RECIST and EASL 腫瘤評價標準

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 disease 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 technique (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 reported but not measured, in order that 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 lesions                          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 sum 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 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  disease:       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       |  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 CriteriaThe 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 the 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  treatment  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  previously 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                         |  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                       |  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.