放疗药物Xofigo获准用于治疗特定前列腺癌患者

圣路易斯(MD Consult)——2013年5月15日，拜耳公司宣布美国食品药品管理局(FDA)已经批准Xofigo(二氯化镭-223)用于治疗患去势耐药性前列腺癌、伴有骨转移症状且无已知内脏转移性疾病的患者。Xofigo是一种发射α粒子的放疗药物。

FDA批准Xofigo是基于一项关键性Ⅲ期临床试验的数据。该研究的中期分析结果显示，使用Xofigo显著改善了患者的总生存时间(OS)[危险比(HR)，0.695；95%置信区间(CI)，0.552~0.875；P=0.00185]，Xofigo+最佳标准治疗方案组的中位OS为14.0个月，而安慰剂+最佳标准治疗方案组为11.2个月。另外，中期分析还显示，Xofigo治疗组与对照组相比，发生首次症状性骨骼事件的时间推迟。之后进行的一项非盲分析表明，OS显著改善，Xofigo治疗组与安慰剂对照组的中位OS分别为14.9个月和11.3个月。

在这项Ⅲ期试验中，接受Xofigo治疗者的最常见不良反应是恶心、腹泻、呕吐及周围水肿。最常见的血液学指标异常为贫血、淋巴细胞减少、白细胞减少、血小板减少以及中性粒细胞减少。

在这项随机试验中，与安慰剂对照组相比，Xofigo治疗组有2%的患者曾发生骨髓衰竭或进行性全血细胞减少。有2例死亡归因于骨髓衰竭。在13例接受Xofigo治疗的患者中有7例在死亡时仍存在进行性骨髓衰竭。

仅允许由获得授权者在特定临床条件下接收和使用Xofigo。使用Xifigo会给他人带来潜在危险，患者的尿液等体液、粪便或呕吐物外泄可能给他人造成辐射或污染，因此必须按照国家及地方法规采取放射防护措施。

化疗联合Xofigo的安全性和有效性尚未得到证实。考虑到叠加性骨髓抑制作用，在临床试验之外不推荐化疗患者联用Xofigo。

爱思唯尔版权所有  未经授权请勿转载

ST LOUIS (MD Consult) - On May 15, 2013, Bayer HealthCare announced that the US Food and Drug Administration (FDA) has approved Xofigo (radium Ra 223 dichloride) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. Xofigo is an alpha particle-emitting radioactive therapeutic agent.

The approval of Xofigo was granted on the basis of data from a pivotal phase 3 trial. At the interim analysis, the use of Xofigo significantly improved overall survival (OS) (hazard rate, 0.695 [95% confidence interval, 0.552-0.875: P = .00185]). Median OS was 14.0 months with Xofigo plus best standard of care versus 11.2 months with placebo plus best standard of care. Additionally, at the interim analysis, a delay in time to first symptomatic skeletal event was noted for patients treated with Xofigo versus placebo. An updated analysis, conducted after the study was unblinded, showed improvement in OS, with a median OS of 14.9 months versus 11.3 months.

The most common adverse reactions in patients who received Xofigo during the phase 3 trial were nausea, diarrhea, vomiting, and peripheral edema. The most common hematologic laboratory abnormalities were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.

In the randomized trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared with no patients treated with placebo. Two deaths occurred as a result of bone marrow failure. For 7 of 13 patients treated with Xofigo, bone marrow failure was ongoing at the time of death.

Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit.Therefore, radiation protection precautions must be taken in accordance with national and local regulations.

The safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended because of the potential for additive myelosuppression.

---------------------------------------------------------------------------------------------------------------------------------------------
欢迎关注Elseviermed官方微信