Survival of patients with newly diagnosed glioblastoma treated with radiation and temozolomide in research studies in the United States.
Survival of patients with newly diagnosed glioblastoma treated with radiation and temozolomide in research studies in the United States.
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DOI：
10.1158/1078-0432.ccr-09-3106
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发表时间：
2010-04-15
期刊：
影响因子：
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通讯作者：
NABTT CNS Consortium
中科院分区：
文献类型：
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作者：
Grossman SA;Ye X;Piantadosi S;Desideri S;Nabors LB;Rosenfeld M;Fisher J;NABTT CNS Consortium
目前，新药物联合放疗和替莫唑胺（RT + TMZ）治疗新诊断的胶质母细胞瘤，以总生存率为主要终点。这些II期研究的结果通常与导致RT + TMZ成为标准治疗的III期EORTC生存数据进行比较。脑肿瘤治疗新方法（NABTT）联盟将365例胶质母细胞瘤患者纳入4项具有相似资格标准的单队列研究。患者接受RT + TMZ联合他仑帕奈（N = 72）、聚ICLC（N = 97）或西仑吉肽（N = 112）或RT + TMZ单药治疗并监测CD 4计数（n = 84）。将18 - 70岁胶质母细胞瘤患者的总生存率与已发表的EORTC数据进行比较。NABTT和EORTC患者的体能状态和减积手术相当。EORTC患者（N = 287）和接受RT + TMZ和新型药物治疗的相当NABTT患者（N = 244）的中位、12个月和24个月生存率分别为14.6个月vs 19.6个月、61% vs 81%和27% vs 37%。这意味着通过两年的随访，死亡几率降低了37%（P <0.0001）。仅接受RT + TMZ的NABTT和EORTC患者的生存率相似。最近接受RT + TMZ和他仑帕奈、聚ICLC或西仑吉肽治疗的新诊断胶质母细胞瘤患者的生存期显著长于2000年至2002年国际上累积的仅接受RT + TMZ治疗的类似患者。这些差异可能是由于新的药物或不断变化的护理模式。在阐明这些不同生存率的原因之前，应谨慎解释II期研究结果与已发表的RT + TMZ生存数据的比较。
Novel agents are currently combined with radiation and temozolomide (RT+TMZ) in newly diagnosed glioblastoma using overall survival as the primary endpoint. Results of these phase II studies are typically compared to the phase III EORTC survival data that resulted in RT+TMZ becoming standard therapy. The New Approaches to Brain Tumor Therapy (NABTT) Consortium accrued 365 patients with glioblastoma to four single-cohort studies with similar eligibility criteria. Patients received RT+TMZ with talampanel (N=72), poly ICLC (N=97), or cilengitide (N=112) or RT+TMZ alone with monitoring of CD4 counts (n=84). Overall survival of those ages 18–70 with glioblastoma were compared to published EORTC data. NABTT and EORTC patients had comparable performance status and debulking surgery. Median, 12 month, and 24 month survival rates for the EORTC patients (N=287) and the comparable NABTT patients receiving RT+TMZ and novel agents (N=244) are 14.6 months vs 19.6 months, 61% vs 81%, and 27% vs 37%. This represents a 37% reduction in odds of death (P<0.0001) through two years of follow-up. NABTT and EORTC patients receiving only RT+TMZ had similar survival. Newly diagnosed glioblastoma treated recently with RT+TMZ and talampanel, poly-ICLC, or cilengitide had significantly longer survival than similar patients treated with only RT+TMZ accrued internationally from 2000 to 2002. These differences could result from the novel agents or changing patterns of care. Until the reasons for these different survival rates are clarified, comparisons of outcomes from phase II studies with published RT+TMZ survival data should be interpreted with caution.