Duerinck Johnny, Clement Paul M, Bouttens Frank, Andre Chantal, Neyns Bart, Staelens Yves, Van Fraeyenhove Frank, Baurain Jean-Francois, Luce Sylvie, D'hondt Lionel, Joosens Eric, Specenier Pol, Verschaeve Vincent, Filleul Bertrand, Vroman Philippe, Stragier Barbara, Rogiers Anne
Department of Neurosurgery, UZ Brussel, Brussels, Belgium,
J Neurol. 2015 Mar;262(3):742-51. doi: 10.1007/s00415-014-7633-z. Epub 2015 Jan 9.
Bevacizumab (BEV) has demonstrated anti-tumor activity in patients with recurrent glioblastoma (rGB). Given the unmet need for active therapeutic options in rGB patients, a medical need program was initiated by the Belgian competent authorities. Between November 2010 and February 2013, a total of 313 patients with rGB initiated treatment with BEV administered at a dose of 10 mg/kg every 2 weeks. All patients had failed prior treatment with at least radiation therapy and temozolomide and the majority of patients (70 %) were treated with corticosteroids at baseline. Patients received a median of 6 BEV administrations (range 1-53). Overall, BEV was well tolerated. During BEV treatment the WHO-Performance Score (WHO-PS) improved in 59 patients (19 %) and stabilized for at least 6 weeks in an additional 139 (44 %) patients. Corticosteroid treatment could be stopped in 16 % or reduced in dose in 32 % of patients. The best objective tumor response rate using RANO criteria (investigator's assessment) was 3.5 % CR, 22 % PR, 38 % SD and 37 % PD. The median and 6-month PFS were 13 weeks (95 % CI 12.7-14) and 27.3 % (95 % CI 22.3-32.5), median and 6-month OS rates were 26 weeks (23-29) and 52 % (46.4-58.6), respectively. WHO-PS (0-1 vs. 2-3) and baseline steroid use were significantly correlated with PFS and OS. Our observations support the use of BEV as a monotherapy for patients with rGB who have no alternative treatment options. Optimal benefit from BEV treatment is likely to be obtained when treatment is initiated before the performance status deteriorates to two or less.
贝伐单抗（BEV）已在复发性胶质母细胞瘤（rGB）患者中显示出抗肿瘤活性。鉴于rGB患者对有效治疗方案的需求未得到满足，比利时主管当局启动了一项医疗需求计划。在2010年11月至2013年2月期间，共有313例rGB患者开始接受BEV治疗，剂量为每2周10mg/kg。所有患者先前至少接受过放疗和替莫唑胺治疗均失败，且大多数患者（70%）在基线时接受了皮质类固醇治疗。患者接受BEV治疗的中位次数为6次（范围1 - 53次）。总体而言，BEV耐受性良好。在BEV治疗期间，59例患者（19%）的世界卫生组织表现状态评分（WHO-PS）有所改善，另有139例患者（44%）至少稳定6周。16%的患者可停用皮质类固醇治疗，32%的患者皮质类固醇剂量可减少。根据RANO标准（研究者评估），最佳客观肿瘤缓解率为3.5%完全缓解（CR）、22%部分缓解（PR）、38%疾病稳定（SD）和37%疾病进展（PD）。中位无进展生存期（PFS）和6个月PFS率分别为13周（95%CI 12.7 - 14）和27.3%（95%CI 22.3 - 32.5），中位总生存期（OS）和6个月OS率分别为26周（23 - 29）和52%（46.4 - 58.6）。WHO-PS（0 - 1 vs. 2 - 3）和基线时使用类固醇与PFS和OS显著相关。我们的观察结果支持将BEV作为无可替代治疗选择的rGB患者的单一疗法。当在表现状态恶化至2级或更低之前开始治疗时，可能从BEV治疗中获得最佳益处。
