法国国家妇科和产科医院(CNGOF)卵巢交界性肿瘤指南 (2020,上部) || 流行病学,生物病理学,影像学和生物标志物

2021-01-23 红梅-小艾 师前 张师前公众号

【摘要】

【摘要】交界性卵巢肿瘤(BOTs)的发病率随着年龄而增加,中位发病年龄为46岁,自15-19岁开始发生,55-59岁达到高峰,年发病率约4.5/10万例,FIGO I、 II、III、IV期患者的 5年生存率分别为99.7%,99.6%,95.3%, 77.1% (LE3)。其高危因素包括:恶性肿瘤家族史(胰腺癌、肺癌、骨癌、白血病)(LE3)、卵巢良性囊肿(LE2)、输卵管卵巢炎症(LE3)、左炔诺孕酮宫内节育器(LE3)、口服避孕药(LE3)、经产(LE3)、激素替代治疗(LE3)、大量进食香豆醇(LE4)、使用孕酮治疗不孕症(LE3)和非甾体类抗炎药(LE3)等,不推荐对BOTs进行筛查(C级)。BOTs复发风险为2%~24%,10年总生存率超过94%,侵袭性复发的风险为0.5%~3.8%,评分和列线图有助于评估风险,为患者提供预后信息(C级)。建议采用WHO组织分类法对BOTs进行分类,应报告肿瘤内是否存在微浸润病灶(<5mm)和浸润性癌(<5mm 伴非典型细胞核和间质纤维化反应),对于浆液性BOTs,建议标注组织学亚型或微乳头型/筛孔型(C级),侵袭发生时会产生促结缔组织间质反应,建议根据底层脂肪或腹膜组织反应来确定侵袭性或非侵袭性(B级);对于双侧黏液性肿瘤和/或腹膜种植或腹膜假性黏液瘤患者,建议排除原发性消化道癌或胰胆管癌(C级);对于疑似病例,组织标本固定后,直径小于10cm的肿瘤,建议切片间距不超过1cm,大于10cm的肿瘤间距不超过0.5cm(C级);如果没有发现大网膜明显受累,建议至少4~6个系统采样,应包括可疑区域(C级),当疑诊BOTs,术中冰冻取样时建议咨询妇科病理专家(C级)。推荐经阴道和腹部超声用于BOTs诊断(A级),如果不能确定卵巢病变性质,建议进行盆腔MRI(A级),使用T2、T1、T1脂肪饱和序列、动态序列和扩散序列以及钆注射(B级),报告应采用恶性肿瘤评分系统(MR/O-RADS)(C级),并提出组织学假设(C级),盆腔MRI也推荐用于疑似BOTs(C级),应描述MRI特征,以区分BOTs亚型(C级)。盆腔超声是妊娠期附件区包块诊断和鉴别的首选方法(C级),对于附件区不明肿物,建议从妊娠12周开始行盆腔MRI 检查,要求提供诊断评分(C级),应尽量减少钆的使用(C级)。建议血清CA125和HE4检测及ROMA评分系统(A级),如果影像学疑诊黏液性肿瘤,建议检测血清CA199(C级),如果术前肿瘤标志物正常,不建议常规标志物随访(C级),如术前血清CA125升高,建议用于术后随访(B级),BOTs接受保守治疗,推荐经阴道和经腹超声进行随访(B级)。

前言

卵巢交界性肿瘤(BOTs)占所有卵巢上皮性肿瘤的10%~20%,平均发病年龄较卵巢癌提早10年,预后较好,5年生存率为95%,10年生存率为90%,组织学类型主要包括浆液性和黏液性两种。术前诊断较为困难,需要仔细鉴别,全面了解超声和MRI 特征,有助于手术方式选择。

由于患者发病年轻,预后良好,妊娠期确诊时间倾向晚孕,因此,妊娠期BOTs患者的手术治疗趋向保守。目前对BOTs的管理各不相同,所有手术医生均应知晓保守性手术的可行性,也包括晚期患者,系统性子宫切除或阑尾切除无明显获益,腹腔镜手术可降低术后病率。晚期BOTs手术治疗的目的是肿瘤细胞减灭,术前不需要辅助治疗,分期或再分期手术必须标明FIGO分期和种植灶部位。对于希望保持生育力的患者应咨询生殖专家,告知患者保守治疗后复发的风险高于根治性手术,需要长期随访,复发时间可能超过10年,而接受根治性手术的患者则需要讨论激素替代治疗的必要性。

“法国国家妇科和产科医院”(CNGOF)制定BOTs临床实践和管理指南,旨在提高医疗水平,指南制定遵循法国国家卫生管理局(HAS)的标准。本文重点讨论BOTs的流行病学、病理学、生物标志物和影像学内容。

 

流行病学

1 流行病学特征 在法国,没有BOTs流行病学数据,据报道BOTs占卵巢上皮性肿瘤10%~20%,中位发病年龄为46岁,较上皮性卵巢癌提前10年,预后良好(LE3)。BOTs患者总体5年生存率为95%,10年生存率为90%,FIGO I, II, III, IV期 5年生存率分别为99.7% (95% CI: 96.2-100%),99.6% (95% CI: 92.6-100%),95.3% (95%CI:91.8-97.4%)、 77.1% (95% CI: 58.0-88.3%)(LE3)。BOTs发病率随着年龄而增加,自15-19岁开始发生,55-59岁达到高峰,年发病率约4.5/10万例 (LE3)。如果卵巢肿瘤考虑为良性,浆液性或黏液性BOTs标准化风险比分别为1.69(95%CI:1.39-2.03)和1.75(95%CI:1.45-2.10)(LE2),高危因素是40岁以下和实性肿瘤(LE2),与恶性肿瘤(45.3%)相比,BOTs大多为单侧(79.7%),FIGO I期占63.7%(LE3)。

2 风险因素  BOTs发病风险与癌症家族史(胰腺癌、肺癌、骨癌和白血病)(LE3)、卵巢良性囊肿(LE2)、盆腔炎症(LE3)有关, 吸烟与黏液性BOTs有关(LE2),肥胖与浆液性BOTs有关(LE2),体力活动与BOTs没有关联(LE4),输卵管结扎和BOTs无关(LE4), 激素治疗有关联(LE3),其中曼月乐使用可降低BOTs风险(0.76 95%CI 0.57-0.99)(LE3),关于口服避孕药结论尚存争议。多胎妇女BOTs发生的相对风险为0.44(0.26~0.75)(LE3),激素替代(LE2)、不孕症患者孕酮治疗也与BOTs存在关联(LE3),维生素D大量服用可降低浆液性BOTs发生风险(LE4),关于咖啡、茶和咖啡因的研究有矛盾结果,使用非甾体抗炎药(NSAIDs)与BOTs风险相关(LE3),对乙酰氨基酚与粘液BOTs有关(LE3)。

3 BOTs筛查   BOTs在临床、影像、生物标记、危险因素方面缺乏充足的数据,没有筛查策略推荐。

4 复发  BOTs复发的总体风险为2%~24%(LE2),浸润性种植患者复发风险为0.5%~3.8%(LE2),复发时间可能超过10年(LE2)。40岁以下是复发的危险因素(LE3),而年龄大于50岁是不良预后因素,进展为浸润癌的风险更高,预后差(LE3),复发的风险随着FIGO分期而增加(LE3)。保守性手术与根治性双侧附件切除术相比,尽管生存不受影响,但复发风险高(LE2)。对于浆液性BOTs,彻底的分期手术能够降低复发的风险,但对整体生存没有影响(LE2), 病灶残留可降低无进展生存期 (LE4)。关于微乳头型和微浸润对于复发的影响结论不同,对于浆液性BOTs,微乳头型和微浸润似乎不是复发的危险因素(LE3),但微乳头样结构增加了复发风险(侵袭性复发或死亡)(LE2),浸润性种植病灶患者复发的风险也增加(LE2);而对于黏液性BOTs,微浸润与复发无关(LE3)。与开腹手术(LE2)相比,腹腔镜手术和淋巴结受累与复发无关(LE3),CA125异常是浆液性BOTs复发的独立危险因素(LE4),Ouldamer评分和Bendifallah列线图是评估复发风险的有效工具(LE3),可向患者提供预后信息(C级)。

 

生物病理学

交界性卵巢肿瘤的组织学诊断标准及分类  BOTs包括6种组织学亚型:浆液性、黏液性、浆粘性、子宫内膜样、透明细胞、Brenner,其中浆液性和黏液性是最常见类型(LE2), 建议按照WHO标准进行分类。小乳头/筛孔状浆液性BOTs大多为双侧、外生型、FIGO分期超过I期,合并浸润性种植(LE2),该组织学类型被定义为低级别侵袭性浆液性癌(LE3),所以, 对于浆液性BOTs,建议注明组织学亚型(C级),评估腹膜种植灶的侵袭潜能(B级),伴浸润性种植者复发和死亡的风险增加(LE2),推荐评估种植灶是否具有浸润性(B级)。浸润性种植的定义为肿瘤接触部位促结缔组织增生的基质反应相关的潜在脂肪或腹膜组织破坏。如果没有浸润性种植或不确定,建议定义为浸润性种植未确定类型。有腹膜种植和/或双侧黏液性BOTs,倾向粘液腺癌卵巢转移的可能(LE3),该类患者或腹膜假性粘液瘤患者建议进一步检查排除消化道肿瘤或胰胆癌(C级)。透明细胞BOTs是一种特殊类型,与透明细胞癌密切相关(LE3),建议对肿瘤组织广泛取材,以排除透明细胞癌(C级)。免疫组化有助于鉴别BOTs组织学亚型(LE3),但不能区分交界性肿瘤与浸润癌,侵袭性完全基于形态学改变,不推荐免疫组化鉴别浸润癌(C级)。

建议明确BOTs是否存在微浸润病灶(<5mm)或微小浸润癌(<5mm,核异型,促结缔组织增生间质反应),考虑肿瘤和种植灶诊断的可重复性及过度诊断的风险,建议以下情况由妇科病理专家进行审查(C级):肿瘤边缘性质判断、组织学亚型、转移灶侵袭性、非典型浆液性BOTs合并腹膜转移、黏液性和透明细胞BOTs。

2 组织学方法  建议对疑似BOTs进行广泛采样,以排除浸润癌,特别是实性区域及转移灶、肿瘤包膜和性状改变区域。对于直径超过10cm的肿瘤,取材间隔不超过1cm,而直径大于10cm的肿瘤,取材间隔不超过0.5cm,应包括所有乳头和实性区域(C级)。具有微乳头的浆液性BOTs需要更广泛取样(1cm取2块))(C级),以排除微浸润或明显浸润性病变(LE3)。黏液性BOTs比其他组织学亚型异质性更强,不应忽视微浸润或浸润性癌的风险,需要更广泛取材(LE3),即使肿瘤直径<10cm,也建议每厘米取样2块(C级)。如果发生微浸润或上皮内癌,建议进一步取样以排除浸润性病变(C级), 腹膜种植灶必须全部取材。没有肉眼病变的网膜组织,应取材4~6块(取决于网膜切除的大小)(LE3),以避免漏诊(C级),所有淋巴结和种植灶均应取材(C级)。

3 术中快速冰冻病理的价值  BOTs术中冰冻诊断效率低,符合率仅为69-73%(LE2),20%~21%患者诊断不足,6%至10%患者诊断过度(LE2)。应注意提高快速冰冻诊断性能,减少过度诊断(LE4)。影响诊断准确性的其他因素有粘液亚型、单侧性(LE2)、肿瘤体积大(LE4), 病理科和妇科病理学家的专业水平是否影响准确度存在争议,组织学类型对诊断的影响并不明显(LE4),当疑诊BOTs时,应咨询妇科病理学家(C级)。

4 腹腔镜手术标本分析  BOTs 细胞学诊断性能差(LE3),对于附件区可疑包块无保护性穿刺有肿瘤播散的风险,建议不要盲目穿刺(C级)。手术结束囊肿或卵巢需送病理检查(LE3),不能将囊液处理为细胞学 (LE3)。取自病变区域腹膜涂片有助于判断侵袭性(LE4),对于种植灶切除及取材要求范围足够大,包含肿瘤及相邻组织(C级)。

5 组织固定及转运保存  冷却时间、固定类型和固定时间影响形态学、蛋白质和核酸的保存(LE4),建议将组织标本及时固定在中性福尔马林液中(4%甲醛),不得迟于切除后1小时(C级),对于大型手术标本可在4°C密封储存,保存时间可延长至48小时(C级), 固定时间至少6小时(C级)。

6 其他生物学指标  没有任何生物分子被推荐用于BOTs的诊断(LE4), TILs、BRAF和KRAS突变分析尚不规范,但对预后可能有影响(LE4),不推荐BRCA、MMR、BRAF、KRAS检测(C级)。

7 病理学质量标准和报告  肿瘤破裂对FIGO分期有影响(LE2),病理报告应注明标本的完整性、肿瘤部位和大网膜情况(B级),明确组织学亚型(LE2),对于浆液性BOTs应报告是否有微乳头,是否有种植(浸润性或非浸润性),是否存在微浸润,其他部位是否有肿瘤,腹腔冲洗液细胞学结果、FIGO类别(B级)。如果BOTs组织学亚型不能确定,建议行免疫组化辅助诊断(C级),并提交妇科专家和病理学家(C级)。

 

影像学

1 诊断  超声是附件肿块的首选检查方法,而MRI 最为准确,由INCA、CNGOF、FRANCOGYN、ARCAGY-GINECO联合发表的指南建议如下:推荐经阴道和经腹超声用于卵巢肿瘤的诊断(A级),由超声专家诊断时,建议仔细描述(A级),如果检查者并非专家,建议使用简单规则(A级)。超声检查有困难时,建议行盆腔MRI(A级),钆注射后推荐T2、T1、T1序列检查(B级), 报告应包括恶性肿瘤风险评分(ADNEXMR/O-RADS)(C级),并提出组织学假设(C级)。

2 与良性肿瘤的鉴别  对于囊内有赘生物的卵巢囊肿,良性征象包括:赘生物小、数量少、钙化、没有血供(LE4)、MRI I型曲线(LE4)。当超声检查不确定(A级)或疑诊BOTs患者(B级),建议MRI,不支持CT或PET-CT。

3 与卵巢癌的鉴别   超声和MRI特征有助于BOTs鉴别(LE2),实性、月牙征、圆形或椭圆形、轮廓清晰、纯囊性、外生或分支生长和表面扩散率低(ADC)是BOTs的特征,当超声检查疑诊BOTs或浸润癌时推荐MRI,PET-CT在鉴别诊断方面没有帮助(LE2),CT有助于排除腹膜癌(C级)。

联合生物标记和影像学意义  有研究报道联合超声、生物学参数与围绝经期状态评估附件区包块的性质,但由于是回顾性研究,在FIGO分期和组织学类型方面存在异质性,证据水平低。因此,不建议联合超声、生物学参数与更年期状态来诊断BOTs。

5 转移灶影像特征 影像学对于BOTs 腹膜转移的价值尚不明确。

组织学亚型  从 MRI形态学上可区分浆液性、浆粘性、黏液性(肠型)(LE3),因此,需要对MRI影像进行分析,以区分BOTs亚型(C级)。

7 预测保守性手术的可行性  已有研究利用影像学特征来预测保守性手术的可行性,但结果相互矛盾,不予推荐。

8 BOTs 与妊娠 妊娠期区分BOTs和功能性囊肿有一定困难, 但最近研究数据证实了妊娠12周后进行MRI检查对母婴的安全性。盆腔超声是妊娠相关的附件肿块的首选检查方法(C级), 盆腔MRI建议从妊娠第12周开始,用于超声检查不确定的附件肿块,并做出诊断评分(ADNEXMR/O-RADS)(C级),由于钆应用受限,应进行讨论,告知病人知情同意(C级)。

9 复发患者的影像学评估 浆液性BOTs复发通常表现为薄壁囊肿,在IOTA分类属单房囊肿(LE2),<2cm的囊肿也不应忽视(LE2);黏液性BOTs复发表现为多房或实性多房囊肿(LE4),非浸润性复发包块的典型特征是月牙征(NP4),推荐经阴道和腹部超声检查监测复发(B级)。

 

肿瘤标记物

1 肿瘤标志物在良性、交界性和恶性卵巢肿瘤鉴别诊断中有参考价值。

1.1 CA125  CA125又称粘蛋白16或MUC16,是MUC16基因编码的糖蛋白,在上皮癌过表达, 其他良性疾病(子宫肌瘤、子宫内膜异位症、炎症)、妊娠、排卵期/月经期 ,CA125也可升高,特异性较低。浆液性BOTs患者术前血清CA125水平升高(LE4),与肿瘤大小和FIGO分期正相关(LE4),但CA125水平正常也不能排除BOTs(LE4)。血清CA125水平用于鉴别良性、BOTs和恶性卵巢肿瘤的价值缺乏依据。

1.2 CA19 9  CA199是一种定位于细胞膜的糖脂(单唾液酸神经节苷脂),也是黏液性肿瘤标志物,在胃肠道肿瘤、食道癌和胰腺癌中CA199水平升高。对于BOTs患者,术前CA199升高的频率低于CA125,黏液性BOTs患者术前CA199随肿瘤大小和FIGO分期而增加(LE4),关于血清CA199对卵巢良性肿瘤、BOTs和卵巢恶性肿瘤的鉴别价值,文献中有没有依据。不推荐CA199用于卵巢良性肿瘤、BOTs和卵巢恶性肿瘤的鉴别诊断,当影像学疑诊黏液性BOTs,可检测CA199(C级)。

1.3 CEA  对于BOTs,CEA阳性率低于CA125和CA199(LE4),没有文献论证CEA在鉴别卵巢良性肿瘤、BOTs和卵巢恶性肿瘤中的作用,不推荐CEA用于鉴别诊断。

1.4 HE4  HE4 位于染色体 20q12-13 ,由WFDC2基因编码,血清HE4不能区分BOTs组织学亚型(LE4)。根据2018年上皮性卵巢癌指南,对于影像学不能确定性质的卵巢肿瘤,建议血清HE4(A级)和CA125(A级)检测,并使用ROMA评分(A级)。

2 肿瘤标志物和评分系统 文献中没有证据表明肿瘤标志物和评分系统可用于BOTs诊断,没有特别推荐。

3 肿瘤标志物在诊断和监测复发中的价值  术前CA125升高是转移灶存在的预测因素(LE4),也是BOTs复发的独立预测因子(LE4),对于浆液性BOTs,CA125≥35IU/ml是复发的独立风险因素(LE4),其敏感性为33%~66.6%(LE2)。当术前肿瘤标志物正常,不建议其作为随访策略(C级),如果术前肿瘤标志物升高,建议随访监测(B级)。

Huchon C, BourdelN.  Wahab C. et al. BorderlineOvarian Tumors: French Guidelines from the CNGOF. Part 1. Epidemiology,Biopathology, Imaging and Biomarkers.Journal of Gynecology Obstetrics and Human Reproduction.Availableonline 4 November 2020, 101965

 

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    2021-01-24 neurowu
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    2021-01-24 xugumin
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    2021-01-24 jktdtl
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