Clin Cancer Res:联合用药治疗胸腺上皮肿瘤效果显著

2014-11-06 佚名 生物谷

近日,来自美国国家癌症中心的研究人员通过研究在I/II期临床试验中评估了药物belinostat同顺铂、多柔比星及环磷酰胺联合用于治疗胸腺上皮性肿瘤的效果,相关研究刊登于国际杂志Clinical Cancer Research上。 文章中,研究者Thomas表示,进行I/II期临床试验的目的就是确定药物belinostat的最安全剂量及患者的最大耐受剂量(MTD, maximum toler

近日,来自美国国家癌症中心的研究人员通过研究在I/II期临床试验中评估了药物belinostat同顺铂、多柔比星及环磷酰胺联合用于治疗胸腺上皮性肿瘤的效果,相关研究刊登于国际杂志Clinical Cancer Research上。

文章中,研究者Thomas表示,进行I/II期临床试验的目的就是确定药物belinostat的最安全剂量及患者的最大耐受剂量(MTD, maximum tolerated dose),药物belinostat是一种组蛋白去乙酰化酶抑制剂(HDAC),其已被欧盟委员会指定为孤儿药,用于治疗外周T细胞淋巴瘤(PTCL)。此前研究人员利用belinostat同顺铂、多柔比星及环磷酰胺联合用于治疗胸腺上皮性肿瘤(TET),文章中研究者对药物的抗肿瘤活性、药代动力学及生物标记物的反应均进行了评估。

研究者表示,恶性且TET不能切除的患者接受增加剂量的belinostat来进行治疗,药物belinostat通过持续静脉注射入患者体内,持续时间超过48小时;同时患者进行为期3周循环的化疗过程(belinostat、顺铂、多柔比星及环磷酰胺联合使用),在II期临床试验阶段研究者利用最大耐受剂量的药物belinostat来进行治疗。

在招募的26位病人中,两位患者机体的药物belinostat均达到了最大的容许毒性剂量(2000mg/m2),另外24位病人被以最大耐受剂量(1000mg/m2)的化疗药物进行治疗(顺铂:第二天用量为50mg/m2、多柔比星:第二天和第三天用量为25 mg/m2、环磷酰胺第三天用量为500 mg/m2)。患者胸腺癌和胸腺上皮癌的客观反映率分别为64%(95%的置信区间,30.8%-80.1%)和21%(4.7%-50.8%)。

与此同时,研究人员观察到了组蛋白去乙酰化酶抑制剂(HDAC)药效标记物的调节、调节性T细胞水平的下降及CD8+ T细胞的衰竭现象;调节性T细胞水平的下降和药物对患者的无进展存活期及效应直接相关,CD8+ T细胞的下降水平在药物响应者机体中表现更为明显。

最后研究者总结道,本文中通过研究我们揭示了药物belinostat联合顺铂、多柔比星及环磷酰胺进行患者化疗的最大耐受剂量,这就表明这种药物联合使用在治疗TET患者中是积极而且可行的,而治疗过程中调节性T细胞及CD8+ T细胞的免疫调节效应值得我们后期进一步深入研究。

原始出处

Thomas A1, Rajan A1, Szabo E2, Tomita Y1, Carter CA3, Scepura B1, Lopez-Chavez A1, Lee MJ1, Redon CE4, Frosch A1, Peer CJ1, Chen Y1, Piekarz R5, Steinberg SM6, Trepel JB1, Figg WD1, Schrump DS7, Giaccone G8.A Phase I/II Trial of Belinostat in Combination with Cisplatin, Doxorubicin, and Cyclophosphamide in Thymic Epithelial Tumors: A Clinical and Translational Study.Clin Cancer Res. 2014 Nov 1

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