Gilbert Mark R, Friedman Henry S, Kuttesch John F, Prados Michael D, Olson Jeffrey J, Reaman Gregory H, Zaknoen Sara L
Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030-4009, USA.
Neuro Oncol. 2002 Oct;4(4):261-7. doi: 10.1093/neuonc/4.4.261.
Temozolomide is a novel second-generation oral alkylating agent with demonstrated efficacy and safety in patients with recurrent glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA). A multicenter phase II trial was conducted to determine the efficacy and safety of temozolomide before radiotherapy in patients with newly diagnosed GBM and AA. Fifty-seven patients (51 adult, 6 pediatric) with newly diagnosed supratentorial GBM or AA were treated with temozolomide (200 mg/m ( 2 ) per day for 5 consecutive days every 28 days) for a maximum of 4 cycles. All patients were then treated with external beam radiotherapy. Twenty-two patients (39%) achieved objective response, including 6 (11%) with complete response (CR) and 16 (28%) with partial response (PR). Additionally, 18 (32%) patients had stable disease (SD). Of 21 patients (18 adult, 3 pediatric) with AA, 2 (10%) achieved CR, 5 (24%) achieved PR, and 8 (38%) had SD. Among adult patients with AA, the median progression-free and overall survival rates were 7.6 and 23.5 months, respectively. Among 36 patients (33 adult, 3 pediatric) with GBM, 4 (11%) had CR, 11 (31%) had PR, and 10 (28%) had SD. The median progression-free and overall survival rates among adult patients with GBM were 3.9 and 13.2 months, respectively. Temozolomide was safe and well tolerated in adult and pediatric patients. Grades 3 and 4 adverse events were reported in 16 (28%) and 7 (12%) patients, respectively. Temozolomide was safe and effective in treating newly diagnosed GBM and AA before radiotherapy. This pre-irradiation treatment approach appears promising, but will require additional evaluation in comparative studies.
替莫唑胺是一种新型的第二代口服烷化剂，在复发性多形性胶质母细胞瘤（GBM）和间变性星形细胞瘤（AA）患者中已证明其有效性和安全性。进行了一项多中心II期试验，以确定替莫唑胺在新诊断的GBM和AA患者放疗前的有效性和安全性。57例新诊断为幕上GBM或AA的患者（51例成人，6例儿童）接受替莫唑胺治疗（每28天连续5天每天200mg/m²），最多4个周期。然后所有患者接受外照射放疗。22例患者（39%）达到客观缓解，包括6例（11%）完全缓解（CR）和16例（28%）部分缓解（PR）。此外，18例（32%）患者疾病稳定（SD）。在21例AA患者（18例成人，3例儿童）中，2例（10%）达到CR，5例（24%）达到PR，8例（38%）疾病稳定。在成年AA患者中，无进展生存期和总生存期的中位数分别为7.6个月和23.5个月。在36例GBM患者（33例成人，3例儿童）中，4例（11%）达到CR，11例（31%）达到PR，10例（28%）疾病稳定。成年GBM患者的无进展生存期和总生存期中位数分别为3.9个月和13.2个月。替莫唑胺在成人和儿童患者中安全且耐受性良好。分别有16例（28%）和7例（12%）患者报告了3级和4级不良事件。替莫唑胺在放疗前治疗新诊断的GBM和AA安全有效。这种放疗前治疗方法似乎很有前景，但需要在比较研究中进行进一步评估。
