RECIST(The Response Evaluation Criteria In Solid Tumors)标准是一系列肿瘤治疗效果的定义,即有效、稳定、无效。该标准最早于 2000 年由美国国家肿瘤研究所和加拿大国立肿瘤研究院制定(v1.0),2009 年经修订再版(v1.1),目前已成为肿瘤治疗评价标准的基石。
具体评价步骤为:1、基线期记录目标病灶和非目标病灶;2、按照标准对目标病灶和非目标病灶进行评价;3、综合进行总体评价
image.pngBaseline documentation of ‘target’ and ‘non-target’ lesions
At baseline, tumour lesions/lymph nodes will be categorised measurable or non-measurable as follows:
Measurable
Tumour lesions: Must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of:
- 10 mm by CT scan (CT scan slice thickness no greater than 5 mm; see Appendix II on imaging guidance).
- 10 mm caliper measurement by clinical exam (lesions which cannot be accurately measured with calipers should be recorded as non-measurable).
- 20 mm by chest X-ray.
Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node must be ≥15 mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm). At baseline and in follow-up, only the short axis will be measured and followed.
Measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST).可测量病灶举例。A 64岁男性结肠癌患者胸部CT扫描。左下叶分叶状结节,最长直径2.5 cm,为转移灶。B 75岁肺癌女性腹部CT扫描显示肝脏转移病灶,最长直径2.1厘米。C 女性胸部正位片显示最长直径4.2厘米的肿块(箭头所指),代表肺癌。
Non-measurable
All other lesions, including small lesions (longest diameter <10 mm or pathological lymph nodes with ≥10 to <15 mm short axis) as well as truly non-measurable lesions.
Lesions considered truly non-measurable include: leptomeningeal disease, ascites, pleural or pericardial effusion, inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal masses/abdominal organomegaly identified by physical exam that is not measurable by reproducible imaging techniques.
Nonmeasurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST)不可测量病灶举例。A 52岁女性肺癌患者胸部CT扫描显示肺内多处小于10毫米的小结节,这些结节为粟粒转移。B 59岁女性乳腺癌患者肺基底部CT扫描显示硬化性骨转移。C 45岁男性胃癌患者腹部CT显示大量腹水。D 70岁女性肺癌患者胸部CT显示下叶小叶间隔及支气管血管束不规则增厚;这些发现与肺癌的淋巴管播散相一致。
疗效评价标准(Response criteria)
Evaluation of target lesions
image.png image.png非小细胞肺癌患者,使用 EGFR 抑制剂治疗。A 患者治疗前肺部 CT 显示右肺占位,长径 2.8 cm;B 图为治疗 1 周期后复查,病灶长径缩小为 1.3 cm,减小 54%,因此是部分缓解(PR)(≥ 30%);C 图为再次复查,病灶长径 1.7 cm,虽然较 B 图 1.3 cm 增加 30%(≥ 20%),但变化长度绝对值小于 0.5 cm,因此仍为稳定(SD);D 图为再次复查,与治疗后第一次 B 图比较,增加>30%,长度超过 0.5 cm,为疾病进展(PD)
Evaluation of non-target lesions
image.pngEvaluation of best overall response
Time point response
It is assumed that at each protocol specified time point, a response assessment occurs. Table 1 provides a summary of the overall response status calculation at each time point for patients who have measurable disease at baseline.
When patients have non-measurable (therefore non-target) disease only, Table 2 is to be used.
image.png image.pngBest overall response: all time points
The best overall response is determined once all the data for the patient is known.
Best response determination in trials where confirmation of complete or partial response IS NOT required: Best response in these trials is defined as the best response across all time points (for example, a patient who has SD at first assessment, PR at second assessment, and PD on last assessment has a best overall response of PR).
image.pngRef
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Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45:228–247.
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Nishino M, Jagannathan JP, Ramaiya NH, Van den Abbeele AD. Revised RECIST guideline version 1.1: What oncologists want to know and what radiologists need to know. AJR Am J Roentgenol. 2010;195(2):281-289.
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Brufau, Blanca Paño et al. “Metastatic renal cell carcinoma: radiologic findings and assessment of response to targeted antiangiogenic therapy by using multidetector CT.” Radiographics : a review publication of the Radiological Society of North America, Inc vol. 33,6 (2013): 1691-716.
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