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尼妥珠单抗和贝伐单抗联合替莫唑胺及放疗用于新诊断的多形性胶质母细胞瘤患者:一项回顾性单臂研究

Nimotuzumab and bevacizumab combined with temozolomide and radiotherapy in patients with newly diagnosed glioblastoma multiforme: a retrospective single-arm study.

作者信息

Wu Yaping, Chen Zhiying, Shi Mingtao, Qiu Shuo, Zhang Yongchun

机构信息

Department of Radiation Oncology, The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, China.

出版信息

J Neurooncol. 2025 Apr;172(2):429-436. doi: 10.1007/s11060-024-04932-8. Epub 2025 Jan 6.

Abstract

PURPOSE

Glioblastoma (GBM), the most common malignant tumor of the central nervous system (CNS) in adults, continues to result in poor survival rates despite standard treatment. Advancements in understanding GBM's molecular complexity have increased interest in targeted therapeutic approaches. This retrospective, single-center, single-arm study combined nimotuzumab and bevacizumab with radiotherapy (RT) and temozolomide (TMZ) for the treatment of newly diagnosed GBM. The objectives were to determine the efficacy of this treatment combination and the associated toxicity.

METHODS

A retrospective analysis of clinical data of GBM patients treated at our institution from September 2021 to May 2023 with postoperative combination therapy of nimotuzumab, bevacizumab, and TMZ concurrent with RT, as well as maintenance therapy with bevacizumab and TMZ. Follow-ups were performed every 3 to 6 months via hospital visits and telephone interviews. The primary endpoints were overall survival (OS) and progression-free survival (PFS). The secondary endpoint was the incidence of adverse events (AEs).

RESULTS

A total of 18 patients were included. The median follow-up time was 23 months. The one-year PFS rate was 77.8%, and the one-year OS rate was 94.4%. The median PFS was 18 months (95%CI, 15.9-20.1), and the median OS was 28 months (95%CI, 18.9-37.1). All AEs were controllable.

CONCLUSION

The combination of nimotuzumab and bevacizumab with TMZ and RT appears to demonstrate efficacy and safety in newly diagnosed GBM patients, providing a reference for clinical treatment. Further prospective studies are needed to confirm our results.

摘要

目的

胶质母细胞瘤(GBM)是成人中枢神经系统(CNS)最常见的恶性肿瘤,尽管采用了标准治疗,其生存率仍然很低。对GBM分子复杂性认识的进展增加了对靶向治疗方法的兴趣。这项回顾性、单中心、单臂研究将尼妥珠单抗和贝伐单抗与放疗(RT)和替莫唑胺(TMZ)联合用于治疗新诊断的GBM。目的是确定这种联合治疗的疗效及相关毒性。

方法

回顾性分析2021年9月至2023年5月在本机构接受尼妥珠单抗、贝伐单抗和TMZ术后联合治疗并同步放疗,以及贝伐单抗和TMZ维持治疗的GBM患者的临床数据。通过医院就诊和电话访谈每3至6个月进行一次随访。主要终点是总生存期(OS)和无进展生存期(PFS)。次要终点是不良事件(AE)的发生率。

结果

共纳入18例患者。中位随访时间为23个月。一年PFS率为77.8%,一年OS率为94.4%。中位PFS为18个月(95%CI,15.9 - 20.1),中位OS为28个月(95%CI,18.9 - 37.1)。所有AE均可控。

结论

尼妥珠单抗和贝伐单抗联合TMZ及RT在新诊断的GBM患者中似乎显示出疗效和安全性,为临床治疗提供了参考。需要进一步的前瞻性研究来证实我们的结果。

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