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首页> 外文期刊>Journal of Immune Based Therapies Vaccines >Safety, immunogenicity and preliminary efficacy of multiple-site vaccination with an Epidermal Growth Factor (EGF) based cancer vaccine in advanced non small cell lung cancer (NSCLC) patients
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Safety, immunogenicity and preliminary efficacy of multiple-site vaccination with an Epidermal Growth Factor (EGF) based cancer vaccine in advanced non small cell lung cancer (NSCLC) patients

机译：基于表皮生长因子（EGF）的癌症疫苗多点疫苗接种在晚期非小细胞肺癌（NSCLC）患者中的安全性，免疫原性和初步疗效

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The prognosis of patients with advanced non small cell lung (NSCLC) cancer remains dismal. Epidermal Growth Factor Receptor is over-expressed in many epithelial derived tumors and its role in the development and progression of NSCLC is widely documented. CimaVax-EGF is a therapeutic cancer vaccine composed by human recombinant Epidermal Growth Factor (EGF) conjugated to a carrier protein, P64K from Neisseria Meningitides. The vaccine is intended to induce antibodies against self EGF that would block EGF-EGFR interaction. CimaVax-EGF has been evaluated so far in more than 1000 advanced NSCLC patients, as second line therapy. Two separate studies were compared to assess the impact of high dose vaccination at multiple anatomic sites in terms of immunogenicity, safety and preliminary efficacy in stage IIIb/IV NSCLC patients. In both clinical trials, patients started vaccination 1 month after finishing first line chemotherapy. Vaccination at 4 sites with 2.4 mg of EGF (high dose) was very safe. The most frequent adverse events were grade 1 or 2 injection site reactions, fever, headache and vomiting. Patients had a trend toward higher antibody response. The percent of very good responders significantly augmented and there was a faster decrease of circulating EGF. All vaccinated patients and those classified as good responders immunized with high dose at 4 sites, had a large tendency to improved survival.
机译：晚期非小细胞肺癌（NSCLC）患者的预后仍然不佳。表皮生长因子受体在许多上皮来源的肿瘤中过表达，其在NSCLC发生和发展中的作用已得到广泛的证明。 CimaVax-EGF是一种治疗性癌症疫苗，由与人脑膜炎奈瑟氏球菌（Nisseria Meningitides）的载体蛋白P64K缀合的人重组表皮生长因子（EGF）组成。该疫苗旨在诱导针对自身EGF的抗体，该抗体会阻断EGF-EGFR的相互作用。迄今为止，已经对超过1000名晚期NSCLC患者进行了CimaVax-EGF的二线治疗评估。比较了两项单独的研究，以评估IIIb / IV期NSCLC患者在免疫原性，安全性和初步疗效方面在多个解剖部位进行大剂量疫苗接种的影响。在两项临床试验中，患者在完成一线化疗后1个月开始接种疫苗。用4 mg EGF（高剂量）在4个部位进行疫苗接种非常安全。最常见的不良事件是1级或2级注射部位反应，发烧，头痛和呕吐。患者具有更高的抗体应答趋势。非常好的应答者的百分比显着增加，循环中的EGF下降更快。所有接种疫苗的患者以及在4个部位以高剂量免疫后被分类为良好反应者的患者，都有很大的提高生存率的趋势。

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