| Autor: |
Gilles Freyer, Noelia Martinez-Jañez, Bożena Kukielka-Budny, Malgorzata Ulanska, Hugues Bourgeois, Montserrat Muñoz, Serafin Morales, Juan Bayo Calero, Laura Cortesi, Tamás Pintér, Markéta Palácová, Nelli Cherciu, Edgar Petru, Johannes Ettl, Cécilia de Almeida, Gustavo Villanova, Romain Raymond, Christine Ta Thanh Minh, Ana Rodrigues, Marina E. Cazzaniga |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
Breast, Vol 74, Iss , Pp 103681- (2024) |
| Druh dokumentu: |
article |
| ISSN: |
1532-3080 |
| DOI: |
10.1016/j.breast.2024.103681 |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
|
Full Text from ScienceDirect