临床研究

以疾病的诊断、治疗、预后、病因为目标;以病人为对象;以群体研究为主要研究方法;以医疗机构为基地的一类医学研究的总称。通过临床研究获得治疗方法的安全性和有效性。在群体中进行药物测试,以期获得剂量、药物作用、不良反应等相关资料,从而对治疗方法进行安全性有效性评价。

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首页 » 临床研究 » ASCO2016:派姆单抗或可有效治疗头颈癌患者

ASCO2016:派姆单抗或可有效治疗头颈癌患者

来源:生物谷 2016-06-08 00:30

图片摘自:www.healthxchange.com.sg

2016年6月8日 讯 /生物谷BIOON/ --近日,来自宾州大学阿博拉姆逊癌症中心的研究人员通过进行II期临床试验发现,利用PD-1抑制剂派姆单抗(pembrolizumab)治疗复发性或转移性头颈癌患者或可使五分之一的患者出现明显的临床反应,相关研究发表于近日的2016年美国临床肿瘤学会年会上。

这项初期研究结果来自研究者进行的KEYNOTE-055临床试验,研究者发现,派姆单抗可以使得92名患者中的17%的患者病情发生部分缓解(171名患者进行治疗),另外的18名患者病情稳定;相比药物甲氨蝶呤而言,癌症患者进行派姆单抗的总体反应率为17%,高于前者,甲氨蝶呤是一种被批准的药物制剂,用来治疗对基于铂的化疗及西妥昔单抗治疗耐药的头颈癌患者。

研究者表示,所招募的患者均对基于铂的化疗及西妥昔单抗治疗没有任何反应,同时也未获益,利用这种疗法治疗的患者的总体生存期为8个月,但很多患者都会在6个月内死亡。当然药物派姆单抗在治疗HPV阳性和阴性癌症患者上具有相同的效力,人乳头瘤病毒是引发口咽癌的主要原因。

研究者Bauml表示,派姆单抗是一种治疗特殊癌症群体的潜在疗法,该研究或填补了当前的一种疗法空缺,可以帮助延长恶性头颈癌患者的生存率。派姆单抗是一种被FDA批准的抗PD-1抗体,其可以促进机体免疫系统功能,使得T细胞侵入并且攻击肿瘤,同时该药物还可以用于治疗表达PD-1的转移性黑色素瘤和转移性的非小细胞肺癌患者。

目前在美国每年有将近5.4万的头颈癌新发病例,其中90%的患者都为头颈部鳞状细胞癌(HNSCC),这种类型的癌症发生于口腔、咽喉的多个部位,随后可以扩散到机体其它部位,比如淋巴结、肺部等;仅有大约一半的患者在诊断后生存期超过了5年。

最后研究者Bauml说道,目前I期和II期临床试验结果都令人可喜,结果表明,靶向PD-1的免疫疗法可以帮助治疗那些目前疗法选择非常少的癌症患者;III期临床试验中我们将对比派姆单抗和标准化疗治疗头颈癌的效果,这些临床试验的结果最终将帮助阐明派姆单抗在治疗头颈癌过程中真正的临床价值。(生物谷Bioon.com)

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Pembrolizumab elicits significant antitumor activity in head and neck cancer patients

Treating head and neck cancer patients with recurrent or metastatic disease with the PD-1 inhibitor pembrolizumab resulted in significant clinical responses in a fifth of the patients from a phase II clinical trial, researchers at the Abramson Cancer Center of the University of Pennsylvania and other institutions reported at the 2016 American Society of Clinical Oncology (ASCO) annual meeting.

The preliminary results from the KEYNOTE-055 trial are being presented by Joshua Bauml, MD, an assistant professor of Hematology/Oncology at the Perelman School of Medicine at the University of Pennsylvania. Robert I. Haddad, MD, of the Dana-Farber Cancer Institute and an associate professor of Medicine at Harvard Medical School, is the senior author.

Pembrolizumab elicited a partial response in 17 percent of the 92 patients evaluable for a response (171 were treated). An additional 18 patients had stable disease. The overall response rate was 17 percent, more than triple the rate observed with methotrexate, the approved agent for head and neck cancer resistant to platinum-based chemotherapy and cetuximab. Patients enrolled in the trial had all stopped responding to or did not benefit from treatment with platinum-based drugs and cetuximab. The overall survival was eight months -- an encouraging result since many patients who don't respond to chemotherapy or cetuximab die within six months.

The drug seemed to be equally effective in patients who were both positive and negative for human papillomavirus (HPV), which is now the leading cause of head and neck cancers of the oropharynx. The drug was also well-tolerated.

"Pembrolizumab is a promising therapy for certain patient populations," Bauml said. "This could help potentially fill a treatment void and prolong survival for patients with an aggressive form of head and neck cancer, regardless of their HPV status."

Pembrolizumab is an FDA-approved, anti-PD-1 antibody that serves to lift a brakes on the immune system, allowing T cells to infiltrate and attack tumor cells. It is approved to treat metastatic melanoma and metastatic non-small cell lung cancer patients whose tumor express PD-1, and is currently being tested in various other disease sites......

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