Slavomir Krajnak1, Thomas Decker2, Lukas Schollenberger3, Christian Rosé4, Christian Ruckes3, Tanja Fehm5, Christoph Thomssen6, Nadia Harbeck7, Marcus Schmidt8. 1. Department of Gynaecology and Obstetrics, University Medical Centre, Mainz, Germany. 2. Haematology and Oncology Outpatient Clinic, Ravensburg, Germany. 3. Interdisciplinary Centre for Clinical Trials, University Medical Centre, Mainz, Germany. 4. Pierre-Fabre GmbH, Freiburg, Germany. 5. Department of Gynaecology and Obstetrics, University Medical Centre, Düsseldorf, Germany. 6. Department of Gynaecology, University Medical Centre, Halle (Saale), Germany. 7. Breast Centre, Department of Gynaecology and Obstetrics and CCC Munich LMU, University Hospital, LMU Munich, Munich, Germany. 8. Department of Gynaecology and Obstetrics, University Medical Centre, Mainz, Germany. marcus.schmidt@unimedizin-mainz.de.
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.
PURPOSE: Metronomic chemotherapy (MCT) is an increasingly used treatment option in hormone receptor-positive (HR+)/humanepidermal 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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