Survival and neurologic outcomes in a randomized trial of motexafin gadolinium and whole-brain radiation therapy in brain metastases
Survival and neurologic outcomes in a randomized trial of motexafin gadolinium and whole-brain radiation therapy in brain metastases
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DOI：
10.1200/jco.2003.12.122
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发表时间：
2003-07-01
影响因子：
45.3
通讯作者：
Renschler, MF
中科院分区：
文献类型：
--
作者：
Mehta, MP;Rodrigus, P;Renschler, MF
目的：这项III期随机试验评估了实体瘤脑转移患者接受加或不加莫特沙芬钆（MGd）全脑放射治疗（WBRT）的生存率以及神经和神经认知功能。患者和方法：患者被随机分配到30 Gy的WBRT +/- 5 mg/kg/d MGd。生存期和由盲法事件审查委员会（ERC）确定的神经系统进展时间是主要终点。进行标准化研究者神经学评估和神经认知测试。结果：纳入4101例（251例非小细胞肺癌）患者。两组患者的生存期（MGd组中位值为5.2个月，WBRT组中位值为4.9个月，P = 0.48）或神经系统进展时间（MGd组中位值为9.5个月，WBRT组中位值为8.3个月，P = 0.95）无显著差异。MGd治疗改善了肺癌患者到神经系统进展的时间（未达到MGd的中位数vs WBRT的7.4个月，P = 0.048，未经调整）。研究者发现，MGd改善了所有患者到神经系统进展的时间（MGd为4.3个月，WBRT为3.8个月，P = 0.018）和肺癌患者（MGd为5.5个月，WBRT为3.7个月，P = 0.025）。MGd改善肺癌患者的神经认知功能。结论：不同治疗组的生存期和ERC时间对神经系统进展的影响没有显著差异。研究者的神经学评估显示所有患者的MGd治疗获益。在肺癌患者中，ERC和研究者确定的神经系统进展时间证明了MGd治疗的益处。MGd可能缩短肺癌神经和神经认知进展的时间。(C) 2003年由美国临床肿瘤学会出版。
Purpose: This phase III randomized trial evaluated survival as well as neurologic and neurocognitive function in patients with brain metastases from solid tumors receiving whole-brain radiation therapy (WBRT) with or without motexafin gadolinium (MGd).Patients and Methods: Patients were randomly assigned to 30 Gy of WBRT +/- 5 mg/kg/d MGd. Survival and time to neurologic progression determined by a blinded events review committee (ERC) were coprimary end points. Standardized investigator neurologic assessment and neurocognitive testing were evaluated.Results: Four hundred one (251 non-small-cell lung cancer) patients were enrolled. There was no significant difference by treatment arm in survival (median, 5.2 months for MGd v 4.9 months for WBRT, P = .48) or time to neurologic progression (median, 9.5 months for MGd v 8.3 months for WBRT, P = .95). Treatment with MGd improved time to neurologic progression in patients with lung cancer (median, not reached for MGd v 7.4 months for WBRT, P = .048, unadjusted). By investigator, MGd improved time to neurologic progression in all patients (median, 4.3 months for MGd v 3.8 months for WBRT, P = .018) and in lung cancer patients (median, 5.5 months for MGd v 3.7 months for WBRT, P = .025). MGd improved neurocognitive function in lung cancer patients.Conclusion: The overall results did not demonstrate significant differences by treatment arm for survival and ERC time to neurologic progression. Investigator neurologic assessments demonstrated an MGd treatment benefit in all patients. In lung cancer patients, ERC- and investigator-determined time to neurologic progression demonstrated an MGd treatment benefit. MGd may improve time to neurologic and neurocognitive progression in lung cancer. (C) 2003 by American Society of Clinical Oncology.