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自本年度诺贝尔医学或生理学奖获得者Ralph M.Steinman于1973年发现DC及其在获得性免疫应答中关键作用以来,有关DC肿瘤疫苗的研究持续进行了数十年,直到2010年4月,美国FDA才批准了首个以DC为主要效应细胞的自体细胞免疫治疗药物sipuleucel-T(又称APC8015或Provenge)用于无症状或轻微症状的转移性去势拮抗性前列腺癌的治疗,成为自1971年理查德·尼克松颁布《国家癌症法》以来癌症研究40年中的重要事件之一。为了详细了解美国Dendreon公司为临床开发sipuleucel-T所经历的坎坷历程,本文对sipuleucel-T的制备过程和作用机制、sipuleucel-T I/Ⅱ期和Ⅲ期临床试验的设计情况及研究结果、sipuleucel-T上市的竞争情况作了回顾和介绍,同时分析了临床应用sipuleucel-T所亟待解决的一些问题,如疗效评价体系的建立等,希望对致力于DC肿瘤疫苗研发乃至肿瘤免疫治疗的同行有所借鉴和启示。
Since this year’s Ralph M. Steinman, winner of the Nobel Prize in Medicine or Physiology, found that DC and its key role in the adaptive immune response were discovered in 1973, research on DC tumor vaccines has been ongoing for decades until April 2010, US FDA approved the first autologous cellular immunotherapy with DC as the primary effector sipuleucel-T (also known as APC8015 or Provenge) for the treatment of asymptomatic or mild symptoms of metastatic castrate-antagonistic prostate cancer, One of the most important events in the 40 years of cancer research since Richard Nixon enacted the National Cancer Law in 1971. In order to know more about the ups and downs experienced by Dendreon Company for the clinical development of sipuleucel-T in the United States, the preparation process and mechanism of sipuleucel-T, the design and results of sipuleucel-T phase I and phase II clinical trial and sipuleucel -T listing of the competition was reviewed and introduced at the same time analyzed the clinical application of sipuleucel-T some problems to be solved, such as the establishment of efficacy evaluation system, hoping to contribute to the development of DC tumor vaccine and even cancer immunotherapy counterparts Reference and inspiration.