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信迪利单抗、贝伐单抗和替莫唑胺用于复发性胶质母细胞瘤患者的临床活性和安全性

Clinical activity and safety of sintilimab, bevacizumab, and TMZ in patients with recurrent glioblastoma.

作者信息

Lu Yinghao, Liao Limin, Du Kunpeng, Mo Jianhua, Zou Xia, Liang Junxian, Chen Jiahui, Tang Wenwen, Su Liwei, Wu Jieping, Zhang Junde, Tan Yujing

机构信息

Department of Radiation Oncology, Zhujiang Hospital, Southern Medical University, No 253, Gongye Road, Guangzhou, 510280, China.

Department of Image, Zhujiang Hospital, Southern Medical University, Guangzhou, 510280, China.

出版信息

BMC Cancer. 2024 Jan 25;24(1):133. doi: 10.1186/s12885-024-11848-z.

DOI:10.1186/s12885-024-11848-z
PMID:38273249
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10811825/
Abstract

PURPOSE

There are limited and no standard therapies for recurrent glioblastoma. We herein report the antitumour activity and safety of sintilimab, bevacizumab and temozolomide (TMZ) in recurrent glioblastoma.

METHODS

We retrospectively analysed eight patients with recurrent glioblastoma treated with sintilimab (200 mg) every three weeks + bevacizumab (10 mg/kg) every three weeks + TMZ (200 mg/m²orally) (5 days orally every 28 days for a total of four weeks). The primary objective was investigator-assessed median progression-free survival(mPFS). Secondary objectives were to assess the 6-month PFS, objective response rate (ORR) and duration of response (DOR) accroding to RANO criteria.

RESULTS

The mPFS time for 8 patients was 3.340 months (95% CI: 2.217-4.463), The longest PFS was close to 9 months. Five patients were assessed to have achieved partial response (PR), with an overall remission rate of 62.5%, Four patients experienced a change in tumour volume at the best response time of greater than 60% shrinkage from baseline, and one patient remained progression free upon review, with a DOR of more than 6.57 months. The 6-month PFS was 25% (95% CI: 5.0-55.0%). Three patients had a treatment-related adverse events, though no grade 4 or 5 adverse events occurred.

CONCLUSION

In this small retrospective study, the combination regimen of sintilimab, bevacizumab and TMZ showed promising antitumour activity in treatment of recurrent glioblastoma, with a good objective remission rate.

摘要

目的

复发性胶质母细胞瘤的治疗方法有限且缺乏标准疗法。我们在此报告信迪利单抗、贝伐单抗和替莫唑胺(TMZ)治疗复发性胶质母细胞瘤的抗肿瘤活性和安全性。

方法

我们回顾性分析了8例接受信迪利单抗(200mg)每3周一次+贝伐单抗(10mg/kg)每3周一次+TMZ(200mg/m²口服)(每28天口服5天,共4周)治疗的复发性胶质母细胞瘤患者。主要目标是研究者评估的中位无进展生存期(mPFS)。次要目标是根据RANO标准评估6个月无进展生存期、客观缓解率(ORR)和缓解持续时间(DOR)。

结果

8例患者的mPFS时间为3.340个月(95%CI:2.217-4.463),最长无进展生存期接近9个月。5例患者被评估为部分缓解(PR),总缓解率为62.5%,4例患者在最佳缓解时间肿瘤体积变化较基线缩小超过60%,1例患者复查时仍无进展,缓解持续时间超过6.57个月。6个月无进展生存期为25%(95%CI:5.0-55.0%)。3例患者发生与治疗相关的不良事件,但未发生4级或5级不良事件。

结论

在这项小型回顾性研究中,信迪利单抗、贝伐单抗和TMZ联合方案在治疗复发性胶质母细胞瘤中显示出有前景的抗肿瘤活性,客观缓解率良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ec0/10811825/c08afd3a652a/12885_2024_11848_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ec0/10811825/f889c527fe17/12885_2024_11848_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ec0/10811825/4b20cc0c7733/12885_2024_11848_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ec0/10811825/c08afd3a652a/12885_2024_11848_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ec0/10811825/f889c527fe17/12885_2024_11848_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ec0/10811825/4b20cc0c7733/12885_2024_11848_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ec0/10811825/c08afd3a652a/12885_2024_11848_Fig3_HTML.jpg

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