RECIST and EASL 腫瘤評價標準

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1、RECIST Criteria Measurement and identification of target lesions Patients? must? have? at? least one measurable lesion, defined as a longest diameter >10mm (the slice thickness and/or algorithm must be appropriate to allow? for? measurement of lesions down to 10mm in longest diameter). Where diseas

2、e?is? restricted to a solitary lesion, its neoplastic nature must be confirmed by cytology/histology. Hepatic?target?lesions?should?be?selected?on the basis of lesions for treatment. Baseline?measurements must be taken no more than 2 weeks prior to commencement of treatment.? The same measurement t

3、echnique (CT/MRI) must be?used at baseline and follow up.? Whenever possible, the same individual scanner should be used throughout the study.? No more than 5 target lesions may?be identified in the liver. Those with the largest diameters should be included.? All?other?(non-target)?lesions?should?be

4、?reported?but not measured,?in?order?that their presence of lack thereof may be tracked at follow up. Criteria for target lesions Complete? response:?????? disappearance? of? all? target? lesions? (note: ????????????????????????? elevated tumor markers at baseline must return to ????????????????

5、????????? normal? levels? for a patient to be considered in ????????????????????????? complete clinical response when all tumor lesions ????????????????????????? have disappeared) Partial? response:??????? at least 30% decrease in the sum of the longest ?????????????????? ???????diameter? of? ta

6、rget lesions, taking as reference ????????????????????????? the baseline sum of longest diameter Progressive? disease:???? at least 20% increase in the sum of the longest ????????????????????????? diameter? of? target lesions, taking as reference ????????????????????????? the? smallest sum longe

7、st diameter recorded since ????????????????????????? start? of? treatment OR appearance of one or more ????????????????????????? new lesions Stable? disease:????????? neither? sufficient? shrinkage? to? qualify for ????????????????????????? partial?? response? nor? sufficient? increase? to ????

8、????????????????????? qualify?? for?? progressive? disease,? taking? as ????????????????????????? reference the smallest sum longest diameter since ????????????????????????? start of treatment Criteria for non-target lesions Complete? response:???????? the disappearance of all non target lesions

9、 AND ????????????????????????? normalization of tumor marker level Incomplete? response/stable? disease: persistence of one or more non-target ????????????????????????? lesions? AND/OR maintenance of tumor marker level ????????????????????????? above normal limits Progressive? disease:?????? ap

10、pearance? of? one? or more new lesions AND/OR ????????????????????????? unequivocal? progression? of? existing non-target ????????????????????????? lesions? (progression? of non-target lesions will ????????????????????????? be determined at the investigator’s discretion) Response evaluation and

11、reporting Table 4???? Overall Response??????????????????????????????? ?????????????????????????????????????????? ?? Target??????? |? Non-target?????? |? New Lesions??? |? Overall???????? ?? Lesions?????? |? Lesions????????? |???????????????? |? Response??????? ?----------------+---------------

12、----+-----------------+----------------- ?? CR??????????? |? CR?????????????? |? No???????????? |? CR*???????????? ?----------------+-------------------+-----------------+----------------- ?? CR??????????? |? Incomplete ??????|? No???????????? |? PR????????????? ???????????????? |? response/

13、SD????? |???????????????? |????????????????? ?----------------+-------------------+-----------------+----------------- ?? PR??????????? |? Non-PD?????????? |? No???????????? |? PR? ???????????? ?----------------+-------------------+-----------------+----------------- ?? SD??????????? |? Non-P

14、D?????????? |? No???????????? |? SD????????????? ?----------------+-------------------+-----------------+----------------- ?? PD??????????? |? Any????????????? |? Yes or no????? |? PD????????????? ?----------------+-------------------+-----------------+----------------- ?? Any?????????? |? P

15、D?????????????? |? Yes or no????? |? PD????????????? ?----------------+-------------------+-----------------+----------------- ?? Any?????????? |? Any????????????? |? Yes????????? ?? |? PD????????????? ????????????????????????????????????????????????????????? EASL Tumor Response Evaluation Cri

16、teria The?assessment?of?tumor response using RECIST does not take into account the extent of tumor necrosis that occurs following loco-regional treatment. Extensive?tumor?necrosis?might?not?be paralleled by a reduction in the diameter of the tumor. In 2000, therefore, the European Association for t

17、he Study?of? the? Liver (EASL) recommended a modification to the WHO criteria for use in HCC (Bruix et al 2001). The?EASL Consensus Conference proposed that a reduction in viable tumor is more?appropriate.?? The? use? of? the? EASL criteria (see Table xx) is now accepted? in? assessment? of? treatm

18、ent? response? in? HCC, particularly so following? the? use? of? loco-regional therapies such as chemoembolization; however, a formal guideline for measurement is not currently available. Local?tumor?response?will be measured as progression of treated lesions. New?tumor?development?in? a? previousl

19、y untreated area and extra-hepatic disease will not be considered progression. Table EASL tumor response evaluation of target lesions ?? CR (complete????? |? Complete disappearance of all viable tumors ?? response)???????? |? (target lesions) and no new lesions, determined??? ?????????????????

20、??? |? by two observations not less than 4 weeks apart.?? ?--------------------+---------------------------------------------------- ?? PR (partial?????? |? >50%? reduction in total viable tumor load of all? ?? response)???????? |? measurable??? lesions,??? determined??? by??? two? ?????????

21、??????????? |? observations not less than 4 weeks apart.????????? ?--------------------+---------------------------------------------------- ?? OR (objective???? |? The sum of CR and PR.????????????????????????????? ?? response)???????? |???????????????????????????????????????????????????? ?

22、--------------------+---------------------------------------------------- ?? PD (progressive?? |? At least a 25% increase in size of one or more???? ?? disease)????????? |? target lesions, or the appearance of new lesions.? ?--------------------+---------------------------------------------------- ?? SD (stable??????? |? Any cases that do not qualify for complete???????? ?? disease)????????? |? response, partial response or progressive????????? ???????????????????? |? disease.????????????????????