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同期加辅助替莫唑胺与辅助替莫唑胺治疗原发性胶质母细胞瘤患者的毒性和生存:单机构回顾性配对分析结果。

Toxicity and survival in primary glioblastoma patients treated with concomitant plus adjuvant temozolomide versus adjuvant temozolomide: results of a single-institution, retrospective, matched-pair analysis.

机构信息

Department of Neurosurgery, University of Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.

出版信息

Acta Neurochir (Wien). 2013 Mar;155(3):429-35. doi: 10.1007/s00701-012-1583-y. Epub 2012 Dec 20.

Abstract

BACKGROUND

To compare survival and hematological toxicity rates between two postoperative therapy regimens in patients with primary glioblastoma (GBM), namely temozolomide (TMZ) concomitant to radiation, followed by adjuvant TMZ, versus adjuvant TMZ after radiation only.

PATIENTS AND METHODS

A total of 191 patients with primary GBM were postoperatively treated with either radiation and concomitant TMZ, followed by adjuvant TMZ (Stupp protocol) (n = 154), or radiation followed by adjuvant TMZ (n = 37). The incidence of hematological adverse effects (AE) was recorded for all patients. From both treatment groups, 26 patients were matched according to age, Karnofsky performance scale (KPS) score, and O6-methylguanine-DNA-methyltransferase (MGMT) promoter methylation.

RESULTS

Hematological AEs were mild in both unmatched groups, but were significantly more frequent in the concomitant plus adjuvant TMZ group (p < 0.001). Matched-pair analysis confirmed significantly more frequent hematological AEs in the concomitant and adjuvant group compared to the sequential (adjuvant) TMZ group (p = 0,012). Patients treated with concomitant plus adjuvant TMZ showed significantly longer progression-free survival (PFS) (10.6 versus 6.6 months; p = 0.014), but no prolonged overall survival (OS) (16.9 vs. 15.6 months; p = 0.717) compared to patients who received the sequential treatment regimen.

CONCLUSION

In this retrospective study, the OS in patients with primary GBM treated with sequential TMZ following radiation appeared to be similar to that in patients treated with concomitant plus adjuvant TMZ. Given the significantly higher risk of hematological AE for concomitant treatment, the role of concomitant plus adjuvant TMZ use compared to sequential administration of TMZ, especially for patients with MGMT-unmethylated tumors, should be further evaluated.

摘要

背景

比较原发性脑胶母细胞瘤(GBM)患者两种术后治疗方案(替莫唑胺[T]联合放疗,然后辅助 T;或仅放疗后辅助 T)的生存和血液学毒性发生率。

方法

共有 191 例原发性 GBM 患者术后接受放疗联合 T,然后辅助 T(Stupp 方案)(n=154)或放疗后辅助 T(n=37)。记录所有患者血液学不良事件(AE)的发生率。从两组治疗中,根据年龄、卡氏功能状态评分(KPS)和 O6-甲基鸟嘌呤-DNA-甲基转移酶(MGMT)启动子甲基化,匹配 26 例患者。

结果

未匹配组的血液学 AE 均为轻度,但联合加辅助 T 组更频繁(p<0.001)。配对分析证实,联合加辅助 T 组与序贯(辅助)T 组相比,血液学 AE 更频繁(p=0.012)。与接受序贯治疗的患者相比,接受联合加辅助 T 治疗的患者无进展生存期(PFS)更长(10.6 与 6.6 个月;p=0.014),但总生存期(OS)无延长(16.9 与 15.6 个月;p=0.717)。

结论

在这项回顾性研究中,接受序贯 T 治疗的原发性 GBM 患者的 OS 似乎与接受联合加辅助 T 治疗的患者相似。鉴于联合治疗血液学 AE 风险显著增加,联合加辅助 T 与序贯 T 相比的应用价值,尤其是对于 MGMT 未甲基化肿瘤患者,应进一步评估。

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