2007年7月1日刊的“臨床癌癥研究”雜志刊登一篇關(guān)于腫瘤免疫治療臨床研究標(biāo)準(zhǔn)的文章,，提出了腫瘤治療尤其是免疫治療新的概念,。作者Jeffrey Schlom博士在文章中指出，現(xiàn)在進(jìn)行的臨床研究,，無論是免疫治療還是標(biāo)準(zhǔn)療法如化療，都是以縮小腫瘤為標(biāo)準(zhǔn),。然而，免疫治療藥物需要更多的時(shí)間擊發(fā)體內(nèi)免疫系統(tǒng),，所以觀察不到腫瘤縮小的證據(jù),。這就是為什么腫瘤免疫治療臨床失敗的原因,。Schlom博士在文中總結(jié)了5個(gè)前列腺癌免疫治療的臨床研究，包括現(xiàn)在已經(jīng)進(jìn)入美國(guó)FDA審批階段Denderon公司（Nasdaq: DNDN）的Provenge,。這些免疫治療（也有人稱之為治療性疫苗）能夠在低毒狀態(tài)下使癌癥患者有更長(zhǎng)的生存期,。可以說,，這類藥不僅在關(guān)注腫瘤大小的變化,，更應(yīng)注重建立患者的免疫體系和延長(zhǎng)生存期。作者建議,，癌癥的治療應(yīng)該把患者的生存期放在第一位,。
文中提到的Denderon公司（Nasdaq: DNDN）股價(jià)受此影響大幅攀升，在7月3日開盤的第一個(gè)小時(shí)增長(zhǎng)了14%,，收盤時(shí)上升了6.5%達(dá)7.70美元/股。
原始出處:
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: [email protected] .
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.
