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SHR Neuro Cancer Cardio Lipid Metab Microb

Freyer, G; Martinez-Jañez, N; Kukielka-Budny, B; Ulanska, M; Bourgeois, H; Muñoz, M; Morales, S; Calero, JB; Cortesi, L; Pintér, T; Palácová, M; Cherciu, N; Petru, E; Ettl, J; de, Almeida, C; Villanova, G; Raymond, R; Minh, CTT; Rodrigues, A; Cazzaniga, ME.
Single-agent metronomic versus weekly oral vinorelbine as first-line chemotherapy in patients with HR-positive/HER2-negative advanced breast cancer: The randomized Tempo Breast study.
Breast. 2024; 74:103681 Doi: 10.1016/j.breast.2024.103681 [OPEN ACCESS]
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Co-authors Med Uni Graz: Petru Edgar
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Abstract:: INTRODUCTION: Single-agent oral vinorelbine is a standard of care for hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) that has progressed on endocrine therapy. Metronomic administration may offer a better balance of efficacy and safety than standard regimens, but data from previous trials are scarce. METHODS: In this open-label, multicenter, phase II trial, patients were randomized to oral vinorelbine administered on a metronomic (50 mg three times weekly) or weekly (60 mg/m² in cycle 1, increasing to 80 mg/m² if well tolerated) schedule. Treatment was continued until disease progression or intolerance. The primary endpoint was disease control rate (DCR, the proportion of patients with a best overall confirmed response of CR, PR, or stable disease lasting 6 months or more). RESULTS: One-hundred sixty-three patients were randomized and treated. The DCR was 63.4% (95% confidence interval [CI]: 52.0-73.8) with metronomic vinorelbine and 72.8% (95% CI: 61.8-82.1) with weekly vinorelbine. Weekly vinorelbine was also associated with longer progression-free survival (5.6 vs 4.0 months) and overall survival (26.7 vs 22.3 months) than metronomic vinorelbine, but was associated with more adverse events. CONCLUSIONS: In this randomized phase II trial, single-agent metronomic oral vinorelbine was effective and well tolerated as first-line chemotherapy for patients with HR-positive/HER2-negative ABC. Formal comparisons are not done in this phase II study and one can simply observe that confidence intervals of all endpoints overlap. When deciding for a chemotherapy after failure of endocrine therapy and CDK 4/6 inhibitors, oral vinorelbine might be an option to be given with either schedule. CLINICAL TRIAL REGISTRATION NUMBER: EudraCT 2014-003860-19.
Find related publications in this database (Keywords): Administration; Metronomic; Oral; Chemotherapy; Disease control rate; HR+/HER2-advanced breast cancer; Vinorelbine; Weekly administration