Phase III study of efaproxiral as an adjunct to whole-brain radiation therapy for brain metastases.
Phase III study of efaproxiral as an adjunct to whole-brain radiation therapy for brain metastases.
复制标题
efaproxiral 作为脑转移全脑放射治疗的辅助药物的 III 期研究。
DOI：
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复制
发表时间：
2006
影响因子：
45.3
通讯作者：
E. Shaw
中科院分区：
文献类型：
--
作者：
J. Suh;B. Stea;A. Nabid;J. Kresl;A. Fortin;J. Mercier;N. Senzer;E. Chang;A. Boyd;P. Cagnoni;E. Shaw
目的
确定作为全脑放射治疗（WBRT）的辅助治疗时，作为血红蛋白变构调节剂的依法依伐他汀是否能改善脑转移患者的生存率。
患者和方法
实体瘤脑转移且Karnofsky评分≥ 70的患者被随机分配接受WBRT，并补充氧气和75或100 mg/kg的依非替尼（依非替尼组）或无依非替尼（对照组）。主要终点是生存率。
结果
该研究包括515例合格患者（依非替尼组，n = 265;对照组，n = 250）。中位生存时间（MST）为5.4个月的efaaviral组与4.4个月的对照组（风险比[HR] = 0.87; P = 0.16）。对于非小细胞肺癌（NSCLC）或乳腺癌患者亚组，MST分别为6.0和4.4个月（HR = 0.82; P = 0.07）。考克斯多元回归分析表明，在两个主要人群中，efaaviral组的死亡风险显著降低。进一步分析表明，受益可能仅限于乳腺癌患者亚组。所有患者以及非小细胞肺癌和乳腺癌患者的缓解率（放射学完全缓解加部分缓解）分别提高了7%（P = 0.10）和13%（P = 0.01）。接受依非替尼治疗的患者中最常见的严重不良事件是低氧血症，这是可逆的，大多数患者可通过补充氧气有效治疗。
结论
在WBRT中加入非细胞毒性放射增敏剂efaaviral可提高脑转移患者的缓解率和生存率，特别是乳腺癌转移。一项针对乳腺癌患者的验证性试验已经启动。
PURPOSE
To determine whether efaproxiral, an allosteric modifier of hemoglobin, improves survival in patients with brain metastases when used as an adjunct to whole-brain radiation therapy (WBRT).
PATIENTS AND METHODS
Patients with brain metastases from solid tumors and a Karnofsky performance score of > or = 70 were randomly assigned to receive WBRT with supplemental oxygen and either efaproxiral at 75 or 100 mg/kg (efaproxiral arm) or no efaproxiral (control arm). The primary end point was survival.
RESULTS
The study consisted of 515 eligible patients (efaproxiral arm, n = 265; control arm, n = 250). The median survival time (MST) was 5.4 months for the efaproxiral arm versus 4.4 months for the control arm (hazard ratio [HR] = 0.87; P = .16). For the subgroup of patients with non-small-cell lung cancer (NSCLC) or breast cancer, the MST was 6.0 and 4.4 months, respectively (HR = 0.82; P = .07). Cox multiple regression analysis demonstrated a significant reduction in the risk of death for the efaproxiral arm in both primary populations. Further analysis indicated that the benefit may be restricted to the subgroup of patients with breast cancer. Response rates (radiographic complete response plus partial response) improved by 7% (P = .10) and 13% (P = .01) for all patients and for NSCLC and breast cancer patients in the efaproxiral arm, respectively. The most common severe adverse event in patients treated with efaproxiral was hypoxemia, which was reversible and effectively managed with supplemental oxygen in most patients.
CONCLUSION
The addition of efaproxiral, a noncytotoxic radiation sensitizer, to WBRT may improve response rates and survival in patients with brain metastases, particularly metastases from breast cancer. A confirmatory trial for breast cancer patients has been initiated.
RSR13 加颅脑放射治疗脑转移患者：与放射治疗肿瘤学组递归分区分析脑转移数据库的比较。
DOI：
10.1200/jco.2003.08.116
发表时间：
2003
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
Shaw,Edward;Scott,Charles;Suh,John;Kadish,Sidney;Stea,Baldassarre;Hackman,John;Pearlman,Andrew;Murray,Kevin;Gaspar,Laurie;Mehta,Minesh;Curran,Walter;Gerber,Michael
通讯作者：
Gerber,Michael
DOI：
10.1016/s0360-3016(99)00198-4
发表时间：
1999-09-01
影响因子：
7
作者：
Kondziolka, D;Patel, A;Flickinger, JC
通讯作者：
Flickinger, JC