刘筱玫医生9月21日主题帖: 意大利可接种乳腺癌宫颈癌两种疫苗吗

宫颈癌carcinoma cervice uterina和乳腺癌carcinoma mammario是女性的两大致命杀手， 很多女性朋友为了避免罹患尖锐湿疣、 宫颈癌或肛门癌到我的诊所进行宫颈癌疫苗接种， 这也是我作为医生积极推荐的一种很有效的疫苗，这种疫苗不但适合女性可以接种，男性为了避免罹患尖锐湿疣、阴茎癌或肛门癌同样可以接种，此类疫苗与乙肝疫苗注射方式类似，分3针3次注射，在今天的主题帖里，我主要讲解一下大家不太熟悉的乳腺癌疫苗。

说起乳腺癌，全球每年大约130万妇女罹患且有大约60万死于该病。在美国、加拿大、澳洲以及欧洲的发达国家，乳腺癌的发病率有占女性恶性肿瘤首位的趋势。城市女性乳腺癌发病率远远高于农村女性，城市女性乳腺癌高发的因素是普遍的晚婚晚育、较少的生育次数、较短的哺乳时间，以及快节奏压力大的都市生活，都可以导致内分泌紊乱，诱发乳腺癌发病。对于不放置避孕环而单纯依赖口服避孕药的妇女而言，肝癌与乳腺癌机率会明显升高。

另外，值得注意的是乳腺癌其实不是女性的专利，由于男性也存在少量乳腺组织，乳腺癌也同样会发生在男性中间，但比例明显降低。

意大利可以进行乳腺癌疫苗接种吗

这是居住在意大利的同胞最关心的问题。其实，乳腺癌疫苗从2006年在丹麦Pharmexa生物科技公司就已经开始投资研发并在英国和丹麦进行试验，主要是针对大部分乳腺癌中表达的HER-2蛋白。随后，是2007年台湾糖蛋白分子领域院士翁启惠率领研究团队初步研发出针对乳腺癌“合成多醣体”的有效疫苗，美国食品药物管理局FDA与台湾“卫生署”已达成合作协议，同意近期同步进行第二、第三阶段人体试验。

2009年，德国默克公司开始进行新疫苗Stimuvax的III期临床实验，该疫苗由默克和美国Oncothyreon制药公司共同研发， 在2010年暂停临床试验，之后又重新开始新一轮临床验证。目前，研究人员也正在通过另一项III期临床检测Stimuvax用于治疗非小细胞肺癌的疗效。这种疫苗可以激活人体免疫系统，使之确定并靶向作用于表达MUC1的癌细胞，而MUC1则是一种通常在乳腺癌、非小细胞肺癌、多发性骨髓瘤、结肠癌、前列腺癌和卵巢癌患者身上出现的抗原。

2013年， 辛辛那提大学(UC)癌症研究所和美国国立卫生研究院(NIH)进行的一项联合研究发现，一种新型口服乳腺癌疫苗可对癌细胞发起双重免疫系统攻击，有效避免乳腺癌的复发。

这是相关领域首次将口服特殊病毒---重组腺相关病毒(AAV)---作为癌症疫苗。首席研究员、辛辛那提大学医学院助理教授Jason Steel和同事们将相关研究成果发表在1月8日的《分子疗法》杂志上。

关于上述这个万众瞩目的Stimuvax的研究进展原文如下：

Late-stage trial results for Merck kGaA's lung-cancer drug Stimuvax （不单单是乳腺癌疫苗也是肺癌疫苗） won't be available until 2013 as the trial needs to continue, the German pharmaceutical and chemical company said in a presentation to analysts Tuesday.

Merck KGaA has an exclusive licensing agreement with U.S.-based Oncothyeron Inc.for Stimuvax, an investigational cancer immunotherapy. The drug is supposed to work by stimulating the body's immune system to identify and destroy cancer cells that contain a specific gene（激发免疫系统来识别破坏含特定基因的癌细胞）.

News that Stimuvax's late-stage results won't be known until next year weighed on shares of Oncothyreon. The company has no other products on the market, and much of its valuation is tied to the trial outcome of Stimuvax; if it ends positively, Oncothyreon said it would be eligible for up to $90 million in milestones and royalties on sales.

Analysts also estimate that Stimuvax revenues could approach $1 billion by 2016 if approved.

Oncothyreon shares fell 38% to $5.20 in early afternoon trading Tuesday on the Nasdaq Stock Market. Investors had hoped to see the results sooner.

Because the trial looks at the survivability rates of patients using Stimuvax compared with those using the placebo, it is hard to measure exactly how long the trial will take to reach completion. An independent data-monitoring committee analyzing the results recently decided to finish the trial after reviewing its preliminary results.

The review was triggered when three-quarters of the required deaths in the trial were recorded. The committee then had three options: to halt the trial because it deemed the treatment ineffective, to end the study because it viewed the results as clearly effective, or to continue the study until the required number of deaths have occurred and examine all the data at that time.

Oncothyreon's Chief Executive Dr. Robert Kirkman said during a presentation at Cowen & Co.'s annual health-care conference that he has little to add to Merck KGaA's commentary about the trial for the therapeutic vaccine for non-small cell lung cancer except that it will continue through the end of the study.

The trial was designed to be a more stringent hurdle because Merck KGaA plans to rely on it for approval filings, Dr. Kirkman said.

"This was the most likely outcome of this interim look," he said. "We are not surprised."

Oncothyreon is also working on the development of two other drugs, PX-866, a small-molecule drug with implications for cancer treatment, and ONT-10, its second-generation cancer vaccine（Oncothyreon同时还在研发PX-866小分子癌症药物以及二代癌疫苗ONT-10 ).

通过上段stimuvax的研究情况的报道可见新疫苗的研制以及临床实验周期之长, 所有的这些世界范围内对乳腺癌疫苗的研究进展，到目前为止获得的最新临床试验数据还不足以支持大规模的上市， 因此，在意大利境内目前只可以接种宫颈癌疫苗尚不可以接种乳腺癌疫苗。

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