2007年7月1日刊的“临床癌症研究”杂志刊登一篇关于肿瘤免疫治疗临床研究标准的文章，提出了肿瘤治疗尤其是免疫治疗新的概念。作者Jeffrey Schlom博士在文章中指出，现在进行的临床研究，无论是免疫治疗还是标准疗法如化疗，都是以缩小肿瘤为标准。然而，免疫治疗药物需要更多的时间击发体内免疫系统，所以观察不到肿瘤缩小的证据。这就是为什么肿瘤免疫治疗临床失败的原因。Schlom博士在文中总结了5个前列腺癌免疫治疗的临床研究，包括现在已经进入美国FDA审批阶段Denderon公司（Nasdaq: DNDN）的Provenge。这些免疫治疗（也有人称之为治疗性疫苗）能够在低毒状态下使癌症患者有更长的生存期。可以说，这类药不仅在关注肿瘤大小的变化，更应注重建立患者的免疫体系和延长生存期。作者建议，癌症的治疗应该把患者的生存期放在第一位。
文中提到的Denderon公司（Nasdaq: DNDN）股价受此影响大幅攀升，在7月3日开盘的第一个小时增长了14%，收盘时上升了6.5%达7.70美元/股。
原始出处:
Clinical Cancer Research 13, 3776-3782, July 1, 2007. doi: 10.1158/1078-0432.CCR-07-0588
Cancer Vaccines: Moving Beyond Current Paradigms
Jeffrey Schlom, Philip M. Arlen and James L. Gulley
Authors' Affiliation: Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland
Requests for reprints: Jeffrey Schlom, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, NIH, Room 8B09, 10 Center Drive, Bethesda, MD 20892. Phone: 301-496-4343; Fax: 301-496-2756; E-mail: js141c@nih.gov .
The field of cancer vaccines is currently in an active state of preclinical and clinical investigations. Although no therapeutic cancer vaccine has to date been approved by the Food and Drug Administration, several new paradigms are emerging from recent clinical findings both in the use of combination therapy approaches and, perhaps more importantly, in clinical trial design and end point analyses. This article will review recent clinical trials involving several different cancer vaccines from which data are emerging contrasting classic "tumor response" (Response Evaluation Criteria in Solid Tumors) criteria with "patient response" in the manifestation of increased patient survival post-vaccine therapy. Also described are several strategies in which cancer vaccines can be exploited in combination with other agents and therapeutic modalities that are quite unique when compared with "conventional" combination therapies. This is most likely due to the phenomena that (a) cancer vaccines initiate a dynamic immune process that can be exploited in subsequent therapies and (b) both radiation and certain chemotherapeutic agents have been shown to alter the phenotype of tumor cells as to render them more susceptible to T-cell–mediated killing. Consequently, evidence is emerging from several studies in which patient cohorts who first receive a cancer vaccine (as contrasted with control cohorts) benefit clinically from subsequent therapies.
