Clinical activity of regorafenib in elderly patients with recurrent glioblastoma.

IF 1.4 Q4 ONCOLOGY Molecular and clinical oncology Pub Date : 2023-02-01 DOI:10.3892/mco.2023.2605
Morena Fasano, Mario Pirozzi, Vincenzo Famiglietti, Sergio Facchini, Marianna Caterino, Mara Caroprese, Angela Barillaro, Ilaria Di Giovanni, Annunziata Auriemma, Silvia Ileana Sara Fattoruso, Teresa Somma, Domenico Solari, Marco Bocchetti, Manuel Conson, Roberto Pacelli, Fortunato Ciardiello, Raffaele Addeo
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Abstract

Glioblastoma multiforme is one of the most frequent and aggressive primary tumors in the central nervous system, representing >60% of all brain tumors in adults. Despite treatment, prognosis remains poor with most if not all patients experiencing disease recurrence and a 2-year survival rate of 27%. At present, no confirmed standard treatment exists for recurrent glioblastoma. Regorafenib is one of the few options available, based on results from the REGOMA trial. In the present study, a real-life retrospective investigation on the role of regorafenib in patients with recurrent glioblastoma (>60 years old) from two main Oncological Units in South Italy (Azienda Ospedaliera Universitaria Luigi Vanvitelli, Naples, Italy and Ospedale Civile San Giovanni di Dio, Frattamaggiore, Naples, Italy), was performed. The primary endpoint was overall survival (OS), whereas progression-free survival (PFS), objective response rate and disease control were secondary endpoints. Survival was then analyzed according to age, isocitrate dehydrogenase (IDH) and methylated methylguanine-DNA-methyltransferase (MGMT) status. A total of 56 patients met the eligibility criteria. The intention to treat population median PFS (mPFS) was 4.1 months and median OS (mOS) was 6.8 months. Age did not appear to have a significant influence on mPFS. mOS in MGMT-methylated patients was improved compared with that of the unmethylated group (7.7 months vs. 5.6 months). Both mOS and mPFS were longer in IDH-mutant patients. The present study was one of the first real life analyses of regorafenib in recurrent glioblastoma. The results were in line with the REGOMA trial. Age did not appear to be a prognostic factor, thus suggesting that treatment choice should not be different in elderly. MGMT methylation appeared to influence OS. To the best of our knowledge, this was the first report of regorafenib activity in older patients and, while the results were statistically significant, these should be confirmed in further studies.

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瑞非尼治疗老年复发性胶质母细胞瘤的临床疗效。
多形性胶质母细胞瘤是中枢神经系统最常见、最具侵袭性的原发性肿瘤之一,占成人所有脑肿瘤的60%以上。尽管接受了治疗,但预后仍然很差,大多数(如果不是全部)患者经历疾病复发,2年生存率为27%。目前,对于复发性胶质母细胞瘤尚无明确的标准治疗方法。根据REGOMA试验的结果,regafenib是为数不多的可用选择之一。在本研究中,对regorafenib在意大利南部两个主要肿瘤单位(意大利那不勒斯的Azienda Ospedaliera Universitaria Luigi Vanvitelli和意大利那不勒斯Frattamaggiore的Ospedale Civile San Giovanni di Dio)复发性胶质母细胞瘤患者(>60岁)中的作用进行了现实回顾性调查。主要终点是总生存期(OS),而无进展生存期(PFS)、客观缓解率和疾病控制是次要终点。然后根据年龄、异柠檬酸脱氢酶(IDH)和甲基鸟嘌呤- dna -甲基转移酶(MGMT)状态分析生存率。共有56例患者符合入选标准。意向治疗人群中位PFS (mPFS)为4.1个月,中位OS (mOS)为6.8个月。年龄似乎对mPFS没有显著影响。与未甲基化组相比,mgmt -甲基化组患者的mOS得到改善(7.7个月对5.6个月)。idh突变患者的mOS和mPFS均较长。目前的研究是瑞非尼治疗复发性胶质母细胞瘤的首个实际分析之一。结果与REGOMA试验一致。年龄似乎不是一个预后因素,因此表明治疗选择不应该在老年人中有所不同。MGMT甲基化似乎影响OS。据我们所知,这是第一篇关于regorafenib在老年患者中的活性的报道,虽然结果具有统计学意义,但这些还需要进一步的研究来证实。
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