FDA批准针对某些类型的神经内分泌肿瘤的新疗法

The drug, Lutathera, is an option for people whose tumors fail to respond to first-line therapies.

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FDA approves new treatment for neuroendocrine tumors
新药为影响胃肠道和胰腺的神经内分泌肿瘤的人提供了新的希望。 Shutterstock; Novartis

患有神经内分泌肿瘤(网)的人pancreas或者胃肠道如果标准疗法无法控制其症状,则管道通常几乎没有治疗选择。一月份,食品和药物管理局(FDA)批准了一种新的放射性药物这可以延长这组患者的生命。该药物称为Lutathera(lutetium lu 177 dotatate),是批准胃肠道的第一种放射性药物neuroendocrine tumors— GEP-NETs. These cancers can occur in the pancreas, stomach, intestines, colon, or rectum. They are fairly rare, occurring in 5 per 100,000 people.

Lutathera consists of a radioactive isotope, Lu 177, that is linked to a molecule called dotatate. The molecule attaches itself to certain types of neuroendocrine cancer cells that have a receptor called somatostatin on their surface, delivering the radiation released by Lu 177, which helps kill the cells.

The therapy is expected to benefit many patients because most of these patients have tumors that express somatostatin receptors.

新药为患者带来了明显的优势

通常对患者进行生长抑素类似物的注射治疗。这些药物是影响胃肠道功能的大脑和消化道中产生的激素的合成版本。这些药物可以帮助控制症状并控制胃肠道神经内分泌肿瘤的生长。一些没有反应或停止反应的疾病患者,也为生长抑素类似物做出了处方药。Afinitor(依维莫司)。但是AFINITOR与副作用有关,目前尚不清楚它实际上如何改善患者的生存情况。

根据229名患者的随机,临床试验,卢特纳(Lutathera)获得了批准Jonathan Strosberg, MD, an associate member of the gastrointestinal oncology department at Moffitt Cancer Center in Tampa, Florida. The trial, which appeared in theJanuary 12, 2017, issue of the新英格兰医学杂志, compared Lutathera with the conventional therapy — a somatostatin analog. All of the patients had inoperable, somatostatin-receptor-positive NETs that had not responded adequately to standard treatment.

患者要么接受Lutathera,再加上生长抑素类似物的标准剂量或仅较高剂量的生长抑素类似物。与仅接受较高剂量的生长抑素类似物的患者相比,接受Lutathera和生长抑素类似物的患者没有癌症进展的时间更长,没有癌症的进展。Strosberg博士说,总体而言,这项研究的Lutathera部门的患者的寿命长80%,没有癌症的进展。

Another study, performed in the Netherlands, found that 16 percent of patients with neuroendocrine tumors of the pancreas or gastrointestinal tract receiving Lutathera had partial or complete shrinkage of their tumors. This new medication has been used extensively in Europe but is just now available in the United States.

GEP-NETS: Difficult to Treat Tumors

Gastroenteropancreatic neuroendocrine tumors are challenging to treat, says Strosberg. About one-third to one-half of patients are diagnosed when the cancer is already at an advanced stage. “These tumors are sometimes slow growing, but in general these are a very diverse group of tumors, and the treatment options have been limited,” he says.

“We use imaging to see if a patient is somatostatin receptor positive,” says Strosberg. “These drugs target that receptor so they require imaging that visualizes the somatostatin receptor. In recent years, we’ve seen the development of more sensitive and accurate scans. Most patients with GEP-NETs have this癌症类型。”

然而,卢特纳(Lutathera)为对一线疗法做得不好的患者提供了最明显的优势。该药物在八个月内静脉内静脉注射。Lutathera与某些副作用有关,包括恶心和白细胞计数的减少。斯特罗斯伯格说,但是这些问题是可以治疗的。

Patients Should Seek Out Care in Academic Centers

斯特罗斯伯格指出,卢塔瑟拉的成功是近年来在所有类型的神经内分泌肿瘤治疗的一系列进步的一部分。去年,该领域的一群专家发表了《中肠神经内分泌肿瘤的监视和医疗管理》的北美神经内分泌肿瘤协会的共识指南,以确保对患者进行适当的治疗。该准则发表在2017年7月发行该期刊胰腺

Patients seeking treatment for neuroendocrine tumors should be aware that a lot has changed in recent years.

“Lutathera won’t be widely available in community practices,” Strosberg says. “But it will be available in academic centers, and that’s where the majority of patients with neuroendocrine tumors are treated. Patients with these tumors should seek care from a neuroendocrine tumor specialist.”

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