CHICAGO – In an abstract presented at the American Society of Clinical Oncology's annual meeting on Saturday, researchers demonstrated that Razor Genomics' RiskReveal 14-gene assay could help clinicians determine which patients with early-stage non-squamous non-small cell lung cancer should undergo adjuvant chemotherapy after surgery.

芝加哥——在周六美国临床肿瘤学会年会上发表的一项摘要中，研究人员展示了Razor Genomics的RiskReveal 14基因检测可以帮助临床医生确定哪些早期非鳞状非小细胞肺癌患者应在手术后接受辅助化疗。

.

。

At a press conference to discuss the results, lead study author David Spigel, chief scientific officer at Sarah Cannon Research Institute, said that the five-year disease-free survival remains lower than 65 percent for stage IA patients with NSCLC. However, adjuvant chemotherapy is typically not recommended for stage IA patients and is 'often deferred' in stages IB and IIA, he said.

在讨论研究结果的新闻发布会上，主要研究作者、Sarah Cannon研究所首席科学官David Spigel表示，对于IA期非小细胞肺癌患者，五年无病生存率仍然低于65%。然而，辅助化疗通常不推荐用于IA期患者，并且在IB期和IIA期“常常被推迟”。

.

。

Spigel and his colleagues' study, dubbed Adjuvant Intervention in Molecular-HIGH Risk Patients (AIM-HIGH), was intended to determine whether RiskReveal could risk stratify patients to help select the people who would benefit most from chemotherapy.

Spigel及其同事的这项研究被称为“分子高危患者辅助干预（AIM-HIGH）”，旨在确定RiskReveal是否可以对患者进行风险分层，以帮助选择最能从化疗中受益的人群。

'Identifying patients who are at highest risk for recurrence is a priority in the treatment of non-small cell lung cancer,' he said. 'Those who have the highest chance of cancer coming back are probably the ones who would benefit most from any therapy.'

“确定复发风险最高的患者是治疗非小细胞肺癌的优先事项，”他说。“那些癌症复发几率最高的患者可能是从任何治疗中获益最多的。”

'Even modest therapy can make a big impact' in patients with a high risk of cancer coming back, he added.

他补充说：“即使适度的治疗也能对癌症复发高风险的患者产生重大影响。”

The international, multicenter AIM-HIGH study enrolled 421 patients with stage IA to IIA non-squamous NSCLC who had definitive surgery to remove their tumors and tested their tissue with RiskReveal to determine if they were at low, intermediate, or high risk of early death. Low-risk patients were excluded because there was no need for them to undergo adjuvant chemotherapy, Spigel said in an interview.

国际多中心 AIM-HIGH 研究招募了 421 名接受了确定性手术切除肿瘤的 IA 至 IIA 期非鳞状非小细胞肺癌患者，并使用 RiskReveal 检测了他们的组织，以确定他们是否面临早死的低、中或高风险。Spigel 在一次采访中表示，低风险患者被排除在外，因为他们不需要接受辅助化疗。

.

。

Patients who were intermediate or high risk were randomized to either four cycles of platinum-based adjuvant chemotherapy or to observation, and researchers then compared the time to disease recurrence for each arm. Eighty-nine patients were included in the adjuvant arm and 111 patients were included in the control arm, and patients were 'well-balanced' by gender and smoking history, he said, adding the primary endpoint was disease-free survival.

中高危患者被随机分配接受四个周期的铂类辅助化疗或观察，研究人员随后比较了两组的疾病复发时间。他说，辅助组包括89名患者，对照组包括111名患者，患者在性别和吸烟史方面“分布均衡”，主要终点是无病生存期。

.

。

At the time the study was stopped by the Data Safety Monitoring Board (DSMB), 79 percent of patients in the observation group were alive without disease progression and 96 percent of patients in the adjuvant chemotherapy group were alive without disease progression. After 24 months, the researchers saw a 78 percent reduction in recurrence or death in the adjuvant chemotherapy group compared to the observation group.

在数据安全监测委员会（DSMB）终止研究时，观察组中有79%的患者存活且疾病未进展，辅助化疗组中有96%的患者存活且疾病未进展。24个月后，研究人员发现，与观察组相比，辅助化疗组的复发或死亡风险降低了78%。

In Stage IA patients, the researchers saw an 85 percent reduction in recurrence or death in the adjuvant chemotherapy group. .

在IA期患者中，研究人员发现辅助化疗组的复发或死亡率降低了85%。

The DSMB stopped the researchers from enrolling new patients because of the assay's success in determining which patients could benefit from adjuvant chemotherapy.

由于该检测在确定哪些患者能从辅助化疗中获益方面的成功，DSMB阻止了研究人员招募新患者。

According to Charu Aggarwal, associate director at the Penn Center for Cancer Care Innovation, who spoke at the press conference, the interim results from 'this very promising prospective randomized study will help us lay the foundation for precise and precision therapy in early-stage non-small cell lung cancer.' .

根据宾夕法尼亚大学癌症护理创新中心副主任查鲁·阿加瓦尔在新闻发布会上的发言，这项“非常有前景的前瞻性随机研究”的中期结果将“帮助我们为早期非小细胞肺癌的精确和精准治疗奠定基础”。

'I think in the future we will be able to use advanced assays, potentially including liquid biopsies, radiomic signatures, and artificial intelligence models to better stratify risk and eventually increase cure rates for these patients,' she added.

“我认为在未来，我们将能够使用先进的检测方法，可能包括液体活检、放射组学特征和人工智能模型，以更好地分层风险，并最终提高这些患者的治愈率，”她补充道。

Aggarwal noted that the study is 'still relatively small' and that caution must be exercised when looking at the results but added that the test 'showed a tremendous benefit.'

阿加瓦尔指出，这项研究“规模仍然相对较小”，在看待结果时必须谨慎，但补充说，测试“显示出巨大的益处。”

These are 'foundational results,' she said. but the test's use in clinical practice is dependent on availability, feasibility, and uptake. 'Biomarkers are only biomarkers if we test for them,' she said.

她说：「这些是『基础性成果』，但该测试在临床实践中的应用取决于可用性、可行性和接受度。生物标志物只有在我们对其进行检测时才成为生物标志物。」

In Spigel's view, the PCR-based assay would be best used for patients who may be unsure about undergoing chemotherapy.

在斯皮格尔看来，基于PCR的检测方法最适合那些可能对是否接受化疗犹豫不决的患者。

'If you're planning to give chemotherapy anyway … this test plays no role because you're going to give therapy. At the other extreme, if your patient has made a decision that they will not do chemotherapy no matter what, then this test doesn't play a role. But for those patients where we're on the fence and we understand the risk and benefits but we're still not sure what to do … this test is available to help us with more information to make that decision,' he said..

‘如果你无论如何都计划进行化疗……这个测试没有任何作用，因为你将会进行治疗。在另一个极端，如果你的病人已经决定无论什么情况都不接受化疗，那么这个测试也没有作用。但是对于那些我们犹豫不决、理解风险和益处但仍不确定该如何处理的患者……这个测试可以为我们提供更多信息，帮助我们做出决定，’他说道。

'We are at a point now where you can use molecular features to actually better interrogate the tumor and understand its behavior,' Spigel added.

“我们现在到了一个可以通过分子特征更好地研究肿瘤并了解其行为的阶段，”斯皮格尔补充道。

Razor Genomics offers the RiskReveal assay out of its CLIA-certified Nashville, Tennessee laboratory. The test was previously known as DetermaRx. Diagnostics firm Oncocyte was previously the sole shareholder of the company,

Razor Genomics公司从其位于田纳西州纳什维尔的CLIA认证实验室提供RiskReveal检测。该测试以前被称为DetermaRx。诊断公司Oncocyte曾是该公司的唯一股东。

closing its

关闭其

second investment

二次投资

in the firm in 2021. In 2023, however, Oncocyte

在2021年公司。然而，到2023年，Oncocyte

sold

已售出

70 percent of its ownership stake

70% 的所有权股份

in the company to Dragon Scientific. Oncocyte said it retained a 30 percent equity stake in Razor Genomics but was no longer responsible for Razor's annual operating expenses and future milestone and development payments.

在公司出售给Dragon Scientific时，Oncocyte表示其保留了Razor Genomics 30%的股权，但不再负责Razor的年度运营费用及未来的里程碑和开发款项支付。

Despite the turbulent road for the company, the test itself has been validated in the NSCLC population since 2012, when the

尽管公司经历了动荡的道路，但自2012年以来，该测试本身已在NSCLC人群中得到验证，当时

test's developers published

test的开发者发布了

its

它的

1,400-patient validation study

1400名患者的验证研究

in the

在

Lancet

柳叶刀

. In that study, the researchers found that the test 'improved prognostic accuracy beyond National Comprehensive Cancer Network criteria for stage I high-risk tumors' and was able to differentiate between low-, intermediate-, and high-risk patients within all disease stages.

在那项研究中，研究人员发现该测试“提高了对I期高风险肿瘤的预后准确性，超越了国家综合癌症网络标准”，并且能够在所有疾病阶段中区分低、中、高风险患者。

When it was validated, the test developers' focus was in adenocarcinoma 'largely because of the expression of those 14 genes,' Spigel said. But squamous cancer 'is on the list for additional development,' and the recently reported non-squamous results may help encourage further development of the assay.

斯皮格尔说，当它被验证时，测试开发者的重点是腺癌，“很大程度上是因为这14个基因的表达”。但鳞状细胞癌“也在进一步开发的列表上”，最近报道的非鳞状细胞癌结果可能有助于推动该检测方法的进一步开发。

.

。

'These results will hopefully push forward for the development in squamous … but you're likely looking at a different collection of genes in terms of their expression profiles,' Spigel said.

“这些结果有望推动鳞状细胞……但你可能会看到一组不同的基因在表达谱方面，”斯皮格尔说。