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替莫唑胺用于复发性或进行性脑转移瘤患者的II期试验。

A phase II trial of temozolomide for patients with recurrent or progressive brain metastases.

作者信息

Abrey L E, Olson J D, Raizer J J, Mack M, Rodavitch A, Boutros D Y, Malkin M G

机构信息

Department of Neurology, Memorial Sloan Kettering Cancer Center, New York, NY 10021, USA.

出版信息

J Neurooncol. 2001 Jul;53(3):259-65. doi: 10.1023/a:1012226718323.

DOI:10.1023/a:1012226718323
PMID:11718258
Abstract

BACKGROUND

Treatment options for patients with recurrent brain metastases are extremely limited. This study was designed to determine the safety and efficacy of temozolomide in the treatment of recurrent or progressive brain metastases.

PATIENTS AND METHODS

Forty-one patients (11 men, 30 women) with a median KPS of 80 were treated with temozolomide 150 mg/m2/day (200 mg/m3/day if no prior chemotherapy) for 5 days; treatment cycles were repeated every 28 days. Primary tumor types included 22 non-small cell lung, 10 breast, three melanoma, two small cell lung, two rectal, one ovarian and one endometrial cancer.

RESULTS

There were five episodes of grade 3 thrombocytopenia and one grade 4 leukopenia. Significant non-hematologic toxicity possibly related to temozolomide included pneumonitis [21, constipation [1], and elevated liver enzymes [21. Thirty-four patients were assessed for radiographic response; two had a partial response, 15 stable disease and 17 progressed. Both objective responses were seen in patients with non-small cell lung cancer. Overall median survival was 6.6 months.

CONCLUSIONS

Single agent temozolomide achieved disease control (PR or SD) in 41% of patients with recurrent brain metastases from a variety of primary malignancies with minimal toxicity. Therefore, temozolomide may be a reasonable treatment option for some patients with recurrent brain metastases.

摘要

背景

复发性脑转移瘤患者的治疗选择极其有限。本研究旨在确定替莫唑胺治疗复发性或进展性脑转移瘤的安全性和有效性。

患者与方法

41例患者(11例男性,30例女性),中位KPS为80,接受替莫唑胺150mg/m²/天(若未接受过化疗则为200mg/m³/天)治疗5天;每28天重复治疗周期。原发肿瘤类型包括22例非小细胞肺癌、10例乳腺癌、3例黑色素瘤、2例小细胞肺癌、2例直肠癌、1例卵巢癌和1例子宫内膜癌。

结果

发生5例3级血小板减少症和1例4级白细胞减少症。可能与替莫唑胺相关的显著非血液学毒性包括肺炎[21例]、便秘[1例]和肝酶升高[21例]。对34例患者进行了影像学反应评估;2例部分缓解,15例病情稳定,17例进展。在非小细胞肺癌患者中观察到了这两种客观反应。总体中位生存期为6.6个月。

结论

单药替莫唑胺使41%的来自各种原发性恶性肿瘤的复发性脑转移瘤患者实现了疾病控制(部分缓解或病情稳定),且毒性极小。因此,替莫唑胺可能是一些复发性脑转移瘤患者的合理治疗选择。

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