??RECIST（The Response Evaluation Criteria In Solid Tumors）標(biāo)準(zhǔn)是一系列腫瘤治療效果的定義，即有效、穩(wěn)定、無效。該標(biāo)準(zhǔn)最早于 2000 年由美國國家腫瘤研究所和加拿大國立腫瘤研究院制定（v1.0），2009 年經(jīng)修訂再版（v1.1），目前已成為腫瘤治療評價標(biāo)準(zhǔn)的基石。
??具體評價步驟為：1、基線期記錄目標(biāo)病灶和非目標(biāo)病灶；2、按照標(biāo)準(zhǔn)對目標(biāo)病灶和非目標(biāo)病灶進行評價；3、綜合進行總體評價
Baseline 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.
??可測量病灶舉例。A 64歲男性結(jié)腸癌患者胸部CT掃描。左下葉分葉狀結(jié)節(jié)，最長直徑2.5 cm，為轉(zhuǎn)移灶。B 75歲肺癌女性腹部CT掃描顯示肝臟轉(zhuǎn)移病灶，最長直徑2.1厘米。C 女性胸部正位片顯示最長直徑4.2厘米的腫塊(箭頭所指)，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.
??不可測量病灶舉例。A 52歲女性肺癌患者胸部CT掃描顯示肺內(nèi)多處小于10毫米的小結(jié)節(jié)，這些結(jié)節(jié)為粟粒轉(zhuǎn)移。B 59歲女性乳腺癌患者肺基底部CT掃描顯示硬化性骨轉(zhuǎn)移。C 45歲男性胃癌患者腹部CT顯示大量腹水。D 70歲女性肺癌患者胸部CT顯示下葉小葉間隔及支氣管血管束不規(guī)則增厚;這些發(fā)現(xiàn)與肺癌的淋巴管播散相一致。
療效評價標(biāo)準(zhǔn)（Response criteria）
Evaluation of target lesions
??非小細胞肺癌患者，使用 EGFR 抑制劑治療。A 患者治療前肺部 CT 顯示右肺占位，長徑 2.8 cm；B 圖為治療 1 周期后復(fù)查，病灶長徑縮小為 1.3 cm，減小 54%，因此是部分緩解（PR）（≥ 30%）；C 圖為再次復(fù)查，病灶長徑 1.7 cm，雖然較 B 圖 1.3 cm 增加 30%（≥ 20%），但變化長度絕對值小于 0.5 cm，因此仍為穩(wěn)定（SD）；D 圖為再次復(fù)查，與治療后第一次 B 圖比較，增加＞30%，長度超過 0.5 cm，為疾病進展（PD）
Evaluation of non-target lesions
Evaluation 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.
Best 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).
Ref
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.
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.
Brufau, Blanca Pa?o 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.
