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

Overview

Journal J Cancer Res Clin Oncol

Specialty Oncology

Date 2021 Mar 20

PMID 33743073

Citations 5

Authors

Slavomir Krajnak

Thomas Decker

Lukas Schollenberger

Christian Rose

Christian Ruckes

Tanja Fehm

Christoph Thomssen

Nadia Harbeck

Marcus Schmidt

Affiliations

Soon will be listed here.

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.

Trial Registration Number And Date Of Registration: ClinicalTrials.gov Identifier: NCT03007992; December 15, 2016.

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