Neurosurgery, Department of Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden.
Glioma Immunotherapy Group, Neurosurgery, Department of Clinical Sciences, Lund University, Lund, Sweden.
BMC Neurol. 2023 Feb 18;23(1):76. doi: 10.1186/s12883-023-03119-4.
Glioblastoma (GBM) is the most common primary malignant brain tumor in adults. Despite the best available treatment, prognosis remains poor. Current standard therapy consists of surgical removal of the tumor followed by radiotherapy and chemotherapy with the alkylating agent temozolomide (TMZ). Experimental studies suggest that antisecretory factor (AF), an endogenous protein with proposed antisecretory and anti-inflammatory properties, may potentiate the effect of TMZ and alleviate cerebral edema. Salovum is an egg yolk powder enriched for AF and is classified as a medical food in the European Union. In this pilot study, we evaluate the safety and feasibility of add-on Salovum in GBM patients.
Eight patients with newly diagnosed, histologically confirmed GBM were prescribed Salovum during concomitant radiochemotherapy. Safety was determined by the number of treatment-related adverse events. Feasibility was determined by the number of patients who completed the full prescribed Salovum treatment.
No serious treatment-related adverse events were observed. Out of 8 included patients, 2 did not complete the full treatment. Only one of the dropouts was due to issues directly related to Salovum, which were nausea and loss of appetite. Median survival was 23 months.
We conclude that Salovum is safe to use as an add-on treatment for GBM. In terms of feasibility, adherence to the treatment regimen requires a determined and independent patient as the large doses prescribed may cause nausea and loss of appetite.
ClinicalTrials.gov NCT04116138. Registered on 04/10/2019.
胶质母细胞瘤（GBM）是成人中最常见的原发性恶性脑肿瘤。尽管采用了最佳的治疗方法，但预后仍然较差。目前的标准治疗包括手术切除肿瘤，然后进行放疗和化疗，并用烷化剂替莫唑胺（TMZ）治疗。实验研究表明，具有潜在抗分泌和抗炎特性的内源性蛋白抗分泌因子（AF）可能增强 TMZ 的作用并减轻脑水肿。Salovum 是一种富含 AF 的蛋黄粉，在欧盟被归类为医用食品。在这项初步研究中，我们评估了 GBM 患者添加 Salovum 的安全性和可行性。
8 名新诊断的、组织学证实的 GBM 患者在同期放化疗期间服用 Salovum。通过治疗相关不良事件的数量来确定安全性。通过完成全剂量 Salovum 治疗的患者数量来确定可行性。
未观察到严重的治疗相关不良事件。8 名入组患者中，有 2 名未完成全疗程。仅 1 名脱落患者是由于与 Salovum 直接相关的问题，即恶心和食欲不振。中位生存期为 23 个月。
我们得出结论，Salovum 作为 GBM 的附加治疗是安全的。在可行性方面，由于规定的大剂量可能会引起恶心和食欲不振，因此需要一个坚定且独立的患者才能坚持治疗方案。
ClinicalTrials.gov NCT04116138。注册于 2019 年 4 月 10 日。
