Brems-Eskildsen Anne Sofie, Kenholm Julia, Brixen Annette Torbøl, Rønlev Jeanette Dupont, Stenbygaard Lars, Danø Hella, Grunnet Mie, Jakobsen Erik Hugger, Neimann Jeppe, Langkjer Sven Tyge, Geisler Jürgen
Department of Oncology, University Hospital Aarhus, Aarhus, Denmark.
Department of Oncology, Regional Hospital West Jutland, Goedstrup, Denmark.
Breast Cancer Res Treat. 2025 Sep;213(2):237-246. doi: 10.1007/s10549-025-07777-5. Epub 2025 Jul 11.
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.
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.
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.
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.
恶性肿瘤化疗的节拍器原则，即使用频繁的小剂量给药，已被认为与传统给药方式相比具有更高的疗效。因此，我们旨在研究按照节拍器给药方案使用长春瑞滨治疗在临床疗效和安全性方面是否优于传统口服治疗。欧盟临床试验注册号：2016 - 002165 - 63。
NAME试验是一项开放标签、随机、多中心的II期研究。我们纳入了2017年至2022年丹麦的163例转移性乳腺癌患者。所有参与者被随机分为A组接受标准治疗，即第1天和第8天口服长春瑞滨，每三周一次；或B组接受节拍器治疗，即每日口服长春瑞滨。
两个治疗组的患者分布均衡。两组的中位年龄均为68 - 69岁，研究入组时的身体状况良好。我们发现A组的中位无进展生存期（PFS）为3.9个月，B组的中位PFS为2.3个月（P = 0.236）。A组的中位总生存期（OS）为16.6个月，B组为15.1个月（P = 0.355）。不良事件评估显示，两种治疗方案的耐受性都很好，没有显著差异。
我们对NAME试验结果的总体评估表明，节拍器口服长春瑞滨并不优于长春瑞滨的标准治疗，且在副作用方面没有任何显著差异。
