Senologie - Zeitschrift für Mammadiagnostik und -therapie 2021; 18(02): e20
DOI: 10.1055/s-0041-1730185
Abstracts
Senologie

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

S Krajnak
1   Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Geburtshilfe und Frauengesundheit, Mainz, Deutschland
,
T Decker
2   Schwerpunktpraxis für Hämatologie und Onkologie, Ravensburg, Deutschland
,
L Schollenberger
3   Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Interdisziplinäres Zentrum Klinische Studien (IZKS), Mainz, Deutschland
,
C Rosé
4   Pierre-Fabre GmbH, Freiburg, Deutschland
,
C Ruckes
3   Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Interdisziplinäres Zentrum Klinische Studien (IZKS), Mainz, Deutschland
,
T Fehm
5   Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde und Geburtshilfe, Düsseldorf, Deutschland
,
C Thomssen
6   Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Gynäkologie, Halle (Saale), Deutschland
,
N Harbeck
7   Klinikum der Ludwig-Maximilians-Universität München, Brustzentrum, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, CCC München, München, Deutschland
,
M Schmidt
1   Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Geburtshilfe und Frauengesundheit, Mainz, Deutschland
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    Purpose Metronomic chemotherapy 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. VinoMetro aimed to investigate a truly metronomic schedule with daily oral vinorelbine (VRL) in HR+/HER2- MBC patients following endocrine resistance.

    Methods VinoMetro was a multicentre, open-label, single-arm, phase II study of metronomic oral 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. Secondary endpoints were duration of disease control (DoDC), progression-free survival (PFS) and time to treatment failure (TTF). Assessment of safety and tolerability of metronomic VRL was conducted according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

    Results Between January 2017 and April 2019, 9 patients were enrolled. All patients presented with visceral metastases at the time of treatment initiation. The CBR was 22.2 % (90 % confidence interval 4.1-55.0), p=0.211. The median DoDC was 45.8 weeks (range: 31.4-60.1). The median PFS was 12.0 weeks (95 % CI 11.3-12.7), median TTF was 13.4 weeks (95 % CI 9.0-17.8). Grade 3-4 AEs occurred in 22.2 % of patients. One patient died of febrile neutropenia.

    Conclusions VinoMetro (AGO-B-046) was closed early after 9 patients and occurrence of one grade 5 toxicity. Metronomic dosing of oral VRL in HR+/HER2- MBC as first-line CT after failure of endocrine-based therapies showed only limited benefit in this population.


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    Interessenkonflikt

    Slavomir Krajnak: VinoMetro was supported by an unrestricted grant provided by Pierre Fabre Pharma GmbH (Freiburg, Germany) Marcus Schmidt: VinoMetro was supported by an unrestricted grant provided by Pierre Fabre Pharma GmbH (Freiburg, Germany) VinoMetro was an investigator initiated trial (NCT03007992) sponsored by the University Medical Centre of the Johannes Gutenberg-University Mainz, Germany, and supported by an unrestricted grant provided by Pierre Fabre Pharma GmbH (Freiburg, Germany).

    Publication History

    Article published online:
    01 June 2021

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