同期替莫唑胺和低分割立体定向放射治疗复杂脑转移瘤的 II 期试验。
A Phase II Trial of Concurrent Temozolomide and Hypofractionated Stereotactic Radiotherapy for Complex Brain Metastases.
机构信息
Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
出版信息
Oncologist. 2019 Sep;24(9):e914-e920. doi: 10.1634/theoncologist.2018-0702. Epub 2019 Apr 17.
PURPOSE
Complex brain metastases (BMs), such as large lesions, lesions within or close to eloquent locations, or multiple recurrent/progressive BMs, remain the most challenging forms of brain cancer because of decreased intracranial control rates and poor survival. In the present study, we report the results from a single institutional phase II trial of concurrent temozolomide (TMZ) with hypofractionated stereotactic radiotherapy (HFSRT) in patients with complex brain metastases, including assessment of its feasibility and toxicity.
PATIENTS AND METHODS
Fifty-four patients with histologically proven primary cancer and complex BMs were enrolled between 2010 and 2015. All the patients were treated with concurrent HFSRT and TMZ (administrated orally at a dosage of 75 mg/m per day for at least 20 days). The primary endpoint was overall survival (OS).
RESULTS
The median follow-up time was 30.6 months. The local control rates at 1 and 2 years were 96% and 82%, respectively. The median OS was 17.4 months (95% confidence interval [CI], 12.6-22.2), and the OS rates at 1 and 2 years were 65% (95% CI, 52%-78%) and 33% (19%-47%). Only six patients (15.8%) died of intracranial disease. The median brain metastasis-specific survival was 46.9 months (95% CI, 35.5-58.4). Treatment-related grade 3-4 adverse events were rare and included one grade 3 hematological toxicity and two grade 3 liver dysfunctions.
CONCLUSION
Treatment using HFSRT concurrent with TMZ was well tolerated and could significantly extend OS compared with historical controls in complex BMs. Large randomized clinical trials are warranted. Trial registration ID: NCT02654106.
IMPLICATIONS FOR PRACTICE
The treatment using hypofractionated stereotactic radiotherapy concurrent with temozolomide appeared to be safe and could significantly extend overall survival compared with historical control in complex brain metastases. Large randomized clinical trials are warranted to verify our results.
目的
大病灶、位于功能区附近或内部的病灶，或多发复发/进展性脑转移瘤等复杂脑转移瘤，由于颅内控制率降低和生存预后较差，仍然是最具挑战性的脑癌形式。在本研究中，我们报告了一项单机构 II 期试验的结果，该试验在复杂脑转移瘤患者中使用替莫唑胺（TMZ）联合低分割立体定向放射治疗（HFSRT），包括评估其可行性和毒性。
方法
2010 年至 2015 年期间，共纳入 54 例经组织学证实的原发性癌症和复杂脑转移瘤患者。所有患者均接受 HFSRT 和 TMZ 同步治疗（口服，每天 75mg/m，至少 20 天）。主要终点为总生存期（OS）。
结果
中位随访时间为 30.6 个月。1 年和 2 年局部控制率分别为 96%和 82%。中位 OS 为 17.4 个月（95%置信区间 [CI]，12.6-22.2），1 年和 2 年 OS 率分别为 65%（95%CI，52%-78%）和 33%（19%-47%）。仅有 6 例患者（15.8%）死于颅内疾病。脑转移瘤特异性中位生存时间为 46.9 个月（95%CI，35.5-58.4）。治疗相关的 3-4 级不良事件罕见，包括 1 例 3 级血液学毒性和 2 例 3 级肝功能障碍。
结论
与复杂脑转移瘤的历史对照相比，HFSRT 联合 TMZ 治疗耐受性良好，可显著延长 OS。需要进行大型随机临床试验。试验注册 ID：NCT02654106。
实践意义
与历史对照相比，低分割立体定向放疗联合替莫唑胺治疗复杂脑转移瘤似乎是安全的，可显著延长总生存期。需要进行大型随机临床试验来验证我们的结果。
Zotero 插件