第二阶段研究的安全性和有效性的多药耐药性抑制剂vx - 710结合阿霉素、长春新碱在复发性小细胞肺癌患者。

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甘地L,哈丁兆瓦,纽鲍尔M,兰格CJ,摩尔M,罗斯HJ,约翰逊,林奇TJ

第二阶段研究的安全性和有效性的多药耐药性抑制剂vx - 710结合阿霉素、长春新碱在复发性小细胞肺癌患者。

癌症。2007年3月1日,109 (5):924 - 32。

PubMed ID

17285598 (在PubMed

]

文摘

背景:肿瘤的多药耐药性(MDR)频繁调控流出蛋白质,包括MDR-associated蛋白质(MRP-1)和22 (Pgp)。MDR是阻碍成功的治疗和化疗是可逆的Pgp或MRP-1-expressing抑制剂vx - 710细胞。第二阶段的研究旨在评估vx - 710结合阿霉素、长春新碱敏感,患者复发性小细胞肺癌(SCLC)。方法:符合条件的患者复发后SCLC应对一线化疗。第一阶段安全性评价与扩张计划完成9反应被证实在第一个35的病人。每21天患者治疗直到进展或难以忍受的不良事件(AEs)。结果:36例为从1998年到2000年。嗜中性白血球减少症是主要的毒性,发生在26日的36例(72%)。嗜中性白血球减少症更严重(30% vs 20%等级4)和开发周期1 (58% vs 38%)早些时候在15个病人登记前需要嗜中性白血球减少症预防的一项修正案。4名患者死于研究:2从感染可能与治疗从癌症恶化和2。 Seven of 36 patients (19%) had partial responses; 6 patients sustained responses through 6 cycles of treatment, with 1 response lasting 3 years. Three additional patients had unconfirmed responses, and 4 patients had stable disease. The median survival was 6 months. No correlative (99m)Tc-sestamibi uptake in tumor tissue was observed with the addition of VX-710 in this study. CONCLUSIONS: The addition of VX-710 to doxorubicin and vincristine therapy did not significantly enhance antitumor activity or survival. Although there were durable responses, criteria were not met to proceed with Stage 2 expansion.

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