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1、RECIST CriteriaMeasurement 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 diseaseis restr
2、icted to a solitary lesion, its neoplastic nature must be confirmed by cytology/histology.Hepatictargetlesionsshouldbeselectedon the basis of lesions for treatment. Baselinemeasurements must be taken no more than 2 weeks prior to commencement of treatment. The same measurement technique (CT/MRI) mus
3、t beused at baseline and follow up. Whenever possible, the same individual scanner should be used throughout the study. No more than 5 target lesions maybe identified in the liver. Those with the largest diameters should be included. Allother(non-target)lesionsshouldbereportedbut not measured,inorde
4、rthat their presence of lack thereof may be tracked at follow up.Criteria for target lesionsComplete response: disappearance of all target lesions (note: elevated tumor markers at baseline must return to normal levels for a patient to be considered in complete clinical response when all tumor lesion
5、s have disappeared)Partial response: at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameterProgressive disease: at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest s
6、um longest diameter recorded since start of treatment OR appearance of one or more new lesionsStable disease: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since start of
7、treatmentCriteria for non-target lesionsComplete response: the disappearance of all non target lesions AND normalization of tumor marker levelIncomplete response/stable disease: persistence of one or more non-target lesions AND/OR maintenance of tumor marker level above normal limitsProgressive dise
8、ase: appearance 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 investigators discretion)Response evaluation and reportingTable 4 Overall Response Target | Non-target | New Lesions | Overall Lesions
9、 | Lesions | | Response -+-+-+- CR | CR | No | CR* -+-+-+- CR | Incomplete | No | PR | response/SD | | -+-+-+- PR | Non-PD | No | PR -+-+-+- SD | Non-PD | No | SD -+-+-+- PD | Any | Yes or no | PD -+-+-+- Any | PD | Yes or no | PD -+-+-+- Any | Any | Yes | PD EASL Tumor Response Evaluation CriteriaT
10、heassessmentoftumor response using RECIST does not take into account the extent of tumor necrosis that occurs following loco-regional treatment. Extensivetumornecrosismightnotbe paralleled by a reduction in the diameter of the tumor. In 2000, therefore, the European Association for the Studyof the L
11、iver (EASL) recommended a modification to the WHO criteria for use in HCC (Bruix et al 2001).TheEASL Consensus Conference proposed that a reduction in viable tumor is moreappropriate. The use of the EASL criteria (see Table xx) is now accepted in assessment of treatment response in HCC, particularly
12、 so following the use of loco-regional therapies such as chemoembolization; however, a formal guideline for measurement is not currently available.Localtumorresponsewill be measured as progression of treated lesions. Newtumordevelopmentin a previously untreated area and extra-hepatic disease will no
13、t 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 | by two observations not less than 4 weeks apart. -+- PR (partial | 50% reduction in total viable
14、 tumor load of all response) | measurable lesions, determined by two | observations not less than 4 weeks apart. -+- OR (objective | The sum of CR and PR. response) | -+- 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.
RECIST and EASL 腫瘤評(píng)價(jià)標(biāo)準(zhǔn)
