Br J Cancer:替莫唑胺与nabiximols大麻素喷雾治疗复发性胶质母细胞瘤的安全性和疗效分析

2021-02-24 xiaozeng MedSci原创

胶质母细胞瘤(GBM)作为成人中最常见的一种恶性原发性脑肿瘤,其发病率约为每10万人中3.2例病例,患者的5年生存率小于6%。

胶质母细胞瘤(GBM)作为成人中最常见的一种恶性原发性脑肿瘤,其发病率约为每10万人中3.2例病例,患者的5年生存率小于6%。

既往研究显示,GBM是无法治愈的,目前最佳的治疗方法为最大程度的减瘤手术,并结合术后的局部大剂量放疗和替莫唑胺(temozolomide,TMZ)化疗。接受该治疗策略的患者的平均总生存期(OS)可达14.6个月。然而,几乎所有的患者在治疗后6–9个月后均出现了肿瘤的复发。患者复发后的中位生存期降至1.0–10.8个月,且目前尚无针对此类患者有效的治疗策略。


大麻素天然存在于大麻植物中,且在几个世纪前已应用于在医学治疗上。临床前数据显示,某些大麻素或可对GBM发挥抗肿瘤作用。因此,该研究旨在首次复发的GBM患者中评估nabiximols大麻素喷雾以及加强剂量替莫唑胺(DIT)的安全性和初步疗效。

试验相关流程图

该临床试验的第1部分为开放性的非盲试验,第2部分为随机的双盲试验并采用安慰剂作为对照。患者接受了nabiximols(第1部分,n=6;第2部分,n = 12)或安慰剂(仅第2部分,n=9)治疗;每天最多进行12次DIT喷雾,持续时间长达12个月。安全性、疗效和替莫唑胺药代动力学(PK)为相关检测指标。


结果显示,最常见的治疗诱发的不良事件(TEAEs)为呕吐、头晕、疲劳、恶心和头痛。大多数的患者经历了2级或3级TEAEs(CTCAE)。在第2部分的接受nabiximols和安慰剂治疗的患者中,有33%的患者在6个月时疾病无进展。nabiximols组的1年生存率为83%,而安慰剂组为44%。进一步的研究显示,nabiximols对替莫唑胺的药代动力学没有明显作用。

Kaplan-Meier生存曲线

总而言之,该研究显示,通过个性化给药,nabiximols具有可接受的安全性和耐受性,且并未发现药物的相互作用。而该试验观察到的生存差异还需要进一步的在后续的随机对照试验进行验证。


原始出处:

Twelves, C., Sabel, M., Checketts, D. et al. A phase 1b randomised, placebo-controlled trial of nabiximols cannabinoid oromucosal spray with temozolomide in patients with recurrent glioblastoma. Br J Cancer (24 February 2021).

 

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    2021-02-26 kcb069
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    2021-02-25 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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