Temozolomide as first-line agent in treating high-grade gliomas:: phase II study
Temozolomide as first-line agent in treating high-grade gliomas:: phase II study
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DOI：
10.1023/b:neon.0000021728.36747.93
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发表时间：
2004-03-01
影响因子：
3.9
通讯作者：
Gagliardi, R
中科院分区：
文献类型：
--
作者：
Chibbaro, S;Benvenuti, L;Gagliardi, R
替莫唑胺是一种新的口服第二代烷化剂，是一种治疗高级别胶质瘤的化疗药物，其疗效已在临床前和I期和II期研究中得到证实。本研究的目的是确定替莫唑胺在改善恶性胶质瘤患者的总生存期（OS）、无进展生存期（PFS）和健康相关生活质量（HQL）方面的有效性和安全性，研究了42例新诊断的胶质母细胞瘤、间变性星形细胞瘤和间变性少突胶质细胞瘤患者。平均随访时间为12个月。所有组织学组的总体缓解率（仅缓解患者）为40%，10例患者（24%）显示疾病稳定。中位PFS和OS分别为8.35和14.1个月;至进展时间为34周，范围为21 - 47周。在所有患者中，替莫唑胺治疗与体力状态改善相关，包括显示疾病进展的患者;所有患者的Karnofski评分在6个月时至少改善10分，中位数为20分。没有病人停止治疗，由于副作用，没有重大不良事件recorded.Conclusion：替莫唑胺似乎是一个理想的，一线，单药，具有安全的配置文件，并表现出HQL的好处，在高级别胶质瘤患者。
Temozolomide a recent, oral, second generation alkylating agent is a chemotherapeutic with demonstrated efficacy for the treatment of high-grade gliomas; its efficacy has been demonstrated in both pre-clinical and phase I and II studies. The goal of this study is to determine the activity and safety of temozolomide in improving overall survival (OS), progression-free survival (PFS) and health-related quality of life (HQL) in patient with malignant gliomas.Forty-two patients with newly diagnosed glioblastoma, anaplastic astrocytoma and anaplastic oligodendroglioma were studied. The mean follow-up period was 12 months. The overall response rate (only responsive patient) for all histological groups was 40%, 10 patients (24%) showed a stabilization of disease. The median PFS and OS was respectively 8.35 and 14.1 months; time to progression was 34 week ranging from 21 to 47. In all patients, treatment with temozolomide was associated with improvement of performance status including the patient showing disease progression; Karnofski score improved in all patients by a minimum of 10, with a median of 20 at 6 months. No patient stopped the treatment due to side-effects, no major adverse events were recorded.Conclusion: Temozolomide appears to be an ideal, first-line, single-agent, with a safe profile and demonstrated HQL benefits in patients with high-grade gliomas.