Phase 2 study of temozolomide-based chemoradiation therapy for high-risk low-grade gliomas: preliminary results of Radiation Therapy Oncology Group 0424.
Phase 2 study of temozolomide-based chemoradiation therapy for high-risk low-grade gliomas: preliminary results of Radiation Therapy Oncology Group 0424.
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DOI：
10.1016/j.ijrobp.2014.11.012
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发表时间：
2015-03-01
影响因子：
7
通讯作者：
Mehta, Minesh
中科院分区：
文献类型：
--
作者：
Fisher, Barbara J.;Hu, Chen;Macdonald, David R.;Lesser, Glenn J.;Coons, Stephen W.;Brachman, David G.;Ryu, Samuel;Werner-Wasik, Maria;Bahary, Jean-Paul;Liu, Junfeng;Chakravarti, Arnab;Mehta, Minesh
放射治疗肿瘤组（RTOG）0424是一项2期研究，研究对象是接受替莫唑胺（TMZ）和放射治疗（RT）的高危低级别胶质瘤（LGG）人群，并将结局与历史对照进行比较。本研究旨在检测中位生存时间（MST）从40.5个月增加43%至57.9个月，3年总生存率（OS）从54%增加20%至65%，显著性水平（单侧）为10%，把握度为96%。复发风险因素少于3个（年龄≥40岁、星形细胞瘤组织学类型、双半球肿瘤、术前肿瘤直径≥6 cm或术前神经功能状态>1）的LGG患者接受RT（54戈伊，分30次）和同时辅助TMZ治疗。从2005年到2009年，累积了129名可评价患者（75名男性和54名女性）。中位年龄为49岁; 91%的Zubrod评分为0或1; 69%、25%和6%的患者分别有3、4和5个风险因素。患者的中位和最短随访检查时间分别为4.1年和3年。3年OS率为73.1%（95%置信区间：65.3%-80.8%），与预先设定的历史对照值相比显著改善（P<0.01）。中位生存时间尚未达到。3年无进展生存率为59.2%。3级和4级不良事件分别发生在43%和10%的患者中。1例患者死于疱疹性脑炎。RTOG 0424高风险LGG患者的3年OS率为73.1%，高于历史对照组（P<0.001）和研究假设的65%。
Radiation Therapy Oncology Group (RTOG) 0424 was a phase 2 study of a high-risk low-grade glioma (LGG) population who were treated with temozolomide (TMZ) and radiation therapy (RT), and outcomes were compared to those of historical controls. This study was designed to detect a 43% increase in median survival time (MST) from 40.5 to 57.9 months and a 20% improvement in 3-year overall survival (OS) rate from 54% to 65% at a 10% significance level (1-sided) and 96% power. Patients with LGGs with fewer than 3 risk factors for recurrence (age ≥40 years, astrocytoma histology, bihemispherical tumor, preoperative tumor diameter of ≥6 cm, or a preoperative neurological function status of >1) were treated with RT (54 Gy in 30 fractions) and concurrent and adjuvant TMZ. From 2005 to 2009, 129 evaluable patients (75 males and 54 females) were accrued. Median age was 49 years; 91% had a Zubrod score of 0 or 1; and 69%, 25%, and 6% of patients had 3, 4, and 5 risk factors, respectively. Patients had median and minimum follow-up examinations of 4.1 years and 3 years, respectively. The 3-year OS rate was 73.1% (95% confidence interval: 65.3%–80.8%), which was significantly improved compared to that of prespecified historical control values (P<.01). Median survival time has not yet been reached. Three-year progression-free survival was 59.2%. Grades 3 and 4 adverse events occurred in 43% and 10% of patients, respectively. One patient died of herpes encephalitis. The 3-year OS rate of 73.1% for RTOG 0424 high-risk LGG patients is higher than that reported for historical controls (P<.001) and the study-hypothesized rate of 65%.
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影响因子：
15.9
作者：
Gorlia, Thierry;Wu, Wenting;van den Bent, Martin J.
通讯作者：
van den Bent, Martin J.
DOI：
10.1016/s0360-3016(96)00352-5
发表时间：
1996-10-01
影响因子：
7
作者：
Karim, ABMF;Maat, B;Fabrini, MG
通讯作者：
Fabrini, MG
影响因子：
158.5
作者：
Hegi, ME;Diserens, A;Stupp, R
通讯作者：
Stupp, R
影响因子：
45.3
作者：
Cairncross, Gregory;Wang, Meihua;Mehta, Minesh
通讯作者：
Mehta, Minesh
影响因子：
11.5
作者：
Kesari, Santosh;Schiff, David;Wen, Patrick Y.
通讯作者：
Wen, Patrick Y.