肿瘤康复网,内容丰富有趣,生活中的好帮手!
肿瘤康复网 > RECIST(v1.1)— 实体瘤疗效评估标准

RECIST(v1.1)— 实体瘤疗效评估标准

时间:2022-07-17 14:02:49

相关推荐

RECIST是简称,是每个单词的首字母,1.1是版本号,我们一般称其为RECIST1.1。

最重要的是(已经标红)

2.可测量病灶,不可测量病灶

3.靶病灶,非靶病灶

4.靶病灶、非靶病灶、新发病灶的疗效评估

为了让大家先有个大致认识,我画了这个结构图,文末有更详细的图。

范围:实体瘤!!!

工欲善其事,必先利其器。

我们在进行评估前先对测量器具进行下定义。

米制单位:一般是用毫米,病灶的直径XXmm,可不是Xm

该部分原文如下,或者大家自行查找下原文。

3.2.2. Method of assessment

The same method of assessment and the same technique should be used to characterise each identified and reported lesion at baseline and during follow-up. Imaging based evaluation should always be done rather than clinical examination

unless the lesion(s) being followed cannot be imaged but are assessable by clinical exam.

Clinical lesions: Clinical lesions will only be considered measurable when they are superficial and P10mm diameter as assessed using calipers (e.g. skin nodules). For the case of skin lesions, documentation by colour photography including a ruler to estimate the size of the lesion is suggested. As noted above, when lesions can be evaluated by both clinical exam and imaging, imaging evaluation should be undertaken since it is more objective and may also be reviewed at the end of the study.

Chest X-ray: Chest CT is preferred over chest X-ray, particularly when progression is an important endpoint, since CT is more sensitive than X-ray, particularly in identifying new lesions.

However, lesions on chest X-ray may be considered measurable if they are clearly defined and surrounded by aerated lung. See Appendix II for more details.

CT, MRI: CT is the best currently available and reproducible method to measure lesions selected for response assessment.

This guideline has defined measurability of lesions on CT scan based on the assumption that CT slice thickness is 5mm or less. As is described in Appendix II, when CT scans have slice thickness greater than 5 mm, the minimum size for a measurable lesion should be twice the slice thickness. MRI is also acceptable in certain situations (e.g. for body scans). More details concerning the use of both CT and MRI for assessment of objective tumour response evaluation are

provided in Appendix II.

Ultrasound: Ultrasound is not useful in assessment of lesion size and should not be used as a method of measurement. Ultrasound examinations cannot be reproduced in their entirety for independent review at a later date and, because

they are operator dependent, it cannot be guaranteed that the same technique and measurements will be taken from one assessment to the next (described in greater detail in Appendix II). If new lesions are identified by ultrasound in the course of the study, confirmation by CT or MRI is advised. If there is concern about radiation exposure at CT, MRI may be used instead of CT in selected instances.

Endoscopy, laparoscopy: The utilisation of these techniques for objective tumour evaluation is not advised. However, they can be useful to confirm complete pathological response when biopsies are obtained or to determine relapse in trials

where recurrence following complete response or surgical resection is an endpoint.

Tumour markers: Tumour markers alone cannot be used to assess objective tumour response. If markers are initially above the upper normal limit, however, they must normalise for a patient to be considered in complete response. Because tumour markers are disease specific, instructions for their measurement should be incorporated into protocols on a disease specific basis. Specific guidelines for both CA-125 response (in recurrent ovarian cancer) and PSA response (in recurrent prostate cancer), have been published.16–18 In addition, the Gynecologic Cancer Intergroup has developed CA125 progression criteria which are to be integrated with objective tumour assessment for use in first-line trials in ovarian cancer.19

Cytology, histology: These techniques can be used to differentiate

between PR and CR in rare cases if required by protocol (for example, residual lesions in tumour types such as germ cell tumours, where known residual benign tumours can remain). When effusions are known to be a potential adverse effect of treatment (e.g. with certain taxane compounds or angiogenesis inhibitors), the cytological confirmation of the neoplastic origin of any effusion that appears or worsens during treatment can be considered if the measurable tumour has met criteria for response or stable disease in order to differentiate between response (or stable disease) and progressive disease.

正式开始前先展示几个重要的数据,这几个数字是需要记住的,但是先别急着死记硬背,继续往下看,便于理解记忆。

特别注意我标红的部分,这张片子记住肿瘤病灶,最长径≥10mm。出现了第一个重要数字10mm。

再提示下,是长径,长长长长长长!最长的那个轴向。实体瘤一般是立体的,怎么描述呢,不规则的球体?找个最长的轴,就是最长径。

当然尽管是要找个最长的,但是不能穿出肿瘤,如下图:

接下来是淋巴结啦,淋巴结短径≥15mm。

这个怎么理解呢?一开始我也很纠结。后来慢慢想通了点。

肿瘤评估从严,所有对于肿瘤的评估选择长径,只要长径达到标准就认定可测量,不仅如此,这个标准还要选的严格点,10mm,相比之下呢,对待淋巴结就要温柔点了,毕竟生理状态下有时候都能摸到,比如颌下淋巴结,我刚才就顺手轻轻揉了揉,是椭圆球状的,这时候就要把标准放宽松点了,要不然我都判为淋巴结肿大了,标准为≥15mm,光标准放宽不行,对于淋巴结本身也要宽松点,不用长径,而是用短径,长径达到15mm没关系,只要短径没到15mm,[10,15)mm,我依然是“不可测量的”。你体会下,看下下张片子右下角的图。

总结下,可测量病灶定义。解决了两个数字,10mm和15mm。

接下来看下不可测量病灶,是不是除了可测量病灶,剩下的就全是不可测量病灶了呢?没那么简单,继续往下看。

对于肿瘤病灶除了可测量病灶就是不可测量病灶,但是对于淋巴结就不是了,因为还有正常的淋巴结,比如上面介绍的颈部淋巴结,生理状态下也是不小的,这个生理状态下是10mm以下是正常的。所以呢,只有在10mm及以上才算是病灶,而10mm及以上,也就是病灶的基础上才又分了可测量和不可测量两种,还有一类不可测量可归为其他。

实际临床评估中是比较复杂的,往往是各种情况参杂在一起,好在指南中有进一步说明。继续看下一些特殊的考虑

要不要做个测试?都是单选(一共3个字母),下期或者留言区出答案。

Q1

Q2&3

好了,今天先到这里,下次再介绍靶和非靶等。

通过上边第一条就可以看出来,靶病灶一定是可测量病灶(但是反过来就不一定了)

最多5个病灶,每个器官最多选择两个。思考,要是不是器官的该怎么选?比如纵隔,淋巴系统。这个也就回答了为什么可测量病灶不一定是靶病灶了,比如,第6个可测量病灶就不可以被选为靶病灶。

记住这里的“a sum of diameters”,是所有靶病灶的径长之和!肿瘤的长径和淋巴结的短径。

靶病灶说完了,再看下非靶病灶,注意靶病灶要通过“a sum of diameters”来反应,或者说要通过定量描述。

但是非靶病灶就不用了,非靶病灶很简单。仅需要定性描述(“有”或“无”),就可以了。

用个图来总结下可测量病灶、非可测量病灶、靶病灶、非靶病灶之间的关系。

来,下面一选哪些是可测量病灶,哪些是靶病灶,靶病灶的总径长是多少?

如果能分辨出来,说明你看懂了。

介绍下相关疗效评估的流程。

在介绍疗效评估、缓解的标准之前先看下需要评估的对象,即靶病灶、非靶病灶和新病灶,对于靶靶病灶、非靶病灶,刚介绍过,不赘述,不记得的可先回去看下。

这里有个新概念:新病灶,何为新病灶?看下定义:

了解完这几个定义后,接下来就开始进行评估了。

我们先整体看下疗效评估的程序,然后再展开讨论。

注意:TL=靶病灶,NTL=非靶病灶,NL=新病灶

概念和流程了解后,我们先展开看一下靶病灶的缓解标准。

一共有四种“结果”。

注意:判断PR时是与基线比,但是判断PD时可不一定是与基线比了(敲黑板),继续往下看。

PD是与最小值比。

整体看下这个靶病灶的疗效评估,从左到右,评估结果呈递进关系。这里出现了第2期中纰漏的几几个数字≥30%,≥20%,5mm

临床试验Note:RECIST(v1.1)— 实体瘤疗效评估标准

还有几个注意事项:

还是想提醒一下,评估PD时要注意,因为RECIST标准从严,所以PD是跟最小值比较的。

有时候会出现评估结果“同时”满足PD和PR,同样从严,要判为PD。

我一般习惯按照如下先后顺序进行判定:CR-PD-PR-SD

分享一个case吧,看看你的判定结果:

【某肿瘤试验中,基线期靶病灶总长为80mm,C1为40mm,C2为48mm,请问C1和C2评估结果分别是:

A. C1 PR,C2 PD

B. C1 PR,C2 PR

C. C1 PR,C2 SD】

你选哪个?

不同于靶病灶,非靶有三种评估结果

结合上图不难理解,如果第一次发现可疑的新病灶,但是呢到第二次才确认,那么新病灶出现的日期是第一次可疑的时间。

下面简单汇总下:

针对所有的情况,三种评估对象:靶病灶,非靶病灶及新病灶,一共是6种评估结果(注意还有NE,也就是未进行评估)

下表是临床试验中常用的肿瘤评估表。

仔细看的话,表中设计有靶病灶,非靶病灶和新病灶的评估选项。

我们再来复习下,肿瘤评估的这个过程,看图。

最后一个内容,整体判断肿瘤的缓解情况。

也就是综合考虑靶病灶、非靶病灶及新病灶之后,给出一个结果,来说明肿瘤是恶化了、是稳定还是好转了。

这个评估还是从严进行的,几种情况的分类在table1中有清晰的展示。

最后再提供一张图,大家可以根据这张图,利用图中的数据及符号,讲一个完整的故事。

再来一张自制脑图。

以上自于New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)。

Happy End!*★,°*:.☆( ̄▽ ̄)/$:*.°★*

如果觉得《RECIST(v1.1)— 实体瘤疗效评估标准》对你有帮助,请点赞、收藏,并留下你的观点哦!

本内容不代表本网观点和政治立场,如有侵犯你的权益请联系我们处理。
网友评论
网友评论仅供其表达个人看法,并不表明网站立场。