免疫治疗药物的使用范围已扩大到五种类型癌症

美国食品药品监督管理局（FDA）宣布，已批准扩大免疫治疗药物-纳武单抗（Opdivo）的使用范围，其中包括某些头颈癌患者的治疗。确切地说，尽管已使用含铂类化疗方案治疗复发或转移的头颈部鳞癌（SCCHN）患者，但仍有疾病进展，FDA批准了纳武单抗用于治疗此类患者。基于这个决定，目前已批准纳武单抗用于治疗5种类型癌症。

头颈部癌症实际上是由口腔、喉、咽部、唾液腺以及鼻部/鼻腔通道等癌症所组成的一组癌症。据国立癌症研究所估计，在美国每年所有诊断的新癌症病理中，约有3%病例为头颈部癌症。2016年预计出现头颈部癌症的新病例有5万左右。

大多数头颈部癌症都起源于鳞状细胞，这些鳞状细胞由扁平细胞构成，其覆盖于皮肤表面以及衬于体内肺、消化道等潮湿表面，统称为SCCHN。

俄亥俄州大学综合性癌症中心（即Arthur G. James癌症中心和Richard J. Solove 研究院）内科教授Maura L.Gillison在2016年美国癌症研究协会年度会议中提出纳武单抗临床试验的结果，即对含铂类化疗无应答的复发或转移的SCCHN疾病进展非常迅速，而且患者有非常差的预后。Gillison补充说明“治疗方法通常是单药化疗。然而，目前的治疗方法未显示可以提高该患者群体的生存率，故极需新的治疗方法。”

纳武单抗的用药批准主要取决于Gillison提出以及后来发表在新英格兰医学杂志的III期CheckMate-141临床试验的结果。简而言之，试验表明与研究者选择的单药化疗相比，纳武单抗提高了含铂类化疗后但仍旧出现进展的复发或转移的SCCHN患者的生存率。服用纳武单抗患者的中位总生存期是7.5个月，而单药化疗患者的中位总生存期是5.1个月。

纳武单抗不通过靶向癌症-特定分子起作用，而是通过释放-抗免疫T细胞抑制癌症起作用，希望进一步研究能表明纳武单抗具有抗其他类型癌症的活性。事实上，研发了纳武单抗的百时美施贵宝公司曾宣布该药在III期临床试验中提高了某些胃癌患者的总体生存率。

这种希望是可以触及的，因为某些使用纳武单抗治疗的患者已取得了明显且持久的效果。例如，2016年美国癌症研究协会癌症进展报告中的Philip Prichard，于2013年2月，在肾癌扩散到全身之后，被告知仅有几个月的时间可以存活。后来，通过临床试验接受了纳武单抗进行治疗。目前其身体里癌症的迹象已不存在。（美域健康郭娜编译）

Use of Immunotherapeutic Expanded to Fifth Type of Cancer

This post originally appeared on Cancer Research Catalyst, the official blog of the American Association of Cancer Research.

By Karen Honey, PhD

On Thursday, the U.S. Food and Drug Administration (FDA) announced that it had approved expanding the use of the immunotherapeutic nivolumab (Opdivo) to include the treatment of certain patients with head and neck cancer. Specifically, the FDA approved nivolumab for treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) that has progressed despite treatment with a platinum-containing chemotherapeutic.

With this decision, nivolumab is now approved for treating five types of cancer.

Credit PJ Kaszas

Head and neck cancer is actually a group of cancers that includes cancers of the oral cavity, larynx, pharynx, salivary glands, and nose/nasal passages. The National Cancer Institute estimates that it accounts for about 3 percent of all new cases of cancer diagnosed each year in the United States. In 2016, this is predicted to translate into about 50,000 new cases of head and neck cancer.

Most head and neck cancers begin in squamous cells—flat cells that form the surface of the skin and line moist surfaces of the body like the lungs and digestive tract—and are referred to as SCCHNs.

Recurrent or metastatic SCCHN that is not responsive to platinum-based chemotherapy progresses very rapidly, and patients have a very poor prognosis, according to Maura L. Gillison, MD, PhD, a professor in the Department of Internal Medicine at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, who presented results from the clinical trial that led to this week’s approval of nivolumab at the AACR Annual Meeting 2016.

“Treatment usually involves single-agent chemotherapy. However, no therapy has been shown to improve survival for this patient population. New treatment options are desperately needed,” Gillison added.

This week’s approval of nivolumab was based on results from the phase III CheckMate-141 clinical trial that werepresented by Gillison and published later in The New England Journal of Medicine. In brief, they show that nivolumab improved survival for patients with recurrent or metastatic SCCHN that progressed after platinum-based chemotherapy compared with single-agent chemotherapy of the investigator’s choice. Median overall survival was 7.5 months for those assigned nivolumab versus 5.1 months for those assigned therapy of investigator’s choice.

Given that nivolumab acts not by targeting cancer-specific molecules, but rather works by releasing a brake on cancer-fighting immune cells called T cells, it is hoped that further research will show that it has activity against additional types of cancer. In fact, Bristol-Myers Squibb, the company that developed nivolumab, announcedThursday that nivolumab had improved overall survival for certain patients with gastric cancer in a phase III clinical trial.

The hope is palpable because some patients who have been treated with nivolumab have had remarkable and durable responses. Take Philip Prichard, who is featured in theAACR Cancer Progress Report 2016, for instance. In February 2013, Prichard was given just months to live after kidney cancer had spread throughout his body. He received nivolumab through a clinical trial and there is now no evidence of cancer in his body.