s00432-021-03599-2 |
Enthalten in den Sammlungen: | JGU-Publikationen |
Dateien zu dieser Ressource:
Datei | Beschreibung | Größe | Format | ||
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phase_ii_study_of_metronomic_-20220812153128606.pdf | 524.1 kB | Adobe PDF | Öffnen/Anzeigen |