Lövey József, Fedorcsák Imre, Bajcsay András, Sipos László, Mangel László, Kásler Miklós, Bagó Attila
Országos Onkológiai Intézet, Budapest, Hungary.
Országos Klinikai Idegtudományi Intézet, Budapest, Hungary.
Magy Onkol. 2013 Dec;57(4):232-9. Epub 2013 Nov 1.
Glioblastoma multiforme has one of the worst prognoses of all cancers. A substantial progression in its treatment has been achieved only eight years ago when a new adjuvant radiochemotherapy regimen containing temozolomid has been introduced to the clinical practice. In this paper we evaluate the treatment results in adjuvant radiochemotherapy of glioblastoma carried out by two neurosurgery and oncology centers in Budapest, Hungary and we compared our results to the data of the reference phase III registration trial of the EORTC/NCIC. We analyzed the data of 210 patients treated for glioblastoma between 2005 and 2013. The primary endpoints of our study were overall survival and side effects. We studied and statistically analyzed the influence of multiple factors on survival. We compared our results with the data of the reference study and other results published in the literature. The median follow-up for the surviving patients in our study was 52 months. The median age of our patients was 58 (18-79) years. Seventy-two women and 138 men have been treated. The median overall survival was 17 (3-96) months, the progression-free survival 11 (3-96) months. The radiochemotherapy phase was completed in 95.2% and the monotherapy phase in 68% of all cases.Univariate analysis showed that age, ECOG status and RPA class had significant influence on survival. In multivariate analysis only RPA class remained statistically significant (RR 1.86, 95% CI 1.14-3.05). The proportion of grade III and worse side effects during the chemoradiation phase was 3.8% and in the monotherapy phase 1.9%. These were hematological side effects only. Serious hematological sequelae occurred nearly exclusively in women. Comparing to the reference study the demographic distribution of the patients was similar in our study but among our patients there were less patients with unfavorable prognosis (ECOG 2 or RPA V), and it resulted in a longer median survival than in the original trial (17 vs. 14.6 months). With this analysis of our patients treated according to the Stupp-protocol for glioblastoma multiforme we validated the results of the original EORTC/NCIC study in a Hungarian patient population. Moreover, this comparison proves that the comprehensive Hungarian neuro-oncology service is not at all inferior when compared to any of the developed countries in Europe.
多形性胶质母细胞瘤是所有癌症中预后最差的之一。仅仅在八年前,当一种包含替莫唑胺的新辅助放化疗方案被引入临床实践后,其治疗才取得了实质性进展。在本文中,我们评估了匈牙利布达佩斯的两个神经外科和肿瘤中心对胶质母细胞瘤进行辅助放化疗的治疗结果,并将我们的结果与欧洲癌症研究与治疗组织(EORTC)/加拿大国家癌症研究所(NCIC)的参考III期注册试验数据进行了比较。我们分析了2005年至2013年间接受胶质母细胞瘤治疗的210例患者的数据。我们研究的主要终点是总生存期和副作用。我们研究并统计分析了多种因素对生存期的影响。我们将我们的结果与参考研究的数据以及文献中发表的其他结果进行了比较。我们研究中存活患者的中位随访时间为52个月。我们患者的中位年龄为58(18 - 79)岁。共治疗了72名女性和138名男性。中位总生存期为17(3 - 96)个月,无进展生存期为11(3 - 96)个月。所有病例中,95.2%完成了放化疗阶段,68%完成了单一疗法阶段。单因素分析表明,年龄、东部肿瘤协作组(ECOG)状态和递归分区分析(RPA)分级对生存期有显著影响。多因素分析中,只有RPA分级仍具有统计学意义(风险比1.86,95%置信区间1.14 - 3.05)。放化疗阶段III级及更严重副作用的比例为3.8%,单一疗法阶段为1.9%。这些均仅为血液学副作用。严重血液学后遗症几乎仅发生在女性中。与参考研究相比,我们研究中患者的人口统计学分布相似,但我们的患者中预后不良(ECOG 2或RPA V)的患者较少,这导致中位生存期比原试验更长(17个月对14.6个月)。通过对我们按照斯图普方案治疗多形性胶质母细胞瘤患者的分析,我们在匈牙利患者群体中验证了原EORTC/NCIC研究的结果。此外,这种比较证明,匈牙利全面的神经肿瘤服务与欧洲任何发达国家相比丝毫不逊色。