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碳离子放疗与光子放疗单独或联合替莫唑胺治疗高级别脑胶质瘤患者的比较:探索性假设生成回顾性分析。

Comparison of carbon ion radiotherapy to photon radiation alone or in combination with temozolomide in patients with high-grade gliomas: explorative hypothesis-generating retrospective analysis.

机构信息

University Hospital of Heidelberg, Department of Radiation Oncology, Germany.

出版信息

Radiother Oncol. 2013 Jul;108(1):132-5. doi: 10.1016/j.radonc.2013.06.026. Epub 2013 Aug 6.

DOI:10.1016/j.radonc.2013.06.026
PMID:23932193
Abstract

PURPOSE

To compare retrospectively outcome after photon radiotherapy alone, radiochemotherapy with temozolomide (TMZ), and carbon ion radiotherapy in patients with high-grade gliomas and to generate a hypothetical outcome curve for C12 and TMZ.

PATIENTS AND METHODS

Patients treated within a Phase I/II Trial with a carbon ion boost were compared retrospectively with randomly chosen patients treated with photons or photons in combination with TMZ in a retrospective analysis. Per treatment group, 16 patients with anaplastic astocytoma (AA), and 32 patients with glioblastoma (GBM) were included. Treatment outcome with focus on progression-free survival (PFS) and overall survival (OS) was analyzed.

RESULTS

Median OS for patients with GBM was 9 months with RT, 14 months with RCHT group, and 18 months in the C12 group. There was no significant difference between the C12 and the RCHT group. For patients with AA, median OS was 13 months for RT, 39 months for RCHT, and 35 months after C12. The difference from RCHT to C12 was not significant. Median PFS for patients with GBM was 5 months in the RT group, 6 months in the RCHT group, and 8 months in the C12 group. There was a significant difference between the RCHT group and the C12 group. For AA, median PFS was 15 months with RT, 6 months with RCHT, and 34 with C12. Comparing subgroups, C12 was significantly different from RCHT. Based on the significant OS increase from RT to RCHT, and from RT to C12, we projected the potential increase in outcome when combined C12 and TMZ would have been applied. A generated hypothetical curve based on the abovementioned outcome as well as preclinical examinations suggests there might be a benefit from the addition of C12 in patients with high-grade gliomas.

CONCLUSIONS

This exploratory retrospective study suggests a potential benefit of carbon ions in patients with high-grade gliomas. This hypothesis is now being evaluated prospectively in GBM within the randomized CLEOPATRA clinical trial.

摘要

目的

比较单纯光子放疗、替莫唑胺放化疗和碳离子放疗治疗高级别胶质瘤患者的疗效,并为 C12 和 TMZ 生成假设的疗效曲线。

方法

在一项 I/II 期碳离子增敏试验中接受治疗的患者,通过回顾性分析与随机选择的接受光子或光子联合 TMZ 治疗的患者进行比较。每组各有 16 例间变性星形细胞瘤(AA)和 32 例胶质母细胞瘤(GBM)患者。重点分析无进展生存期(PFS)和总生存期(OS)。

结果

GBM 患者的中位 OS 分别为 RT 组 9 个月、RCHT 组 14 个月和 C12 组 18 个月,C12 组与 RCHT 组无显著差异。AA 患者的中位 OS 分别为 RT 组 13 个月、RCHT 组 39 个月和 C12 组 35 个月,与 RCHT 相比,C12 无显著差异。GBM 患者的中位 PFS 分别为 RT 组 5 个月、RCHT 组 6 个月和 C12 组 8 个月,RCHT 组与 C12 组有显著差异。AA 患者的中位 PFS 分别为 RT 组 15 个月、RCHT 组 6 个月和 C12 组 34 个月,C12 与 RCHT 相比,差异显著。基于 RT 到 RCHT 和 RT 到 C12 的 OS 显著增加,我们预测了如果联合 C12 和 TMZ 应用可能会带来的疗效增加。根据上述结果以及临床前检查生成的假设曲线表明,碳离子可能会使高级别脑肿瘤患者获益。

结论

这项探索性回顾性研究表明,碳离子治疗高级别脑肿瘤患者可能具有潜在获益。这一假设目前正在 GBM 中通过 CLEOPATRA 临床试验进行前瞻性评估。

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