PHASE-III COMPARISON OF BCNU, HYDROXYUREA, AND RADIATION-THERAPY TO BCNU AND RADIATION-THERAPY FOR TREATMENT OF PRIMARY MALIGNANT GLIOMAS
PHASE-III COMPARISON OF BCNU, HYDROXYUREA, AND RADIATION-THERAPY TO BCNU AND RADIATION-THERAPY FOR TREATMENT OF PRIMARY MALIGNANT GLIOMAS
复制标题
DOI：
10.3171/jns.1979.51.4.0526
复制
发表时间：
1979-01-01
影响因子：
4.1
通讯作者：
IRWIN, L
中科院分区：
文献类型：
--
作者：
LEVIN, VA;WILSON, CB;IRWIN, L
这项III期临床试验比较了1,3-双(2-氯乙基)-1-亚硝基脲(BCNU)、放射治疗和羟基脲联合治疗(BHR组)与BCNU和放射治疗联合治疗(BR组)治疗恶性胶质瘤的有效性。在该研究的两个组中，BCNU 均通过静脉注射给药。在开始放射治疗前连续 3 天，此后每隔 8 周进行一次，直到出现明确的肿瘤进展。在该研究的 BHR 组中，在放射治疗期间每隔一天口服羟基脲。每组患者均按肿瘤类型（多形性胶质母细胞瘤 (GM) 或其他多形性非胶质母细胞瘤恶性胶质瘤 (NGM)）和肿瘤手术切除范围进行几乎相同的分层。使用卡诺夫斯基体能状态（KPS）量表对患者进行评估。通过比较连续神经学检查、放射性核素和计算机断层扫描的结果来确定进展时间。在参与研究的 130 名患者中，99 名构成有效研究组。使用 Kaplan-Meier 表示法以及 Gehan 和 Cox 的统计方法对数据进行分析。 KPS 评级为.gtoreq 的 NGM 患者。 60 名受试者在研究的两个组中均表现较好，BHR 和 BR 的中位肿瘤进展时间 (MTP) 分别为 50 周和 72 周。 GM 患者在研究的 2 个组之间表现出统计学显着差异 (P = 0.03)，BHR 和 BR 的 MTP 分别为 41 周和 31 周。接受肿瘤次全切除的 GM 患者在 BHR 上的表现略好于 BR，各组的 MTP 分别为 49 周（P = 0.03）和 31 周。
This Phase III clinical trial compared the effectiveness of the combination of 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU), radiation therapy and hydroxyurea (BHR group) to the combination of BCNU and radiation therapy (BR group) for the treatment of malignant gliomas. In both arms of the study, BCNU was administered i.v. for 3 consecutive days before the initiation of radiation therapy, and at 8 wk intervals thereafter until unequivocal tumor progression. In the BHR arm of the study, hydroxyurea was administered orally on alternate days during radiation therapy. Patients in each arm were stratified almost equally by tumor type (glioblastoma multiforme (GM) or other nonglioblastoma multiforme malignant gliomas (NGM)) and extent of surgical resection of tumor. Patients were evaluated with the Karnofsky Performance Status (KPS) scale. Time to progression was determined by comparing the results of sequential neurological examinations and radionuclide and computerized tomographic scans. Of the 130 patients entered into the study, 99 constitute the valid study group. Data were analyzed with Kaplan-Meier representations and the statistical methods of Gehan and Cox. The NGM patients with KPS ratings of .gtoreq. 60 did better on both arms of the study, with median times to tumor pregression (MTP''s) of 50 and 72 wk for BHR and BR, respectively. GM patients showed statistically significant differences (P = 0.03) between the 2 arms of the study, with MTP of 41 and 31 wk for BHR and BR, respectively. The GM patients with subtotal tumor resection did slightly better on BHR than on BR, with MTP of 49 wk (P = 0.03) and 31 wk for the respective groups.