A direct comparison of classical oral Navelbine vs metronomic Navelbine in metastatic breast cancer: results from the Danish Breast Cancer Group's (DBCG) NAME-trial.

Purpose: The metronomic principle of chemotherapy for malignancies, using frequent small doses, has been suggested to show superior efficacy compared with classical administration. Thus, we aimed at investigating whether treatment with Navelbine, according to the metronomic drug schedule, was superior to conventional oral treatment in terms of clinical efficacy and safety. EUDRACT no: 2016-002165-63.

Methods: The NAME-trial was an open label, randomized, multicenter phase II study. We included 163 patients with metastatic breast cancer in Denmark between 2017 and 2022. All participants were randomized between standard treatment in arm A with classical per oral Vinorelbine day 1 and day 8, every three weeks, or in arm B metronomic treatment with per oral Vinorelbine given as daily doses.

Results: The distribution of patients was well balanced between the two treatment arms. The median age was 68-69 years in both arms, with a good performance status at study entry. We found a median progression-free survival (PFS) in arm A of 3.9 months and a median PFS in arm B of 2.3 months (P = 0.236). The median overall survival (OS) was 16.6 months in arm A and 15.1 months in arm B (P = 0.355). The evaluation of the adverse events showed that both regimes were well tolerated without significant differences.

Conclusion: Our overall evaluation of the NAME-trial results showed that metronomic oral Navelbine is not superior to the standard treatment with Vinorelbine and without any significant differences concerning side effects.