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Response Evaluation Criteria in Solid Tumors (RECIST) Quick Reference:Eligibility·Only patients with measurable disease at baseline should be included in protocols where objective tumor response is the primary endpoint. Measurable disease - the presence of at least one measurable lesion. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions - lesions that can be accurately measured in at least one dimension with longest diameter ³20 mm using conventional techniques or ³10 mm with spiral CT scan.Non-measurable lesions - all other lesions, including small lesions (longest diameter <20 mm with conventional techniques or <10 mm with spiral CT scan), i.e., bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, cystic lesions, and also abdominal masses that are not confirmed and followed by imaging techniques; and.·All measurements should be taken and recorded in metric notation, using a ruler or calipers. All baseline evaluations should be performed as closely as possible to the beginning of treatment and never more than 4 weeks before the beginning of the treatment. ·The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow-up. ·Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion, is remended. Methods of Measurement –·CT and MRI are the best currently available and reproducible methods to measure target lesions selected for response assessment. Conventional CT and MRI should be performed with cuts of 10 mm or less in slice thickness contiguously. SpiralCT should be performed using a 5 mm contiguous reconstruction algorithm. This applies to tumors of the chest, abdomen and pelvis. Head and neck tumors and those of extremities usually require specific protocols.·Lesions on chest X-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable. ·When the primary endpoint of the study is objective response evaluation, ultrasound (US) should not be used to measure tumor lesions. It is, however, a possible alternative to clinical measurements of superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules. US might also be useful to confirm the plete disappearance of superficial lesions usually assessed by clinical examination.·The utilization of endoscopy and laparoscopy for objective tumor evaluation has not yet been fully and widely validated. Their uses in this specific context require sophisticated equipment and a high level of expertise that may only be available in some centers. Therefore, the utilization of such techniques for objective tumor response should be restricted to validation purposes in specialized centers. However, such techniques can be useful in confirming plete pathological response when biopsies are obtained.·Tumor markers alone cannot be used to assess response. If markers are initially above the upper normal limit, they must normalize for a patient to be considered in plete clinical response when all lesions have disappeared.·Cytology and histology can be used to differentiate between PR and CR in rare cases (e.g., after treatment to differentiate between residual benign lesions and residual malignant lesions in tumor types such as germ cell tumors).Baseline documentation of “Target〞and “Non-Target〞lesions·All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total, representative of all involved organs should be identified as target lesions and recorded and measured at baseline. ·Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniquesor clinically). ·A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor.所有目标病灶的最长长径总和将会被计算和汇报成基线的长径和，该和作为有效缓解记录的参考基线。
New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)新版实体瘤疗效评价标准：修订的RECIST指南（1.1版本）Abstract摘要Background背景介绍Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics: both tumour shrinkage (objective response) and disease progression are useful endpoints in clinical trials. Since RECIST was published in 2000, many investigators, cooperative groups, industry and government authorities have adopted these criteria in the assessment of treatment outcomes. However, a number of questions and issues have arisen which have led to the development of a revised RECIST guideline (version 1.1). Evidence for changes, summarised in separate papers in this special issue, has come from assessment of a large data warehouse (>6500 patients), simulation studies and literature reviews.临床上评价肿瘤治疗效果最重要的一点就是对肿瘤负荷变化的评估：瘤体皱缩（目标疗效）和病情恶化在临床试验中都是有意义的判断终点。
疗效评判标准recist1·1
RECIST 1.1是癌症治疗效果评价的标准，它基于RECIST标准进行修订和完善，于2009年在欧洲癌症杂志上发表。
在RECIST 1.1中，对于肿瘤负荷的改变评价是关键特征之一，包括病变最小大小的确定、对随访病变数目的建议（最多10个；每个器官最大5个）、一维而不是二维的使用以及肿瘤负荷的总体评价。
这些标准后来被学术团体、协作组和制药工业广泛采用。
总体疗效评价标准如下：
CR（完全缓解）：肿瘤完全消失，并且该状态至少持续4周（对于先前存在肿瘤的情况）。
PR（部分缓解）：肿瘤缩小超过50%，并且该状态至少持续4周（对于先前存在肿瘤的情况）。
SD（稳定疾病）：肿瘤大小没有变化，或者缩小但未达到PR的标准，或者增大但未达到PD的标准。
PD（疾病进展）：肿瘤增大超过25%，或者出现新的肿瘤病灶。
需要注意的是，对于非随机试验中，需要确认PR和CR以确保所评估的肿瘤缓解不是测量误差导致的。
在随机试验（2期或3期）或以SD或PD为主要终点的研究中，不需要确认CR或PR，因为这对解
释试验结果没有价值。
以上信息仅供参考，可以查阅关于RECIST 1.1的文献资料获取更多信息。
肿瘤疗效评价标准随着医学科技的不断进步，肿瘤治疗的有效性评价成为了重要的研究领域。
肿瘤疗效评价标准的制定旨在准确评估治疗的效果，为医生和患者提供科学依据，帮助决策医疗方案和预测预后。
本文将从临床常用的肿瘤疗效评价标准入手，探讨其分类和应用。
一、WHO疗效评价标准WHO（World Health Organization）疗效评价标准是最早用于肿瘤治疗效果评价的标准之一。
该标准通过对肿瘤病人体质状况的观察和测定，分为完全缓解（complete response, CR）、部分缓解（partial response, PR）、稳定病情（stable disease, SD）和进展病情（progressive disease, PD）四个等级来评价治疗的疗效。
完全缓解（CR），指肿瘤病灶完全消失，同时患者的相关疾病症状和体征也完全消失。
部分缓解（PR），指肿瘤病灶缩小了至少50%。
稳定病情（SD），指肿瘤病灶没有进一步增大，但也没有明显缩小。
进展病情（PD），指肿瘤病灶增大了50%以上。
二、RECIST疗效评价标准由于肿瘤治疗效果的评价需要更加准确的定量化指标，美国国立癌症研究所（National Cancer Institute）于2000年提出了RECIST （Response Evaluation Criteria in Solid Tumors）疗效评价标准。
RECIST标准主要针对实体肿瘤（solid tumors）的治疗效果进行评价，包括测量适用的肿瘤长径（longest diameter）以及最大垂直直径（perpendicular diameter）。
根据测量结果，将治疗效果分为完全缓解（CR）、部分缓解（PR）、稳定病情（SD）、进展病情（PD）和不可评估病情（unevaluable disease）五个等级。
与WHO标准不同的是，RECIST标准将稳定病情的判定更为严格。
根据RECIST 1.1版本，稳定病情至少需要三个周期的评估结果达到标准，同时需要有临床症状稳定的证据。
recist1标准RECIST1标准。
RECIST1标准是肿瘤疗效评价的国际通用标准，其全称为Response Evaluation Criteria in Solid Tumors。
该标准是由美国癌症研究协会（AACR）、国际抗癌联盟（UICC）和国家癌症研究所（NCI）共同制定的，旨在为临床试验和治疗提供一致的肿瘤反应评价标准。
RECIST1标准主要用于评估固体肿瘤的治疗效果，包括肿瘤的缩小、增大、稳定等情况。
该标准通过测量肿瘤的直径和体积变化，对肿瘤的治疗效果进行客观、标准化的评价，为临床医生提供科学依据，指导临床决策。
根据RECIST1标准，肿瘤治疗效果主要分为完全缩小（CR）、部分缩小（PR）、稳定（SD）、进展（PD）四种情况。
完全缩小指肿瘤在治疗后完全消失，部分缩小指肿瘤直径或体积减小超过一定比例，稳定指肿瘤直径或体积变化在一定范围内，进展指肿瘤直径或体积增大或出现新的病灶。
在临床实践中，RECIST1标准被广泛应用于肿瘤药物临床试验和临床治疗中。
通过对肿瘤治疗效果的准确评估，可以帮助临床医生及时调整治疗方案，提高患者的治疗效果和生存率。
同时，该标准也为不同临床试验结果的比较提供了统一的评价标准，促进了临床试验的开展和结果的解释。
需要注意的是，RECIST1标准虽然在临床实践中被广泛应用，但并不适用于所有类型的肿瘤治疗效果评价。
对于一些非固体肿瘤、转移性肿瘤或特殊类型肿瘤，需要结合其他评价指标进行综合评估。
因此，在使用RECIST1标准进行肿瘤治疗效果评价时，临床医生需要根据具体情况综合考虑，不可片面依赖标准结果。
总之，RECIST1标准作为肿瘤治疗效果评价的国际通用标准，对于临床试验和治疗具有重要意义。
通过对肿瘤治疗效果的客观、标准化评价，可以为临床医生提供科学依据，指导临床决策，提高患者的治疗效果和生存率。
然而，在实际应用中，需要结合具体情况综合考虑，不可片面依赖标准结果。
希望未来能够进一步完善和优化肿瘤疗效评价标准，为肿瘤患者的治疗带来更多的益处。
（完整版）实体瘤疗效评价标准RECIST1.1版中文实体瘤疗效评价标准RECIST（1.1版）1 背景1.1 RECIST标准的历史评价肿瘤负荷的改变是癌症治疗的临床评价的一个重要特征。
肿瘤缩小（客观反应）和疾病进展的时间都是癌症临床试验中的重要端点。
为了筛查新的抗肿瘤药物，肿瘤缩小作为II期试验端点被多年研究的证据所支持。
这些研究提示对于多种实体肿瘤来说，促使部分病人肿瘤缩小的药物以后都有可能（尽管不完美）被证实可提高病人的总体生存期或在随机Ⅲ期试验中有进入事件评价的其他机会。
目前在Ⅱ期筛查试验中评价治疗效果的指标中，客观反应比任何其他生物标记更可靠。
而且，在Ⅱ和Ⅲ期药物试验中，进展期疾病中的临床试验正越来越利用疾病进展的时间（无进展生存）作为得出有治疗效果结论的端点，而这些也是建立在肿瘤大小的基础上。
然而这些肿瘤端点、客观反应和疾病进展时间，只有建立在以肿瘤负荷解剖学基础上的广泛接受和容易使用的标准准则上才有价值。
1981年世界卫生组织（WHO）首次出版了肿瘤反应标准，主要用于肿瘤反应是主要终点的试验中。
WHO标准通过测量病变二维大小并进行合计介绍了肿瘤负荷总体评价的概念，通过评价治疗期间基线的改变而判断治疗的反应。
然而，在该标准出版后的十几年中，使用该标准的协作组和制药公司通常对其进行修改以适应新的技术或在原始文献中提出了不清楚的地方，这就导致了试验结果解释的混乱。
事实上，各种反应标准的应用导致同一种治疗方法的治疗效果大相径庭。
对这些问题的反应是国际工作组于19世纪中期形成，并对反应标准进行了标准化和简化。
新的标准，也称为RECIST（实体肿瘤的反应评价标准）于2000年出版。
最初的TECIST关键特征包括病变最小大小的确定、对随访病变数目的建议（最多10个；每个器官最大5个）、一维而不是二维的使用、肿瘤负荷的总体评价。
这些标准后来被学术团体、协作组和制药工业广泛采用，而该标准的最初端点就是客观反应或疾病进展。
癌症化疗新的疗效评价标准中国医学科学院肿瘤医院冯奉仪一. 实体瘤的疗效评价标准( Response Evaluation Criteria in Solid Tumors 、RECIST ) 细胞毒化疗药是通过肿瘤缩小量耒评价其抗肿瘤作用，1979年WHO ( World Health Organization ) 确定了实体瘤双径测量的疗效评价标准。
20多年来，这个标准被国内外的研究者和研究组普遍采用，但WHO的标准存在如下问题：(1)由WHO确定可评价的和可测量大小病灶的改变混为一体，来判断疗效在各研究组间各不相同。
(2)最小病灶的大小及病灶的数量亦无明确的规定。
(3)PD 的定义在涉及单个病灶还是全部肿瘤( 可测量肿瘤病灶的总和)不明确。
(4)新的诊断病变范围的影像学方法，如CT和MRI己被广泛的应用。
因此，多年来造成了对于单个药物、联合化疗方案及治疗方法各研究组之间疗效评价存在差异而难以比较，往往导致不正确的结论。
针对以上问题，1994年EORTC ( European Organization for Research and Treatment of Cancer )、美国NCI ( National Cancer Institute ) 和加拿大NCI在回顾普遍使用的WHO疗效评价的基础上，进行了充分的交流和讨论，以后又相继的召开了多次会议，讨论和完成尚未解决的问题，直至1998年10月在包括学术界、企业、官方当局的会议上取得了一致的意见。
在WHO疗效评价标准的基础上进行了必要的修改和补充，采用简易精确的单径测量代替传统的双径测量方法，保留了WHO标准中的CP、PR、SD、PD。
RECIST首次在1999年美国的ASCO会议上介绍，并于同年的JNCI杂志上正式发表。
抗癌药物的疗效评价至少包括三个不同的目的：(1)在早期临床试验中，客观肿瘤疗效是试验药物或方案的预期目的，其结果是决定该药物或方案是否值得进一步研究的依据，体现在II期临床研究中。
实体肿瘤疗效评价标准
实体肿瘤的疗效评价标准主要有以下几个级别：
1. 完全缓解（Complete Response，CR）：可评价病灶完全消失，并维持至少4周。
2. 部分缓解（Partial Response，PR）：可评价病灶减少50%以上，并维持至少4周。
3. 无变化（Stable Disease，SD）：可评价病灶缩小未达到部分缓解，或增大未达到进展。
4. 进展（Progressive Disease，PD）：可评价病灶增加25%或者出现新的病灶。
请注意，实体肿瘤的疗效评价是一个复杂的过程，需要综合考虑患者的临床表现、影像学检查、肿瘤标志物等多个因素。
具体的评价标准可能会因不同的临床试验和研究而有所差异。
肿瘤治疗常用的评价观察指标及英文对照缩写！作者：佚名来源：网络实体瘤疗效评价新标准: RECIST （Response Evaluation Criteria in Solid Tumors）1.完全缓解（CR，complete response）：所有靶病灶消失，无新病灶出现，且肿瘤标志物正常，至少维持4周。
2.部分缓解（PR，partial response）：靶病灶最大径之和减少≥30%，至少维持4周。
3.疾病稳定（SD，stable disease）靶病灶最大径之和缩小未达PR，或增大未达PD。
4.疾病进展（PD，progressive disease）靶病灶最大径之和至少增加≥20%，或出现新病灶。
注：如仅一个靶病灶的最长径增大≥20%，而记录到的所有靶病灶的最长径之和增大未达20%，则不应评价为“PD”。
常用指标：1.总生存期（OS，overall survival）从随机化开始至因任何原因引起死亡的时间。
2.总缓解期（Duration of overall response）从第一次出现CR 或PR，到第一次诊断PD或复发的时间。
3.疾病稳定期（duration of stable disease）是指从治疗开始到评价为疾病进展时的这段时间。
4.无病生存期（DFS， Disease-free survival）或者无疾病生存时间，是从随机入组开始到第一次复发或死亡的时间。
5.无进展生存期（PFS，progression-free survival）从入组开始到肿瘤进展或死亡之间的时间。
6.至疾病进展时间（TTP，Time to Progression）是指从随机化开始至出现疾病进展或死亡的时间。
7.治疗失败时间（TTF，time to failure）从随机化开始至治疗中止/终止的时间，包括任何中止/终止原因。
8.疾病控制率（DCR，disease control rate）：CR PR SD。
Response Evaluation Criteria in Solid Tumors (RECIST) Quick Reference:Eligibility· Only patients with measurable disease at baseline should be included in protocols where objective tumor response is the primary endpoint.Measurable disease - the presence of at least one measurable lesion. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions - lesions that can be accurately measured in at least one dimension with longest diameter ³20 mm using conventional techniques or ³10 mm with spiral CT scan.Non-measurable lesions - all other lesions, including small lesions (longest diameter <20 mm with conventional techniques or <10 mm with spiral CT scan), i.e., bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, cystic lesions, and also abdominal masses that are not confirmed and followed by imaging techniques; and.· All measurements should be taken and recorded in metric notation, using a ruler or calipers. All baseline evaluations should be performed as closely as possible to the beginning of treatment and never more than 4 weeks before the beginning of the treatment.· The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow-up.· Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion, is recommended.Methods of Measurement –· CT and MRI are the best currently available and reproducible methods to measure target lesions selected for response assessment. Conventional CT and MRI should be performed with cuts of 10 mm or less in slice thickness contiguously. Spiral CT should be performed using a 5 mm contiguous reconstruction algorithm. This applies to tumors of the chest, abdomen and pelvis. Head and neck tumors and those of extremities usually require specific protocols.· Lesions on chest X-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.· When the primary endpoint of the study is objective response evaluation, ultrasound (US) should not be used to measure tumor lesions. It is, however, a possible alternative to clinical measurements of superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules. US might also be useful to confirm the complete disappearance of superficial lesions usually assessed by clinical examination.· The utilization of endoscopy and laparoscopy for objective tumor evaluation has not yet been fully and widely validated. Their uses in this specific context require sophisticated equipment and a high level of expertise that may only be available in some centers. Therefore, the utilization of such techniques for objective tumor response should be restricted to validation purposes in specialized centers. However, such techniques can be useful in confirmingcomplete pathological response when biopsies are obtained.· Tumor markers alone cannot be used to assess response. If markers are initially above the upper normal limit, they must normalize for a patient to be considered in complete clinical response when all lesions have disappeared.· Cytology and histology can be used to differentiate between PR and CR in rare cases (e.g., after treatment to differentiate between residual benign lesions and residual malignant lesions in tumor types such as germ cell tumors).Baseline documentation of “Target” and “Non-Target” lesions· All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total, representative of all involved organs should be identified as target lesions and recorded and measured at baseline.· Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).· A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor. 所有目标病灶的最长长径总和将会被计算和汇报成基线的长径和，该和作为有效缓解记录的参考基线。
