Yamamoto Tetsuya, Nakai Kei, Kageji Teruyoshi, Kumada Hiroaki, Endo Kiyoshi, Matsuda Masahide, Shibata Yasushi, Matsumura Akira
Department of Neurosurgery, University of Tsukuba, Tsukuba City, Japan.
Radiother Oncol. 2009 Apr;91(1):80-4. doi: 10.1016/j.radonc.2009.02.009. Epub 2009 Mar 11.
The efficacy, safety, and dose distribution of neutron capture therapy (NCT) were evaluated in 15 patients with newly diagnosed glioblastoma.
Seven patients received intraoperative NCT (protocol-1) and eight patients received external beam NCT (protocol-2). Sulfhydryl borane (5 g/body) was administered intravenously. Additionally, p-dihydroxyboryl-phenylalanine (250 mg/kg) was given in protocol-2. The external beam NCT was combined with fractionated photon irradiation.
Four of 15 patients were alive at analysis for a mean follow-up time from diagnosis of 23.0M. Twelve of the 15 patients were followed up for more than one year, and 10 (83.3%) of the 12 patients maintained their Karnofsky Performance Status (KPS; 90 in eight patients and 100 in two patients) at 12 months. The median overall survival and the time to tumor progression (TTP) for all patients were 25.7 and 11.9 M, respectively. There was no difference in TTP between the protocol-1 (12.0 M) and protocol-2 (11.9 M). The 1- and 2-year survival rates were 80.0% and 53.3%, respectively. Three protocol-1 patients and one protocol-2 patient suffered transient orbital swelling accompanied by double vision (Grade 2); one of the three protocol-1 patients suffered post-epileptic brain swelling (Grade 4) requiring surgical intervention.
It is suggested that NCT is effective for survival of newly diagnosed glioblastoma with acceptable adverse effects. Because of the limitation of the present NCT pilot study without the contemporary control arm, it is unconvincing whether the neutron capture reaction led to distinct survival benefits, and further optimized studies on less invasive external beam NCT in large series of patients are warranted.
评估15例新诊断的胶质母细胞瘤患者接受中子俘获疗法(NCT)的疗效、安全性和剂量分布。
7例患者接受术中NCT(方案1),8例患者接受外照射NCT(方案2)。静脉注射巯基硼烷(5 g/体)。此外,方案2中给予对二羟基硼基苯丙氨酸(250 mg/kg)。外照射NCT与分次光子照射联合应用。
15例患者中有4例在分析时存活,自诊断起的平均随访时间为23.0个月。15例患者中有12例随访超过1年,12例患者中有10例(83.3%)在12个月时维持其卡氏功能状态(KPS;8例患者为90,2例患者为100)。所有患者的中位总生存期和肿瘤进展时间(TTP)分别为25.7个月和11.9个月。方案1(12.0个月)和方案2(11.9个月)的TTP无差异。1年和2年生存率分别为80.0%和53.3%。3例方案1患者和1例方案2患者出现短暂性眼眶肿胀伴复视(2级);3例方案1患者中有1例出现癫痫后脑肿胀(4级),需要手术干预。
提示NCT对新诊断的胶质母细胞瘤的生存有效,且不良反应可接受。由于本NCT试点研究没有同期对照臂的局限性,中子俘获反应是否带来明显的生存益处尚无说服力,因此有必要在大量患者中对侵入性较小的外照射NCT进行进一步优化研究。