非盲、跨国G17DT疫苗接种的多中心研究结合顺铂、5 -氟尿嘧啶治疗患者,癌症晚期胃或胃食管:GC4研究。

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贝克Ajani是的,赫克特小,L, J, Oortgiesen M, Eduljee, Michaeli D

非盲、跨国G17DT疫苗接种的多中心研究结合顺铂、5 -氟尿嘧啶治疗患者,癌症晚期胃或胃食管:GC4研究。

癌症。2006年5月1日,106 (9):1908 - 16。

PubMed ID

16568451 (在PubMed

]

文摘

背景:胃泌激素激素营养体外胃癌,antigastrin抗体(aga)抗增殖和antimetastatic。人类胃癌症胃泌激素基因过表达和应对胃泌激素受体的营养效果。免疫原G17DT引发特定的高亲和性AGA和。作者评估G17DT接种给定与顺铂+ 5 -氟尿嘧啶治疗胃腺癌。方法:多中心、二期研究中,患者接受G17DT疫苗肌肉在周1,5、9和25每28天,顺铂+ 5 -氟尿嘧啶。符合条件的患者治疗,转移性、不可切除的胃或胃食管腺癌与器官功能接近正常水平。这项研究的主要终点是在反应率(ORR)和次要终点包括总生存期(OS),安全,以及成功的疫苗接种的影响病人的结果。结果:总共有103名患者参加5个国家。七个病人过量无意中与5 -氟尿嘧啶(主要协议违反)从分析中删除。确认或者是79年的30%患者评估响应。 The median time-to-progression (TTP) was 5.4 months, and the median survival (MS) was 9.0 months (n = 96 patients). Sixty-five of 94 patients who were vaccinated (69%) had 2 consecutive AGA titers of > or =1 units (successfully vaccinated patients or immune-responders). The TTP was longer in immune-responders than in immune-nonresponders (P = .0005). Similarly, the MS was longer in immune-responders than in immune-nonresponders (10.3 months vs. 3.8 months; P < or =.0001). In a multivariate analysis, successful vaccination was an independent OS prognosticator (P = .0001). G17DT did not have an adverse effect on safety. CONCLUSIONS: The results demonstrated that successful G17DT vaccination was correlated with longer TTP and MS. AGA response was an independent OS prognosticator. A Phase III evaluation of G17DT in gastric cancer is warranted.

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药物

G17DT