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胶质母细胞瘤同步放化疗后辅助替莫唑胺治疗的临床结局:单中心经验

Clinical outcome of concomitant chemoradiotherapy followed by adjuvant temozolomide therapy for glioblastaomas: single-center experience.

作者信息

Jeon Hyung Jun, Kong Doo Sik, Park Kwon Byong, Lee Jung Il, Park Kwan, Kim Jong Hyun, Kim Sung Tae, Lim Do Hun, Kim Won Seok, Nam Do-Hyun

机构信息

Department of Neurosurgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

出版信息

Clin Neurol Neurosurg. 2009 Oct;111(8):679-82. doi: 10.1016/j.clineuro.2009.06.013. Epub 2009 Jul 28.

Abstract

INTRODUCTION

The use of radiotherapy plus temozolomide administered concomitantly with and after radiotherapy for glioblastoma was recently shown to improve median and 2-year survival in a large international multicenter study. To compare this result in routine clinical practice, an audit of the management and outcome of patients with glioblastoma at our institute was performed.

METHODS

A total of 79 patients with pathologically confirmed glioblastoma were treated with radiotherapy (daily fractions of 2 Gy for a total of 60 Gy) combined with temozolomide at a dose of 75 mg/m(2) per day, followed by 6 cycles of adjuvant temozolomide (150-200 mg/m(2), 5 consecutive days per month). The primary end point was overall survival (OS). Secondary endpoints included progression-free survival (PFS) and toxicity. We evaluated the clinical outcome of concomitant chemoradiotherapy for newly diagnosed glioblastomas at a single institute in Korea.

RESULTS

The median age was 52 years (15-76 years), 47 patients were male and 32 patients were female. 92.4% of the patients had undergone debulking surgery. The median overall survival (OS) was 18.3 months (95% CI, 16.3-20.1 months), and the time to progression was 6.7 months (95% CI, 5.2-8.3 months). The 1-year and 2-year survival rates were 70.1% and 37.1%, respectively. In the retrospective analysis, the patients with a post-operative KPS over 80 showed more prolonged survival than those who had a KPS less 80 (23.1 months vs. 13.4 months; p<0.001). Age and extent of surgery did not emerge as significant factors. Twenty-four patients (30%) were treated with low-dose continuous temozolomide therapy after the tumor had recurred. Hematologic toxicity was the main adverse effect, occurring in seven patients (8.8%). Patients with lymphopenia were not reported.

CONCLUSIONS

This study is the largest study of radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma in Korean patients, who share a common genetic feature. The median and 2-year survival outcomes in this study are comparable to the previous reports. However, for the recurrent glioblastomas refractory to temozolomide, further clinical trials using other agents should be studied continuously in the future.

摘要

引言

在一项大型国际多中心研究中,近期显示胶质母细胞瘤患者在放疗期间及放疗后使用放疗联合替莫唑胺可改善中位生存期和2年生存率。为了在常规临床实践中比较这一结果,我们对本研究所胶质母细胞瘤患者的治疗管理及转归进行了一项审计。

方法

共有79例经病理确诊的胶质母细胞瘤患者接受了放疗(每日分次剂量2 Gy,共60 Gy)联合替莫唑胺治疗,替莫唑胺剂量为每日75 mg/m²,随后进行6个周期的辅助替莫唑胺治疗(150 - 200 mg/m²,每月连续5天)。主要终点为总生存期(OS)。次要终点包括无进展生存期(PFS)和毒性。我们评估了韩国一家单一机构对新诊断胶质母细胞瘤同步放化疗的临床疗效。

结果

中位年龄为52岁(15 - 76岁),男性47例,女性32例。92.4%的患者接受了肿瘤切除术。中位总生存期(OS)为18.3个月(95%可信区间,16.3 - 20.1个月),疾病进展时间为6.7个月(95%可信区间,5.2 - 8.3个月)。1年和2年生存率分别为70.1%和37.1%。在回顾性分析中,术后KPS评分超过80分的患者生存期比KPS评分低于80分的患者更长(23.1个月对13.4个月;p < 0.001)。年龄和手术范围未成为显著因素。24例患者(30%)在肿瘤复发后接受了低剂量持续替莫唑胺治疗。血液学毒性是主要不良反应,7例患者(8.8%)出现该不良反应。未报告淋巴细胞减少的患者。

结论

本研究是韩国患者中关于放疗联合同步及辅助替莫唑胺治疗胶质母细胞瘤的最大规模研究,韩国患者具有共同的基因特征。本研究中的中位生存期和2年生存结果与先前报告相当。然而,对于对替莫唑胺耐药的复发性胶质母细胞瘤,未来应持续开展使用其他药物的进一步临床试验。

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