一种表皮生长因子疫苗在晚期非小细胞肺癌第二期的临床随机对照试验

jimmy112199

作者:<br/>Elia Neninger Vinageras, Ana de la Torre, Marta Osorio Rodríguez, Mauricio Catalá Ferrer, Idania Bravo, Mario Mendoza del Pino, Daniel Abreu Abreu, Soraida Acosta Brooks, Rolando Rives, Concepción del Castillo Carrillo, Marta González Due&#241;as, Carmen Viada, Beatriz García Verdecia, Tania Crombet Ramos, Gisela González Marinello, Agustín Lage Dávila<br/><br/>From the Hermanos Ameijeiras Hospital; National Institute of Oncology and Radiobiology; Center for Medical and Surgical Research; National Institute of Neumology; Center of Molecular Immunology, Havana; Celestino Hernández Hospital, Villa Clara; Third Congress Hospital, Pinar del Río; Maria Curie Hospital, Camagüey, Cuba; V.I. Lenin Hospital, Holguín; and Saturnino Lora Hospital, Santiago de Cuba<br/><br/>Corresponding author: Elia Neninger Vinageras, MD, Hospital Hermanos Ameijeiras, San Lázaro 701, PO Box 10300, Ciudad Habana, Cuba<br/><br/><br/>目的：我们证明了这样一种结果，随机II期临床试验，与表皮生长因子（ EGF ）为基础的癌症疫苗在晚期非小细胞肺癌（ NSCLC ）患者，评价免疫原性，安全性和效果上生存。<br/><br/>病人与方法： 80例阶段第IIIB部/四期非小细胞肺癌后整理第一线化疗，随机分配接受最佳支持护理或EGF接种。<br/><br/>结果：注射疫苗是安全的。不良事件的观察，在不到25 ％的情况下，被等级1或2根据美国国家癌症研究所共同毒性标准。良好的抗表皮生长因子抗体反应（林佳）获得51.3 ％的接种和病人在没有对照组。血清表皮生长因子浓度的一个主要下降64.3 ％接种疫苗的病人。明嘉病人存活显着多于那些穷人的抗体反应（杆）。此外，病人的血清中EGF跌破168编号/毫升存活显着多于其他国家。有一种趋势，以提高存活率接种患者与对照组相比。生存优势，为患者接种疫苗与对照组相比，在统计学上有意义，在分组的患者年龄小于60岁。<br/><br/>结论：预防接种与表皮生长因子是一种安全，挑起增加抗表皮生长因子抗体滴度和减少血清EGF的。有一种直接关联抗体反应和生存。有直接相关关系，减少血清中表皮生长因子和生存。患者年龄小于60岁，疫苗注射，会增加存活率。<br/><br/>条款蓝色定义在词汇，发现在结束这篇文章，并在网上www.jco.org 。<br/><br/>作者披露的或潜在的利益冲突和作者的贡献是发现于去年底这篇文章。<br/><br/><h2>
Phase II Randomized Controlled Trial of an Epidermal Growth Factor Vaccine in Advanced Non–Small-Cell Lung Cancer</h2>


<p>
<strong>
<nobr>Elia Neninger Vinageras</nobr>,
<nobr>Ana de la Torre</nobr>,
<nobr>Marta Osorio Rodríguez</nobr>,
<nobr>Mauricio Catalá Ferrer</nobr>,
<nobr>Idania Bravo</nobr>,
<nobr>Mario Mendoza del Pino</nobr>,
<nobr>Daniel Abreu Abreu</nobr>,
<nobr>Soraida Acosta Brooks</nobr>,
<nobr>Rolando Rives</nobr>,
<nobr>Concepción del Castillo Carrillo</nobr>,
<nobr>Marta González Due&#241;as</nobr>,
<nobr>Carmen Viada</nobr>,
<nobr>Beatriz García Verdecia</nobr>,
<nobr>Tania Crombet Ramos</nobr>,
<nobr>Gisela González Marinello</nobr>,
<nobr>Agustín Lage Dávila</nobr>
</strong></p><p>
<font size="-1">
From the Hermanos Ameijeiras Hospital; National Institute of Oncology
and Radiobiology; Center for Medical and Surgical Research; National
Institute of Neumology; Center of Molecular Immunology, Havana;
Celestino Hernández Hospital, Villa Clara; Third Congress Hospital,
Pinar del Río; Maria Curie Hospital, Camagüey, Cuba; V.I. Lenin
Hospital, Holguín; and Saturnino Lora Hospital, Santiago de Cuba
</font></p><p>

<font size="-1">Corresponding author: Elia Neninger Vinageras, MD,
Hospital Hermanos Ameijeiras, San Lázaro 701, PO Box 10300, Ciudad
Habana, Cuba</font></p><p>
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Purpose: We show the result of a randomized phase II clinical trial withan epidermal growth factor (EGF)-based cancer vaccine in advancednon–small-cell lung cancer (NSCLC) patients, evaluatingimmunogenicity, safety, and effect on survival.</p><p>

Patients and Methods: Eighty patients with stage IIIB/IV NSCLC after finishing first-linechemotherapy were randomly assigned to receive best supportivecare or EGF vaccinations.</p><p>

Results: Vaccination was safe. Adverse events were observed in less than25% of cases and were grade 1 or 2 according to National CancerInstitute Common Toxicity Criteria. Good anti-EGF antibody response(GAR) was obtained in 51.3% of vaccinated patients and in noneof the control group. Serum EGF concentration showed a majordecrease in 64.3% of vaccinated patients. GAR patients survivedsignificantly more than those with poor antibody response (PAR).Also, patients whose serum EGF dropped below 168 pg/mL survivedsignificantly more than the rest. There was a trend to an increasedsurvival for vaccinated patients compared with controls. Thesurvival advantage for vaccinated patients compared with controlswas statistically significant in the subgroup of patients withage younger than 60 years.</p><p>

Conclusion: Vaccination with EGF was safe and provoked an increase in anti-EGFantibody titers and a decrease in serum EGF. There was a directcorrelation between antibody response and survival. There wasa direct correlation between decrease in serum EGF and survival.In patients younger than 60 years, vaccination was associatedwith increased survival.</p><p>



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Terms in blue are defined in the glossary, found at the endof this article and online at <a href="http://www.jco.org/">www.jco.org</a>.</p>

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Authors' disclosures of potential conflicts of interest andauthor contributions are found at the end of this article.<br/>

[此贴子已经被作者于2008-4-18 5:13:46编辑过]

kikitty

关注中．．．可是等中国引进这种疫苗，恐怕又是很长久之后了．．．．

春暖花开

看了，很好．

小路

<p>thank you !</p>

玖╃-尾狐oο

盼望

春暖花开

<p>小路:</p><p>&nbsp; 在这里看见你,太高兴了.真的.</p><p>&nbsp; 加油啊!</p>