Kurup P D, Pajak T F, Hendrickson F R, Nelson J S, Mansell J, Cohen L, Awschalom M, Rosenberg I, Ten Haken R K
Int J Radiat Oncol Biol Phys. 1985 Apr;11(4):679-86. doi: 10.1016/0360-3016(85)90298-6.
Twenty-five patients with biopsy proven malignant supratentorial astrocytomas were entered into a Phase I/II study of misonidazole combined with neutron radiation at Fermilab Neutron Therapy Facility (NTF) between August 1979 and April 1981. The main objectives were to determine tissue tolerance in terms of acute and late effects, and to estimate tumor clearance and survival rates. The total dose was 18.0 Gy given in weekly fractions of 3.0 Gy over 39 days. Four hours before each irradiation, 2.5 gm/m2 misonidazole was administered orally. Patients' ages ranged from 28-69 years. Karnofsky status for most patients was 80 or 90; the lowest grade was 60. The majority of patients had glioblastoma multiforms. Most were already on steroids prior to initiation of therapy. The median survival for the whole group was 12.0 months; 25% were alive at 18 months with some neurological compromise. The median survival remained unchanged for subgroups of patients with ages between 40-60 years and with Karnofsky performance status above 80. Among the 19 patients with glioblastoma multiforme, the median survival was 10 months. Acute toxicity was within tolerable limits. Details of toxicity and tissue analysis from post mortems and second craniotomy samples are presented.
1979年8月至1981年4月期间，25例经活检证实为幕上恶性星形细胞瘤的患者进入了一项在费米实验室中子治疗设施（NTF）进行的米索硝唑联合中子辐射的I/II期研究。主要目的是确定组织对急性和晚期效应的耐受性，并评估肿瘤清除率和生存率。总剂量为18.0 Gy，在39天内每周分剂量给予3.0 Gy。每次照射前4小时，口服2.5 gm/m2米索硝唑。患者年龄在28 - 69岁之间。大多数患者的卡诺夫斯基评分是80或90；最低评分为60。大多数患者患有多形性胶质母细胞瘤。大多数患者在开始治疗前已经在使用类固醇。整个组的中位生存期为12.0个月；25%的患者在18个月时存活，但有一些神经功能损害。年龄在40 - 60岁之间且卡诺夫斯基表现状态高于80的患者亚组的中位生存期保持不变。在19例多形性胶质母细胞瘤患者中，中位生存期为10个月。急性毒性在可耐受范围内。本文还介绍了尸检和二次开颅手术样本的毒性细节和组织分析情况。
