<link rel="stylesheet" href="https://studioyszimg.yxj.org.cn/css/video-js.min.css?v=1"><link rel="stylesheet" href="https://studioyszimg.yxj.org.cn/article/css/base.css?v=5"><link rel="stylesheet" href="https://studioyszimg.yxj.org.cn/article/css/index.css?v=35"><link rel="stylesheet" href="https://ysz-web.yxj.org.cn/live/dist/static/base/index.css?ysz_v=2.0"><script src="https://studioyszimg.yxj.org.cn/js/dsbridge.js?v=13" type="text/javascript"></script><script src="https://ysz-web.yxj.org.cn/dsBridge/main.js?v=26" type="text/javascript"></script><script src="https://ysz-web.yxj.org.cn/live/dist/static/base/fun.js?ysz_v=3" type="text/javascript"></script><script src="https://ysz-web.yxj.org.cn/live/dist/static/js/nativeToWeb.js?v=1" type="text/javascript"></script><div id="ysz-header" style="margin:0;overflow:hidden;"><h1 style="font-size:24px;line-height:1.8;color:#333333;word-wrap:break-word;">病理诊断——非小细胞肺癌2022NCCN v1篇(一)</h1><h2 style="font-size:16px;color:#999999;word-wrap:break-word;"><em style="font-style:normal;margin-right:10px;color:#7f7f7f;display:inline-block;">2022-03-28</em><em style="font-style:normal;margin-right:10px;color:#7f7f7f;display:inline-block;">徐剑豪</em><em style="font-style:normal;margin-right:10px;color:#7f7f7f;display:inline-block;">原创:医学界肿瘤频道</em></h2></div><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">在临床工作中,病理医师常参考世界卫生组织(WHO)/国际癌症研究机构(IARC)肿瘤分类研究肿瘤,临床医师则更常用美国国家综合癌症网络(NCCN)指南、欧洲肿瘤内科学会(ESMO)指南、中国临床肿瘤学会(CSCO)指南等对肿瘤患者进行诊疗。</span></section><section style="text-align: justify;"><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">前者偏重组织学形态、组化及分子遗传,对于肿瘤进行精准诊断;后者对病理诊断的需求更偏重临床应用,这种差异常常体现在平时的多学科小组(MDT)会诊中。因此,熟悉临床肿瘤指南中对于病理的要求,有助于病理医师临床思维的提升,促进病理与临床之间的沟通理解。</span></section><section style="text-align: justify;"><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">NCCN作为美国21家顶尖肿瘤中心组成的非营利性学术组织,其宗旨是为在全球范围内提高肿瘤服务水平,造福肿瘤患者。NCCN每年发布的各种恶性肿瘤临床实践指南,得到了全球临床医师的认可和遵循。</span></section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">继前文非小细胞肺癌ESMO篇,本文着重介绍最新版2022 v1版非小细胞肺癌(NSCLC)的NCCN指南中病理诊断部分。</span></section><section style="text-align: justify;"><br/></section><section><section><section><section><section><section><section><section><p style="text-align: justify;"><span class="ysz-ueditor-title-one" style="font-size: 16px; line-height: 28px; font-weight: bold; color: rgb(215, 0, 15); text-align: left;">一、NSCLC的病理评估目的</span></p></section></section></section></section></section></section></section></section><section><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><strong><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">1.用于初步诊断的活检或细胞学标本</span></strong></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><br/></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">对于尚未明确诊断的活检或细胞学标本,病理评估的主要目的是:</span></section><section><br/></section></section></section><section><section><section><section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">(1)使用2015年WHO/IARC肿瘤分类作出准确诊断</span></section></section></section></section></section></section></section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">2021版WHO肺肿瘤现已发布,但在最新版(2022.V1)NSCLC的NCCN指南中并未及时更新。指南提出,在差分化癌的小活检中,应尽量避免使用“非小细胞癌”( NSCC)或“&nbsp;非小细胞癌非特指型”( NSCC-NOS)。而“NSCC倾向于腺癌”和“NSCC倾向于鳞癌”是可以接受的诊断。NSCC-NOS*用于免疫组化(IHC)检测信息不足或不明确的情况。</span></section><section style="text-align: justify;"><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">*&nbsp;NSCC没有显示明显的腺癌或鳞癌形态或IHC标志物,被认为是NSCC-NOS。在这种情况下,建议病理学家使用术语NSCC而不是NSCLC,因为在小活检或细胞学检查中缺乏肺细胞标记物表达,无法排除转移癌可能。肺原发须由临床排除其他原发部位后确定。</span></section><section><br/></section><section><section><section><section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">(2)保存组织用于分子检测(特别是晚期患者)</span></section></section></section></section></section></section></section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">保存用于分子检测的组织至关重要。对于不能仅通过组织学检查分类的标本,应尽量减少蜡块的使用(例如减少IHC染色数量)。</span></section><section><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><strong><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">2.手术切除标本</span></strong></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><br/></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">对于手术切除标本的病理学诊断,病理评估的主要目的是:</span></section></section></section><section><section><section><section><section><section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">(1)准确诊断,肿瘤分类(同小标本)</span></section><section><br/></section></section></section></section></section></section></section><section><section><section><section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">(2)确定美国癌症联合委员会(AJCC)分期参数</span></section></section></section></section></section></section></section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">AJCC分期参数包括肿瘤大小、浸润程度、手术边缘情况以及是否存在淋巴结转移。指南将原发肿瘤直接延伸到邻近的淋巴结被认为是淋巴结受累。根据第8版AJCC,受累的淋巴结站数具有预后意义,所有肺叶切除术标本均应进行广泛解剖,以寻找受累的淋巴结。</span></section><section><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><strong><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">3. 明确诊断后的分子评估</span></strong></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">在明确诊断并进行靶向治疗进展后,通过小活检或细胞学标本进行分子检测,其主要目的是:</span></section></section></section><section><section><section><section><section><section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">(1)确认原始病理类型</span></section></section></section></section></section></section></section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">仅在疑似小细胞癌转化或组织学类型改变时,使用尽可能少的组织进行IHC确认病理类型。</span></section><section><br/></section><section><section><section><section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">(2)保存组织用于分子检测</span></section></section></section></section></section></section></section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">福尔马林固定石蜡包埋(FFPE)材料适用于大多数分子检测。酸性脱钙溶液处理过的骨活检组织不适用于分子检测,非酸脱钙法可弥补这一缺陷。指南鼓励分子病理学实验室确立非FFPE细胞病理学标本检测方法,例如细胞块、直接涂片等。</span></section><section><br/></section><section><section><section><section><section><section><section><section><p style="text-align: justify;"><span class="ysz-ueditor-title-one" style="font-size: 16px; line-height: 28px; font-weight: bold; color: rgb(215, 0, 15); text-align: left;">二、NSCLC分类</span></p></section></section></section></section></section></section></section></section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">NSCLC的类型为:腺癌、鳞癌、腺鳞癌、大细胞癌和肉瘤样癌。</span></section><section><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><strong><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">1.腺癌</span></strong></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">对于长径&lt;3cm的已切除病变,确定浸润程度至关重要。</span></section></section></section><section><section><section><section><section><section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">(1)原位腺癌(AIS)</span></section></section></section></section></section></section></section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">长径≤3cm的局部结节,贴壁生长,大多为非粘液性,可同时多中心发生。</span></section><p><span style="color: rgb(0, 0, 0); font-size: 16px; text-align: justify;"><br/></span></p><p><span style="color: rgb(0, 0, 0); font-size: 16px; text-align: justify;">(2)微浸润癌(MIA)</span></p><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">长径≤3cm孤立性腺癌,贴壁生长为主,最大浸润深度≤5mm,大多为非粘液性。</span></section><p><span style="color: rgb(0, 0, 0); font-size: 16px; text-align: justify;"><br/></span></p><p><span style="color: rgb(0, 0, 0); font-size: 16px; text-align: justify;">(3)浸润性腺癌</span></p><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">一种具有腺体分化、粘蛋白产生或肺细胞标记物表达的恶性上皮性肿瘤。肿瘤表现为腺泡样、乳头状、微乳头状、贴壁或实体生长,浸润性腺癌成分应至少存在于一个最大径>5 mm的病灶。有粘蛋白或肺细胞标记物表达。浸润性腺癌变异:浸润性粘液腺癌、胶体腺癌、胎儿腺癌和肠腺癌。</span></section><section style="text-align: justify;"><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><strong><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">2.鳞癌</span></strong></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><br/></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">一种恶性上皮性肿瘤,显示角化和/或细胞间桥,或形态学上未分化的NSCC,表达鳞状细胞分化的IHC标记物。</span></section><section><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><strong><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">3.鳞腺癌</span></strong></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><br/></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">一种同时显示鳞癌和腺癌成分的癌,且每种成分至少占肿瘤的10%,该诊断只适用于手术切除的标本。活检标本中鳞癌组织出现腺癌成分应进行分子检测。</span></section><section><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><strong><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">4.大细胞癌</span></strong></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><br/></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">未分化的NSCC,缺乏小细胞癌、腺癌或鳞癌特征。该诊断需对切除标本彻底取样,不能在活检或细胞学标本中做出诊断。</span></section><section><br/></section></section></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><strong><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">5.肉瘤样癌</span></strong></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">肉瘤样癌是一个通用术语,包括多形性癌、癌肉瘤和肺母细胞瘤。因此,指南建议尽可能使用后者这些特定术语做出诊断。</span></section><p><span style="color: rgb(0, 0, 0); font-size: 16px; text-align: justify;"><br/></span></p><p><span style="color: rgb(0, 0, 0); font-size: 16px; text-align: justify;">(1)多形性癌</span></p></section></section></section></section></section></section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">一种低分化的NSCC,包含至少10%的梭形和/或巨细胞,或仅由梭形和巨细胞组成的癌,后者又被称为梭形细胞癌/巨细胞癌。</span></section><p><span style="color: rgb(0, 0, 0); font-size: 16px; text-align: justify;"><br/></span></p><p><span style="color: rgb(0, 0, 0); font-size: 16px; text-align: justify;">(2)癌肉瘤</span></p><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">一种由NSCC和异源肉瘤(如横纹肌肉瘤、软骨肉瘤、骨肉瘤)组成的混合肿瘤。</span></section><p><span style="color: rgb(0, 0, 0); font-size: 16px; text-align: justify;"><br/></span></p><p><span style="color: rgb(0, 0, 0); font-size: 16px; text-align: justify;">(3)肺母细胞瘤</span></p><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">是一种由胎儿性腺癌(通常为低级别)和原始间充质成分组成的双向分化肿瘤。</span></section><section><br/></section><section><section><section><section><section><section><section><section><p style="text-align: justify;"><span class="ysz-ueditor-title-one" style="font-size: 16px; line-height: 28px; font-weight: bold; color: rgb(215, 0, 15); text-align: left;">三、免疫组化</span></p></section></section></section></section></section></section></section></section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">指南强烈建议精简IHC检测以保存足够的组织用于分子检测,这一点在小标本中尤其重要。当腺癌或鳞癌分化较差时,IHC或粘蛋白染色是必要的。</span></section><section><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">1.小标本</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><br/></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">在小标本中,使用一个肺腺癌标记物(TTF1,NapsinA)和一个鳞癌标记物(P40,P63)的IHC就足以解决大多数诊断问题。因P63特异性不高,指南建议将P63和TTF1共表达且缺乏鳞状细胞形态的肿瘤归类为腺癌。指南推荐应用简单的TTF1+P40组化模式对大多数NSCC-NOS病例进行分类。</span></section><section><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">2.NUT癌</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><br/></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">所有缺乏腺分化的低分化癌,尤其是发生在非吸烟者或年轻患者,应进行IHC以明确是否为肺NUT癌**。</span></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">&nbsp;</span></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">**NUT中线癌是一种罕见的遗传相关、侵袭性很强的鳞状细胞癌,通常发生在身体的中线,其特征是睾丸核蛋白基因(Nuclear protein in testis gene, NUT)重排(位于15号染色体)。肿瘤细胞各种细胞角蛋白、P63、CEA和CD34 IHC阳性。</span></section><section><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">3.原发性肺腺癌</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">对于原发部位不明确的癌,建议采用适当的IHC鉴别肺转移癌。</span></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">&nbsp;</span></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">TTF1是NKX2基因家族中一个含有同源结构域的核转录蛋白,在胚胎和成熟肺和甲状腺的上皮细胞中表达。70%-90%原发性肺非粘液性腺癌TTF1阳性,而其他肺转移性腺癌TTF1阴性(除外肺转移性甲状腺腺癌)。肺转移性甲状腺腺癌除TTF1阳性外,甲状腺球蛋白和PAX8亦阳性。</span></section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">NapsinA是一种在正常Ⅱ型肺泡上皮和肾小管中表达的天冬氨酸蛋白酶。80%以上肺腺癌NapsinA阳性,可作为TTF1辅助指标。</span></section><section><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">4.神经内分泌肿瘤</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">当肿瘤出现神经内分泌形态(如椒盐状核染色质、外周栅栏状结构),NCAM(CD56)、嗜铬粒蛋白、突触蛋白和INSM1可用于识别神经内分泌肿瘤,且上述指标只要有一个超过10%的肿瘤细胞阳性即有诊断意义。</span></section><section><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">5.恶性间皮瘤与肺腺癌的比较</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">间皮瘤IHC指标:WT-1、钙维甲、CK5/6和D2-40;肺腺癌IHC指标:pCEA、Claudin4、TTF1和NapsinA。</span></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">&nbsp;</span></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">其他辅助鉴别的标记物包括B72.3、Ber-EP4、MOC31和CD15,敏感性和特异性均较差。</span></section><section><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">6.其他转移性肿瘤及其标记物</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">乳腺癌(ERα、PR、GCDFP15、乳腺球蛋白和GATA-3)、肾细胞癌(PAX8)、乳头状浆液性癌(PAX8、PAX2和ER)、胃肠道腺癌(CDX2)和前列腺癌(NKX3.1)。此外,P40(或P63)有助于区分具有假性鳞状形态的上皮样间皮瘤和鳞状细胞癌。广谱角蛋白(如AE1/AE3)阴性提示非上皮肿瘤。</span></section><section><br/></section></section></section></section></section></section></section><section><section><section><section><section><section><section><section><p style="text-align: justify;"><span class="ysz-ueditor-title-one" style="font-size: 16px; line-height: 28px; font-weight: bold; color: rgb(215, 0, 15); text-align: left;">四、分子和生物标志物分析</span></p></section></section></section></section></section></section></section></section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">目前已知许多基因的改变会影响治疗,检测肺癌标本的这些改变有助于确定潜在有效的靶向治疗以及规避无效治疗。</span></section><section><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><strong><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">1.样本采集和管理</span></strong></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">分子和生物标志物检测主要使用FFPE组织样本。值得一提的是,尽管美国食品药品监督管理局(Food and Drug Administration, FDA)批准的多种伴随诊断检测不包括细胞块检测,但当这些样本是唯一或最好的材料时,指南强烈建议对这些样本进行检测。</span></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">&nbsp;</span></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">指南建议支气管镜医生和介入放射科医生获取足够的组织来进行后续检测,但当组织很少时,实验室应最大限度地利用组织进行分子和辅助检查,包括专门的小活检组织学流程及用于诊断和预测性检查的预切片。另外,外周血(血浆循环肿瘤DNA)可以作为替代样本。</span></section><section><br/></section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section style="text-align: justify;"><strong><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">2.检测方法</span></strong></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><br/></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">首先,指南明确分子检测实验室需获得适当认证,至少获得CLIA认证***。</span></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">&nbsp;</span></section><section style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">***&nbsp;临床检验改进修正计划(Clinical Laboratory Improvement Amendments, CLIA)认证,由美国临床实验室委员会颁发实验室资质证书,表明该实验室符合美国联邦政府实验室修正案的相关规定,达到优质实验室标准。CLIA认证也代表了目前国际最高水平的认证标准。</span></section><section><br/></section><p style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;">检测方法包括二代测序(Next-generation sequencing, NGS)、实时聚合酶链式反应(Real-time polymerase chain reaction, Real-time PCR)、Sanger测序、荧光原位杂交(Fluorescence in situ hybridization, FISH)、IHC等,部分方法有时需要联合使用。</span></p><p style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;"><br/></span></p><p style="text-align: justify;"><span style="line-height: 28px; color: rgb(0, 0, 0); font-size: 16px;"><img src="https://studioyszimg.yxj.org.cn/59ybgylyzcc.png" title="" alt="" style="max-width:100%;"/></span></p><p><br/></p></section></section></section></section></section></section></section></section></section></section>

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