VicTORia: a randomised phase II study to compare vinorelbine in combination with the mTOR inhibitor everolimus versus vinorelbine monotherapy for second-line chemotherapy in advanced HER2-negative breast cancer.

Autor: Decker, Thomas, Marschner, Norbert, Muendlein, Axel, Welt, Anja, Hagen, Volker, Rauh, Jaqueline, Schröder, Helge, Jaehnig, Peter, Potthoff, Karin, Lerchenmüller, Christian
Zdroj: Breast Cancer Research & Treatment; Aug2019, Vol. 176 Issue 3, p637-647, 11p
Abstrakt: Purpose: Improving the outcome of patients with HER2-negative metastatic breast cancer experiencing tumour progression following first-line chemotherapy remains an urgent medical need. The purpose of the VicTORia trial was to show superiority of everolimus in combination with vinorelbine versus vinorelbine monotherapy as second-line chemotherapy for patients with advanced HER2 negative breast cancer. Methods: In this randomised phase II trial, 133 patients were recruited in 32 centres in Germany. Patients were randomised 1:1 to second-line chemotherapy either with vinorelbine plus everolimus (arm1) or vinorelbine alone (arm2). Primary endpoint was progression-free survival (PFS). Secondary endpoints were PFS rate at 6 months, overall survival (OS), overall response rate (ORR) and safety. Baseline PI3 K mutational status was determined in plasma samples. Results: Median progression-free survival was not different between arms (arm1 vs. arm2: 4.01 months, 95% CI 2.40–6.09 vs. 4.08, 95% CI 2.80–5.33). PFS rate at 6 months (arm1 vs. arm2: 39.4%, 95% CI 27.6–50.9% vs. 36.6%, 95% CI 24.6–48.6%), median OS (arm1 vs. arm2: 16.3 months, 95% CI 11.4–19.0 vs. 13.8 months, 95% CI 10.2–19.1) and ORR were not different between arms. Most frequent grade 3/4 adverse events were neutropenia (50% vs. 40%), gastrointestinal toxicities (19.1% vs. 6.1%), and infections (19.1% vs. 7.7%). PI3 K mutational status was neither associated with PFS nor with OS. Conclusion: Although well tolerated, the efficacy of everolimus and vinorelbine combination therapy was not superior to vinorelbine monotherapy. There was no correlation between PI3 K mutational status and efficacy. EudracCT No 2011-001024-38, ClinicalTrials.gov No NCT01520103 [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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