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本帖最后由 StephenW 于 2011-4-1 06:16 编辑
我偶然读到,关于癌症的治疗性疫苗.看见:
"classic criteria for measuring the efficacy of a therapeutic may not apply to vaccines"
“经典标准“可能并不适用于衡量治疗疫苗治疗效果““.
The FDA Draft Guidance for Industry on designing trials for therapeutic cancer vaccines[17] stated that a delayed effect could be expected in subjects receiving a vaccine because "cancer vaccines need time to elicit an immune response that could manifest as biological activity".
用于治疗癌症的疫苗设计试验,FDA的工业指南草案指出，接受疫苗受试者,延迟的效应可能会发生，因为“癌症疫苗需要时间来引发一种免疫反应，可作为明显生物活性“。
[Stephen]:这"延迟的效应"适用于乙肝治疗性疫苗?
问题: 癌细胞从身体内, 乙肝病毒从体外,免疫反应该是不同的?
http://en.wikipedia.org/wiki/Sipuleucel-T#cite_note-rethinking-15
Although the three phase III trials, D9901, D9902a and IMPACT, confirmed the survival benefit of Sipuleucel-T, they did not demonstrate that Sipuleucel-T delayed tumor progression. Only D9901 indicated such a possibility with P value 0.052 for the time-to-progression endpoint (like progression-free survival but not counting death as progression), slightly higher than the traditionally accepted level of statistical significance at 0.05.[4] This has led to a question as stated in a review from the New England Journal of Medicine[5] (NEJM) on how survival prolongation was possible without "some apparent measurable change in the tumor".
However, the possibility of such an anomalous result was well-known in cancer vaccine research. For example, an article in the Journal of the National Cancer Institute (JNCI)[16] observed that the "classic criteria for measuring the efficacy of a therapeutic may not apply to vaccines" and multiple cancer vaccine trials had shown that patients lived longer even though very little shrinkage of tumors was seen.
The FDA Draft Guidance for Industry on designing trials for therapeutic cancer vaccines[17] stated that a delayed effect could be expected in subjects receiving a vaccine because "cancer vaccines need time to elicit an immune response that could manifest as biological activity". Such a delayed effect could mean that "the endpoint curves of the trial results may show no effect for the initial portion of the study." In particular, an endpoint such as progression-free survival or time-to-progression would be difficult to achieve in a clinical trial of a cancer vaccine as tumor progression often happens while the immune system is being activated.
As the JNCI article further discussed, progression events are not always critical. Thus, once activated by an effective vaccine such as Sipuleucel-T, the immune system could still help to keep tumor growth in check and prolong survival.[16]
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发表于 2011-4-1 04:29
问题乙克是什么玩意我们还不知道呢~！
